DDrare: Database of Drug Development for Rare Diseases

告示番号	疾患名（ページ内リンク）	臨床試験数
35	天疱瘡	1
37	膿疱性乾癬（汎発型）	3
38	スティーヴンス・ジョンソン症候群	2
39	中毒性表皮壊死症	3
40	高安動脈炎	3
41	巨細胞性動脈炎	2
42	結節性多発動脈炎	1
43	顕微鏡的多発血管炎	2
45	好酸球性多発血管炎性肉芽腫症	1
46	悪性関節リウマチ	178
49	全身性エリテマトーデス	4
50	皮膚筋炎／多発性筋炎	1
55	再発性多発軟骨炎	1
56	ベーチェット病	6
65	原発性免疫不全症候群	1
84	サルコイドーシス	4
95	自己免疫性肝炎	1
96	クローン病	189
97	潰瘍性大腸炎	124
98	好酸球性消化管疾患	1
162	類天疱瘡（後天性表皮水疱症を含む。）	1
164	眼皮膚白皮症	1
269	化膿性無菌性関節炎・壊疽性膿皮症・アクネ症候群	1
271	強直性脊椎炎	42

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT00283712 (ClinicalTrials.gov)	March 2006	26/1/2006	Use of Infliximab for the Treatment of Pemphigus Vulgaris	A Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Infliximab in Subjects With Pemphigus Vulgaris Receiving Prednisone	Pemphigus	Drug: Infliximab;Other: Placebo Comparator	National Institute of Allergy and Infectious Diseases (NIAID)	Autoimmunity Centers of Excellence	Completed	18 Years	N/A	All	20	Phase 2	United States

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT03885089 (ClinicalTrials.gov)	October 21, 2019	4/3/2019	Infliximab Biosimilar for Intravenous Drip Infusion 100 mg Pfizer Drug Use Investigation (Psoriasis)	Infliximab BS for Intravenous Drip Infusion 100 mg Pfizer General Investigation (Psoriasis Vulgaris, Psoriasis Arthropathica, Pustular Psoriasis, or Erythrodermic Psoriasis)	Psoriasis Vulgaris;Psoriasis Arthropathica;Pustular Psoriasis;Erythrodermic Psoriasis	Drug: Infliximab [infliximab biosimilar 3]	Pfizer	NULL	Recruiting	N/A	N/A	All	100		Japan
2	JPRN-jRCTs031180367	20/02/2018	18/03/2019	The effect of infliximab on endothelial function in patients with psoriasis	A pilot study for the effect of infliximab on endothelial function in patients with psoriasis	Psoriasis vulgaris, Psoriatic arthritis, Pustular psoriasis, Erythrodermic psoriasis Psoriasis vulgaris, Psoriatic arthritis, Pustular psoriasis, Erythrodermic psoriasis;D011565, D015535	Endothelial function is measured in patients with psoriasis treated with infliximab before and after the first, second, and third infusions.	ASANO YOSHIHIDE	NULL	Recruiting	>= 20age old	< 80age old	Both	25	N/A	Japan
3	JPRN-UMIN000027208	2017/06/01	01/06/2017	A pilot study for the effect of infliximab on endothelial function in patients with psoriasis	A pilot study for the effect of infliximab on endothelial function in patients with psoriasis - The effect of infliximab on endothelial function in patients with psoriasis	Psoriasis vulgaris, Psoriatic arthritis, Pustular psoriasis, Erythrodermic psoriasis	Endothelial function is measured in patients with psoriasis treated with infliximab before and after the first, second, and third infusions.	The University of Tokyo Hospital	NULL	Recruiting	20years-old	80years-old	Male and Female	25	Not applicable	Japan

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT02126020 (ClinicalTrials.gov)	November 2014	27/4/2014	Topical Infliximab in Autoimmune Eyes With Keratoprosthesis	Topical Infliximab in Autoimmune Eyes With Keratoprosthesis	Stevens-Johnson Syndrome;Toxic Epidermal Necrolysis (Lyell) Syndrome;Mucous Membrane Pemphigoid	Drug: topical infliximab	James Chodosh, MD, MPH	Massachusetts Eye and Ear Infirmary;Fonds de recherche en ophtalmologie de l'Université de Montréal (FROUM)	Withdrawn	18 Years	80 Years	All	0	Phase 1;Phase 2	United States;Canada
2	NCT01256489 (ClinicalTrials.gov)	December 2010	19/11/2010	Infliximab to Improve Retention of the Boston Keratoprosthesis in Patients After Stevens Johnson Syndrome/ Toxic Epidermal Necrolysis (SJS/TENS)	Infliximab Therapy to Improve Retention of the Boston Keratoprosthesis in Patients After Stevens Johnson Syndrome/ Toxic Epidermal Necrolysis	Stevens-Johnson Syndrome;Corneal Blindness	Drug: Infliximab	Massachusetts Eye and Ear Infirmary	NULL	Withdrawn	18 Years	N/A	Both	0	Phase 1;Phase 2	United States

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Phase	Countries
1	NCT02126020 (ClinicalTrials.gov)	November 2014	27/4/2014	Topical Infliximab in Autoimmune Eyes With Keratoprosthesis	Topical Infliximab in Autoimmune Eyes With Keratoprosthesis	Stevens-Johnson Syndrome;Toxic Epidermal Necrolysis (Lyell) Syndrome;Mucous Membrane Pemphigoid	Drug: topical infliximab	James Chodosh, MD, MPH	Massachusetts Eye and Ear Infirmary;Fonds de recherche en ophtalmologie de l'Université de Montréal (FROUM)	Withdrawn	18 Years	80 Years	All	Phase 1;Phase 2	United States;Canada
2	NCT01256489 (ClinicalTrials.gov)	December 2010	19/11/2010	Infliximab to Improve Retention of the Boston Keratoprosthesis in Patients After Stevens Johnson Syndrome/ Toxic Epidermal Necrolysis (SJS/TENS)	Infliximab Therapy to Improve Retention of the Boston Keratoprosthesis in Patients After Stevens Johnson Syndrome/ Toxic Epidermal Necrolysis	Stevens-Johnson Syndrome;Corneal Blindness	Drug: Infliximab	Massachusetts Eye and Ear Infirmary	NULL	Withdrawn	18 Years	N/A	Both	Phase 1;Phase 2	United States
3	NCT00372723 (ClinicalTrials.gov)	July 2006	5/9/2006	Study of a Potential New Treatment for Patients With Toxic Epidermal Necrolysis (TEN)	Pilot Study Comparing Remicade (Infliximab) vs. Standard Care in the Treatment of Toxic Epidermal Necrolysis	Toxic Epidermal Necrolysis	Drug: Remicaide (infliximab)	Loyola University	NULL	Withdrawn	18 Years	N/A	Both	Phase 2	United States

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT04564001 (ClinicalTrials.gov)	September 2020	21/9/2020	Multicentre, Randomized, Prospective Trial Evaluating the Efficacy and Safety of Infliximab to Tocilizumab in Refractory or Relapsing Takayasu Arteritis	Multicentre, Randomized, Prospective Trial Evaluating the Efficacy and Safety of Infliximab to Tocilizumab in Refractory or Relapsing Takayasu Arteritis	Takayasu Arteritis	Drug: Infliximab;Drug: Tocilizumab	Assistance Publique - Hôpitaux de Paris	NULL	Not yet recruiting	18 Years	N/A	All	50	Phase 2	NULL
2	EUCTR2018-003753-13-FR (EUCTR)	19/03/2019	13/12/2018	INTOReTAK : INfliximab and TOcilizumab in Refractory/relapsing TAKayasu arteritis	Multicentre, randomized, prospective trial comparing the efficacy and safety of Infliximab to tocilizumab in refractory or relapsing Takayasu arteritis	Patients with refractory or relapsing Takayasu Arteritis desease;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]	Trade Name: RoActemra 20mg/ml Product Name: Tocilizumab INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB Product Name: Infliximab INN or Proposed INN: INFLIXIMAB	ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	50	Phase 3	France
3	NCT03192878 (ClinicalTrials.gov)	March 1, 2017	9/5/2017	Infliximab Biosimilar in Takayasu's Arteritis	A Prospective Observational Study of Infliximab Biosimilar in the Treatment of Takayasu's Arteritis Resistant to Corticosteroids and Conventional Immune-suppressive Treatments	Takayasu Arteritis	Drug: Infliximab	Ospedale San Raffaele	NULL	Recruiting	18 Years	N/A	All	30	N/A	Italy

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2019-003964-30-GB (EUCTR)	22/10/2020	31/07/2020	Biologics in refractory vasculitis (BIOVAS): A pragmatic, randomised, double-blind, placebo-controlled, modified-crossover trial of biologic therapy for refractory vasculitis in adults and children.	Biologics in refractory vasculitis (BIOVAS): A pragmatic, randomised, double-blind, placebo-controlled, modified-crossover trial of biologic therapy for refractory primary non-ANCA associated vasculitis in adults and children - Biologics in refractory vasculitis (BIOVAS)	Non-ANCA associated vasculitides: 1.Giant cell arteritis (GCA)2.Takayasu’s arteritis (TA)3.Polyarteritis nodosa (PAN) or cutaneous polyarteritis unrelated to hepatitis B (CPAN)4.Relapsing polychondritis (RP)5.IgA vasculitis (IgAV)6.Cogan’s syndrome7.Non-infective cryoglobulinaemia8.Primary angiitis of central nervous system (PACNS) MedDRA version: 21.1;Level: PT;Classification code 10047115;Term: Vasculitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Infliximab Product Code: N/A INN or Proposed INN: Infliximab Trade Name: Rituximab Product Name: Rituximab INN or Proposed INN: Rituximab Trade Name: Tocilizumab Product Name: Tocilizumab Product Code: N/A INN or Proposed INN: Tocilizumab	Cambridge University Hospitals NHS Foundation Trust	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	140	Phase 2	United Kingdom
2	NCT00076726 (ClinicalTrials.gov)	November 2003	2/2/2004	A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Giant Cell Arteritis	A Randomized, Double-Masked, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of Infliximab in Subjects With Giant Cell Arteritis	Giant Cell Arteritis	Drug: Infliximab	Centocor, Inc.	The Cleveland Clinic	Terminated	50 Years	N/A	Both	44	Phase 2	United States;Belgium;Italy;Spain;United Kingdom

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2019-003964-30-GB (EUCTR)	22/10/2020	31/07/2020	Biologics in refractory vasculitis (BIOVAS): A pragmatic, randomised, double-blind, placebo-controlled, modified-crossover trial of biologic therapy for refractory vasculitis in adults and children.	Biologics in refractory vasculitis (BIOVAS): A pragmatic, randomised, double-blind, placebo-controlled, modified-crossover trial of biologic therapy for refractory primary non-ANCA associated vasculitis in adults and children - Biologics in refractory vasculitis (BIOVAS)	Non-ANCA associated vasculitides: 1.Giant cell arteritis (GCA)2.Takayasu’s arteritis (TA)3.Polyarteritis nodosa (PAN) or cutaneous polyarteritis unrelated to hepatitis B (CPAN)4.Relapsing polychondritis (RP)5.IgA vasculitis (IgAV)6.Cogan’s syndrome7.Non-infective cryoglobulinaemia8.Primary angiitis of central nervous system (PACNS) MedDRA version: 21.1;Level: PT;Classification code 10047115;Term: Vasculitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Infliximab Product Code: N/A INN or Proposed INN: Infliximab Trade Name: Rituximab Product Name: Rituximab INN or Proposed INN: Rituximab Trade Name: Tocilizumab Product Name: Tocilizumab Product Code: N/A INN or Proposed INN: Tocilizumab	Cambridge University Hospitals NHS Foundation Trust	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	140	Phase 2	United Kingdom

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT00307593 (ClinicalTrials.gov)	May 2004	24/3/2006	RATTRAP: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides	Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides With Positive ANCA After Relapse or Resistant Immunosuppressant Therapies	Wegener's Granulomatosis;Churg-Strauss Syndrome;Microscopic Polyangiitis	Drug: Infliximab;Drug: Rituximab	Assistance Publique - Hôpitaux de Paris	NULL	Completed	18 Years	N/A	Both	20	N/A	France
2	NCT00753103 (ClinicalTrials.gov)	January 2003	15/9/2008	Anti-Cytokine Therapy for Vasculitis	Phase II Pilot Cohort Study to Investigate the Safety and Efficacy of Infliximab as Additional Therapy in the Treatment if Anti-Neutrophil Cytoplasm Antibody Associated Vasculitis	Wegener's Granulomatosis;Renal Limited Vasculitis;Microscopic Polyangiitis	Biological: Infliximab;Drug: Cyclophosphamide;Drug: Prednisolone;Drug: Azathioprine;Procedure: Plasma exchange;Drug: Mycophenolate mofetil;Drug: Methylprednisolone	University Hospital Birmingham NHS Foundation Trust	NULL	Completed	18 Years	N/A	Both	37	Phase 2	United Kingdom

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT00307593 (ClinicalTrials.gov)	May 2004	24/3/2006	RATTRAP: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides	Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides With Positive ANCA After Relapse or Resistant Immunosuppressant Therapies	Wegener's Granulomatosis;Churg-Strauss Syndrome;Microscopic Polyangiitis	Drug: Infliximab;Drug: Rituximab	Assistance Publique - Hôpitaux de Paris	NULL	Completed	18 Years	N/A	Both	20	N/A	France

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	JPRN-jRCTs071200007	01/01/2021	20/04/2020	Discontinuation of biosimilar infliximab in Japanese patients with rheumatoid arthritis achieving sustained clinical remission or low disease activity during the IFX SIRIUS STUDY I (the IFX-SIRIUS STUDY II): Study protocol for an interventional, multicenter ,open label, single arm clinical trial with clinical, ultrasound and biomarker assessments	Discontinuation of biosimilar infliximab in Japanese patients with rheumatoid arthritis achieving sustained clinical remission or low disease activity during the IFX SIRIUS STUDY I (the IFX-SIRIUS STUDY II): Study protocol for an interventional, multicenter ,open label, single arm clinical trial with clinical, ultrasound and biomarker assessments	Rheumatoid arthritis	Rheumatoid arthritis patients who have been treated with infliximab BS during IFX-SIRIUS STUDY I period and persisted with clinical remission or low disease activity discontinue infliximab BS. If they have relapse after discontinuation of infliximab BS,infliximab BS will be re-administered.	Kawakami Atsushi	NULL	Recruiting	>= 20age old	Not applicable	Both	80	Phase 4	Japan
2	JPRN-jRCTs071190030	28/07/2020	11/10/2019	Switching from originator infliximab to biosimilar infliximab in Japanese patients with rheumatoid arthritis achieving clinical remission (the IFX-SIRIUS study I): Study protocol for an interventional, multicenter, open-label, single-arm and noninferiority clinical trial with clinical, ultrasound and biomarker assessments	Switching from originator infliximab to biosimilar infliximab in Japanese patients with rheumatoid arthritis achieving clinical remission (the IFX-SIRIUS study I): Study protocol for an interventional, multicenter, open-label, single-arm and noninferiority clinical trial with clinical, ultrasound and biomarker assessments	Rheumatoid arthritis	Rheumatoid arthritis patients who have been treated with Remicade over 24 weeks and persisted with clinical remission are switched to infliximab BS from Remicade. The dose and infusion intervals of infliximab BS are kept unchanged from those of Remicade.	Kawakami Atsushi	NULL	Recruiting	>= 20age old	Not applicable	Both	80	Phase 4	Japan
3	NCT04115423 (ClinicalTrials.gov)	April 1, 2020	2/10/2019	A Retrospective Cohort Study on the Risk of Serious Infections in Rheumatoid Arthritis Patients Receiving Tocilizumab	A Retrospective Cohort Study to Examine the Risk of Serious Infections in Rheumatoid Arthritis Patients Receiving Tocilizumab Compared With Tumor Necrosis Factor Inhibitors Using the National Health Insurance Database	Infection;Rheumatoid Arthritis	Drug: Tocilizumab;Drug: Tumor Necrosis Factor Inhibitor (etanercept, infliximab, adalimumab, and golimumab)	Sungkyunkwan University	Ministry of Food and Drug Safety, Korea	Active, not recruiting	18 Years	N/A	All	9508		Korea, Republic of
4	EUCTR2019-003700-12-FR (EUCTR)	13/03/2020	04/06/2020	Association between metabolits of methotrexate and clinical response in rheumatoid arthritis patients	Association between methotrexate erythrocyte polyglutamate concentration and biological drug concentration and clinical response in rheumatoid arthritis patients treated with subcutaneous injectable methotrexate and a first biological drug	rheumatoid arthritis MedDRA version: 21.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Methotrexate Product Code: MTX Other descriptive name: METHOTREXATE DISODIUM Product Code: bDMARD INN or Proposed INN: INFLIXIMAB INN or Proposed INN: ETANERCEPT INN or Proposed INN: ADALIMUMAB INN or Proposed INN: CERTOLIZUMAB PEGOL INN or Proposed INN: GOLIMUMAB	CHU Saint-Etienne	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	60	Phase 4	France
5	NCT03885037 (ClinicalTrials.gov)	March 20, 2019	4/3/2019	Infliximab Biosimilar for Intravenous Drip Infusion 100 mg Pfizer Drug Use Investigation (Rheumatoid Arthritis)	Infliximab BS for Intravenous Drip Infusion 100 mg Pfizer General Investigation (Rheumatoid Arthritis)	Rheumatoid Arthritis	Drug: Infliximab [infliximab biosimilar 3]	Pfizer	NULL	Recruiting	N/A	N/A	All	300		Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	EUCTR2018-002368-18-ES (EUCTR)	25/07/2018	25/07/2018	Phase IV, open, low-level intervention, clinical trial to compare the immunogenicity inimmunosuppressed patients of an adjuvanted anti-hepatitis B vaccine with an anti-hepatitis Bvaccine with increased antigenic load	Phase IV, open, low-level intervention, clinical trial to compare the immunogenicity inimmunosuppressed patients of an adjuvanted anti-hepatitis B vaccine with an anti-hepatitis Bvaccine with increased antigenic load	1. Autoinmune rheumatic diseases undertreated by rituximab or infliximab.2. breast and lung cancer undertreated by chemotherapy3. HIV4. Haematopoietic progenitor cell transplantation (TCPH). MedDRA version: 20.0;Level: PT;Classification code 10006187;Term: Breast cancer;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 20.0;Classification code 10058467;Term: Lung neoplasm malignant;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.1;Classification code 10020161;Term: HIV infection;System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.0;Classification code 10063581;Term: Stem cell transplant;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Fendrix suspension for injection Product Name: Fendrix Product Code: Fendrix INN or Proposed INN: Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed). Other descriptive name: HEPATITIS B VACCINE (RDNA) Trade Name: HBVAXPRO 5 micrograms/0.5 ml Product Name: HBVAXPRO® 40 micrograms Product Code: HBVAXPRO® 40 micrograms INN or Proposed INN: HBVAXPRO 5 micrograms/0.5 ml Suspension for injection Hepatitis B vaccine (rDNA) Other descriptive name: HEPATITIS B VIRUS SURFACE ANTIGEN RECOMBINANT (S PROTEIN)	FUNDACIÓ HOSPITAL UNIVERSITARI VALL D’HEBRON – INSTITUT DE RECERCA (VHIR)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	740	Phase 4	Spain
7	NCT03100253 (ClinicalTrials.gov)	March 1, 2018	17/3/2017	Rheumatoid Arthritis Treatment After First Anti-TNF INvestiGation	Open-label, Randomized Controlled Trial Comparing Tocilizumab to Anti-TNF Treatment and Discovery of Biomarkers for Treatment Selection in Rheumatoid Arthritis Patients With Inadequate Response to a First Anti-TNF	Rheumatoid Arthritis	Drug: Tocilizumab;Drug: Etanercept;Drug: Infliximab;Drug: Adalimumab;Drug: Golimumab;Drug: Certolizumab Pegol	Mario Negri Institute for Pharmacological Research	NULL	Recruiting	18 Years	N/A	All	208	Phase 4	Italy
8	NCT04178850 (ClinicalTrials.gov)	October 13, 2017	25/11/2019	Clinical Comparative Study to Evaluate the Efficacy and Safety of Recombinant Anti-TNF-alpha Antibodies for Injection	A Randomized, Double-blind, Multi-center Phase ? Comparative Study to Evaluate the Efficacy and Safety of Recombinant Human-mouse Chimeric Anti-TNF-alpha Monoclonal Antibody for Injection.	Rheumatoid Arthritis	Biological: GB242;Biological: Infliximab	Genor Biopharma Co., Ltd.	NULL	Recruiting	18 Years	45 Years	All	568	Phase 3	China
9	EUCTR2016-001064-11-GB (EUCTR)	18/07/2017	31/03/2017	Efficacy and safety study of Remicade® (infliximab) and NI-071 (a proposed infliximab biosimilar) for the treatment of patients with rheumatoid arthritis	A Randomized, Double-Blind, Multicenter, 3-Stage, Efficacy and Safety Study of NI-071 and US-Licensed Remicade® (Infliximab) for the Treatment of Patients with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Nichi-Iko Pharmaceutical Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	585	Phase 3	United States;Czech Republic;Puerto Rico;Poland;Spain;Ukraine;Russian Federation;United Kingdom
10	EUCTR2016-002125-11-ES (EUCTR)	06/07/2017	08/05/2017	Evaluating efficacy, pharmacokinetics and safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis	A Randomized, Parallel-Group, Phase I/III Study to Evaluate Efficacy, Pharmacokinetics and Safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis	Active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: REMSIMA Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB	Celltrion, Inc	NULL	Not Recruiting			Female: yes Male: yes	258	Phase 1;Phase 3	Lithuania;Russian Federation;Chile;Italy;Czech Republic;Hungary;Mexico;Poland;Belgium;Peru;South Africa;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of;Estonia;Slovakia;Spain;Ukraine
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
11	EUCTR2016-001064-11-CZ (EUCTR)	20/04/2017	31/03/2017	Efficacy and safety study of Remicade® (infliximab) and NI-071 (a proposed infliximab biosimilar) for the treatment of patients with rheumatoid arthritis	A Randomized, Double-Blind, Multicenter, 3-Stage, Efficacy and Safety Study of NI-071 and US-Licensed Remicade® (Infliximab) for the Treatment of Patients with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Nichi-Iko Pharmaceutical Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	585	Phase 3	United States;Czech Republic;Puerto Rico;Poland;Spain;Ukraine;Russian Federation;United Kingdom
12	EUCTR2016-001064-11-PL (EUCTR)	13/04/2017	12/04/2017	Efficacy and safety study of Remicade® (infliximab) and NI-071 (a proposed infliximab biosimilar) for the treatment of patients with rheumatoid arthritis	A Randomized, Double-Blind, Multicenter, 3-Stage, Efficacy and Safety Study of NI-071 and US-Licensed Remicade® (Infliximab) for the Treatment of Patients with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Nichi-Iko Pharmaceutical Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	585	Phase 3	United States;Czech Republic;Puerto Rico;Spain;Poland;Ukraine;Russian Federation;United Kingdom
13	EUCTR2016-001064-11-ES (EUCTR)	07/04/2017	07/04/2017	Efficacy and safety study of Remicade® (infliximab) and NI-071 (a proposed infliximab biosimilar) for the treatment of patients with rheumatoid arthritis	A Randomized, Double-Blind, Multicenter, 3-Stage, Efficacy and Safety Study of NI-071 and US-Licensed Remicade® (Infliximab) for the Treatment of Patients with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Nichi-Iko Pharmaceutical Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	585	Phase 3	United States;Czech Republic;Puerto Rico;Poland;Spain;Ukraine;Russian Federation;United Kingdom
14	NCT03348046 (ClinicalTrials.gov)	March 23, 2017	16/11/2017	Safety Study of Remsima® (Infliximab) in Rheumatoid Arthritis Patients in Jordan	Post-Authorization Safety Study of Remsima® (Infliximab) in Rheumatoid Arthritis Patients in Jordan	Rheumatoid Arthritis	Drug: Biosimilar Infliximab	Hikma Pharmaceuticals LLC	Syneos Health	Completed	18 Years	N/A	All	22		Jordan
15	EUCTR2014-004704-29-DE (EUCTR)	19/12/2016	23/08/2016	This trial is designed to determine what effects the human body has on the investigational medicine, ABP 710, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, infliximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.	A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 3	United States;Hungary;Czech Republic;Canada;Poland;Spain;Romania;Australia;Bulgaria;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
16	EUCTR2014-004704-29-CZ (EUCTR)	15/12/2016	02/08/2016	This trial is designed to determine what effects the human body has on the investigational medicine, ABP 710, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, infliximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.	A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ABP 710 Product Code: ABP 710 INN or Proposed INN: ABP 710 Other descriptive name: ABP 710 - Biosimilar to infliximab Trade Name: Remicade Product Name: infliximab INN or Proposed INN: INFLIXIMAB	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 3	United States;Hungary;Czech Republic;Canada;Poland;Spain;Romania;Australia;Bulgaria;Germany
17	NCT03016260 (ClinicalTrials.gov)	December 2016	4/1/2017	RABIOPRED - a Validation Study of Theranostic Test to PREDict Treatment Response of Anti-TNFa BIologicals in Rheumatoid Arthritis	Proof-of-Performance Study of RABIOPRED Assay as an In Vitro Diagnostic Test to Identify Patients With Rheumatoid Arthritis Who Are Unlikely to Show Response to 1st Treatment With Anti-TNFa and Methotrexate Combination.	RheumatoId Arthritis	Biological: Infliximab;Biological: Adalimumab;Biological: Etanercept;Biological: Golimumab;Biological: Certolizumab Pegol;Biological: Infliximab biosimilar;Biological: Etanercept biosimilar	TcLand Expression S.A.	European Commission	Terminated	18 Years	N/A	All	250		Czechia;France;Israel;Netherlands;Turkey;Czech Republic
18	NCT02990806 (ClinicalTrials.gov)	December 2016	21/11/2016	A Phase 3 Study of NI-071 in Patients With Rheumatoid Arthritis (RADIANCE)	A Randomized, Double-Blind, Multicenter, 3 Stage, Efficacy and Safety Study of NI-071 and US-Licensed Remicade® (Infliximab) for the Treatment of Patients With Rheumatoid Arthritis	Rheumatoid Arthritis (RA)	Biological: NI-071;Biological: Infliximab	Nichi-Iko Pharmaceutical Co., Ltd.	NULL	Completed	18 Years	75 Years	All	683	Phase 3	United States;Czechia;Poland;Puerto Rico;Russian Federation;Spain;Ukraine;United Kingdom
19	EUCTR2014-004704-29-BG (EUCTR)	29/11/2016	15/09/2016	This trial is designed to determine what effects the human body has on the investigational medicine, ABP 710, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, infliximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.	A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 3	United States;Hungary;Czech Republic;Canada;Poland;Spain;Romania;Australia;Bulgaria;Germany
20	EUCTR2014-004704-29-PL (EUCTR)	25/11/2016	04/10/2016	This trial is designed to determine what effects the human body has on the investigational medicine, ABP 710, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, infliximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.	A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ABP 710 Product Code: ABP 710 INN or Proposed INN: ABP 710 Other descriptive name: ABP 710 - Biosimilar to infliximab Trade Name: Remicade Product Name: infliximab INN or Proposed INN: INFLIXIMAB	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 3	United States;Hungary;Czech Republic;Canada;Spain;Poland;Romania;Australia;Bulgaria;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
21	EUCTR2016-002061-54-IT (EUCTR)	13/10/2016	15/11/2018	Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases.	Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases.Evaluation of immunogenicity and clinical response - Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®)	Rheumatoid arthritis, seronegative spondylo arthritis,Crohn's Disease, Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10039073;Term: Rheumatoid arthritis;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Classification code 10075634;Term: Acute haemorrhagic ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: REMSIMA - 100 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLANCONCINO (VETRO) - 1 FLACONCINO Product Name: Remsima Product Code: 42942019	UNIVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLI	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 4	Italy
22	NCT02937701 (ClinicalTrials.gov)	October 10, 2016	30/8/2016	Study to Assess if ABP710 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis Compared to Infliximab	A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects With Moderate to Severe Rheumatoid Arthritis	Arthritis, Rheumatoid	Biological: ABP 710;Biological: Infliximab	Amgen	NULL	Completed	18 Years	80 Years	All	558	Phase 3	United States;Australia;Bulgaria;Canada;Czechia;Germany;Hungary;Poland;Spain;Czech Republic
23	EUCTR2014-004704-29-HU (EUCTR)	05/10/2016	08/08/2016	This trial is designed to determine what effects the human body has on the investigational medicine, ABP 710, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, infliximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.	A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ABP 710 Product Code: ABP 710 INN or Proposed INN: ABP 710 Other descriptive name: ABP 710 - Biosimilar to infliximab Trade Name: Remicade Product Name: infliximab INN or Proposed INN: INFLIXIMAB	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 3	United States;Czech Republic;Hungary;Canada;Poland;Spain;Romania;Australia;Bulgaria;Germany
24	EUCTR2014-004704-29-ES (EUCTR)	03/10/2016	05/08/2016	This trial is designed to determine what effects the human body has on the investigational medicine, ABP 710, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, infliximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.	A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable	Rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ABP 710 Product Code: ABP 710 INN or Proposed INN: ABP 710 Other descriptive name: ABP 710 - Biosimilar to infliximab Trade Name: Remicade Product Name: infliximab INN or Proposed INN: INFLIXIMAB	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 3	United States;Hungary;Czech Republic;Canada;Poland;Spain;Romania;Australia;Bulgaria;Germany
25	EUCTR2014-004904-31-BE (EUCTR)	21/09/2016	29/07/2016	A clinical study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission.	An open-label, multicentre, phase IV study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission.	Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA).;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Remsima (infliximab)	Mundipharma Pharmaceuticals B.V.	NULL	Not Recruiting			Female: yes Male: yes	156	Phase 4	Belgium;Netherlands
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
26	EUCTR2016-002125-11-HU (EUCTR)	08/09/2016	11/07/2016	Evaluating efficacy, pharmacokinetics and safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis	A Randomized, Parallel-Group, Phase I/III Study to Evaluate Efficacy, Pharmacokinetics and Safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis	Active Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: REMSIMA Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB	Celltrion, Inc	NULL	Not Recruiting			Female: yes Male: yes	258	Phase 1;Phase 3	Estonia;Slovakia;Spain;Ukraine;Lithuania;Russian Federation;Chile;Italy;Hungary;Czech Republic;Mexico;Poland;Belgium;Peru;South Africa;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of
27	JPRN-UMIN000021929	2016/06/01	15/04/2016	Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis	Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis - OPTIWIT Study	Rheumatoid arthritis	Discontinuation of infliximab	Chiba University	NULL	Complete: follow-up continuing	18years-old	Not applicable	Male and Female	200	Not selected	Japan
28	JPRN-jRCTs031180001	30/05/2016	12/06/2018	Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis	Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis - OPTIWIT	Rheumatoid arthritis	Infliximab Withdrawal	Ikeda Kei	NULL	Not Recruiting	>= 18age old	Not applicable	Both	200	Phase 4	Japan
29	NCT02770794 (ClinicalTrials.gov)	May 2016	11/5/2016	Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis	Multicenter Prospective Trial to Investigate Accuracy of Ultrasound to Predict Relapse After Discontinuation of Infliximab and Efficacy/Safety of Readministration of Infliximab in Patients With Rheumatoid Arthritis in Low Disease Activity	Arthritis, Rheumatoid	Drug: Infliximab	Chiba University	NULL	Not yet recruiting	18 Years	N/A	Both	200	Phase 4	NULL
30	JPRN-UMIN000021492	2016/03/01	20/03/2016	To investigate the safety of switch from infliximab biosimilar 1 in rheumatoid arthritis patients.		Rheumatoid arthritis	switch from infliximab to infliximab biosimilar 1 in rheumatoid arthritis patients.	Inoue Hospital	NULL	Complete: follow-up complete	18years-old	Not applicable	Male and Female	40	Not selected	Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
31	NCT02728934 (ClinicalTrials.gov)	February 25, 2016	31/3/2016	Comparative and Pragmatic Study of Golimumab Intravenous (IV) (Simponi Aria) Versus Infliximab (Remicade) in Rheumatoid Arthritis	Comparative and Pragmatic Study of Simponi Aria Versus Remicade in Rheumatoid Arthritis	Arthritis, Rheumatoid	Biological: Golimumab Intravenous (IV);Biological: Infliximab;Biological: Biosimilar Infliximab	Janssen Scientific Affairs, LLC	NULL	Completed	18 Years	N/A	All	1279		United States
32	NCT02683564 (ClinicalTrials.gov)	February 2016	9/2/2016	BOW015 (Infliximab-EPIRUS) and Infliximab in Patients With Active Rheumatoid Arthritis: The UNIFORM Study	A Study of BOW015 (Infliximab-EPIRUS) and Infliximab in Patients With Active Rheumatoid Arthritis on Stable Methotrexate: The UNIFORM Study	Rheumatoid Arthritis	Drug: BOW015;Drug: Remicade	Epirus Biopharmaceuticals (Switzerland) GmbH	NULL	Not yet recruiting	18 Years	80 Years	Both	548	Phase 3	NULL
33	NCT02878161 (ClinicalTrials.gov)	January 2016	12/7/2016	Predictability Studies on the Efficacy of TNF-a Inhibitors in Chinese RA From Real World	Screening Protein Predictive of Response to Tumor Necrosis Factor-a Inhibitors Treatment in Chinese Rheumatoid Arthritis From Real World and Investigating Its Mechanism Through Signal Pathway	Rheumatoid Arthritis	Drug: methotrexate(necessary);Biological: infliximab;Biological: etanercept;Biological: adalimumab;Drug: leflunomide (permitted, not necessary);Drug: NSAIDs (permitted,not necessary);Drug: Glucocorticoids (permitted,not necessary)	Fen Li	NULL	Enrolling by invitation	18 Years	75 Years	Both	240	Phase 4	NULL
34	EUCTR2015-004173-32-DK (EUCTR)	18/12/2015	20/10/2015	Personalized medicine: Administration of TNF-alpha inhibitor treatment due to serum concentration measuring.	Personalized medicine: Administration of TNF-alpha inhibitor treatment due to serum concentration measuring. A randomized and investigator initiated study.	Rheumatic diseases MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000005156;Therapeutic area: Body processes [G] - Immune system processes [G12]	Trade Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Remsima INN or Proposed INN: INFLIXIMAB Trade Name: Benepali INN or Proposed INN: ETANERCEPT Trade Name: Remicade INN or Proposed INN: INFLIXIMAB	Department of Clinical Biochemestry, Aarhus University Hospital	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 4	Denmark
35	EUCTR2015-000581-58-CZ (EUCTR)	14/10/2015	16/06/2015	A Randomized,Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action	A Randomized, Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action - BioBio	Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Orencia Product Name: Orencia INN or Proposed INN: ABATACEPT Trade Name: Ro-Actemra Product Name: Ro Actemra INN or Proposed INN: tocilizumabum Other descriptive name: TOCILIZUMAB Trade Name: Mabthera Product Name: Mabthera INN or Proposed INN: RITUXIMAB	Revmatologicky ustav Praha	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 4	Czech Republic
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
36	EUCTR2015-002284-42-FI (EUCTR)	18/09/2015	28/08/2015	The rationale for this study is to gain insight in the extent and impact of immunogenicityof TNF inhibitors in the European daily clinical practice. Furthermore, an European widedatabase will give insight in factors influencing immunogenicity and treatment outcomein terms of disease activit	INTENT: immunogenicity in patients failing response on anti-TNF-Immunogenicity and pharmacokinetics in patients failing torespond to TNF inhibitors (phase 1);-Clinical effectiveness of subsequent TNF inhibitor treatment andpredictive value of pharmacokinetics and immunogenicity (phase2) - INTENT	rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and psoriasis.;Therapeutic area: Not possible to specify	Trade Name: Enbrel Product Name: etanercept Trade Name: Humira Product Name: adalimumab Trade Name: Cimzia Product Name: certolizumab pegol Trade Name: Simponi Product Name: golimumab Trade Name: Remicade Product Name: infliximab	READE	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1650	Phase 1	Finland
37	NCT02605642 (ClinicalTrials.gov)	September 10, 2015	2/9/2015	Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Rheumatoid Diseases Who Are Naïve To Biologics Or Switched From Remicade	PERSIST: PROSPECTIVE OBSERVATIONAL COHORT STUDY TO ASSESS PERSISTENCE OF CT-P13 (INFLIXIMAB) IN PATIENTS WITH RHEUMATOID DISEASES WHO ARE EITHER NAIVE TO BIOLOGICS OR SWITCHED FROM STABLE REMICADE(R) (INFLIXIMAB)	Rheumatoid Diseases;Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis	Drug: CT-P13	Pfizer	Hospira, now a wholly owned subsidiary of Pfizer	Completed	18 Years	N/A	All	351		Bulgaria;Canada;Czechia;Germany;Greece;Spain;United Kingdom;Czech Republic;France;Italy
38	EUCTR2014-004904-31-NL (EUCTR)	19/05/2015	26/01/2015	A clinical study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission.	An open-label, multicentre, phase IV study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission.	Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA).;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Remsima (infliximab)	Mundipharma Pharmaceuticals B.V.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes		Phase 4	Netherlands
39	JPRN-UMIN000016950	2015/03/27	03/04/2015	Clinical outcome in patients with rheumatoid arthritis switched to tumor nesrosis factor blockers after tocilizumab or abatacept		rheumatoid arthritis	Infliximab or adalimumab or golimumab	Osaka Medical College	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	50	Not selected	Japan
40	EUCTR2013-004148-49-FR (EUCTR)	23/02/2015	18/06/2015	RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS	A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Infliximab-Pfizer Product Code: PF-06438179 INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-Pfizer Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-EU	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	614	Phase 3	United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Bulgaria;Georgia;Germany;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
41	EUCTR2013-004148-49-PL (EUCTR)	21/10/2014	27/08/2014	RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS	A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Infliximab-Pfizer Product Code: PF-06438179 INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-Pfizer Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-EU	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	614	Phase 3	United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Georgia;Germany;Japan
42	EUCTR2013-004148-49-BG (EUCTR)	20/10/2014	01/09/2014	RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS	A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Infliximab-Pfizer Product Code: PF-06438179 INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-Pfizer Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-EU	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	614	Phase 3	Japan;Bulgaria;Germany;United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Georgia
43	NCT02148640 (ClinicalTrials.gov)	October 2014	23/5/2014	The NOR-SWITCH Study	A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SWITCHING FROM INNOVATOR INFLIXIMAB TO BIOSIMILAR INFLIXIMAB COMPARED WITH CONTINUED TREATMENT WITH INNOVATOR INFLIXIMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS, SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, ULCERATIVE COLITIS, CROHN'S DISEASE AND CHRONIC PLAQUE PSORIASIS THE NOR-SWITCH STUDY	Rheumatoid Arthritis;Spondyloarthritis;Psoriatic Arthritis;Ulcerative Colitis;Crohn's Disease;Psoriasis Chronic	Drug: Innovator infliximab;Drug: Biosimilar infliximab	Diakonhjemmet Hospital	South-Eastern Norway Regional Health Authority	Completed	18 Years	N/A	All	482	Phase 4	Norway
44	NCT02222493 (ClinicalTrials.gov)	August 26, 2014	19/8/2014	A Study of PF-06438179 (Infliximab-Pfizer) and Infliximab in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis (REFLECTIONS B537-02).	A Phase 3 Randomized, Double-blind Study Assessing The Efficacy And Safety Of Pf-06438179 And Infliximab In Combination With Methotrexate In Subjects With Moderately To Severely Active Rheumatoid Arthritis Who Have Had An Inadequate Response To Methotrexate	Rheumatoid Arthritis	Biological: PF-06438179;Biological: Infliximab	Pfizer	NULL	Completed	18 Years	N/A	All	650	Phase 3	United States;Australia;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Czechia;Georgia;Germany;Guatemala;Hungary;Israel;Japan;Jordan;Korea, Republic of;Lithuania;Mexico;Morocco;Peru;Philippines;Poland;Romania;Russian Federation;Serbia;South Africa;Tunisia;Ukraine;United Kingdom;Colombia;Czech Republic;France
45	EUCTR2013-004148-49-HU (EUCTR)	13/08/2014	06/06/2014	RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS	A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Infliximab-Pfizer Product Code: PF-06438179 INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-Pfizer Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-EU	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	614	Phase 3	United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Bulgaria;Georgia;Germany;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
46	EUCTR2014-002056-40-NO (EUCTR)	12/08/2014	13/06/2014	A study to evaluate the safety and efficacy of switching from regular infliximab to biosimilar infliximab in patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn's disease and psoriasis	A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SWITCHING FROM INNOVATOR INFLIXIMAB TO BIOSIMILAR INFLIXIMAB COMPARED WITH CONTINUED TREATMENT WITH INNOVATOR INFLIXIMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS, SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, ULCERATIVE COLITIS, CROHN’S DISEASEAND CHRONIC PLAQUE PSORIASISTHE NOR-SWITCH STUDY - NOR_SWITCH	Rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn’s disease and chronic plaque psoriasis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 18.0;Level: LLT;Classification code 10071117;Term: Plaque psoriasis;System Organ Class: 100000004858 MedDRA version: 18.0;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 18.0;Classification code 10045365;Term: Ulcerative colitis;Classification code 10002556;Term: Ankylosing spondylitis;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Remicade 100 mg pulver til konsentrat til infusjonsvæske, oppløsning Trade Name: Remsima 100 mg pulver til konsentrat til infusjonsvæske, oppløsning	Diakonhjemmet Hospital AS	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Norway
47	EUCTR2013-004148-49-DE (EUCTR)	28/07/2014	06/06/2014	RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS	A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Infliximab-Pfizer Product Code: PF-06438179 INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-Pfizer Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-EU	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	614	Phase 3	Japan;United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Bulgaria;Georgia;Germany
48	EUCTR2013-004148-49-LT (EUCTR)	14/07/2014	23/05/2014	RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS	A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Infliximab-Pfizer Product Code: PF-06438179 INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-Pfizer Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-EU	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	614	Phase 3	Poland;Brazil;Bulgaria;Georgia;Germany;Japan;United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina
49	EUCTR2013-004148-49-GB (EUCTR)	03/07/2014	06/06/2014	RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS	A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	614	Phase 3	United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Bulgaria;Georgia;Germany;Japan
50	JPRN-UMIN000014311	2014/06/24	24/06/2014	Examination of the clinical remission and functional remission in Infliximab using the increase-in-quantity protocol to TNF-alpha inhibitory drug resistance rheumatoid arthritis		rheumatoid arthritis	The quantity of Infliximab is increased.	Institute of Health Biosciences,The University of Tokushima Graduate School	NULL	Pending	20years-old	75years-old	Male and Female	10	Not selected	Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
51	EUCTR2013-004148-49-CZ (EUCTR)	20/06/2014	05/06/2014	RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS	A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Infliximab-Pfizer Product Code: PF-06438179 INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-Pfizer Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-EU	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	614	Phase 3	United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Bulgaria;Georgia;Germany;Japan
52	JPRN-UMIN000016844	2014/02/07	20/03/2015	The clinical study for seeking strategy how to treat rheumatoid arthritis by TNF Inhibitors		Rheumatoid arthritis	infliximab: standard strategy infliximab: aggressive strategy golimumab: standard strategy golimumab: aggressive strategy	Takarazuka city hospital	NULL	Recruiting	20years-old	90years-old	Male and Female	80	Not applicable	Japan
53	NCT01962974 (ClinicalTrials.gov)	October 2013	11/10/2013	A Golimumab Phase 3b, Multicenter, Assessment of Intravenous Efficacy in Rheumatoid Arthritis Subjects Who Have Diminished Disease Control Despite Treatment With Infliximab (REMICADE®)	A Golimumab Phase 3b, Multicenter, Assessment of Intravenous Efficacy in Rheumatoid Arthritis Subjects Who Have Diminished Disease Control Despite Treatment With Infliximab (REMICADE®)	Arthritis, Rheumatoid	Biological: Golimumab 2 mg/kg IV	Janssen Biotech, Inc.	NULL	Terminated	18 Years	76 Years	All	7	Phase 3	United States;Canada;Argentina;Brazil;Colombia;Mexico
54	EUCTR2012-005733-37-GB (EUCTR)	18/09/2013	23/07/2013	A Study Comparing SB2 to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis	A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	Rheumatoid Arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: SB2 (infliximab biosimilar) Product Code: SB2 INN or Proposed INN: INFLIXIMAB Trade Name: Remicade® Product Name: Remicade INN or Proposed INN: INFLIXIMAB	Samsung Bioepis Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	584	Phase 3	Philippines;Ukraine;Lithuania;United Kingdom;India;Czech Republic;Mexico;Poland;Romania;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of
55	NCT01783015 (ClinicalTrials.gov)	September 2013	31/1/2013	Study of Etanercept in Subjects With Rheumatoid Arthritis Who Have Had an Inadequate Response to Adalimumab or Infliximab Plus Methotrexate	A Randomized, Double-blind, Placebo-controlled Study Of The Safety And Efficacy Of Etanercept In Subjects With Rheumatoid Arthritis Who Have Had An Inadequate Response To Adalimumab Or Infliximab Plus Methotrexate	Rheumatoid Arthritis	Drug: Etanercept;Drug: Placebo	Pfizer	NULL	Terminated	18 Years	79 Years	All	16	Phase 4	Australia;Belgium;France;Hong Kong;Israel;Russian Federation;Spain;Netherlands
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
56	EUCTR2012-005733-37-CZ (EUCTR)	16/08/2013	15/05/2013	A Study Comparing SB2 to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis	A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: SB2 (infliximab biosimilar) Product Code: SB2 INN or Proposed INN: INFLIXIMAB Trade Name: Remicade® Product Name: Remicade INN or Proposed INN: INFLIXIMAB	Samsung Bioepis Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	584	Phase 3	Philippines;Ukraine;Lithuania;United Kingdom;India;Czech Republic;Mexico;Poland;Romania;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of
57	EUCTR2012-005733-37-LV (EUCTR)	02/08/2013	22/05/2013	A Study Comparing SB2 to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis	A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: SB2 (infliximab biosimilar) Product Code: SB2 INN or Proposed INN: INFLIXIMAB Trade Name: Remicade® Product Name: Remicade INN or Proposed INN: INFLIXIMAB	Samsung Bioepis Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	584		Philippines;Ukraine;Lithuania;United Kingdom;India;Czech Republic;Mexico;Poland;Romania;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of
58	NCT01936181 (ClinicalTrials.gov)	August 2013	2/9/2013	A Study Comparing SB2 to Remicade® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy	A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy	Rheumatoid Arthritis	Drug: Remicade (infliximab);Drug: SB2 (proposed biosimilar to infliximab)	Samsung Bioepis Co., Ltd.	NULL	Completed	18 Years	75 Years	All	584	Phase 3	Bulgaria;Lithuania
59	NCT01915537 (ClinicalTrials.gov)	August 2013	30/7/2013	Infliximab and Classic DMARDs in the Rheumatoid Arthritis Patients	A Prospective Cohort Study to Observe the Difference of Efficacy Between Infliximab With Methotrexate and Classic DMARDs in the Severe Rheumatoid Arthritis Patients With Poor Prognosis	Rheumatoid Arthritis(RA)	Drug: Infliximab group;Drug: Classic DMARDs treatment group	Zhang, Xiao, M.D.	Central South University;Tianjin Medical University General Hospital;Xijing Hospital	Not yet recruiting	18 Years	70 Years	Both	170	N/A	China
60	EUCTR2012-005733-37-LT (EUCTR)	11/07/2013	20/05/2013	A Study Comparing SB2 to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis	A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: SB2 (infliximab biosimilar) Product Code: SB2 INN or Proposed INN: INFLIXIMAB Trade Name: Remicade® Product Name: Remicade INN or Proposed INN: INFLIXIMAB	Samsung Bioepis Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	584		Philippines;Ukraine;Lithuania;United Kingdom;India;Czech Republic;Mexico;Poland;Romania;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
61	EUCTR2012-005733-37-BG (EUCTR)	10/07/2013	21/05/2013	A Study Comparing SB2 to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis	A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: SB2 (infliximab biosimilar) Product Code: SB2 INN or Proposed INN: INFLIXIMAB Trade Name: Remicade® Product Name: Remicade INN or Proposed INN: INFLIXIMAB	Samsung Bioepis Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	584	Phase 3	Philippines;Ukraine;Lithuania;United Kingdom;India;Czech Republic;Mexico;Poland;Romania;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of
62	EUCTR2012-003644-71-BE (EUCTR)	08/07/2013	06/02/2013	Randomized, Double-Blind, Placebo-Controlled Trial of etanercept plus methotrexate in monoclonal antibody (mAb) anti-TNF failure	A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Etanercept in Subjects with Rheumatoid Arthritis Who Have Had and Inadequate Response to Adalimumab or Infliximab Plus Methotrexate.	Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 4	France;Hong Kong;Spain;Poland;Belgium;Australia;Russian Federation;Israel;Chile;Netherlands;Colombia;New Zealand
63	NCT01927263 (ClinicalTrials.gov)	July 2013	9/8/2013	A Phase 3 Study of NI-071 in Patients With Rheumatoid Arthritis	A Phase 3 Clinical Study of NI-071 in Patients With Rheumatoid Arthritis ?A Double-blind, Active Drug-controlled Study and Long-term Study?	Rheumatoid Arthritis	Biological: NI-071;Biological: Infliximab	Nichi-Iko Pharmaceutical Co.,Ltd.	NULL	Completed	20 Years	75 Years	Both	242	Phase 3	Japan
64	EUCTR2012-004482-40-ES (EUCTR)	18/06/2013	16/05/2013	Evaluation of a protocol for the reduction of doses in patients with rheumatoid arthritis (RA) in clinical remission in treatment with biological therapies	Evaluation of the clinical utility of a standardized protocol of strategies for the reduction of doses in patients with rheumatoid arthritis (RA) in persistent clinical remission in treatment with biological therapies: open, controlled study and randomized.	Evaluation of the clinical utility of a standardized protocol of strategies for the reduction of doses in patients with rheumatoid arthritis in clinical remission at treatment with biologic therapies;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Infliximab INN or Proposed INN: INFLIXIMAB Trade Name: HUMIRA Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: ENBREL Product Name: Etanercept INN or Proposed INN: ETANERCEPT Trade Name: CIMZIA Product Name: Certolizumab Pegol INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: SIMPONI Product Name: Golimumab INN or Proposed INN: GOLIMUMAB Trade Name: ORENCIA Product Name: Abatacept INN or Proposed INN: ABATACEPT Trade Name: RoActemra Product Name: Tocilizumab INN or Proposed INN: TOCILIZUMAB Product Name: Infliximab INN or Proposed INN: INFLIXIMAB	FRANCISCO J. BLANCO GARCÍA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Spain
65	NCT02132234 (ClinicalTrials.gov)	June 2013	28/4/2014	Effects of Biological Treatment on Blood Pressure and Endothelial Function in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis	Effects of Biological Treatment on Blood Pressure and Endothelial Function in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis	Rheumatoid Arthritis;Psoriatic Arthritis;Ankylosing Spondylitis;Hypertension	Drug: Etanercept;Drug: Adalimumab;Drug: Certolizumab;Drug: Infliximab	Jagiellonian University	Departmet of Rheumatology, J Dietl Hospital, Krakow, Poland	Recruiting	18 Years	N/A	Both	100	Phase 4	Poland
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
66	JPRN-UMIN000009887	2013/04/01	01/04/2013	Associations between the initial concentration of serum TNF alpha and effects due to increasing a dose of Infliximab, and between effects of infliximab and the concentration of serum IL-6		Rheumatoid Arthritis	When 3mg/kg of infliximab brings poor results to RA patients, we will change a dose of infliximab according to the initial concentration of serum TNF alpha. If the initial concentration of serum TNF alpha is less than 1.1 pg/ml, we will raise the dose of infliximab to 6 mg/kg. When 3mg/kg of infliximab brings poor results to RA patients, we will change a dose of infliximab according to the initial concentration of serum TNF alpha. If the initial concentration of serum TNF alpha is more than 1.1 pg/ml, we will raise the dose of infliximab to 10 mg/kg.	Department of Orthopaedic surgery, Tohoku University Hospital	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	100	Not applicable	Japan
67	EUCTR2012-003644-71-ES (EUCTR)	12/03/2013	21/12/2012	Randomized, Double-Blind, Placebo-Controlled Trial of etanercept plus methotrexate in monoclonal antibody (mAb) anti-TNF failure	A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Etanercept in Subjects with Rheumatoid Arthritis Who Have Had and Inadequate Response to Adalimumab or Infliximab Plus Methotrexate.	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	168		France;Hong Kong;Czech Republic;Spain;Australia;Israel;Chile;Russian Federation;Netherlands;Germany;Colombia
68	EUCTR2012-003644-71-NL (EUCTR)	07/01/2013	07/01/2013	Randomized, Double-Blind, Placebo-Controlled Trial of etanercept plus methotrexate in monoclonal antibody (mAb) anti-TNF failure	A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Etanercept in Subjects with Rheumatoid Arthritis Who Have Had and Inadequate Response to Adalimumab or Infliximab Plus Methotrexate.	Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT	Pfizer Inc., 235 EAst 42nd Street, New York, NY 10017, United States	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120		France;Hong Kong;Spain;Belgium;Australia;Russian Federation;Israel;Chile;Colombia;Netherlands
69	NCT01793519 (ClinicalTrials.gov)	January 2013	14/2/2013	Stopping TNF Alpha Inhibitors in Rheumatoid Arthritis	Stopping Tumor Necrosis Factor-Alpha Inhibitors in Rheumatoid Arthritis (STARA) Clinical Trial	Rheumatoid Arthritis	Drug: Etanercept;Drug: Infliximab;Drug: Adalimumab;Drug: Placebo	Georgetown University	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS);University of Maryland, College Park;Washington D.C. Veterans Affairs Medical Center;Medstar Health Research Institute;Patient-Centered Outcomes Research Institute;Arthritis and Pain Associates of PG County;Arthritis & Rheumatism Associates, P.C.;Rheumatology Associates of Baltimore, L.L.C.;The Arthritis Clinic of Northern Virginia, P.C.;Arthritis and Rheumatic Disease Associates, P.C.	Recruiting	18 Years	N/A	All	290	Phase 4	United States
70	JPRN-UMIN000015297	2012/09/19	01/10/2014	The feasibility study of accelated infliximab infusion from initial administration	The feasibility study of accelated infliximab infusion from initial administration - The feasibility study of accelated infliximab infusion from initial administration	patient in whom infliximab is indicated(rheumatoid arthritis, Crohn's disease, Ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis)	Administration of intravenous infliximab infusion with 60 min accelated procedure for patients who are already successfully treated with usual 2hr infuion without infusion reaction. The tolerable patient continue to receive more five treatment with 60min procedure.	Chiba University Hospital	NULL	Recruiting	20years-old	70years-old	Male and Female	54	Phase 2	Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
71	EUCTR2011-005204-15-AT (EUCTR)	20/06/2012	15/05/2012	Could ultrasound help to identify the patients with rheumatoid arthritis, in those the treatment with biological DMARDs could be stopped?	Ultrasound as biomarker for withdrawal of biological DMARDs in rheumatoid arthritis (RA-BioStop) - RABioStop	biological DMARDs may be stopped in RA patients treated with a combination of synthetic DMARD plus biological DMARDs which are in persistent clinical remission. Ultrasound may be useful to predict a disease flare in patients stopping biological DMARDs therapy. MedDRA version: 20.0;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Simponi INN or Proposed INN: GOLIMUMAB Trade Name: Roactemra INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: Orncia INN or Proposed INN: ABATACEPT Trade Name: Roactemra INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: Orncia INN or Proposed INN: ABATACEPT	Med Uni Graz, Univ. Klinik Innere Medizin,Abt. Rheumatologie und Immunologie	NULL	Not Recruiting			Female: yes Male: yes	110	Phase 4	Austria
72	JPRN-UMIN000008281	2012/06/01	28/06/2012	Dose-escalation study of infliximab or methotrexate based on the disease activity in patients with rheumatoid arthritis treated with infliximab		rheumatoid arthritis	Dose-escalation of MTX or IFX	Department of Internal Medicien and Rheumatology, Juntendo University School of Medicine	NULL	Recruiting	20years-old	Not applicable	Male and Female	30	Not selected	Japan
73	JPRN-UMIN000007806	2012/06/01	01/05/2012	The feasibility study of accelated infliximab infusion during maintenance phase		patient in whom infliximab is indicated(rheumatoid arthritis, Crohn's disease, Ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis)	Administration of intravenous infliximab infusion with 60 min accelated procedure for patients who are already successfully treated with usual 2hr infuion without infusion reaction. The tolerable patient continue to receive more five treatment with 60min procedure.	Chiba University Hospital	NULL	Complete: follow-up complete	Not applicable	Not applicable	Male and Female	54	Phase 2	Japan
74	NCT01602302 (ClinicalTrials.gov)	June 2012	16/5/2012	Ultrasound and Withdrawal of Biological DMARDs in Rheumatoid Arthritis	Ultrasound as Biomarker for Withdrawal of Biological DMARDs in Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: bDMARD withdrawal (etanercept, adalimumab, infliximab, certolizumab, golimumab, tozilizumab, abatacept)	Medical University of Graz	NULL	Terminated	18 Years	90 Years	All	40	Phase 4	Austria
75	EUCTR2012-000139-21-AT (EUCTR)	14/05/2012	23/04/2012	Multi-Center Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action	A Randomized, Multi-Center Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action - BioBio	Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Orencia Product Name: Orencia INN or Proposed INN: ABATACEPT Trade Name: Ro-Actemra Product Name: Ro Actemra Other descriptive name: TOCILIZUMAB Trade Name: Mabthera Product Name: Mabthera INN or Proposed INN: RITUXIMAB Trade Name: Orencia Product Name: Orencia INN or Proposed INN: ABATACEPT Trade Name: Ro-Actemra Product Name: Ro Actemra Other descriptive name: TOCILIZUMAB	Medizinische Universität Wien, Universitätsklinik für Innere Medizin III	NULL	Not Recruiting			Female: yes Male: yes		Phase 4	Czech Republic;Slovakia;Austria;Russian Federation;Switzerland
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
76	JPRN-UMIN000007786	2012/05/01	19/04/2012	"Effect examination of infliximab to the effect insufficient example and the example of effect decrease of the 1st TNF inhibitor in rheumatoid arthritis "		Rheumatoid Arthritis	infliximab plus methotrexate	Saitama Medical Center. Saitama Medical University	NULL	Complete: follow-up complete	20years-old	75years-old	Male and Female	40	Not applicable	Japan
77	JPRN-UMIN000007432	2012/04/01	02/03/2012	Prospective research of infliximab treatment in active RA patients refractry to anti-interleukin six receptor monoclonal antibody.		rheumatoid arthritis	Infliximab and Methotrexate. Patient is treated with IFX 3mg/kg for 0, 2, or 6 weeks, and henceforth every 8 weeks till 46weeks. Disease activity is assessed every 4weeks (suitable) or every 8 weeks (indispensable), and if SDAI Score 3.3 or more, it will change into of 3mg/kg 4week or 6mg/kg 4week interval medication, and will administer a drug to patient till 50 weeks. If not remission(SDAI Score 3.3 or more), after change into of 3mg/kg 4week interval medication, it will change into of 6mg/kg 4week interval medication, and will administer a drug to patient till 50 weeks.	Keio University	NULL	Complete: follow-up continuing	20years-old	75years-old	Male and Female	100	Not selected	Japan
78	EUCTR2011-004468-31-LT (EUCTR)	14/03/2012	05/01/2012	Evaluating the long-term Safety and Efficacy effects of CT-P13 together with methotrexate in patients with arthritis	An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab	CELLTRION, Inc	NULL	Not Recruiting			Female: yes Male: yes	617		Portugal;Philippines;Slovakia;Spain;Ukraine;Lithuania;Austria;Chile;Colombia;Italy;United Kingdom;Mexico;Poland;Romania;Peru;Bulgaria;Latvia;Bosnia and Herzegovina
79	NCT01571219 (ClinicalTrials.gov)	March 2012	23/3/2012	An Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patient With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1	An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-Administered With Methotrexate in Patient With Rheumatoid Arthritis Who Were Treated With Infliximab(Remicade or CP-P13) in Study CT-P13 3.1	Rheumatoid Arthritis	Biological: Infliximab	Celltrion	NULL	Completed	18 Years	75 Years	All	302	Phase 3	Korea, Republic of;United Kingdom
80	EUCTR2011-004468-31-ES (EUCTR)	10/02/2012	07/12/2011	Comparing the long-term effects of CT-P13 with remicade together with methotrexate in patients with arthritis	An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1	Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab	CELLTRION, Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	522		Portugal;Colombia;Bulgaria;Chile;Italy;Latvia;Austria;Lithuania;United Kingdom;Slovakia;Ukraine;Peru;Mexico;Romania;Spain;Bosnia and Herzegovina;Philippines;Poland;Jordan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
81	EUCTR2011-004468-31-PL (EUCTR)	07/02/2012	10/02/2012	Evaluating the long-term Safety and Efficacy effects of CT-P13 together with methotrexate in patients with arthritis	An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab	CELLTRION, Inc	NULL	Not Recruiting			Female: yes Male: yes	617		Portugal;Philippines;Slovakia;Spain;Ukraine;Lithuania;Austria;Chile;Colombia;Italy;United Kingdom;Mexico;Poland;Romania;Peru;Bulgaria;Latvia;Bosnia and Herzegovina
82	EUCTR2011-004468-31-LV (EUCTR)	06/02/2012	30/12/2011	Long-term safety and effectivenss CT-P13 together with methotrexate in patients with arthritis	An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab	CELLTRION, Inc	NULL	Not Recruiting			Female: yes Male: yes	617		Portugal;Philippines;Spain;Ukraine;Lithuania;Austria;Chile;Colombia;United Kingdom;Italy;Mexico;Jordan;Poland;Romania;Peru;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of
83	EUCTR2011-004468-31-IT (EUCTR)	02/02/2012	02/03/2012	Comparing the long-term effects of CT-P13 with remicade together with methotrexate in patients with arthritis	An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13-3.1	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CT-P13 Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Other descriptive name: NA	CELLTRION, INC.	NULL	Not Recruiting			Female: yes Male: yes	617		Korea, Republic of;Philippines;Spain;Ukraine;Lithuania;Austria;Chile;Colombia;Italy;United Kingdom;Mexico;Jordan;Poland;Peru;Latvia;Bosnia and Herzegovina
84	NCT01567358 (ClinicalTrials.gov)	February 2012	23/3/2012	Study of NI-071 in Comparison With Remicade in Patients With Rheumatoid Arthritis	A Randomized, Double-Blind, Repeated Dose, Active Control Drug, Parallel-group and Single-center Phase I Study of the Safety of Intravenous Administration of NI-071 in Comparison With Remicade® in Japanese Patients With Rheumatoid Arthritis Inadequately Treated With Methotrexate	Rheumatoid Arthritis	Biological: Infliximab	Nichi-Iko Pharmaceutical Co.,Ltd.	NULL	Completed	20 Years	75 Years	Both	14	Phase 1	Japan
85	EUCTR2011-004468-31-AT (EUCTR)	26/01/2012	30/11/2011	Comparing the long-term effects of CT-P13 with remicade together with methotrexate in patients with arthritis	An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1	Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab	CELLTRION, Inc	NULL	Not Recruiting			Female: yes Male: yes	522		Portugal;Colombia;Bulgaria;Chile;Italy;Latvia;Austria;Lithuania;United Kingdom;Slovakia;Ukraine;Peru;Mexico;Romania;Spain;Bosnia and Herzegovina;Philippines;Jordan;Poland
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
86	EUCTR2011-004468-31-GB (EUCTR)	06/01/2012	25/11/2011	Evaluating the long-term Safety and Efficacy effects of CT-P13 together with methotrexate in patients with arthritis	An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab	CELLTRION, Inc	NULL	Not Recruiting			Female: yes Male: yes	617	Phase 3	Portugal;Philippines;Slovakia;Spain;Ukraine;Lithuania;Austria;Chile;Colombia;Italy;United Kingdom;Mexico;Poland;Romania;Peru;Bulgaria;Latvia;Bosnia and Herzegovina
87	EUCTR2011-004468-31-SK (EUCTR)	30/12/2011	04/01/2012	Comparing the long-term effects of CT-P13 with remicade together with methotrexate in patients with arthritis	An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab	CELLTRION, Inc	NULL	Not Recruiting			Female: yes Male: yes			Portugal;Philippines;Slovakia;Spain;Ukraine;Lithuania;Austria;Chile;Colombia;Italy;United Kingdom;Mexico;Jordan;Poland;Romania;Peru;Bulgaria;Latvia;Bosnia and Herzegovina
88	NCT01592292 (ClinicalTrials.gov)	November 2011	11/4/2012	An Observational Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis And Inadequate Response Or Intolerance to a First Anti-TNF Alpha Therapy	A Non-interventional Study for Relative Efficacy Outcome of Rituximab Treatment in RA Patients Who Have Inadequate Response or Have Been Intolerant to a First Anti-TNF Agent	Rheumatoid Arthritis	Drug: Rituximab;Drug: Adalimumab;Drug: Etanercept;Drug: Infliximab	Hoffmann-La Roche	NULL	Completed	20 Years	N/A	All	90	N/A	Korea, Republic of
89	NCT01295151 (ClinicalTrials.gov)	August 2011	11/2/2011	SWITCH Clinical Trial for Patients With Rheumatoid Arthritis Who Have Failed an Initial TNF-blocking Drug.	Randomised-controlled Trial of Switching to Alternative Tumour-necrosis Factor (TNF)-Blocking Drugs or Abatacept or Rituximab in Patients With Rheumatoid Arthritis Who Have Failed an Initial TNF-blocking Drug	Rheumatoid Arthritis	Drug: Etanercept;Drug: Abatacept;Biological: Rituximab;Drug: Adalimumab;Drug: Certolizumab Pegol;Drug: Infliximab;Drug: Golimumab	Julia Brown	NULL	Completed	18 Years	N/A	Both	122	Phase 4	United Kingdom
90	JPRN-UMIN000013750	2011/07/31	21/04/2014	Study on effects of cytokine targeted therapy on periodontal condition in patients with rheumatoid arthritis		Rheumatoid arthritis, Periodontitis	IL-6 receptor inhibition group: Tocilizumab will be infused in 20 patients, and its effectiveness will be evaluated at 3 and 6 months later. TNF inhibition group: Infliximab, Etanercept, and Adalimumab will be infused in 20 patients, and its effectiveness will be evaluated at 3 and 6 months later.	Division of Periodontology, Niigata University Graduate School of Medical and Dental Sciences	NULL	Complete: follow-up complete	Not applicable	Not applicable	Male and Female	80	Not selected	Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
91	NCT01313520 (ClinicalTrials.gov)	March 1, 2011	25/2/2011	A Study to Evaluate the Effectiveness of Infliximab and Changes in Hand and Wrist Magnetic Resonance Imaging (MRI) in Participants With Active Rheumatoid Arthritis (RA) (P08136)	A Randomized Clinical Trial to Study the Effects of Infliximab on Clinical Efficacy and Hand and Wrist Magnetic Resonance Imaging (MRI) in Patients With Active Rheumatoid Arthritis (RA)(Protocol No. P08136)	Arthritis, Rheumatoid	Drug: Infliximab;Drug: Placebo	Merck Sharp & Dohme Corp.	NULL	Completed	18 Years	N/A	All	61	Phase 2	Moldova, Republic of;Romania
92	EUCTR2010-018646-31-LT (EUCTR)	30/11/2010	06/08/2010	CT-P13 Compared With Remicade When Co-Administered With Methotrexate	A Randomized, Double Blind, Parallel-Group, Phase 3 Study to Demonstrate Equivalence in Efficacy and Safety of CT-P13 Compared With Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis -	Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB	CELLTRION, Inc	NULL	Not Recruiting			Female: yes Male: yes	584	Phase 3	Portugal;Colombia;Bulgaria;Chile;Indonesia;Italy;Latvia;Austria;Lithuania;United Kingdom;Slovakia;Russian Federation;Ukraine;Peru;Mexico;Romania;Spain;Bosnia and Herzegovina;Philippines;Poland;Jordan
93	EUCTR2010-018646-31-ES (EUCTR)	05/11/2010	12/08/2010		Estudio de fase 3, aleatorizado, doble ciego y con grupos paralelos para demostrar la equivalencia en eficacia y seguridad de CT-P13 comparado con Remicade cuando se administra con metotrexato a pacientes con artritis reumatoide activa.A Randomized, Double Blind, Parallel-Group, Phase 3 Study to Demonstrate Equivalence in Efficacy and Safety of CT-P13 Compared With Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis -	Artritis reumatoide.Rheumatoid Arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 12.1;Level: PT;Term: Rheumatoid arthritis	Product Name: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab Trade Name: REMICADE 100 mg polvo para concentrado para solución para perfusión INN or Proposed INN: INFLIXIMAB Other descriptive name: INFLIXIMAB	CELLTRION, Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	584	Phase 3	Portugal;United Kingdom;Bulgaria;Spain;Italy;Latvia;Austria;Lithuania
94	EUCTR2010-018646-31-LV (EUCTR)	11/10/2010	29/06/2010		A Randomized, Double Blind, Parallel-Group, Phase 3 Study to Demonstrate Equivalence in Efficacy and Safety of CT-P13 Compared With Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis -	Rheumatoid Arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 12.1;Level: PT;Term: Rheumatoid arthritis	Product Name: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB	CELLTRION, Inc	NULL	Not Recruiting			Female: yes Male: yes	633	Phase 3	Portugal;United Kingdom;Bulgaria;Spain;Italy;Latvia;Austria;Lithuania
95	EUCTR2010-018646-31-SK (EUCTR)	11/10/2010	23/06/2010	A Randomized, Double Blind, Parallel-Group, Phase 3 Study to Demonstrate Equivalence in Efficacy and Safety of CT-P13 Compared With Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis	A Randomized, Double Blind, Parallel-Group, Phase 3 Study to Demonstrate Equivalence in Efficacy and Safety of CT-P13 Compared With Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 12.1;Level: PT;Term: Rheumatoid arthritis	Product Name: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB	CELLTRION, Inc	NULL	Not Recruiting			Female: yes Male: yes	584	Phase 3	Portugal;Slovakia;Spain;Lithuania;Austria;Bulgaria;Latvia;Italy;United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
96	EUCTR2010-018646-31-BG (EUCTR)	07/10/2010	07/09/2010	A Randomized, Double Blind, Parallel-Group, Phase 3 Study to Demonstrate Equivalence in Efficacy and Safety of CT-P13 Compared With Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis	A Randomized, Double Blind, Parallel-Group, Phase 3 Study to Demonstrate Equivalence in Efficacy and Safety of CT-P13 Compared With Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Product Name: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB	CELLTRION, Inc	NULL	Not Recruiting			Female: yes Male: yes	584	Phase 3	Portugal;Spain;Lithuania;Austria;Bulgaria;Latvia;Italy;United Kingdom
97	EUCTR2010-018646-31-PT (EUCTR)	01/10/2010	23/07/2010	A Randomized, Double Blind, Parallel-Group, Phase 3 Study to Demonstrate Equivalence in Efficacy and Safety of CT-P13 Compared With Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis	A Randomized, Double Blind, Parallel-Group, Phase 3 Study to Demonstrate Equivalence in Efficacy and Safety of CT-P13 Compared With Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 12.1;Level: PT;Term: Rheumatoid arthritis	Product Name: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB	CELLTRION, Inc	NULL	Not Recruiting			Female: yes Male: yes	584	Phase 3	Portugal;Spain;Lithuania;Austria;Bulgaria;Latvia;Italy;United Kingdom
98	NCT01217086 (ClinicalTrials.gov)	October 2010	4/10/2010	Program evaLuating the Autoimmune Disease iNvEstigational Drug cT-p13 in RA Patients(PLANETRA)	Randomized, Double-blind, Parallel-group, Phase 3 Study	Rheumatoid Arthritis	Drug: Infliximab	Celltrion	NULL	Completed	18 Years	75 Years	Both	617	Phase 3	Korea, Republic of
99	EUCTR2010-018646-31-AT (EUCTR)	29/09/2010	03/08/2010		A Randomized, Double Blind, Parallel-Group, Phase 3 Study to Demonstrate Equivalence in Efficacy and Safety of CT-P13 Compared With Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis -	Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Product Name: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB	CELLTRION, Inc	NULL	Not Recruiting			Female: yes Male: yes	584	Phase 3	Portugal;United Kingdom;Bulgaria;Spain;Italy;Latvia;Austria;Lithuania
100	EUCTR2010-018646-31-IT (EUCTR)	14/09/2010	26/07/2010		A Randomized, Double Blind, Parallel-Group, Phase 3 Study to Demonstrate Equivalence in Efficacy and Safety of CT-P13 Compared With Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis - ND	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073	Product Name: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab Trade Name: Remicade INN or Proposed INN: Infliximab	CELLTRION, Inc	NULL	Not Recruiting			Female: yes Male: yes	584	Phase 3	Portugal;United Kingdom;Bulgaria;Spain;Italy;Latvia;Austria;Lithuania
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
101	EUCTR2010-018646-31-GB (EUCTR)	09/09/2010	22/07/2010		A Randomized, Double Blind, Parallel-Group, Phase 3 Study to Demonstrate Equivalence in Efficacy and Safety of CT-P13 Compared With Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis -	Rheumatoid Arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 12.1;Level: PT;Term: Rheumatoid arthritis	Product Name: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB	CELLTRION, Inc	NULL	Not Recruiting			Female: yes Male: yes	633	Phase 3	Portugal;United Kingdom;Bulgaria;Spain;Italy;Latvia;Austria;Lithuania
102	NCT01282528 (ClinicalTrials.gov)	September 2010	24/1/2011	Ultrasonographic Monitoring of Response to Infliximab in Patients With Rheumatoid Arthritis	Ultrasonographic Monitoring of Response to Infliximab in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis;Ultrasonography;Infliximab	Biological: infliximab	Peking Union Medical College Hospital	Shanghai Changzheng Hospital;First Hospital of China Medical University;Shenzhen People's Hospital;Xinhua Hospital, Shanghai Jiao Tong University School of Medicine;Wenzhou Medical University;First People's Hospital of Foshan;West China Hospital	Recruiting	18 Years	65 Years	Both	85	Phase 4	China
103	EUCTR2009-015740-42-DE (EUCTR)	12/05/2010	12/01/2010	A PHASE 3, MULTICENTER, RANDOMIZED, OPEN, PROSPECTIVE, CONTROLLED, PARALLEL-GROUP STUDY OF REDUCTION OF THERAPY IN PATIENTS WITH RHEUMATOID ARTHRITIS IN ONGOING REMISSIONRETRO – REduction of Therapy in RA patients in Ongoing remission,Reduzierung der Therapie bei RA-Patienten in Remission - RETRO	A PHASE 3, MULTICENTER, RANDOMIZED, OPEN, PROSPECTIVE, CONTROLLED, PARALLEL-GROUP STUDY OF REDUCTION OF THERAPY IN PATIENTS WITH RHEUMATOID ARTHRITIS IN ONGOING REMISSIONRETRO – REduction of Therapy in RA patients in Ongoing remission,Reduzierung der Therapie bei RA-Patienten in Remission - RETRO	Rheumatoid arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Product Name: Prednisolon Product Code: Prednisolon INN or Proposed INN: PREDNISOLONE Trade Name: Humira INN or Proposed INN: ADALIMUMAB Product Name: Azathioprin Other descriptive name: AZATHIOPRINE Trade Name: Immunosporin Product Name: Immunosporin INN or Proposed INN: CICLOSPORIN Trade Name: Cimzia Product Name: Cimzia INN or Proposed INN: GOLIMUMAB Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT Product Name: Quensyl Other descriptive name: HYDROXYCHLOROQUINE SULFATE Trade Name: REMICADE Product Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Lantarel Product Name: Lantarel INN or Proposed INN: METHOTREXATE SODIUM Other descriptive name: Lantarel Trade Name: Arava Product Name: Arava INN or Proposed INN: LEFLUNOMIDE Other descriptive name: Arava Product Name: Metex 2,5mg INN or Proposed INN: METHOTREXATE SODIUM Other descriptive name: Metex 2,5mg	Universitätsklinkum Erlangen	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes		Phase 3	Germany
104	EUCTR2009-017379-90-IT (EUCTR)	27/04/2010	31/03/2010	Characterization of the secondary failure to TNF-blockers monoclonal antibodies. Receptor as a rescue therapy - ND	Characterization of the secondary failure to TNF-blockers monoclonal antibodies. Receptor as a rescue therapy - ND	RA patients fulfilling the 1987 ACR criteria who discontinued a first antibody TNF-i (Infliximab or Adalimumab) because of secondary inefficacy MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	INN or Proposed INN: ETANERCEPT	AZIENDA OSPEDALIERA SENESE	NULL	Not Recruiting			Female: yes Male: yes			Italy
105	NCT01000441 (ClinicalTrials.gov)	December 2009	22/10/2009	Rotation or Change of Biotherapy After First Anti-TNF Treatment Failure for Rheumatoid Arthritis	Rotation or Change of Biotherapy After First Anti-TNF Treatment Failure for Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: infliximab, etanercept, adalimumab;Drug: abatacept, rituximab or tocilizumab	University Hospital, Strasbourg, France	NULL	Recruiting	18 Years	N/A	Both	300	Phase 4	France;Monaco
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
106	EUCTR2007-003288-36-GB (EUCTR)	04/11/2009	03/10/2008	A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART	A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis		Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 4	France;Finland;Spain;Austria;Germany;Netherlands;United Kingdom
107	EUCTR2008-005450-20-BE (EUCTR)	29/10/2009	01/10/2009	The cost-effectiveness of abatacept, rituximab or anti-TNF alpha for patients with rheumatoid artritis. - Dutch Rheumatoid Arthritis Monitoring (DREAM) Targetted Immune Modulator Evaluation (TIME)	The cost-effectiveness of abatacept, rituximab or anti-TNF alpha for patients with rheumatoid artritis. - Dutch Rheumatoid Arthritis Monitoring (DREAM) Targetted Immune Modulator Evaluation (TIME)	Rheumatoid arthritis MedDRA version: 12.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Remicade (infliximab) INN or Proposed INN: INFLIXIMAB Other descriptive name: remicade Trade Name: Humira (adalimumab) INN or Proposed INN: ADALIMUMAB Trade Name: Enbrel (etanercept) INN or Proposed INN: ETANERCEPT Other descriptive name: Enbrel Trade Name: Mabthera (rituximab) INN or Proposed INN: RITUXIMAB Other descriptive name: Mabthera Trade Name: Orencia (abatacept) INN or Proposed INN: ABATACEPT Other descriptive name: Orencia	Radboud University Nijmegen Medical Centre, department of Rheumatic Diseases	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	261		Belgium
108	JPRN-UMIN000002340	2009/08/01	20/08/2009	Comparison of effects between higher dosages of infliximab and switching to other biologics for rheumatoid arthritis patients with less responsiveness to infliximab therapy (cHAMLET)		Rheumatoid Arthritis	Treatment with higher dosages of infliximab (3-10 mg/Kg) Every 2 months Follow-up to 54 weeks Treatment with one of other biologics (etanercept, adalimumab, tocilizumab) in standard protocol Follow-up to 54 weeks	Department of Rheumatosurgery, Osaka City University Medical School	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	60	Phase 4	Japan
109	NCT00808210 (ClinicalTrials.gov)	March 5, 2009	11/12/2008	A Study to Evaluate Ocrelizumab in Combination With Methotrexate Compared With Infliximab Plus Methotrexate in Patients With Active Rheumatoid Arthritis Currently Responding Inadequately to Etanercept or Adalimumab	A PHASE II RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCRELIZUMAB IN COMBINATION WITH METHOTREXATE, COMPARED TO INFLIXIMAB PLUS METHOTREXATE IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS CURRENTLY RESPONDING INADEQUATELY TO ETANERCEPT OR ADALIMUMAB	Rheumatoid Arthritis	Drug: Infliximab;Drug: Methotrexate;Drug: Methylprednisolone;Drug: Ocrelizumab;Drug: Placebo	Genentech, Inc.	NULL	Terminated	18 Years	N/A	All	28	Phase 2	United States
110	EUCTR2007-003288-36-ES (EUCTR)	08/01/2009	09/03/2010	Ensayo clínico fase 4, multicéntrico, abierto, asesor ciego, de cambio en el cual se evalúa la eficacia y la seguridad de Infliximab (REMICADE®) en pacientes con artritis reumatoide activa que están respondiendo inadecuadamente a Etanercept (ENBREL®) o Adalimumab (HUMIRA®). - RESTART	Ensayo clínico fase 4, multicéntrico, abierto, asesor ciego, de cambio en el cual se evalúa la eficacia y la seguridad de Infliximab (REMICADE®) en pacientes con artritis reumatoide activa que están respondiendo inadecuadamente a Etanercept (ENBREL®) o Adalimumab (HUMIRA®). - RESTART	Artritis Reumatoide MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Other descriptive name: Chimeric Human-Murine IgG1	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	200		Finland;United Kingdom;Germany;Netherlands;France;Spain;Austria
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
111	EUCTR2007-003288-36-FR (EUCTR)	08/12/2008	21/10/2008	A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART	A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Other descriptive name: Chimeric Human-Murine IgG1	Centocor BV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	200	Phase 4	Finland;United Kingdom;Germany;Netherlands;France;Spain;Austria
112	ChiCTR-TRC-10001060	2008-12-01	2010-10-23	Efficacy and safety of infliximab in Chinese patients with rheumatoid arthritis: a double-blind, randomized, placebo-controlled trial	Efficacy and safety of infliximab in Chinese patients with rheumatoid arthritis: a double-blind, randomized, placebo-controlled trial	rheumatoid arthritis;M05.901	infliximab:intravenous injections of infliximab (3 mg/kg) at weeks 0, 2, 6, 14, with concurrent MTX therapy;placebo:intravenous injections of placebo (3 mg/kg) at weeks 0, 2, 6, 14, with concurrent MTX therapy;	People's Hospital, Beijing University; Shanghai Changzheng Hospital	NULL	Completed	18	65	Both	infliximab:0;placebo:0;	3 (Phase 3 study)	China
113	EUCTR2007-003288-36-FI (EUCTR)	28/11/2008	30/09/2008	A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART	A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Other descriptive name: Chimeric Human-Murine IgG1	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 4	Finland;United Kingdom;Germany;Netherlands;France;Spain;Austria
114	EUCTR2008-006256-22-FR (EUCTR)	21/11/2008	31/10/2008	Evaluation by high resolution micro computerized tomography of bone microarchitecture changes in patients with rheumatoid arthritis under anti-TNF therapy.	Evaluation by high resolution micro computerized tomography of bone microarchitecture changes in patients with rheumatoid arthritis under anti-TNF therapy.	rheumatoid arthritis requiring anti-TNF alpha treatment MedDRA version: 9.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions	Trade Name: remicade INN or Proposed INN: infliximab Trade Name: humira INN or Proposed INN: adalimumab Trade Name: enbrel INN or Proposed INN: etanercept	CHU Saint-Etienne	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			France
115	EUCTR2007-003288-36-DE (EUCTR)	10/11/2008	03/09/2008	A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART	A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Other descriptive name: Chimeric Human-Murine IgG1	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 4	Finland;United Kingdom;Germany;Netherlands;France;Spain;Austria
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
116	NCT00901550 (ClinicalTrials.gov)	November 2008	13/5/2009	The Chinese University of Hong Kong Early Arthritis Study	The Chinese University of Hong Kong Early Arthritis Study	Rheumatoid Arthritis	Drug: Methotrexate;Drug: Infliximab	Chinese University of Hong Kong	NULL	Completed	18 Years	80 Years	Both	40	N/A	China
117	EUCTR2007-003288-36-NL (EUCTR)	15/10/2008	11/07/2008	A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART	A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Other descriptive name: Chimeric Human-Murine IgG1	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 4	Finland;United Kingdom;Germany;Netherlands;France;Spain;Austria
118	EUCTR2008-005212-40-SE (EUCTR)	14/10/2008	14/08/2008	Pain mechanisms and fatigue in rheumatoid arthritis (RA) and healthy volunteers. Can antirheumatic and biological therapy affect pain processing and fatigue in RA? - RA PAIN PROCESSING	Pain mechanisms and fatigue in rheumatoid arthritis (RA) and healthy volunteers. Can antirheumatic and biological therapy affect pain processing and fatigue in RA? - RA PAIN PROCESSING	Rheumatoid arthritis (RA)The overall aim with this project is to investigate central pain mechanisms in RA and healthy controls, and in RA how these are influenced by autonomic neural regulation and TNF-blockade with Remicade. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 9.1;Classification code 10060016;Term: Alpha tumor necrosis factor MedDRA version: 9.1;Classification code 10029817;Term: Nuclear magnetic resonance imaging brain MedDRA version: 9.1;Classification code 10053689;Term: Cardiovascular autonomic function test	Trade Name: Remicade INN or Proposed INN: Infliximab	Karolinska Institute	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: no			Sweden
119	EUCTR2007-003288-36-AT (EUCTR)	01/10/2008	18/08/2008	A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART	A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Other descriptive name: Chimeric Human-Murine IgG1	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 4	Finland;United Kingdom;Germany;Netherlands;France;Spain;Austria
120	NCT00724672 (ClinicalTrials.gov)	September 2008	25/7/2008	A Study of Immune Cells in Patients With Rheumatoid Arthritis During Different Types of Anti-TNF Alpha Treatments (Study P05521)	Whole Human Genome Oligo Microarray Analysis of the Peripheral Blood Mononuclear Cells of Patients With Rheumatoid Arthritis During Different Forms of Anti-Tumor Necrosis-Alpha Treatments.	Rheumatoid Arthritis	Drug: etanercept;Drug: infliximab;Drug: adalimumab	Merck Sharp & Dohme Corp.	NULL	Withdrawn	18 Years	N/A	Both	0	N/A	NULL
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
121	NCT00714493 (ClinicalTrials.gov)	July 2008	10/7/2008	RESTART C0168Z05 Rheumatoid Arthritis Study	A Phase 4, Multicenter, Open-Label, Assessor-Blinded Switch Study of the Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) or Adalimumab (HUMIRA).	Rheumatoid Arthritis	Biological: Infliximab	Centocor Ortho Biotech Services, L.L.C.	Schering-Plough	Completed	18 Years	N/A	All	203	Phase 4	United States;Austria;Canada;Finland;France;Germany;Israel;Netherlands;Spain;United Kingdom;Belgium
122	NCT01072058 (ClinicalTrials.gov)	February 2008	18/2/2010	Heart Function in Rheumatoid Arthritis and Ankylosing Spondylitis Pre and Post-TNF Blocker	Prospective Evaluation of Heart Function by Echocardiographic Study, Pro-brain Natriuretic Peptide Type B and Troponin T in Patients With Rheumatoid Arthritis and Ankylosing Spondylitis Pre and Post-TNF Blocker	Arthritis, Rheumatoid;Spondylitis, Ankylosing	Drug: TNF blockers (infliximab, adalimumab, etanercept)	University of Sao Paulo	NULL	Active, not recruiting	18 Years	70 Years	Both	100	Phase 4	Brazil
123	ChiCTR-CCC-10001054	2008-01-01	2010-08-25	Circulating Dickkopf-1 (DKK-1) is Correlated with Bone Erosion and Inflammation in Rheumatoid Arthritis	Circulating Dickkopf-1 (DKK-1) is Correlated with Bone Erosion and Inflammation in Rheumatoid Arthritis	ra	1:none;2:Infliximab ;	National Sciences Foundation of China	NULL	Completed	28	58	Both	1:39;2:39;		China
124	NCT00741104 (ClinicalTrials.gov)	January 2008	30/7/2008	A Feasibility Study Exploring the Effect of Remicade on the Disease Activity in RA Patients (Study P05417)	A Feasibility Study Exploring the Effect of Remicade on the Disease Activity in RA Patients	Rheumatoid Arthritis	Drug: Infliximab	Merck Sharp & Dohme Corp.	NULL	Completed	N/A	N/A	All	363		NULL
125	NCT00840957 (ClinicalTrials.gov)	November 2007	10/2/2009	Pharmaco Kinetic Variability of Infliximab in Rheumatoid Arthritis	Pharmaco Kinetic and Pharmacokinetic-Pharmacodynamic Variability of Infliximab	Rheumatoid Arthritis	Biological: infliximab	University Hospital, Tours	NULL	Completed	18 Years	N/A	Both	84	N/A	France
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
126	NCT01245361 (ClinicalTrials.gov)	November 2007	19/11/2010	A 6-Months Infliximab Or Placebo Study In UA At High Risk Of RA:Clinical,Radiological And Synovial Benefit	A Comparative Study Of A 6-Month Infliximab (Remicade®) Or Placebo Regimen In Undifferentiated Arthritis At High Risk For The Development Of Rheumatoid Arthritis (RA) : Clinical, Radiological (MRI) And Synovial Benefit P1200/001.	Undifferentiated Arthritis	Drug: Infliximab;Drug: sodium chloride	Patrick Durez	NULL	Completed	N/A	N/A	Both	30	N/A	Belgium
127	EUCTR2007-004694-26-BE (EUCTR)	17/09/2007	10/09/2007	A Comparative Study Of A 6-Month Infliximab (Remicade) Or Placebo Regimen In Undifferentiated Arthritis At High Risk For The Development Of Rheumatoid Arthritis : Clinical, Radiological (MRI) And Synovial Benefit P1200/001. - INFLIXIMAB (REMICADE) in UA	A Comparative Study Of A 6-Month Infliximab (Remicade) Or Placebo Regimen In Undifferentiated Arthritis At High Risk For The Development Of Rheumatoid Arthritis : Clinical, Radiological (MRI) And Synovial Benefit P1200/001. - INFLIXIMAB (REMICADE) in UA	Patient with undifferentiated arthritis and the presence of anti-CCP antibodies are at high risk to develop RA MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Remicade Product Name: REMICADE® (Infliximab) Product Code: -	Saint-Luc Universitary Hospital	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	30		Belgium
128	EUCTR2007-002752-42-FR (EUCTR)	13/09/2007	23/07/2007	FAKIR : Variabilité pharmacocinétique et de la relation pharmacocinétique-phamacodynamique de l'infliximab (Remicade®) dans la polyarthrite rhumatoide - FAKIR	FAKIR : Variabilité pharmacocinétique et de la relation pharmacocinétique-phamacodynamique de l'infliximab (Remicade®) dans la polyarthrite rhumatoide - FAKIR	Polyarthrite rhumatoïde MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Remicade® INN or Proposed INN: INFLIXIMAB	CHRU de Tours	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			France
129	EUCTR2005-001889-13-DE (EUCTR)	09/07/2007	21/12/2006	Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - Re3	Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - Re3	Adult subjects with a diagnosis of Rheumatoid Arthritis presenting with a disease flare after an initial response to infliximab MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: infliximab	Schering-Plough Research Institute (SPRI)	NULL	Not Recruiting			Female: yes Male: yes	315		Portugal;Germany;Netherlands;Denmark;Belgium;France;Greece;Sweden
130	NCT00896168 (ClinicalTrials.gov)	June 2007	7/5/2009	An Efficacy and Safety Study of Infliximab in Participants With Rheumatoid Arthritis	A Multi-Center, Pre-Marketing Clinical Trial to Evaluate the Efficacy and Safety of Infliximab Treatment on Rheumatoid Arthritis	Arthritis, Rheumatoid	Drug: Infliximab;Drug: Methotrexate	Xian-Janssen Pharmaceutical Ltd.	NULL	Completed	18 Years	65 Years	All	234	Phase 4	NULL
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
131	NCT00521924 (ClinicalTrials.gov)	June 2007	27/8/2007	Induction of Remission in RA Patients at Low Disease Activity by Additional Infliximab Therapy (Study P04644AM1) (TERMINATED)	Induction of Remission in RA Patients at Low Disease Activity by Additional Infliximab-therapy	Rheumatoid Arthritis	Biological: infliximab;Drug: DMARDs (methotrexate; chloroquine; leflunomidum; cyclosporin A; sulfasalazine; OM 89.	Merck Sharp & Dohme Corp.	AESCA Pharma GmbH	Terminated	19 Years	65 Years	All	8	Phase 3	Austria
132	NCT00760669 (ClinicalTrials.gov)	May 2007	24/9/2008	An Observational Study of Infliximab Injection in Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis Participants	Post Marketing Surveillance of Remicade in Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis Patients	Spondylitis, Ankylosing;Arthritis, Rheumatoid;Psoriasis;Arthritis, Psoriatic	Drug: Infliximab; observational study;Drug: Methotrexate	Janssen Korea, Ltd., Korea	NULL	Completed	N/A	N/A	All	1061		Korea, Republic of
133	NCT00462072 (ClinicalTrials.gov)	March 2007	17/4/2007	Centocor Microarray Study of Patients	Microarray Analysis of Peripheral Blood and Tissues of Patients With Immune Mediated Inflammatory Diseases	Rheumatoid Arthritis;Psoriatic Arthritis;Psoriasis;Crohn's Disease	Drug: Infliximab	University of Rochester	Centocor, Inc.	Completed	12 Years	N/A	All	31	Phase 4	United States
134	NCT00716248 (ClinicalTrials.gov)	January 2007	8/7/2008	Bucillamine Study of Holding Remission After Infliximab Dose-off	The Bucillamine Study of Holding Remission After Infliximab Dose-off in Patients With Rheumatoid Arthritis Receiving Methotrexate	Rheumatoid Arthritis	Drug: bucillamine;Drug: methotrexate	Saitama Medical University	Keio University	Active, not recruiting	20 Years	N/A	Both	40	Phase 4	Japan
135	EUCTR2005-001889-13-FR (EUCTR)	27/12/2006	30/11/2006	Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - RE3	Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - RE3	Adult subjects with a diganosis of Rheumatoid Arthritis presenting with a disease flare after an initial response to infliximab. MedDRA version: 8.1;Level: LLT;Classification code 10060732;Term: Rheumatoid arthritis flare up		Integrated Therapeutics Group, Inc. - A subsidiary of Schering-Plough Corp.	NULL	Not Recruiting			Female: yes Male: yes	315	Phase 3	Portugal;France;Belgium;Denmark;Austria;Germany;Netherlands;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
136	EUCTR2006-004673-98-HU (EUCTR)	16/10/2006	08/09/2006	Efficacy of Rituximab treatment in patients with rheumatoid arthritis having inadequate response to TNF blocker	Efficacy of Rituximab treatment in patients with rheumatoid arthritis having inadequate response to TNF blocker	To investigate the efficacy of treatment with Rituximab (MabThera®) in patients with active RA whose current treatment with one or more TNF-blocker (Etanercept - Enbrel®, Infliximab – Remicade® or Adalimumab - Humira®) alone or in combination with MTX is insufficient measured by DAS28 activity index.	Trade Name: MabThera 500 mg concentrate for solution for infusion	Roche (Hungary) Ltd.	NULL	Not Recruiting			Female: yes Male: yes	20		Hungary
137	JPRN-UMIN000000512	2006/10/01	03/11/2006	Efficacy of tacrolimus in rheumatoid arthritis patients who have been treated unsuccessfully with infliximab and methotrexate		Rheumatoid Arthritis	If the score of DAS28 is under 3.2 in rheumatoid arthritis patients who have received infliximab and methotrexate, doses of methotrexate will reduced to 2mg/w. When the score of DAS28 increses, tacrolimus will be administered instead of methotrexate. Period of observation is 32 weeks. If the score of DAS28 is over 3.2 in rheumatoid arthritis patients who have received infliximab and methotrexate, tacrolimus will be administered. Period of observation is 32 weeks.	Rheumatosurgery, Osaka City University Medical School	NULL	Complete: follow-up complete	Not applicable	Not applicable	Male and Female	30	Not applicable	Japan
138	NCT01308255 (ClinicalTrials.gov)	September 2006	3/3/2011	Infliximab as Induction Therapy in Early Rheumatoid Arthritis (IDEA)	A Multi-centre Randomised Double Blind Placebo Controlled Study Comparing Two Regimens of Combination Therapy in Early DMARD Naive Rheumatoid Arthritis.	Rheumatoid Arthritis	Drug: Infliximab;Drug: Methylprednisolone;Drug: Methotrexate;Dietary Supplement: Folic acid	University of Leeds	NULL	Completed	18 Years	80 Years	All	112	Phase 4	United Kingdom
139	NCT00732875 (ClinicalTrials.gov)	August 2006	8/8/2008	A Trial of Anti-TNF Chimeric Monoclonal Antibody (cA2) in Korean Patients With Active Rheumatoid Arthritis Despite Methorexate (Extension Part)(Study P05645)(COMPLETED)	A Placebo-controlled, Double-blinded, Randomized Clinical Trial of Anti-TNF Chimeric Monoclonal Antibody (cA2) in Korean Patients With Active Rheumatoid Arthritis Despite Methotrexate Treatment (Open-label Extension Part)	Arthritis, Rheumatoid	Biological: Infliximab + methotrexate (MTX)	Merck Sharp & Dohme Corp.	NULL	Completed	18 Years	75 Years	All	92	Phase 3	NULL
140	EUCTR2005-001889-13-NL (EUCTR)	13/07/2006	20/04/2006	Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - RE3	Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - RE3	Adult subjects with a diganosis of Rheumatoid Arthritis presenting with a disease flare after an initial response to infliximab. MedDRA version: 8.1;Level: LLT;Classification code 10060732;Term: Rheumatoid arthritis flare up		Integrated Therapeutics Group, Inc. - A subsidiary of Schering-Plough Corp.	NULL	Not Recruiting			Female: yes Male: yes	315	Phase 3	France;Portugal;Belgium;Denmark;Austria;Germany;Netherlands;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
141	EUCTR2005-001889-13-DK (EUCTR)	04/05/2006	16/03/2006	Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - RE3	Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - RE3	Adult subjects with a diganosis of Rheumatoid Arthritis presenting with a disease flare after an initial response to infliximab. MedDRA version: 8.1;Level: LLT;Classification code 10060732;Term: Rheumatoid arthritis flare up	Trade Name: Remicade	Integrated Therapeutics Group, Inc. - A subsidiary of Schering-Plough Corp.	NULL	Not Recruiting			Female: yes Male: yes	315		Portugal;Germany;Netherlands;Belgium;Denmark;France;Greece;Sweden
142	EUCTR2005-001889-13-GR (EUCTR)	02/05/2006	23/05/2006	Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - RE3	Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - RE3	Adult subjects with a diganosis of Rheumatoid Arthritis presenting with a disease flare after an initial response to infliximab.		Integrated Therapeutics Group, Inc. - A subsidiary of Schering-Plough Corp.	NULL	Not Recruiting			Female: yes Male: yes	315	Phase 3	France;Portugal;Greece;Belgium;Denmark;Austria;Germany;Netherlands;Sweden
143	EUCTR2005-001633-14-SE (EUCTR)	11/04/2006	27/02/2006	Randomised, multi-center, open-label, parallel-group study comparing adalimumab (Humira[R]) 40 mg s.c. eow versus infliximab (Remicade[R]) 3 mg/kg i.v. every 6. week in RA patients with unsustainable clinical response to infliximab 3 mg/kg every 8. week - The SWITCH Study	Randomised, multi-center, open-label, parallel-group study comparing adalimumab (Humira[R]) 40 mg s.c. eow versus infliximab (Remicade[R]) 3 mg/kg i.v. every 6. week in RA patients with unsustainable clinical response to infliximab 3 mg/kg every 8. week - The SWITCH Study	Rheumatoid arthritis	Trade Name: Humira Product Name: Humira Trade Name: Remicade Product Name: Remicade	Hvidovre Hospital, Dept. Rheumatology	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	112		Denmark;Sweden
144	EUCTR2005-001889-13-PT (EUCTR)	07/04/2006	17/01/2006	Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - Re3	Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - Re3	Adult subjects with a diagnosis of Rheumatoid Arthritis presenting with a disease flare after an initial response to infliximab MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: infliximab	Schering Plough Research Institute, a Division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	315		Portugal;Germany;Netherlands;Denmark;Belgium;France;Greece;Sweden
145	EUCTR2005-005013-37-GB (EUCTR)	06/04/2006	20/01/2006	A multi-centre randomised double dummy double blind study comparing two regimens of combination induction therapy in early DMARD naive Rheumatoid Arthritis: The IDEA study (Infliximab as Induction Therapy in Early Rheumatoid Arthritis) - IDEA	A multi-centre randomised double dummy double blind study comparing two regimens of combination induction therapy in early DMARD naive Rheumatoid Arthritis: The IDEA study (Infliximab as Induction Therapy in Early Rheumatoid Arthritis) - IDEA	Early Rheumatoid Arthritis		University of Leeds	NULL	Not Recruiting			Female: yes Male: yes	112	Phase 4	United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
146	EUCTR2005-001889-13-BE (EUCTR)	06/03/2006	19/12/2005	Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - Re3	Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - Re3	Adult subjects with a diagnosis of Rheumatoid Arthritis presenting with a disease flare after an initial response to infliximab MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis		Schering Plough Research Institute, a Division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	315	Phase 3	France;Portugal;Belgium;Denmark;Austria;Germany;Netherlands;Sweden
147	NCT00394589 (ClinicalTrials.gov)	March 2006	31/10/2006	Re³ (Re-Cube: Retain Remicade® Response)(Study P04249AM3)	Randomised Controlled Trial Evaluating Strategies to Optimize Disease Activity Control in RA Patients Treated With Infliximab in Clinical Practice.	Rheumatoid Arthritis	Drug: Infliximab Control;Drug: Infliximab Increased Frequency;Drug: Infliximab Increased Dose	Merck Sharp & Dohme Corp.	Integrated Therapeutics Group	Terminated	18 Years	N/A	All	43	Phase 3	Austria;Belgium;Denmark;France;Germany;Netherlands;Sweden;Turkey
148	NCT00724243 (ClinicalTrials.gov)	January 2006	25/7/2008	Safety and Effectiveness of Infliximab in Slovakia When Used for Rheumatoid Arthritis (Study P04741)(COMPLETED)	Remicade Treatment Registry in Rheumatoid Arthritis I	Rheumatoid Arthritis	Drug: Infliximab	Merck Sharp & Dohme Corp.	NULL	Completed	N/A	N/A	All	33	N/A	Slovakia
149	EUCTR2005-004530-40-AT (EUCTR)	30/12/2005	25/11/2005	Induction of remission in RA patients at low disease activity by additional Infliximab-therapy	Induction of remission in RA patients at low disease activity by additional Infliximab-therapy	Patients with a diagnose of rheumatoid arthritis according to ACR-criteria at least 1 year (max. 10 years) prior to start of therapy with active disease: DAS 28 between 2,8 and 3,5 and a change in DAS 28 score <0.6 during the last 6 weeks before inclusion.	Trade Name: Remicade Product Name: Remicade	AESCA Pharma Ges.m.b.H	NULL	Not Recruiting			Female: yes Male: yes	160		Austria
150	NCT00705289 (ClinicalTrials.gov)	December 2005	23/6/2008	A Study to Observe Characteristics of Rheumatoid Arthritis in Patients Using Infliximab (Study P04250)	Epidemiology, Correlation and Predictive Value of Disease Activity and Biomarkers in RA Patients Initiated on Infliximab in Clinical Practice	Rheumatoid Arthritis	Biological: Infliximab	Merck Sharp & Dohme Corp.	NULL	Completed	N/A	N/A	All	728	N/A	NULL
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
151	EUCTR2005-001889-13-SE (EUCTR)	24/11/2005	13/10/2005	Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - Re3	Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - Re3	Adult subjects with a diagnosis of Rheumatoid Arthritis presenting with a disease flare after an initial response to infliximab MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: infliximab	Schering-Plough Research Institute, a division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	315		Portugal;Germany;Netherlands;Denmark;Belgium;France;Greece;Sweden
152	EUCTR2005-001889-13-AT (EUCTR)	15/09/2005	08/11/2005	Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - RE3	Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - RE3	Adult subjects with a diganosis of Rheumatoid Arthritis presenting with a disease flare after an initial response to infliximab.	Trade Name: Remicade Product Name: Remicade	Integrated Therapeutics Group, Inc. - A subsidiary of Schering-Plough Corp.	NULL	Not Recruiting			Female: yes Male: yes	315		France;Portugal;Greece;Belgium;Denmark;Austria;Germany;Netherlands;Sweden
153	NCT00216177 (ClinicalTrials.gov)	September 2005	20/9/2005	Comparison of Adalimumab and Infliximab Treatment of Rheumatoid Arthritis	Randomised, Multicenter, Open-label, Parallel-group Study Comparing Adalimumab 40 mg s.c. Eow Versus Infliximab 3 mg/kg i.v. Every 6 Weeks in Rheumatoid Arthritis Patients With Unsustainable Clinical Response to Infliximab 3 mg/kg Every 8 Weeks	Rheumatoid Arthritis	Drug: Infliximab;Drug: Adalimumab	Hvidovre University Hospital	University Hospital, Gentofte, Copenhagen	Recruiting	18 Years	80 Years	Both	112	Phase 4	Denmark
154	NCT00691028 (ClinicalTrials.gov)	September 2005	3/6/2008	Efficacy and Safety of Increased Dose of TA-650(Infliximab) in Patients With Rheumatoid Arthritis	Clinical Study to Assess the Efficacy and Safety of Increased Dose of TA-650(Infliximab) in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: TA-650 3 mg/kg;Drug: TA-650 6 mg/kg;Drug: TA-650 10 mg/kg	Mitsubishi Tanabe Pharma Corporation	NULL	Completed	20 Years	75 Years	All	327	Phase 3	NULL
155	EUCTR2005-001633-14-DK (EUCTR)	17/08/2005	30/06/2005	Randomised, multi-center, open-label, parallel-group study comparing adalimumab (Humira?) 40 mg s.c. eow versus infliximab (Remicade?) 3 mg/kg i.v. every 6. week in RA patients with unsustainable clinical response to infliximab 3 mg/kg every 8. week - The SWITCH Study	Randomised, multi-center, open-label, parallel-group study comparing adalimumab (Humira?) 40 mg s.c. eow versus infliximab (Remicade?) 3 mg/kg i.v. every 6. week in RA patients with unsustainable clinical response to infliximab 3 mg/kg every 8. week - The SWITCH Study	Rheumatoid arthritis	Trade Name: Humira Product Name: Humira Trade Name: Remicade Product Name: Remicade	Hvidovre Hospital, Dept. Rheumatology	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	112		Denmark;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
156	NCT00202852 (ClinicalTrials.gov)	June 1, 2005	13/9/2005	A Placebo-Controlled, Double-Blinded, Randomized Trial of Remicade in Korean Patients With Rheumatoid Arthritis Despite Methotrexate (Study P04280)(COMPLETED)	A Placebo-Controlled, Double-Blinded, Randomized Clinical Trial of Anti-TNF Chimeric Monoclonal Antibody (cA2) in Korean Patients With Active Rheumatoid Arthritis Despite Methotrexate	Arthritis, Rheumatoid	Other: Placebo;Drug: MTX;Biological: Infliximab	Merck Sharp & Dohme Corp.	NULL	Completed	18 Years	75 Years	All	143	Phase 3	Korea, Republic of
157	EUCTR2004-000922-59-CZ (EUCTR)	15/03/2005	15/03/2005	A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled ComparativeStudy of Abatacept or Infliximab in Combination with Methotrexate in ControllingDisease Activity in Subjects with Rheumatoid Arthritis Having an Inadequate ClinicalResponse to Methotrexate	A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled ComparativeStudy of Abatacept or Infliximab in Combination with Methotrexate in ControllingDisease Activity in Subjects with Rheumatoid Arthritis Having an Inadequate ClinicalResponse to Methotrexate	Rheumatoid Arthrithis, Nos	Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab	Bristol Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	675	Phase 3	Czech Republic;Denmark;Spain;Sweden
158	EUCTR2004-000922-59-DK (EUCTR)	02/02/2005	01/12/2004	A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled ComparativeStudy of Abatacept or Infliximab in Combination with Methotrexate in ControllingDisease Activity in Subjects with Rheumatoid Arthritis Having an Inadequate ClinicalResponse to Methotrexate	A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled ComparativeStudy of Abatacept or Infliximab in Combination with Methotrexate in ControllingDisease Activity in Subjects with Rheumatoid Arthritis Having an Inadequate ClinicalResponse to Methotrexate	Rheumatoid Arthrithis, Nos	Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab	Bristol Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	675	Phase 3	Czech Republic;Denmark;Spain;Sweden
159	NCT00095147 (ClinicalTrials.gov)	February 2005	1/11/2004	Abatacept and Infliximab in Combination With Methotrexate in Subjects With Rheumatoid Arthritis	A Phase IIIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Comparative Study of Abatacept or Infliximab in Combination With Methotrexate in Controlling Disease Activity in Subjects With Rheumatoid Arthritis Having an Inadequate Clinical Response to Methotrexate	Rheumatoid Arthritis	Drug: Abatacept (ABA) + Methotrexate (MTX), double-blind (DB);Drug: Infliximab (INF) + MTX, DB;Drug: Placebo (PLA) + MTX, DB;Drug: PLA + MTX switched to ABA+ MTX, DB;Drug: ABA, open-label (OL)	Bristol-Myers Squibb	NULL	Completed	18 Years	75 Years	All	431	Phase 3	United States;Argentina;Australia;Brazil;Canada;Czech Republic;Denmark;Korea, Republic of;Mexico;Peru;Poland;Puerto Rico;Russian Federation;South Africa;Spain;Sweden;Switzerland
160	EUCTR2004-000922-59-ES (EUCTR)	21/12/2004	18/05/2005	A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled ComparativeStudy of Abatacept or Infliximab in Combination with Methotrexate in ControllingDisease Activity in Subjects with Rheumatoid Arthritis Having an Inadequate ClinicalResponse to Methotrexate	A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled ComparativeStudy of Abatacept or Infliximab in Combination with Methotrexate in ControllingDisease Activity in Subjects with Rheumatoid Arthritis Having an Inadequate ClinicalResponse to Methotrexate	Rheumatoid Arthrithis, Nos	Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab	Bristol Myers Squibb International Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	675	Phase 3	Czech Republic;Denmark;Spain;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
161	EUCTR2005-000492-18-IT (EUCTR)	16/12/2004	09/11/2007	Insulin resistance and endothelial dysfunction TNF-Alpha dependent in patients with rheumatoid arthritis or metabolic syndrome	Insulin resistance and endothelial dysfunction TNF-Alpha dependent in patients with rheumatoid arthritis or metabolic syndrome	Metabolic Syndrome and Rheumatoid Arthritis MedDRA version: 6.1;Level: SOC;Classification code 10021428	Trade Name: REMICADE*EV F 100MG+F 2ML INN or Proposed INN: Infliximab	POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI	NULL	Not Recruiting			Female: yes Male: yes			Italy
162	EUCTR2004-000922-59-SE (EUCTR)	01/12/2004	13/10/2004	A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled ComparativeStudy of Abatacept or Infliximab in Combination with Methotrexate in ControllingDisease Activity in Subjects with Rheumatoid Arthritis Having an Inadequate ClinicalResponse to Methotrexate.Revised Protocol 1 , incorporating Amendment 02 (v5.0). Pharmacogenomic Amendment 01. Protocol Amendment 03 - Long-Term Extension. Protocol Amendment 05 - Long Term Extension Site Specific (V2.0, Date 23-Dec-2006).	A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled ComparativeStudy of Abatacept or Infliximab in Combination with Methotrexate in ControllingDisease Activity in Subjects with Rheumatoid Arthritis Having an Inadequate ClinicalResponse to Methotrexate.Revised Protocol 1 , incorporating Amendment 02 (v5.0). Pharmacogenomic Amendment 01. Protocol Amendment 03 - Long-Term Extension. Protocol Amendment 05 - Long Term Extension Site Specific (V2.0, Date 23-Dec-2006).	Rheumatoid Arthrithis, Nos	Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab	Bristol Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	660	Phase 3	Czech Republic;Denmark;Spain;Sweden
163	NCT00236028 (ClinicalTrials.gov)	November 2004	7/10/2005	A Safety and Efficacy Study for Infliximab (Remicade) With Methotrexate in Patients With Early Rheumatoid Arthritis	A Randomized, Double-blind, Trial of Anti-TNFa Chimeric Monoclonal Antibody (Infliximab) in Combination With Methotrexate Compared With Methotrexate Alone for the Treatment of Patients With Early Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Infliximab	Centocor, Inc.	NULL	Completed	18 Years	75 Years	Both	607	Phase 3	NULL
164	NCT00099554 (ClinicalTrials.gov)	May 2004	16/12/2004	Effectiveness and Safety of Enbrel® (Etanercept) in Rheumatoid Arthritis Subjects Who Have Failed Remicade® (Infliximab)	A Phase 4, Open-Label, Single Arm, Observational Study Evaluating the Effectiveness and Safety of Enbrel® (Etanercept) 50 mg Once Weekly in Rheumatoid Arthritis Subjects Who Have Failed Remicade® (Infliximab)	Rheumatoid Arthritis	Drug: Etanercept	Amgen	NULL	Completed	18 Years	N/A	Both	200	Phase 4	United States;Canada
165	NCT00725621 (ClinicalTrials.gov)	March 2004	25/7/2008	Real Life Dosing of Remicade for Rheumatoid Arthritis in Austria Monitored Over 9 Infusions (Study P03756)(COMPLETED)	Real Life Dosing Regimen of Remicade in Austria, Monitored Over 9 Consecutive Infusions in Rheumatoid Arthritis Therapy	Rheumatoid Arthritis	Biological: Infliximab	Merck Sharp & Dohme Corp.	Centocor, Inc.	Completed	N/A	N/A	All	516	N/A	Austria
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
166	NCT00207714 (ClinicalTrials.gov)	November 2003	13/9/2005	An Efficacy and Safety Study of CNTO 148 Subcutaneous Injection Compared With Placebo in Patients With Active Rheumatoid Arthritis	A Randomized, Double-blind, Dose-ranging Trial of CNTO 148 Subcutaneous Injection Compared With Placebo in Subjects With Active Rheumatoid Arthritis Despite Treatment With Methotrexate	Rheumatoid Arthritis	Drug: Golimumab;Drug: MTX;Drug: Placebo;Drug: Infliximab	Centocor, Inc.	Centocor BV	Completed	18 Years	N/A	All	172	Phase 2	NULL
167	NCT00794898 (ClinicalTrials.gov)	July 1, 2003	19/11/2008	Efficacy of Remicade in the Treatment of Active Rheumatoid Arthritis Despite Methotrexate (Study P03027)	Onset of Efficacy of Anti-TNF Chimeric Monoclonal Antibody (Remicade) in the Treatment of Patients With Active Rheumatoid Arthritis Despite Methotrexate Treatment	Arthritis, Rheumatoid	Biological: Infliximab (Remicade)	Merck Sharp & Dohme Corp.	NULL	Completed	18 Years	75 Years	All	19	Phase 4	NULL
168	NCT00396747 (ClinicalTrials.gov)	June 2003	6/11/2006	A Comparison of Methotrexate Alone or Combined to Infliximab or to Pulse Methylprednisolone in Early Rheumatoid Arthritis: A Magnetic Resonance Imaging Study	Phase IV Study of Early RA: a Randomized Magnetic Resonance Imaging Study Comparing the Effects of Methotrexate Alone or in Combination With Infliximab or Intravenous Pulse Methylprednisolone	Rheumatoid Arthritis	Drug: Infliximab, methylprednisolone, methotrexate;Drug: Methotrexate;Drug: Methotrexate + Methylprednisolone;Drug: Methotrexate + Infliximab	Université Catholique de Louvain	NULL	Completed	18 Years	N/A	Both	45	Phase 4	Belgium
169	NCT00317538 (ClinicalTrials.gov)	June 2003	21/4/2006	Open-label, Pilot Protocol of Patients With Rheumatoid Arthritis Who Switch to Infliximab After Incomplete Response to Etanercept	Open-label, Pilot Protocol of Patients With Rheumatoid Arthritis Who Switch to Infliximab After Incomplete Response to Etanercept	Rheumatoid Arthritis	Drug: infliximab, etanercept	Centocor Ortho Biotech Services, L.L.C.	NULL	Completed	18 Years	N/A	Both	28	Phase 3	NULL
170	NCT00213564 (ClinicalTrials.gov)	April 2003	13/9/2005	Gene Expression Profiling in PBMCs as a Tool for Prediction of Infliximab Responsiveness in Rheumatoid Arthritis	Gene Expression Profiling in PBMCs as a Tool for Prediction of Infliximab Responsiveness in Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: response to infliximab associated with methotrexate	University Hospital, Rouen	NULL	Completed	18 Years	N/A	Both	40		France
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
171	NCT00908089 (ClinicalTrials.gov)	March 2003	22/5/2009	TNF-blocking Therapy in Combination With Disease-modifying Antirheumatic Drugs in Early Rheumatoid Arthritis	Use of TNF-blocking Therapy in Combination With DMARDs in Patients With Early Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Trexan+Salazopyrin+Oxiklorin+prednisolone + infliximab;Drug: Trexan+Salazopyrin+Oxiklorin+prednisolone + placebo	Helsinki University	Seinajoki Central Hospital;Oulu University Hospital;Jyväskylä Central Hospital;Kuopio University Hospital;Satakunta Central Hospital;University of Turku;Rheumatism Foundation Hospital;Orton Invalid Foundation;South Karelia central hospital;Lappi Central Hospital;Central Hospital of Kanta-Hame	Active, not recruiting	18 Years	60 Years	Both	100	Phase 4	Finland
172	NCT00029042 (ClinicalTrials.gov)	January 2002	4/1/2002	Infliximab to Treat Children With Juvenile Rheumatoid Arthritis	A Randomized Double Blind Controlled Intra-Patient Dose Escalation Phase II Trial of Infliximab in Pediatric Patients With Refractory Juvenile Rheumatoid Arthritis	Juvenile Rheumatoid Arthritis	Drug: Infliximab	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	NULL	Terminated	N/A	N/A	Both	48	Phase 2	United States
173	NCT00246064 (ClinicalTrials.gov)	December 2001	28/10/2005	The Infliximab Rheumatoid Arthritis Methotrexate Tapering (iRAMT) Protocol	The Infliximab Rheumatoid Arthritis Methotrexate Tapering (iRAMT) Protocol. Tapering Methotrexate in Patients With Rheumatoid Arthritis Beginning Therapy With Infliximab	Arthritis, Rheumatoid	Drug: infliximab	Centocor Ortho Biotech Services, L.L.C.	NULL	Completed	18 Years	80 Years	Both	210	Phase 4	NULL
174	NCT00036387 (ClinicalTrials.gov)	October 2001	9/5/2002	A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Rheumatoid Arthritis.	A Randomized, Double-blind Trial of the Safety of Anti-TNF Chimeric Monoclonal Antibody (Infliximab) in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Rheumatoid Arthritis on Standard Disease-modifying Anti-Rheumatic Drug Background Therapy.	Arthritis, Rheumatoid	Drug: Infliximab	Centocor, Inc.	NULL	Completed	18 Years	N/A	Both	347	Phase 3	United States
175	NCT00036374 (ClinicalTrials.gov)	October 2001	9/5/2002	A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Juvenile Rheumatoid Arthritis	A Randomized, Double-Blind Trial of Anti-TNF Chimeric Monoclonal Antibody (Infliximab) in Combination With Methotrexate for the Treatment of Patients With Polyarticular Juvenile Rheumatoid Arthritis	Rheumatoid Arthritis, Juvenile	Drug: Infliximab	Centocor, Inc.	NULL	Completed	4 Years	18 Years	Both	123	Phase 3	United States
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
176	NCT00006292 (ClinicalTrials.gov)	September 2000	23/9/2000	Infliximab for the Treatment of Early Rheumatoid Arthritis	Randomized Double Blind Active Treatment Controlled Trial of the Anti-TNF-Alpha Antibody Infliximab in Patients With Erosive Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Infliximab	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	NULL	Completed	N/A	N/A	Both	60	Phase 2	United States
177	NCT00269867 (ClinicalTrials.gov)	March 1997	22/12/2005	Infliximab Plus Methotrexate for the Treatment of Rheumatoid Arthritis	A Placebo-Controlled, Double-Blinded, Randomized Clinical Trial of Anti-TNF Chimeric Monoclonal Antibody (cA2) in Patients With Active Rheumatoid Arthritis Despite Methotrexate Treatment	Rheumatoid Arthritis	Drug: Placebo;Drug: Infliximab 3 mg/kg;Drug: Infliximab 10 mg/kg	Centocor, Inc.	NULL	Completed	18 Years	75 Years	Both	428	Phase 3	NULL
178	JPRN-JapicCTI-050146		12/10/2005	Clinical Study to assess the efficacy and safety of increased dose of TA-650 in patients with Rheumatoid Arthritis	Clinical Study to assess the efficacy and safety of increased dose of TA-650 in patients with Rheumatoid Arthritis	Rheumatoid Arthritis	Intervention name : TA-650 (Infliximab) Dosage And administration of the intervention : Intravenous drip infusion	Mitsubishi Tanabe Pharma Corporation	NULL		20	75	BOTH		Phase 3	NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

JPRN-jRCTs071200007

01/01/2021

20/04/2020

Discontinuation of biosimilar infliximab in Japanese patients with rheumatoid arthritis achieving sustained clinical remission or low disease activity during the IFX SIRIUS STUDY I (the IFX-SIRIUS STUDY II): Study protocol for an interventional, multicenter ,open label, single arm clinical trial with clinical, ultrasound and biomarker assessments

Rheumatoid arthritis

Rheumatoid arthritis patients who have been treated with infliximab BS during IFX-SIRIUS STUDY I period and persisted with clinical remission or low disease activity discontinue infliximab BS.
If they have relapse after discontinuation of infliximab BS,infliximab BS will be re-administered.

Kawakami Atsushi

NULL

Recruiting

>= 20age old

Not applicable

Both

Phase 4

Japan

JPRN-jRCTs071190030

28/07/2020

11/10/2019

Switching from originator infliximab to biosimilar infliximab in Japanese patients with rheumatoid arthritis achieving clinical remission (the IFX-SIRIUS study I): Study protocol for an interventional, multicenter, open-label, single-arm and noninferiority clinical trial with clinical, ultrasound and biomarker assessments

Rheumatoid arthritis

Rheumatoid arthritis patients who have been treated with Remicade over 24 weeks and persisted with clinical remission are switched to infliximab BS from Remicade.
The dose and infusion intervals of infliximab BS are kept unchanged from those of Remicade.

Kawakami Atsushi

NULL

Recruiting

>= 20age old

Not applicable

Both

Phase 4

Japan

NCT04115423
(ClinicalTrials.gov)

April 1, 2020

2/10/2019

A Retrospective Cohort Study on the Risk of Serious Infections in Rheumatoid Arthritis Patients Receiving Tocilizumab

A Retrospective Cohort Study to Examine the Risk of Serious Infections in Rheumatoid Arthritis Patients Receiving Tocilizumab Compared With Tumor Necrosis Factor Inhibitors Using the National Health Insurance Database

Infection;Rheumatoid Arthritis

Drug: Tocilizumab;Drug: Tumor Necrosis Factor Inhibitor (etanercept, infliximab, adalimumab, and golimumab)

Sungkyunkwan University

Ministry of Food and Drug Safety, Korea

Active, not recruiting

18 Years

N/A

All

9508

Korea, Republic of

EUCTR2019-003700-12-FR
(EUCTR)

13/03/2020

04/06/2020

Association between metabolits of methotrexate and clinical response in rheumatoid arthritis patients

Association between methotrexate erythrocyte polyglutamate concentration and biological drug concentration and clinical response in rheumatoid arthritis patients treated with subcutaneous injectable methotrexate and a first biological drug

rheumatoid arthritis
MedDRA version: 21.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Methotrexate
Product Code: MTX
Other descriptive name: METHOTREXATE DISODIUM
Product Code: bDMARD
INN or Proposed INN: INFLIXIMAB
INN or Proposed INN: ETANERCEPT
INN or Proposed INN: ADALIMUMAB
INN or Proposed INN: CERTOLIZUMAB PEGOL
INN or Proposed INN: GOLIMUMAB

CHU Saint-Etienne

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

France

NCT03885037
(ClinicalTrials.gov)

March 20, 2019

4/3/2019

Infliximab Biosimilar for Intravenous Drip Infusion 100 mg Pfizer Drug Use Investigation (Rheumatoid Arthritis)

Infliximab BS for Intravenous Drip Infusion 100 mg Pfizer General Investigation (Rheumatoid Arthritis)

Rheumatoid Arthritis

Drug: Infliximab [infliximab biosimilar 3]

Pfizer

NULL

Recruiting

N/A

All

300

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2018-002368-18-ES
(EUCTR)

25/07/2018

Phase IV, open, low-level intervention, clinical trial to compare the immunogenicity inimmunosuppressed patients of an adjuvanted anti-hepatitis B vaccine with an anti-hepatitis Bvaccine with increased antigenic load

1. Autoinmune rheumatic diseases undertreated by rituximab or infliximab.2. breast and lung cancer undertreated by chemotherapy3. HIV4. Haematopoietic progenitor cell transplantation (TCPH).
MedDRA version: 20.0;Level: PT;Classification code 10006187;Term: Breast cancer;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
MedDRA version: 20.0;Classification code 10058467;Term: Lung neoplasm malignant;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 20.1;Classification code 10020161;Term: HIV infection;System Organ Class: 10021881 - Infections and infestations
MedDRA version: 20.0;Classification code 10063581;Term: Stem cell transplant;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Fendrix suspension for injection
Product Name: Fendrix
Product Code: Fendrix
INN or Proposed INN: Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed).
Other descriptive name: HEPATITIS B VACCINE (RDNA)
Trade Name: HBVAXPRO 5 micrograms/0.5 ml
Product Name: HBVAXPRO® 40 micrograms
Product Code: HBVAXPRO® 40 micrograms
INN or Proposed INN: HBVAXPRO 5 micrograms/0.5 ml Suspension for injection Hepatitis B vaccine (rDNA)
Other descriptive name: HEPATITIS B VIRUS SURFACE ANTIGEN RECOMBINANT (S PROTEIN)

FUNDACIÓ HOSPITAL UNIVERSITARI VALL D’HEBRON – INSTITUT DE RECERCA (VHIR)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

740

Phase 4

Spain

NCT03100253
(ClinicalTrials.gov)

March 1, 2018

17/3/2017

Rheumatoid Arthritis Treatment After First Anti-TNF INvestiGation

Open-label, Randomized Controlled Trial Comparing Tocilizumab to Anti-TNF Treatment and Discovery of Biomarkers for Treatment Selection in Rheumatoid Arthritis Patients With Inadequate Response to a First Anti-TNF

Rheumatoid Arthritis

Drug: Tocilizumab;Drug: Etanercept;Drug: Infliximab;Drug: Adalimumab;Drug: Golimumab;Drug: Certolizumab Pegol

Mario Negri Institute for Pharmacological Research

NULL

Recruiting

18 Years

N/A

All

208

Phase 4

Italy

NCT04178850
(ClinicalTrials.gov)

October 13, 2017

25/11/2019

Clinical Comparative Study to Evaluate the Efficacy and Safety of Recombinant Anti-TNF-alpha Antibodies for Injection

A Randomized, Double-blind, Multi-center Phase ? Comparative Study to Evaluate the Efficacy and Safety of Recombinant Human-mouse Chimeric Anti-TNF-alpha Monoclonal Antibody for Injection.

Rheumatoid Arthritis

Biological: GB242;Biological: Infliximab

Genor Biopharma Co., Ltd.

NULL

Recruiting

18 Years

45 Years

All

568

Phase 3

China

EUCTR2016-001064-11-GB
(EUCTR)

18/07/2017

31/03/2017

Efficacy and safety study of Remicade® (infliximab) and NI-071 (a proposed infliximab biosimilar) for the treatment of patients with rheumatoid arthritis

A Randomized, Double-Blind, Multicenter, 3-Stage, Efficacy and Safety Study of NI-071 and US-Licensed Remicade® (Infliximab) for the Treatment of Patients with Rheumatoid Arthritis

Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Nichi-Iko Pharmaceutical Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

585

Phase 3

United States;Czech Republic;Puerto Rico;Poland;Spain;Ukraine;Russian Federation;United Kingdom

EUCTR2016-002125-11-ES
(EUCTR)

06/07/2017

08/05/2017

Evaluating efficacy, pharmacokinetics and safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis

A Randomized, Parallel-Group, Phase I/III Study to Evaluate Efficacy, Pharmacokinetics and Safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis

Active Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: REMSIMA
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB

Celltrion, Inc

NULL

Not Recruiting

Female: yes
Male: yes

258

Phase 1;Phase 3

Lithuania;Russian Federation;Chile;Italy;Czech Republic;Hungary;Mexico;Poland;Belgium;Peru;South Africa;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of;Estonia;Slovakia;Spain;Ukraine

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2016-001064-11-CZ
(EUCTR)

20/04/2017

31/03/2017

Efficacy and safety study of Remicade® (infliximab) and NI-071 (a proposed infliximab biosimilar) for the treatment of patients with rheumatoid arthritis

A Randomized, Double-Blind, Multicenter, 3-Stage, Efficacy and Safety Study of NI-071 and US-Licensed Remicade® (Infliximab) for the Treatment of Patients with Rheumatoid Arthritis

Nichi-Iko Pharmaceutical Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

585

Phase 3

United States;Czech Republic;Puerto Rico;Poland;Spain;Ukraine;Russian Federation;United Kingdom

EUCTR2016-001064-11-PL
(EUCTR)

13/04/2017

12/04/2017

Efficacy and safety study of Remicade® (infliximab) and NI-071 (a proposed infliximab biosimilar) for the treatment of patients with rheumatoid arthritis

A Randomized, Double-Blind, Multicenter, 3-Stage, Efficacy and Safety Study of NI-071 and US-Licensed Remicade® (Infliximab) for the Treatment of Patients with Rheumatoid Arthritis

Nichi-Iko Pharmaceutical Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

585

Phase 3

United States;Czech Republic;Puerto Rico;Spain;Poland;Ukraine;Russian Federation;United Kingdom

EUCTR2016-001064-11-ES
(EUCTR)

07/04/2017

Efficacy and safety study of Remicade® (infliximab) and NI-071 (a proposed infliximab biosimilar) for the treatment of patients with rheumatoid arthritis

A Randomized, Double-Blind, Multicenter, 3-Stage, Efficacy and Safety Study of NI-071 and US-Licensed Remicade® (Infliximab) for the Treatment of Patients with Rheumatoid Arthritis

Rheumatoid Arthritis
MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Nichi-Iko Pharmaceutical Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

585

Phase 3

United States;Czech Republic;Puerto Rico;Poland;Spain;Ukraine;Russian Federation;United Kingdom

NCT03348046
(ClinicalTrials.gov)

March 23, 2017

16/11/2017

Safety Study of Remsima® (Infliximab) in Rheumatoid Arthritis Patients in Jordan

Post-Authorization Safety Study of Remsima® (Infliximab) in Rheumatoid Arthritis Patients in Jordan

Rheumatoid Arthritis

Drug: Biosimilar Infliximab

Hikma Pharmaceuticals LLC

Syneos Health

Completed

18 Years

N/A

All

Jordan

EUCTR2014-004704-29-DE
(EUCTR)

19/12/2016

23/08/2016

This trial is designed to determine what effects the human body has on the investigational medicine, ABP 710, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, infliximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.

A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable

Rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 3

United States;Hungary;Czech Republic;Canada;Poland;Spain;Romania;Australia;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2014-004704-29-CZ
(EUCTR)

15/12/2016

02/08/2016

A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable

Rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: ABP 710
Product Code: ABP 710
INN or Proposed INN: ABP 710
Other descriptive name: ABP 710 - Biosimilar to infliximab
Trade Name: Remicade
Product Name: infliximab
INN or Proposed INN: INFLIXIMAB

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 3

United States;Hungary;Czech Republic;Canada;Poland;Spain;Romania;Australia;Bulgaria;Germany

NCT03016260
(ClinicalTrials.gov)

December 2016

4/1/2017

RABIOPRED - a Validation Study of Theranostic Test to PREDict Treatment Response of Anti-TNFa BIologicals in Rheumatoid Arthritis

Proof-of-Performance Study of RABIOPRED Assay as an In Vitro Diagnostic Test to Identify Patients With Rheumatoid Arthritis Who Are Unlikely to Show Response to 1st Treatment With Anti-TNFa and Methotrexate Combination.

RheumatoId Arthritis

Biological: Infliximab;Biological: Adalimumab;Biological: Etanercept;Biological: Golimumab;Biological: Certolizumab Pegol;Biological: Infliximab biosimilar;Biological: Etanercept biosimilar

TcLand Expression S.A.

European Commission

Terminated

18 Years

N/A

All

250

Czechia;France;Israel;Netherlands;Turkey;Czech Republic

NCT02990806
(ClinicalTrials.gov)

December 2016

21/11/2016

A Phase 3 Study of NI-071 in Patients With Rheumatoid Arthritis (RADIANCE)

A Randomized, Double-Blind, Multicenter, 3 Stage, Efficacy and Safety Study of NI-071 and US-Licensed Remicade® (Infliximab) for the Treatment of Patients With Rheumatoid Arthritis

Rheumatoid Arthritis (RA)

Biological: NI-071;Biological: Infliximab

Nichi-Iko Pharmaceutical Co., Ltd.

NULL

Completed

18 Years

75 Years

All

683

Phase 3

United States;Czechia;Poland;Puerto Rico;Russian Federation;Spain;Ukraine;United Kingdom

EUCTR2014-004704-29-BG
(EUCTR)

29/11/2016

15/09/2016

A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 3

United States;Hungary;Czech Republic;Canada;Poland;Spain;Romania;Australia;Bulgaria;Germany

EUCTR2014-004704-29-PL
(EUCTR)

25/11/2016

04/10/2016

A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable

Rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 3

United States;Hungary;Czech Republic;Canada;Spain;Poland;Romania;Australia;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2016-002061-54-IT
(EUCTR)

13/10/2016

15/11/2018

Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases.

Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases.Evaluation of immunogenicity and clinical response - Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®)

Rheumatoid arthritis, seronegative spondylo arthritis,Crohn's Disease, Ulcerative Colitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Classification code 10039073;Term: Rheumatoid arthritis;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Classification code 10075634;Term: Acute haemorrhagic ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: REMSIMA - 100 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLANCONCINO (VETRO) - 1 FLACONCINO
Product Name: Remsima
Product Code: 42942019

UNIVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLI

NULL

Not Recruiting

Female: yes
Male: yes

250

Phase 4

Italy

NCT02937701
(ClinicalTrials.gov)

October 10, 2016

30/8/2016

Study to Assess if ABP710 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis Compared to Infliximab

A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects With Moderate to Severe Rheumatoid Arthritis

Arthritis, Rheumatoid

Biological: ABP 710;Biological: Infliximab

Amgen

NULL

Completed

18 Years

80 Years

All

558

Phase 3

United States;Australia;Bulgaria;Canada;Czechia;Germany;Hungary;Poland;Spain;Czech Republic

EUCTR2014-004704-29-HU
(EUCTR)

05/10/2016

08/08/2016

A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable

Rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 3

United States;Czech Republic;Hungary;Canada;Poland;Spain;Romania;Australia;Bulgaria;Germany

EUCTR2014-004704-29-ES
(EUCTR)

03/10/2016

05/08/2016

A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable

Rheumatoid arthritis
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 3

United States;Hungary;Czech Republic;Canada;Poland;Spain;Romania;Australia;Bulgaria;Germany

EUCTR2014-004904-31-BE
(EUCTR)

21/09/2016

29/07/2016

A clinical study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission.

An open-label, multicentre, phase IV study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission.

Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA).;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Remsima (infliximab)

Mundipharma Pharmaceuticals B.V.

NULL

Not Recruiting

Female: yes
Male: yes

156

Phase 4

Belgium;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2016-002125-11-HU
(EUCTR)

08/09/2016

11/07/2016

Evaluating efficacy, pharmacokinetics and safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis

A Randomized, Parallel-Group, Phase I/III Study to Evaluate Efficacy, Pharmacokinetics and Safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis

Active Rheumatoid Arthritis
MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: REMSIMA
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB

Celltrion, Inc

NULL

Not Recruiting

Female: yes
Male: yes

258

Phase 1;Phase 3

Estonia;Slovakia;Spain;Ukraine;Lithuania;Russian Federation;Chile;Italy;Hungary;Czech Republic;Mexico;Poland;Belgium;Peru;South Africa;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of

JPRN-UMIN000021929

2016/06/01

15/04/2016

Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis

Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis - OPTIWIT Study

Rheumatoid arthritis

Discontinuation of infliximab

Chiba University

NULL

Complete: follow-up continuing

18years-old

Not applicable

Male and Female

200

Not selected

Japan

JPRN-jRCTs031180001

30/05/2016

12/06/2018

Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis

Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis - OPTIWIT

Rheumatoid arthritis

Infliximab Withdrawal

Ikeda Kei

NULL

Not Recruiting

>= 18age old

Not applicable

Both

200

Phase 4

Japan

NCT02770794
(ClinicalTrials.gov)

May 2016

11/5/2016

Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis

Multicenter Prospective Trial to Investigate Accuracy of Ultrasound to Predict Relapse After Discontinuation of Infliximab and Efficacy/Safety of Readministration of Infliximab in Patients With Rheumatoid Arthritis in Low Disease Activity

Arthritis, Rheumatoid

Drug: Infliximab

Chiba University

NULL

Not yet recruiting

18 Years

N/A

Both

200

Phase 4

NULL

JPRN-UMIN000021492

2016/03/01

20/03/2016

To investigate the safety of switch from infliximab biosimilar 1 in rheumatoid arthritis patients.

Rheumatoid arthritis

switch from infliximab to infliximab biosimilar 1 in rheumatoid arthritis patients.

Inoue Hospital

NULL

Complete: follow-up complete

18years-old

Not applicable

Male and Female

Not selected

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT02728934
(ClinicalTrials.gov)

February 25, 2016

31/3/2016

Comparative and Pragmatic Study of Golimumab Intravenous (IV) (Simponi Aria) Versus Infliximab (Remicade) in Rheumatoid Arthritis

Comparative and Pragmatic Study of Simponi Aria Versus Remicade in Rheumatoid Arthritis

Arthritis, Rheumatoid

Biological: Golimumab Intravenous (IV);Biological: Infliximab;Biological: Biosimilar Infliximab

Janssen Scientific Affairs, LLC

NULL

Completed

18 Years

N/A

All

1279

United States

NCT02683564
(ClinicalTrials.gov)

February 2016

9/2/2016

BOW015 (Infliximab-EPIRUS) and Infliximab in Patients With Active Rheumatoid Arthritis: The UNIFORM Study

A Study of BOW015 (Infliximab-EPIRUS) and Infliximab in Patients With Active Rheumatoid Arthritis on Stable Methotrexate: The UNIFORM Study

Rheumatoid Arthritis

Drug: BOW015;Drug: Remicade

Epirus Biopharmaceuticals (Switzerland) GmbH

NULL

Not yet recruiting

18 Years

80 Years

Both

548

Phase 3

NULL

NCT02878161
(ClinicalTrials.gov)

January 2016

12/7/2016

Predictability Studies on the Efficacy of TNF-a Inhibitors in Chinese RA From Real World

Screening Protein Predictive of Response to Tumor Necrosis Factor-a Inhibitors Treatment in Chinese Rheumatoid Arthritis From Real World and Investigating Its Mechanism Through Signal Pathway

Rheumatoid Arthritis

Drug: methotrexate(necessary);Biological: infliximab;Biological: etanercept;Biological: adalimumab;Drug: leflunomide (permitted, not necessary);Drug: NSAIDs (permitted,not necessary);Drug: Glucocorticoids (permitted,not necessary)

Fen Li

NULL

Enrolling by invitation

18 Years

75 Years

Both

240

Phase 4

NULL

EUCTR2015-004173-32-DK
(EUCTR)

18/12/2015

20/10/2015

Personalized medicine: Administration of TNF-alpha inhibitor treatment due to serum concentration measuring.

Personalized medicine: Administration of TNF-alpha inhibitor treatment due to serum concentration measuring. A randomized and investigator initiated study.

Rheumatic diseases
MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000005156;Therapeutic area: Body processes [G] - Immune system processes [G12]

Trade Name: Enbrel
INN or Proposed INN: ETANERCEPT
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Remsima
INN or Proposed INN: INFLIXIMAB
Trade Name: Benepali
INN or Proposed INN: ETANERCEPT
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB

Department of Clinical Biochemestry, Aarhus University Hospital

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 4

Denmark

EUCTR2015-000581-58-CZ
(EUCTR)

14/10/2015

16/06/2015

A Randomized,Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action

A Randomized, Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action - BioBio

Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Orencia
Product Name: Orencia
INN or Proposed INN: ABATACEPT
Trade Name: Ro-Actemra
Product Name: Ro Actemra
INN or Proposed INN: tocilizumabum
Other descriptive name: TOCILIZUMAB
Trade Name: Mabthera
Product Name: Mabthera
INN or Proposed INN: RITUXIMAB

Revmatologicky ustav Praha

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Czech Republic

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2015-002284-42-FI
(EUCTR)

18/09/2015

28/08/2015

The rationale for this study is to gain insight in the extent and impact of immunogenicityof TNF inhibitors in the European daily clinical practice. Furthermore, an European widedatabase will give insight in factors influencing immunogenicity and treatment outcomein terms of disease activit

INTENT: immunogenicity in patients failing response on anti-TNF-Immunogenicity and pharmacokinetics in patients failing torespond to TNF inhibitors (phase 1);-Clinical effectiveness of subsequent TNF inhibitor treatment andpredictive value of pharmacokinetics and immunogenicity (phase2) - INTENT

rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and psoriasis.;Therapeutic area: Not possible to specify

Trade Name: Enbrel
Product Name: etanercept
Trade Name: Humira
Product Name: adalimumab
Trade Name: Cimzia
Product Name: certolizumab pegol
Trade Name: Simponi
Product Name: golimumab
Trade Name: Remicade
Product Name: infliximab

READE

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1650

Phase 1

Finland

NCT02605642
(ClinicalTrials.gov)

September 10, 2015

2/9/2015

Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Rheumatoid Diseases Who Are Naïve To Biologics Or Switched From Remicade

PERSIST: PROSPECTIVE OBSERVATIONAL COHORT STUDY TO ASSESS PERSISTENCE OF CT-P13 (INFLIXIMAB) IN PATIENTS WITH RHEUMATOID DISEASES WHO ARE EITHER NAIVE TO BIOLOGICS OR SWITCHED FROM STABLE REMICADE(R) (INFLIXIMAB)

Rheumatoid Diseases;Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis

Drug: CT-P13

Pfizer

Hospira, now a wholly owned subsidiary of Pfizer

Completed

18 Years

N/A

All

351

Bulgaria;Canada;Czechia;Germany;Greece;Spain;United Kingdom;Czech Republic;France;Italy

EUCTR2014-004904-31-NL
(EUCTR)

19/05/2015

26/01/2015

Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA).;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Remsima (infliximab)

Mundipharma Pharmaceuticals B.V.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Netherlands

JPRN-UMIN000016950

2015/03/27

03/04/2015

Clinical outcome in patients with rheumatoid arthritis switched to tumor nesrosis factor blockers after tocilizumab or abatacept

rheumatoid arthritis

Infliximab or adalimumab or golimumab

Osaka Medical College

NULL

Complete: follow-up complete

20years-old

Not applicable

Male and Female

Not selected

Japan

EUCTR2013-004148-49-FR
(EUCTR)

23/02/2015

18/06/2015

RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS

A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE

Rheumatoid Arthritis
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Infliximab-Pfizer
Product Code: PF-06438179
INN or Proposed INN: INFLIXIMAB
Other descriptive name: Infliximab-Pfizer
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Other descriptive name: Infliximab-EU

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

614

Phase 3

United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Bulgaria;Georgia;Germany;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2013-004148-49-PL
(EUCTR)

21/10/2014

27/08/2014

RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS

Rheumatoid Arthritis
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

614

Phase 3

EUCTR2013-004148-49-BG
(EUCTR)

20/10/2014

01/09/2014

RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS

Rheumatoid Arthritis
MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

614

Phase 3

Japan;Bulgaria;Germany;United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Georgia

NCT02148640
(ClinicalTrials.gov)

October 2014

23/5/2014

The NOR-SWITCH Study

A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SWITCHING FROM INNOVATOR INFLIXIMAB TO BIOSIMILAR INFLIXIMAB COMPARED WITH CONTINUED TREATMENT WITH INNOVATOR INFLIXIMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS, SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, ULCERATIVE COLITIS, CROHN'S DISEASE AND CHRONIC PLAQUE PSORIASIS THE NOR-SWITCH STUDY

Rheumatoid Arthritis;Spondyloarthritis;Psoriatic Arthritis;Ulcerative Colitis;Crohn's Disease;Psoriasis Chronic

Drug: Innovator infliximab;Drug: Biosimilar infliximab

Diakonhjemmet Hospital

South-Eastern Norway Regional Health Authority

Completed

18 Years

N/A

All

482

Phase 4

Norway

NCT02222493
(ClinicalTrials.gov)

August 26, 2014

19/8/2014

A Study of PF-06438179 (Infliximab-Pfizer) and Infliximab in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis (REFLECTIONS B537-02).

A Phase 3 Randomized, Double-blind Study Assessing The Efficacy And Safety Of Pf-06438179 And Infliximab In Combination With Methotrexate In Subjects With Moderately To Severely Active Rheumatoid Arthritis Who Have Had An Inadequate Response To Methotrexate

Rheumatoid Arthritis

Biological: PF-06438179;Biological: Infliximab

Pfizer

NULL

Completed

18 Years

N/A

All

650

Phase 3

United States;Australia;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Czechia;Georgia;Germany;Guatemala;Hungary;Israel;Japan;Jordan;Korea, Republic of;Lithuania;Mexico;Morocco;Peru;Philippines;Poland;Romania;Russian Federation;Serbia;South Africa;Tunisia;Ukraine;United Kingdom;Colombia;Czech Republic;France

EUCTR2013-004148-49-HU
(EUCTR)

13/08/2014

06/06/2014

RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

614

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2014-002056-40-NO
(EUCTR)

12/08/2014

13/06/2014

A study to evaluate the safety and efficacy of switching from regular infliximab to biosimilar infliximab in patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn's disease and psoriasis

A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SWITCHING FROM INNOVATOR INFLIXIMAB TO BIOSIMILAR INFLIXIMAB COMPARED WITH CONTINUED TREATMENT WITH INNOVATOR INFLIXIMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS, SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, ULCERATIVE COLITIS, CROHN’S DISEASEAND CHRONIC PLAQUE PSORIASISTHE NOR-SWITCH STUDY - NOR_SWITCH

Rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn’s disease and chronic plaque psoriasis
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 18.0;Level: LLT;Classification code 10071117;Term: Plaque psoriasis;System Organ Class: 100000004858
MedDRA version: 18.0;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 18.0;Classification code 10045365;Term: Ulcerative colitis;Classification code 10002556;Term: Ankylosing spondylitis;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Remicade 100 mg pulver til konsentrat til infusjonsvæske, oppløsning
Trade Name: Remsima 100 mg pulver til konsentrat til infusjonsvæske, oppløsning

Diakonhjemmet Hospital AS

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Norway

EUCTR2013-004148-49-DE
(EUCTR)

28/07/2014

06/06/2014

RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS

Rheumatoid Arthritis
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

614

Phase 3

Japan;United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Bulgaria;Georgia;Germany

EUCTR2013-004148-49-LT
(EUCTR)

14/07/2014

23/05/2014

RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

614

Phase 3

Poland;Brazil;Bulgaria;Georgia;Germany;Japan;United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina

EUCTR2013-004148-49-GB
(EUCTR)

03/07/2014

06/06/2014

RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS

Rheumatoid Arthritis
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

614

Phase 3

JPRN-UMIN000014311

2014/06/24

24/06/2014

Examination of the clinical remission and functional remission in Infliximab using the increase-in-quantity protocol to TNF-alpha inhibitory drug resistance rheumatoid arthritis

rheumatoid arthritis

The quantity of Infliximab is increased.

Institute of Health Biosciences,The University of Tokushima Graduate School

NULL

Pending

20years-old

75years-old

Male and Female

Not selected

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2013-004148-49-CZ
(EUCTR)

20/06/2014

05/06/2014

RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

614

Phase 3

JPRN-UMIN000016844

2014/02/07

20/03/2015

The clinical study for seeking strategy how to treat rheumatoid arthritis by TNF Inhibitors

Rheumatoid arthritis

infliximab: standard strategy
infliximab: aggressive strategy
golimumab: standard strategy
golimumab: aggressive strategy

Takarazuka city hospital

NULL

Recruiting

20years-old

90years-old

Male and Female

Not applicable

Japan

NCT01962974
(ClinicalTrials.gov)

October 2013

11/10/2013

A Golimumab Phase 3b, Multicenter, Assessment of Intravenous Efficacy in Rheumatoid Arthritis Subjects Who Have Diminished Disease Control Despite Treatment With Infliximab (REMICADE®)

Arthritis, Rheumatoid

Biological: Golimumab 2 mg/kg IV

Janssen Biotech, Inc.

NULL

Terminated

18 Years

76 Years

All

Phase 3

United States;Canada;Argentina;Brazil;Colombia;Mexico

EUCTR2012-005733-37-GB
(EUCTR)

18/09/2013

23/07/2013

A Study Comparing SB2 to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis

A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy

Rheumatoid Arthritis
MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: SB2 (infliximab biosimilar)
Product Code: SB2
INN or Proposed INN: INFLIXIMAB
Trade Name: Remicade®
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB

Samsung Bioepis Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

584

Phase 3

Philippines;Ukraine;Lithuania;United Kingdom;India;Czech Republic;Mexico;Poland;Romania;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of

NCT01783015
(ClinicalTrials.gov)

September 2013

31/1/2013

Study of Etanercept in Subjects With Rheumatoid Arthritis Who Have Had an Inadequate Response to Adalimumab or Infliximab Plus Methotrexate

A Randomized, Double-blind, Placebo-controlled Study Of The Safety And Efficacy Of Etanercept In Subjects With Rheumatoid Arthritis Who Have Had An Inadequate Response To Adalimumab Or Infliximab Plus Methotrexate

Rheumatoid Arthritis

Drug: Etanercept;Drug: Placebo

Pfizer

NULL

Terminated

18 Years

79 Years

All

Phase 4

Australia;Belgium;France;Hong Kong;Israel;Russian Federation;Spain;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2012-005733-37-CZ
(EUCTR)

16/08/2013

15/05/2013

A Study Comparing SB2 to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis

Rheumatoid Arthritis
MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: SB2 (infliximab biosimilar)
Product Code: SB2
INN or Proposed INN: INFLIXIMAB
Trade Name: Remicade®
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB

Samsung Bioepis Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

584

Phase 3

Philippines;Ukraine;Lithuania;United Kingdom;India;Czech Republic;Mexico;Poland;Romania;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of

EUCTR2012-005733-37-LV
(EUCTR)

02/08/2013

22/05/2013

A Study Comparing SB2 to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis

Rheumatoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: SB2 (infliximab biosimilar)
Product Code: SB2
INN or Proposed INN: INFLIXIMAB
Trade Name: Remicade®
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB

Samsung Bioepis Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

584

Philippines;Ukraine;Lithuania;United Kingdom;India;Czech Republic;Mexico;Poland;Romania;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of

NCT01936181
(ClinicalTrials.gov)

August 2013

2/9/2013

A Study Comparing SB2 to Remicade® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy

A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy

Rheumatoid Arthritis

Drug: Remicade (infliximab);Drug: SB2 (proposed biosimilar to infliximab)

Samsung Bioepis Co., Ltd.

NULL

Completed

18 Years

75 Years

All

584

Phase 3

Bulgaria;Lithuania

NCT01915537
(ClinicalTrials.gov)

August 2013

30/7/2013

Infliximab and Classic DMARDs in the Rheumatoid Arthritis Patients

A Prospective Cohort Study to Observe the Difference of Efficacy Between Infliximab With Methotrexate and Classic DMARDs in the Severe Rheumatoid Arthritis Patients With Poor Prognosis

Rheumatoid Arthritis(RA)

Drug: Infliximab group;Drug: Classic DMARDs treatment group

Zhang, Xiao, M.D.

Central South University;Tianjin Medical University General Hospital;Xijing Hospital

Not yet recruiting

18 Years

70 Years

Both

170

N/A

China

EUCTR2012-005733-37-LT
(EUCTR)

11/07/2013

20/05/2013

A Study Comparing SB2 to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis

Product Name: SB2 (infliximab biosimilar)
Product Code: SB2
INN or Proposed INN: INFLIXIMAB
Trade Name: Remicade®
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB

Samsung Bioepis Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

584

Philippines;Ukraine;Lithuania;United Kingdom;India;Czech Republic;Mexico;Poland;Romania;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2012-005733-37-BG
(EUCTR)

10/07/2013

21/05/2013

A Study Comparing SB2 to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis

Product Name: SB2 (infliximab biosimilar)
Product Code: SB2
INN or Proposed INN: INFLIXIMAB
Trade Name: Remicade®
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB

Samsung Bioepis Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

584

Phase 3

Philippines;Ukraine;Lithuania;United Kingdom;India;Czech Republic;Mexico;Poland;Romania;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of

EUCTR2012-003644-71-BE
(EUCTR)

08/07/2013

06/02/2013

Randomized, Double-Blind, Placebo-Controlled Trial of etanercept plus methotrexate in monoclonal antibody (mAb) anti-TNF failure

A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Etanercept in Subjects with Rheumatoid Arthritis Who Have Had and Inadequate Response to Adalimumab or Infliximab Plus Methotrexate.

Rheumatoid Arthritis
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Enbrel
Product Name: Enbrel
INN or Proposed INN: ETANERCEPT

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 4

France;Hong Kong;Spain;Poland;Belgium;Australia;Russian Federation;Israel;Chile;Netherlands;Colombia;New Zealand

NCT01927263
(ClinicalTrials.gov)

July 2013

9/8/2013

A Phase 3 Study of NI-071 in Patients With Rheumatoid Arthritis

A Phase 3 Clinical Study of NI-071 in Patients With Rheumatoid Arthritis ?A Double-blind, Active Drug-controlled Study and Long-term Study?

Rheumatoid Arthritis

Biological: NI-071;Biological: Infliximab

Nichi-Iko Pharmaceutical Co.,Ltd.

NULL

Completed

20 Years

75 Years

Both

242

Phase 3

Japan

EUCTR2012-004482-40-ES
(EUCTR)

18/06/2013

16/05/2013

Evaluation of a protocol for the reduction of doses in patients with rheumatoid arthritis (RA) in clinical remission in treatment with biological therapies

Evaluation of the clinical utility of a standardized protocol of strategies for the reduction of doses in patients with rheumatoid arthritis (RA) in persistent clinical remission in treatment with biological therapies: open, controlled study and randomized.

Evaluation of the clinical utility of a standardized protocol of strategies for the reduction of doses in patients with rheumatoid arthritis in clinical remission at treatment with biologic therapies;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Infliximab
INN or Proposed INN: INFLIXIMAB
Trade Name: HUMIRA
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: ENBREL
Product Name: Etanercept
INN or Proposed INN: ETANERCEPT
Trade Name: CIMZIA
Product Name: Certolizumab Pegol
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: SIMPONI
Product Name: Golimumab
INN or Proposed INN: GOLIMUMAB
Trade Name: ORENCIA
Product Name: Abatacept
INN or Proposed INN: ABATACEPT
Trade Name: RoActemra
Product Name: Tocilizumab
INN or Proposed INN: TOCILIZUMAB
Product Name: Infliximab
INN or Proposed INN: INFLIXIMAB

FRANCISCO J. BLANCO GARCÍA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Spain

NCT02132234
(ClinicalTrials.gov)

June 2013

28/4/2014

Effects of Biological Treatment on Blood Pressure and Endothelial Function in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis

Rheumatoid Arthritis;Psoriatic Arthritis;Ankylosing Spondylitis;Hypertension

Drug: Etanercept;Drug: Adalimumab;Drug: Certolizumab;Drug: Infliximab

Jagiellonian University

Departmet of Rheumatology, J Dietl Hospital, Krakow, Poland

Recruiting

18 Years

N/A

Both

100

Phase 4

Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

JPRN-UMIN000009887

2013/04/01

01/04/2013

Associations between the initial concentration of serum TNF alpha and effects due to increasing a dose of Infliximab, and between effects of infliximab and the concentration of serum IL-6

Rheumatoid Arthritis

When 3mg/kg of infliximab brings poor results to RA patients, we will change a dose of infliximab according to the initial concentration of serum TNF alpha.
If the initial concentration of serum TNF alpha is less than 1.1 pg/ml, we will raise the dose of infliximab to 6 mg/kg.
When 3mg/kg of infliximab brings poor results to RA patients, we will change a dose of infliximab according to the initial concentration of serum TNF alpha.
If the initial concentration of serum TNF alpha is more than 1.1 pg/ml, we will raise the dose of infliximab to 10 mg/kg.

Department of Orthopaedic surgery, Tohoku University Hospital

NULL

Complete: follow-up complete

20years-old

Not applicable

Male and Female

100

Not applicable

Japan

EUCTR2012-003644-71-ES
(EUCTR)

12/03/2013

21/12/2012

Randomized, Double-Blind, Placebo-Controlled Trial of etanercept plus methotrexate in monoclonal antibody (mAb) anti-TNF failure

Trade Name: Enbrel
Product Name: Enbrel
INN or Proposed INN: ETANERCEPT

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

168

France;Hong Kong;Czech Republic;Spain;Australia;Israel;Chile;Russian Federation;Netherlands;Germany;Colombia

EUCTR2012-003644-71-NL
(EUCTR)

07/01/2013

Randomized, Double-Blind, Placebo-Controlled Trial of etanercept plus methotrexate in monoclonal antibody (mAb) anti-TNF failure

Trade Name: Enbrel
Product Name: Enbrel
INN or Proposed INN: ETANERCEPT

Pfizer Inc., 235 EAst 42nd Street, New York, NY 10017, United States

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

120

France;Hong Kong;Spain;Belgium;Australia;Russian Federation;Israel;Chile;Colombia;Netherlands

NCT01793519
(ClinicalTrials.gov)

January 2013

14/2/2013

Stopping TNF Alpha Inhibitors in Rheumatoid Arthritis

Stopping Tumor Necrosis Factor-Alpha Inhibitors in Rheumatoid Arthritis (STARA) Clinical Trial

Rheumatoid Arthritis

Drug: Etanercept;Drug: Infliximab;Drug: Adalimumab;Drug: Placebo

Georgetown University

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS);University of Maryland, College Park;Washington D.C. Veterans Affairs Medical Center;Medstar Health Research Institute;Patient-Centered Outcomes Research Institute;Arthritis and Pain Associates of PG County;Arthritis & Rheumatism Associates, P.C.;Rheumatology Associates of Baltimore, L.L.C.;The Arthritis Clinic of Northern Virginia, P.C.;Arthritis and Rheumatic Disease Associates, P.C.

Recruiting

18 Years

N/A

All

290

Phase 4

United States

JPRN-UMIN000015297

2012/09/19

01/10/2014

The feasibility study of accelated infliximab infusion from initial administration

The feasibility study of accelated infliximab infusion from initial administration - The feasibility study of accelated infliximab infusion from initial administration

patient in whom infliximab is indicated(rheumatoid arthritis, Crohn's disease, Ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis)

Administration of intravenous infliximab infusion with 60 min accelated procedure for patients who are already successfully treated with usual 2hr infuion without infusion reaction. The tolerable patient continue to receive more five treatment with 60min procedure.

Chiba University Hospital

NULL

Recruiting

20years-old

70years-old

Male and Female

Phase 2

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2011-005204-15-AT
(EUCTR)

20/06/2012

15/05/2012

Could ultrasound help to identify the patients with rheumatoid arthritis, in those the treatment with biological DMARDs could be stopped?

Ultrasound as biomarker for withdrawal of biological DMARDs in rheumatoid arthritis (RA-BioStop) - RABioStop

biological DMARDs may be stopped in RA patients treated with a combination of synthetic DMARD plus biological DMARDs which are in persistent clinical remission. Ultrasound may be useful to predict a disease flare in patients stopping biological DMARDs therapy.
MedDRA version: 20.0;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Enbrel
INN or Proposed INN: ETANERCEPT
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Cimzia
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Simponi
INN or Proposed INN: GOLIMUMAB
Trade Name: Roactemra
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
Trade Name: Orncia
INN or Proposed INN: ABATACEPT
Trade Name: Roactemra
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
Trade Name: Orncia
INN or Proposed INN: ABATACEPT

Med Uni Graz, Univ. Klinik Innere Medizin,Abt. Rheumatologie und Immunologie

NULL

Not Recruiting

Female: yes
Male: yes

110

Phase 4

Austria

JPRN-UMIN000008281

2012/06/01

28/06/2012

Dose-escalation study of infliximab or methotrexate based on the disease activity in patients with rheumatoid arthritis treated with infliximab

rheumatoid arthritis

Dose-escalation of MTX or IFX

Department of Internal Medicien and Rheumatology, Juntendo University School of Medicine

NULL

Recruiting

20years-old

Not applicable

Male and Female

Not selected

Japan

JPRN-UMIN000007806

2012/06/01

01/05/2012

The feasibility study of accelated infliximab infusion during maintenance phase

patient in whom infliximab is indicated(rheumatoid arthritis, Crohn's disease, Ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis)

Chiba University Hospital

NULL

Complete: follow-up complete

Not applicable

Male and Female

Phase 2

Japan

NCT01602302
(ClinicalTrials.gov)

June 2012

16/5/2012

Ultrasound and Withdrawal of Biological DMARDs in Rheumatoid Arthritis

Ultrasound as Biomarker for Withdrawal of Biological DMARDs in Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: bDMARD withdrawal (etanercept, adalimumab, infliximab, certolizumab, golimumab, tozilizumab, abatacept)

Medical University of Graz

NULL

Terminated

18 Years

90 Years

All

Phase 4

Austria

EUCTR2012-000139-21-AT
(EUCTR)

14/05/2012

23/04/2012

Multi-Center Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action

A Randomized, Multi-Center Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action - BioBio

Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Orencia
Product Name: Orencia
INN or Proposed INN: ABATACEPT
Trade Name: Ro-Actemra
Product Name: Ro Actemra
Other descriptive name: TOCILIZUMAB
Trade Name: Mabthera
Product Name: Mabthera
INN or Proposed INN: RITUXIMAB
Trade Name: Orencia
Product Name: Orencia
INN or Proposed INN: ABATACEPT
Trade Name: Ro-Actemra
Product Name: Ro Actemra
Other descriptive name: TOCILIZUMAB

Medizinische Universität Wien, Universitätsklinik für Innere Medizin III

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Czech Republic;Slovakia;Austria;Russian Federation;Switzerland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

JPRN-UMIN000007786

2012/05/01

19/04/2012

"Effect examination of infliximab to the effect insufficient example and the example of effect decrease of the 1st TNF inhibitor in rheumatoid arthritis "

Rheumatoid Arthritis

infliximab plus methotrexate

Saitama Medical Center. Saitama Medical University

NULL

Complete: follow-up complete

20years-old

75years-old

Male and Female

Not applicable

Japan

JPRN-UMIN000007432

2012/04/01

02/03/2012

Prospective research of infliximab treatment in active RA patients refractry to anti-interleukin six receptor monoclonal antibody.

rheumatoid arthritis

Infliximab and Methotrexate.
Patient is treated with IFX 3mg/kg for 0, 2, or 6 weeks, and henceforth every 8 weeks till 46weeks. Disease activity is assessed every 4weeks (suitable) or every 8 weeks (indispensable), and if SDAI Score 3.3 or more, it will change into of 3mg/kg 4week or 6mg/kg 4week interval medication, and will administer a drug to patient till 50 weeks. If not remission(SDAI Score 3.3 or more), after change into of 3mg/kg 4week interval medication, it will change into of 6mg/kg 4week interval medication, and will administer a drug to patient till 50 weeks.

Keio University

NULL

Complete: follow-up continuing

20years-old

75years-old

Male and Female

100

Not selected

Japan

EUCTR2011-004468-31-LT
(EUCTR)

14/03/2012

05/01/2012

Evaluating the long-term Safety and Efficacy effects of CT-P13 together with methotrexate in patients with arthritis

An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1

Product Name: CT-P13
Product Code: CT-P13
INN or Proposed INN: Infliximab

CELLTRION, Inc

NULL

Not Recruiting

Female: yes
Male: yes

617

Portugal;Philippines;Slovakia;Spain;Ukraine;Lithuania;Austria;Chile;Colombia;Italy;United Kingdom;Mexico;Poland;Romania;Peru;Bulgaria;Latvia;Bosnia and Herzegovina

NCT01571219
(ClinicalTrials.gov)

March 2012

23/3/2012

An Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patient With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1

An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-Administered With Methotrexate in Patient With Rheumatoid Arthritis Who Were Treated With Infliximab(Remicade or CP-P13) in Study CT-P13 3.1

Rheumatoid Arthritis

Biological: Infliximab

Celltrion

NULL

Completed

18 Years

75 Years

All

302

Phase 3

Korea, Republic of;United Kingdom

EUCTR2011-004468-31-ES
(EUCTR)

10/02/2012

07/12/2011

Comparing the long-term effects of CT-P13 with remicade together with methotrexate in patients with arthritis

Rheumatoid Arthritis
MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: CT-P13
Product Code: CT-P13
INN or Proposed INN: Infliximab

CELLTRION, Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

522

Portugal;Colombia;Bulgaria;Chile;Italy;Latvia;Austria;Lithuania;United Kingdom;Slovakia;Ukraine;Peru;Mexico;Romania;Spain;Bosnia and Herzegovina;Philippines;Poland;Jordan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2011-004468-31-PL
(EUCTR)

07/02/2012

10/02/2012

Evaluating the long-term Safety and Efficacy effects of CT-P13 together with methotrexate in patients with arthritis

Product Name: CT-P13
Product Code: CT-P13
INN or Proposed INN: Infliximab

CELLTRION, Inc

NULL

Not Recruiting

Female: yes
Male: yes

617

Portugal;Philippines;Slovakia;Spain;Ukraine;Lithuania;Austria;Chile;Colombia;Italy;United Kingdom;Mexico;Poland;Romania;Peru;Bulgaria;Latvia;Bosnia and Herzegovina

EUCTR2011-004468-31-LV
(EUCTR)

06/02/2012

30/12/2011

Long-term safety and effectivenss CT-P13 together with methotrexate in patients with arthritis

Product Name: CT-P13
Product Code: CT-P13
INN or Proposed INN: Infliximab

CELLTRION, Inc

NULL

Not Recruiting

Female: yes
Male: yes

617

Portugal;Philippines;Spain;Ukraine;Lithuania;Austria;Chile;Colombia;United Kingdom;Italy;Mexico;Jordan;Poland;Romania;Peru;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of

EUCTR2011-004468-31-IT
(EUCTR)

02/02/2012

02/03/2012

Comparing the long-term effects of CT-P13 with remicade together with methotrexate in patients with arthritis

Product Name: CT-P13
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Other descriptive name: NA

CELLTRION, INC.

NULL

Not Recruiting

Female: yes
Male: yes

617

Korea, Republic of;Philippines;Spain;Ukraine;Lithuania;Austria;Chile;Colombia;Italy;United Kingdom;Mexico;Jordan;Poland;Peru;Latvia;Bosnia and Herzegovina

NCT01567358
(ClinicalTrials.gov)

February 2012

23/3/2012

Study of NI-071 in Comparison With Remicade in Patients With Rheumatoid Arthritis

A Randomized, Double-Blind, Repeated Dose, Active Control Drug, Parallel-group and Single-center Phase I Study of the Safety of Intravenous Administration of NI-071 in Comparison With Remicade® in Japanese Patients With Rheumatoid Arthritis Inadequately Treated With Methotrexate

Rheumatoid Arthritis

Biological: Infliximab

Nichi-Iko Pharmaceutical Co.,Ltd.

NULL

Completed

20 Years

75 Years

Both

Phase 1

Japan

EUCTR2011-004468-31-AT
(EUCTR)

26/01/2012

30/11/2011

Comparing the long-term effects of CT-P13 with remicade together with methotrexate in patients with arthritis

Product Name: CT-P13
Product Code: CT-P13
INN or Proposed INN: Infliximab

CELLTRION, Inc

NULL

Not Recruiting

Female: yes
Male: yes

522

Portugal;Colombia;Bulgaria;Chile;Italy;Latvia;Austria;Lithuania;United Kingdom;Slovakia;Ukraine;Peru;Mexico;Romania;Spain;Bosnia and Herzegovina;Philippines;Jordan;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2011-004468-31-GB
(EUCTR)

06/01/2012

25/11/2011

Evaluating the long-term Safety and Efficacy effects of CT-P13 together with methotrexate in patients with arthritis

Product Name: CT-P13
Product Code: CT-P13
INN or Proposed INN: Infliximab

CELLTRION, Inc

NULL

Not Recruiting

Female: yes
Male: yes

617

Phase 3

Portugal;Philippines;Slovakia;Spain;Ukraine;Lithuania;Austria;Chile;Colombia;Italy;United Kingdom;Mexico;Poland;Romania;Peru;Bulgaria;Latvia;Bosnia and Herzegovina

EUCTR2011-004468-31-SK
(EUCTR)

30/12/2011

04/01/2012

Comparing the long-term effects of CT-P13 with remicade together with methotrexate in patients with arthritis

Product Name: CT-P13
Product Code: CT-P13
INN or Proposed INN: Infliximab

CELLTRION, Inc

NULL

Not Recruiting

Female: yes
Male: yes

Portugal;Philippines;Slovakia;Spain;Ukraine;Lithuania;Austria;Chile;Colombia;Italy;United Kingdom;Mexico;Jordan;Poland;Romania;Peru;Bulgaria;Latvia;Bosnia and Herzegovina

NCT01592292
(ClinicalTrials.gov)

November 2011

11/4/2012

An Observational Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis And Inadequate Response Or Intolerance to a First Anti-TNF Alpha Therapy

A Non-interventional Study for Relative Efficacy Outcome of Rituximab Treatment in RA Patients Who Have Inadequate Response or Have Been Intolerant to a First Anti-TNF Agent

Rheumatoid Arthritis

Drug: Rituximab;Drug: Adalimumab;Drug: Etanercept;Drug: Infliximab

Hoffmann-La Roche

NULL

Completed

20 Years

N/A

All

N/A

Korea, Republic of

NCT01295151
(ClinicalTrials.gov)

August 2011

11/2/2011

SWITCH Clinical Trial for Patients With Rheumatoid Arthritis Who Have Failed an Initial TNF-blocking Drug.

Randomised-controlled Trial of Switching to Alternative Tumour-necrosis Factor (TNF)-Blocking Drugs or Abatacept or Rituximab in Patients With Rheumatoid Arthritis Who Have Failed an Initial TNF-blocking Drug

Rheumatoid Arthritis

Drug: Etanercept;Drug: Abatacept;Biological: Rituximab;Drug: Adalimumab;Drug: Certolizumab Pegol;Drug: Infliximab;Drug: Golimumab

Julia Brown

NULL

Completed

18 Years

N/A

Both

122

Phase 4

United Kingdom

JPRN-UMIN000013750

2011/07/31

21/04/2014

Study on effects of cytokine targeted therapy on periodontal condition in patients with rheumatoid arthritis

Rheumatoid arthritis, Periodontitis

IL-6 receptor inhibition group:
Tocilizumab will be infused in 20 patients, and its effectiveness will be evaluated at 3 and 6 months later.

TNF inhibition group:
Infliximab, Etanercept, and Adalimumab will be infused in 20 patients, and its effectiveness will be evaluated at 3 and 6 months later.

Division of Periodontology, Niigata University Graduate School of Medical and Dental Sciences

NULL

Complete: follow-up complete

Not applicable

Male and Female

Not selected

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT01313520
(ClinicalTrials.gov)

March 1, 2011

25/2/2011

A Study to Evaluate the Effectiveness of Infliximab and Changes in Hand and Wrist Magnetic Resonance Imaging (MRI) in Participants With Active Rheumatoid Arthritis (RA) (P08136)

A Randomized Clinical Trial to Study the Effects of Infliximab on Clinical Efficacy and Hand and Wrist Magnetic Resonance Imaging (MRI) in Patients With Active Rheumatoid Arthritis (RA)(Protocol No. P08136)

Arthritis, Rheumatoid

Drug: Infliximab;Drug: Placebo

Merck Sharp & Dohme Corp.

NULL

Completed

18 Years

N/A

All

Phase 2

Moldova, Republic of;Romania

EUCTR2010-018646-31-LT
(EUCTR)

30/11/2010

06/08/2010

CT-P13 Compared With Remicade When Co-Administered With Methotrexate

A Randomized, Double Blind, Parallel-Group, Phase 3 Study to Demonstrate Equivalence in Efficacy and Safety of CT-P13 Compared With Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis -

Rheumatoid Arthritis
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: CT-P13
Product Code: CT-P13
INN or Proposed INN: Infliximab
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB

CELLTRION, Inc

NULL

Not Recruiting

Female: yes
Male: yes

584

Phase 3

Portugal;Colombia;Bulgaria;Chile;Indonesia;Italy;Latvia;Austria;Lithuania;United Kingdom;Slovakia;Russian Federation;Ukraine;Peru;Mexico;Romania;Spain;Bosnia and Herzegovina;Philippines;Poland;Jordan

EUCTR2010-018646-31-ES
(EUCTR)

05/11/2010

12/08/2010

Estudio de fase 3, aleatorizado, doble ciego y con grupos paralelos para demostrar la equivalencia en eficacia y seguridad de CT-P13 comparado con Remicade cuando se administra con metotrexato a pacientes con artritis reumatoide activa.A Randomized, Double Blind, Parallel-Group, Phase 3 Study to Demonstrate Equivalence in Efficacy and Safety of CT-P13 Compared With Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis -

Artritis reumatoide.Rheumatoid Arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 12.1;Level: PT;Term: Rheumatoid arthritis

Product Name: CT-P13
Product Code: CT-P13
INN or Proposed INN: Infliximab
Trade Name: REMICADE 100 mg polvo para concentrado para solución para perfusión
INN or Proposed INN: INFLIXIMAB
Other descriptive name: INFLIXIMAB

CELLTRION, Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

584

Phase 3

Portugal;United Kingdom;Bulgaria;Spain;Italy;Latvia;Austria;Lithuania

EUCTR2010-018646-31-LV
(EUCTR)

11/10/2010

29/06/2010

Rheumatoid Arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 12.1;Level: PT;Term: Rheumatoid arthritis

Product Name: CT-P13
Product Code: CT-P13
INN or Proposed INN: Infliximab
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB

CELLTRION, Inc

NULL

Not Recruiting

Female: yes
Male: yes

633

Phase 3

Portugal;United Kingdom;Bulgaria;Spain;Italy;Latvia;Austria;Lithuania

EUCTR2010-018646-31-SK
(EUCTR)

11/10/2010

23/06/2010

Rheumatoid Arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 12.1;Level: PT;Term: Rheumatoid arthritis

Product Name: CT-P13
Product Code: CT-P13
INN or Proposed INN: Infliximab
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB

CELLTRION, Inc

NULL

Not Recruiting

Female: yes
Male: yes

584

Phase 3

Portugal;Slovakia;Spain;Lithuania;Austria;Bulgaria;Latvia;Italy;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2010-018646-31-BG
(EUCTR)

07/10/2010

07/09/2010

Rheumatoid Arthritis
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Product Name: CT-P13
Product Code: CT-P13
INN or Proposed INN: Infliximab
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB

CELLTRION, Inc

NULL

Not Recruiting

Female: yes
Male: yes

584

Phase 3

Portugal;Spain;Lithuania;Austria;Bulgaria;Latvia;Italy;United Kingdom

EUCTR2010-018646-31-PT
(EUCTR)

01/10/2010

23/07/2010

Rheumatoid Arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 12.1;Level: PT;Term: Rheumatoid arthritis

Product Name: CT-P13
Product Code: CT-P13
INN or Proposed INN: Infliximab
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB

CELLTRION, Inc

NULL

Not Recruiting

Female: yes
Male: yes

584

Phase 3

Portugal;Spain;Lithuania;Austria;Bulgaria;Latvia;Italy;United Kingdom

NCT01217086
(ClinicalTrials.gov)

October 2010

4/10/2010

Program evaLuating the Autoimmune Disease iNvEstigational Drug cT-p13 in RA Patients(PLANETRA)

Randomized, Double-blind, Parallel-group, Phase 3 Study

Rheumatoid Arthritis

Drug: Infliximab

Celltrion

NULL

Completed

18 Years

75 Years

Both

617

Phase 3

Korea, Republic of

EUCTR2010-018646-31-AT
(EUCTR)

29/09/2010

03/08/2010

Rheumatoid Arthritis
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Product Name: CT-P13
Product Code: CT-P13
INN or Proposed INN: Infliximab
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB

CELLTRION, Inc

NULL

Not Recruiting

Female: yes
Male: yes

584

Phase 3

Portugal;United Kingdom;Bulgaria;Spain;Italy;Latvia;Austria;Lithuania

100

EUCTR2010-018646-31-IT
(EUCTR)

14/09/2010

26/07/2010

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073

Product Name: CT-P13
Product Code: CT-P13
INN or Proposed INN: Infliximab
Trade Name: Remicade
INN or Proposed INN: Infliximab

CELLTRION, Inc

NULL

Not Recruiting

Female: yes
Male: yes

584

Phase 3

Portugal;United Kingdom;Bulgaria;Spain;Italy;Latvia;Austria;Lithuania

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

101

EUCTR2010-018646-31-GB
(EUCTR)

09/09/2010

22/07/2010

Rheumatoid Arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 12.1;Level: PT;Term: Rheumatoid arthritis

Product Name: CT-P13
Product Code: CT-P13
INN or Proposed INN: Infliximab
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB

CELLTRION, Inc

NULL

Not Recruiting

Female: yes
Male: yes

633

Phase 3

Portugal;United Kingdom;Bulgaria;Spain;Italy;Latvia;Austria;Lithuania

102

NCT01282528
(ClinicalTrials.gov)

September 2010

24/1/2011

Ultrasonographic Monitoring of Response to Infliximab in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis;Ultrasonography;Infliximab

Biological: infliximab

Peking Union Medical College Hospital

Shanghai Changzheng Hospital;First Hospital of China Medical University;Shenzhen People's Hospital;Xinhua Hospital, Shanghai Jiao Tong University School of Medicine;Wenzhou Medical University;First People's Hospital of Foshan;West China Hospital

Recruiting

18 Years

65 Years

Both

Phase 4

China

103

EUCTR2009-015740-42-DE
(EUCTR)

12/05/2010

12/01/2010

A PHASE 3, MULTICENTER, RANDOMIZED, OPEN, PROSPECTIVE, CONTROLLED, PARALLEL-GROUP STUDY OF REDUCTION OF THERAPY IN PATIENTS WITH RHEUMATOID ARTHRITIS IN ONGOING REMISSIONRETRO – REduction of Therapy in RA patients in Ongoing remission,Reduzierung der Therapie bei RA-Patienten in Remission - RETRO

Rheumatoid arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Product Name: Prednisolon
Product Code: Prednisolon
INN or Proposed INN: PREDNISOLONE
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Product Name: Azathioprin
Other descriptive name: AZATHIOPRINE
Trade Name: Immunosporin
Product Name: Immunosporin
INN or Proposed INN: CICLOSPORIN
Trade Name: Cimzia
Product Name: Cimzia
INN or Proposed INN: GOLIMUMAB
Trade Name: Enbrel
Product Name: Enbrel
INN or Proposed INN: ETANERCEPT
Product Name: Quensyl
Other descriptive name: HYDROXYCHLOROQUINE SULFATE
Trade Name: REMICADE
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Lantarel
Product Name: Lantarel
INN or Proposed INN: METHOTREXATE SODIUM
Other descriptive name: Lantarel
Trade Name: Arava
Product Name: Arava
INN or Proposed INN: LEFLUNOMIDE
Other descriptive name: Arava
Product Name: Metex 2,5mg
INN or Proposed INN: METHOTREXATE SODIUM
Other descriptive name: Metex 2,5mg

Universitätsklinkum Erlangen

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

Germany

104

EUCTR2009-017379-90-IT
(EUCTR)

27/04/2010

31/03/2010

Characterization of the secondary failure to TNF-blockers monoclonal antibodies. Receptor as a rescue therapy - ND

RA patients fulfilling the 1987 ACR criteria who discontinued a first antibody TNF-i (Infliximab or Adalimumab) because of secondary inefficacy
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

INN or Proposed INN: ETANERCEPT

AZIENDA OSPEDALIERA SENESE

NULL

Not Recruiting

Female: yes
Male: yes

Italy

105

NCT01000441
(ClinicalTrials.gov)

December 2009

22/10/2009

Rotation or Change of Biotherapy After First Anti-TNF Treatment Failure for Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: infliximab, etanercept, adalimumab;Drug: abatacept, rituximab or tocilizumab

University Hospital, Strasbourg, France

NULL

Recruiting

18 Years

N/A

Both

300

Phase 4

France;Monaco

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

106

EUCTR2007-003288-36-GB
(EUCTR)

04/11/2009

03/10/2008

A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 4

France;Finland;Spain;Austria;Germany;Netherlands;United Kingdom

107

EUCTR2008-005450-20-BE
(EUCTR)

29/10/2009

01/10/2009

The cost-effectiveness of abatacept, rituximab or anti-TNF alpha for patients with rheumatoid artritis. - Dutch Rheumatoid Arthritis Monitoring (DREAM) Targetted Immune Modulator Evaluation (TIME)

Rheumatoid arthritis
MedDRA version: 12.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Remicade (infliximab)
INN or Proposed INN: INFLIXIMAB
Other descriptive name: remicade
Trade Name: Humira (adalimumab)
INN or Proposed INN: ADALIMUMAB
Trade Name: Enbrel (etanercept)
INN or Proposed INN: ETANERCEPT
Other descriptive name: Enbrel
Trade Name: Mabthera (rituximab)
INN or Proposed INN: RITUXIMAB
Other descriptive name: Mabthera
Trade Name: Orencia (abatacept)
INN or Proposed INN: ABATACEPT
Other descriptive name: Orencia

Radboud University Nijmegen Medical Centre, department of Rheumatic Diseases

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

261

Belgium

108

JPRN-UMIN000002340

2009/08/01

20/08/2009

Comparison of effects between higher dosages of infliximab and switching to other biologics for rheumatoid arthritis patients with less responsiveness to infliximab therapy (cHAMLET)

Rheumatoid Arthritis

Treatment with higher dosages of infliximab (3-10 mg/Kg)
Every 2 months
Follow-up to 54 weeks
Treatment with one of other biologics (etanercept, adalimumab, tocilizumab) in standard protocol
Follow-up to 54 weeks

Department of Rheumatosurgery, Osaka City University Medical School

NULL

Complete: follow-up complete

20years-old

Not applicable

Male and Female

Phase 4

Japan

109

NCT00808210
(ClinicalTrials.gov)

March 5, 2009

11/12/2008

A Study to Evaluate Ocrelizumab in Combination With Methotrexate Compared With Infliximab Plus Methotrexate in Patients With Active Rheumatoid Arthritis Currently Responding Inadequately to Etanercept or Adalimumab

A PHASE II RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCRELIZUMAB IN COMBINATION WITH METHOTREXATE, COMPARED TO INFLIXIMAB PLUS METHOTREXATE IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS CURRENTLY RESPONDING INADEQUATELY TO ETANERCEPT OR ADALIMUMAB

Rheumatoid Arthritis

Drug: Infliximab;Drug: Methotrexate;Drug: Methylprednisolone;Drug: Ocrelizumab;Drug: Placebo

Genentech, Inc.

NULL

Terminated

18 Years

N/A

All

Phase 2

United States

110

EUCTR2007-003288-36-ES
(EUCTR)

08/01/2009

09/03/2010

Ensayo clínico fase 4, multicéntrico, abierto, asesor ciego, de cambio en el cual se evalúa la eficacia y la seguridad de Infliximab (REMICADE®) en pacientes con artritis reumatoide activa que están respondiendo inadecuadamente a Etanercept (ENBREL®) o Adalimumab (HUMIRA®). - RESTART

Artritis Reumatoide
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
Other descriptive name: Chimeric Human-Murine IgG1

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

200

Finland;United Kingdom;Germany;Netherlands;France;Spain;Austria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

111

EUCTR2007-003288-36-FR
(EUCTR)

08/12/2008

21/10/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
Other descriptive name: Chimeric Human-Murine IgG1

Centocor BV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

Phase 4

Finland;United Kingdom;Germany;Netherlands;France;Spain;Austria

112

ChiCTR-TRC-10001060

2008-12-01

2010-10-23

Efficacy and safety of infliximab in Chinese patients with rheumatoid arthritis: a double-blind, randomized, placebo-controlled trial

rheumatoid arthritis;M05.901

infliximab:intravenous injections of infliximab (3 mg/kg) at weeks 0, 2, 6, 14, with concurrent MTX therapy;placebo:intravenous injections of placebo (3 mg/kg) at weeks 0, 2, 6, 14, with concurrent MTX therapy;

People's Hospital, Beijing University; Shanghai Changzheng Hospital

NULL

Completed

Both

infliximab:0;placebo:0;

3 (Phase 3 study)

China

113

EUCTR2007-003288-36-FI
(EUCTR)

28/11/2008

30/09/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
Other descriptive name: Chimeric Human-Murine IgG1

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 4

Finland;United Kingdom;Germany;Netherlands;France;Spain;Austria

114

EUCTR2008-006256-22-FR
(EUCTR)

21/11/2008

31/10/2008

Evaluation by high resolution micro computerized tomography of bone microarchitecture changes in patients with rheumatoid arthritis under anti-TNF therapy.

rheumatoid arthritis requiring anti-TNF alpha treatment
MedDRA version: 9.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions

Trade Name: remicade
INN or Proposed INN: infliximab
Trade Name: humira
INN or Proposed INN: adalimumab
Trade Name: enbrel
INN or Proposed INN: etanercept

CHU Saint-Etienne

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

France

115

EUCTR2007-003288-36-DE
(EUCTR)

10/11/2008

03/09/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
Other descriptive name: Chimeric Human-Murine IgG1

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 4

Finland;United Kingdom;Germany;Netherlands;France;Spain;Austria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

116

NCT00901550
(ClinicalTrials.gov)

November 2008

13/5/2009

The Chinese University of Hong Kong Early Arthritis Study

Rheumatoid Arthritis

Drug: Methotrexate;Drug: Infliximab

Chinese University of Hong Kong

NULL

Completed

18 Years

80 Years

Both

N/A

China

117

EUCTR2007-003288-36-NL
(EUCTR)

15/10/2008

11/07/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
Other descriptive name: Chimeric Human-Murine IgG1

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 4

Finland;United Kingdom;Germany;Netherlands;France;Spain;Austria

118

EUCTR2008-005212-40-SE
(EUCTR)

14/10/2008

14/08/2008

Pain mechanisms and fatigue in rheumatoid arthritis (RA) and healthy volunteers. Can antirheumatic and biological therapy affect pain processing and fatigue in RA? - RA PAIN PROCESSING

Rheumatoid arthritis (RA)The overall aim with this project is to investigate central pain mechanisms in RA and healthy controls, and in RA how these are influenced by autonomic neural regulation and TNF-blockade with Remicade.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 9.1;Classification code 10060016;Term: Alpha tumor necrosis factor
MedDRA version: 9.1;Classification code 10029817;Term: Nuclear magnetic resonance imaging brain
MedDRA version: 9.1;Classification code 10053689;Term: Cardiovascular autonomic function test

Trade Name: Remicade
INN or Proposed INN: Infliximab

Karolinska Institute

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: no

Sweden

119

EUCTR2007-003288-36-AT
(EUCTR)

01/10/2008

18/08/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
Other descriptive name: Chimeric Human-Murine IgG1

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 4

Finland;United Kingdom;Germany;Netherlands;France;Spain;Austria

120

NCT00724672
(ClinicalTrials.gov)

September 2008

25/7/2008

A Study of Immune Cells in Patients With Rheumatoid Arthritis During Different Types of Anti-TNF Alpha Treatments (Study P05521)

Whole Human Genome Oligo Microarray Analysis of the Peripheral Blood Mononuclear Cells of Patients With Rheumatoid Arthritis During Different Forms of Anti-Tumor Necrosis-Alpha Treatments.

Rheumatoid Arthritis

Drug: etanercept;Drug: infliximab;Drug: adalimumab

Merck Sharp & Dohme Corp.

NULL

Withdrawn

18 Years

N/A

Both

N/A

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

121

NCT00714493
(ClinicalTrials.gov)

July 2008

10/7/2008

RESTART C0168Z05 Rheumatoid Arthritis Study

A Phase 4, Multicenter, Open-Label, Assessor-Blinded Switch Study of the Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) or Adalimumab (HUMIRA).

Rheumatoid Arthritis

Biological: Infliximab

Centocor Ortho Biotech Services, L.L.C.

Schering-Plough

Completed

18 Years

N/A

All

203

Phase 4

United States;Austria;Canada;Finland;France;Germany;Israel;Netherlands;Spain;United Kingdom;Belgium

122

NCT01072058
(ClinicalTrials.gov)

February 2008

18/2/2010

Heart Function in Rheumatoid Arthritis and Ankylosing Spondylitis Pre and Post-TNF Blocker

Prospective Evaluation of Heart Function by Echocardiographic Study, Pro-brain Natriuretic Peptide Type B and Troponin T in Patients With Rheumatoid Arthritis and Ankylosing Spondylitis Pre and Post-TNF Blocker

Arthritis, Rheumatoid;Spondylitis, Ankylosing

Drug: TNF blockers (infliximab, adalimumab, etanercept)

University of Sao Paulo

NULL

Active, not recruiting

18 Years

70 Years

Both

100

Phase 4

Brazil

123

ChiCTR-CCC-10001054

2008-01-01

2010-08-25

Circulating Dickkopf-1 (DKK-1) is Correlated with Bone Erosion and Inflammation in Rheumatoid Arthritis

1:none;2:Infliximab ;

National Sciences Foundation of China

NULL

Completed

Both

1:39;2:39;

China

124

NCT00741104
(ClinicalTrials.gov)

January 2008

30/7/2008

A Feasibility Study Exploring the Effect of Remicade on the Disease Activity in RA Patients (Study P05417)

A Feasibility Study Exploring the Effect of Remicade on the Disease Activity in RA Patients

Rheumatoid Arthritis

Drug: Infliximab

Merck Sharp & Dohme Corp.

NULL

Completed

N/A

All

363

NULL

125

NCT00840957
(ClinicalTrials.gov)

November 2007

10/2/2009

Pharmaco Kinetic Variability of Infliximab in Rheumatoid Arthritis

Pharmaco Kinetic and Pharmacokinetic-Pharmacodynamic Variability of Infliximab

Rheumatoid Arthritis

Biological: infliximab

University Hospital, Tours

NULL

Completed

18 Years

N/A

Both

N/A

France

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

126

NCT01245361
(ClinicalTrials.gov)

November 2007

19/11/2010

A 6-Months Infliximab Or Placebo Study In UA At High Risk Of RA:Clinical,Radiological And Synovial Benefit

A Comparative Study Of A 6-Month Infliximab (Remicade®) Or Placebo Regimen In Undifferentiated Arthritis At High Risk For The Development Of Rheumatoid Arthritis (RA) : Clinical, Radiological (MRI) And Synovial Benefit P1200/001.

Undifferentiated Arthritis

Drug: Infliximab;Drug: sodium chloride

Patrick Durez

NULL

Completed

N/A

Both

N/A

Belgium

127

EUCTR2007-004694-26-BE
(EUCTR)

17/09/2007

10/09/2007

A Comparative Study Of A 6-Month Infliximab (Remicade) Or Placebo Regimen In Undifferentiated Arthritis At High Risk For The Development Of Rheumatoid Arthritis : Clinical, Radiological (MRI) And Synovial Benefit P1200/001. - INFLIXIMAB (REMICADE) in UA

Patient with undifferentiated arthritis and the presence of anti-CCP antibodies are at high risk to develop RA
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Remicade
Product Name: REMICADE® (Infliximab)
Product Code: -

Saint-Luc Universitary Hospital

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Belgium

128

EUCTR2007-002752-42-FR
(EUCTR)

13/09/2007

23/07/2007

FAKIR : Variabilité pharmacocinétique et de la relation pharmacocinétique-phamacodynamique de l'infliximab (Remicade®) dans la polyarthrite rhumatoide - FAKIR

Polyarthrite rhumatoïde
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Remicade®
INN or Proposed INN: INFLIXIMAB

CHRU de Tours

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

France

129

EUCTR2005-001889-13-DE
(EUCTR)

09/07/2007

21/12/2006

Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - Re3

Adult subjects with a diagnosis of Rheumatoid Arthritis presenting with a disease flare after an initial response to infliximab
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: infliximab

Schering-Plough Research Institute (SPRI)

NULL

Not Recruiting

Female: yes
Male: yes

315

Portugal;Germany;Netherlands;Denmark;Belgium;France;Greece;Sweden

130

NCT00896168
(ClinicalTrials.gov)

June 2007

7/5/2009

An Efficacy and Safety Study of Infliximab in Participants With Rheumatoid Arthritis

A Multi-Center, Pre-Marketing Clinical Trial to Evaluate the Efficacy and Safety of Infliximab Treatment on Rheumatoid Arthritis

Arthritis, Rheumatoid

Drug: Infliximab;Drug: Methotrexate

Xian-Janssen Pharmaceutical Ltd.

NULL

Completed

18 Years

65 Years

All

234

Phase 4

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

131

NCT00521924
(ClinicalTrials.gov)

June 2007

27/8/2007

Induction of Remission in RA Patients at Low Disease Activity by Additional Infliximab Therapy (Study P04644AM1) (TERMINATED)

Induction of Remission in RA Patients at Low Disease Activity by Additional Infliximab-therapy

Rheumatoid Arthritis

Biological: infliximab;Drug: DMARDs (methotrexate; chloroquine; leflunomidum; cyclosporin A; sulfasalazine; OM 89.

Merck Sharp & Dohme Corp.

AESCA Pharma GmbH

Terminated

19 Years

65 Years

All

Phase 3

Austria

132

NCT00760669
(ClinicalTrials.gov)

May 2007

24/9/2008

An Observational Study of Infliximab Injection in Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis Participants

Post Marketing Surveillance of Remicade in Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis Patients

Spondylitis, Ankylosing;Arthritis, Rheumatoid;Psoriasis;Arthritis, Psoriatic

Drug: Infliximab; observational study;Drug: Methotrexate

Janssen Korea, Ltd., Korea

NULL

Completed

N/A

All

1061

Korea, Republic of

133

NCT00462072
(ClinicalTrials.gov)

March 2007

17/4/2007

Centocor Microarray Study of Patients

Microarray Analysis of Peripheral Blood and Tissues of Patients With Immune Mediated Inflammatory Diseases

Rheumatoid Arthritis;Psoriatic Arthritis;Psoriasis;Crohn's Disease

Drug: Infliximab

University of Rochester

Centocor, Inc.

Completed

12 Years

N/A

All

Phase 4

United States

134

NCT00716248
(ClinicalTrials.gov)

January 2007

8/7/2008

Bucillamine Study of Holding Remission After Infliximab Dose-off

The Bucillamine Study of Holding Remission After Infliximab Dose-off in Patients With Rheumatoid Arthritis Receiving Methotrexate

Rheumatoid Arthritis

Drug: bucillamine;Drug: methotrexate

Saitama Medical University

Keio University

Active, not recruiting

20 Years

N/A

Both

Phase 4

Japan

135

EUCTR2005-001889-13-FR
(EUCTR)

27/12/2006

30/11/2006

Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - RE3

Adult subjects with a diganosis of Rheumatoid Arthritis presenting with a disease flare after an initial response to infliximab.
MedDRA version: 8.1;Level: LLT;Classification code 10060732;Term: Rheumatoid arthritis flare up

Integrated Therapeutics Group, Inc. - A subsidiary of Schering-Plough Corp.

NULL

Not Recruiting

Female: yes
Male: yes

315

Phase 3

Portugal;France;Belgium;Denmark;Austria;Germany;Netherlands;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

136

EUCTR2006-004673-98-HU
(EUCTR)

16/10/2006

08/09/2006

Efficacy of Rituximab treatment in patients with rheumatoid arthritis having inadequate response to TNF blocker

To investigate the efficacy of treatment with Rituximab (MabThera®) in patients with active RA whose current treatment with one or more TNF-blocker (Etanercept - Enbrel®, Infliximab – Remicade® or Adalimumab - Humira®) alone or in combination with MTX is insufficient measured by DAS28 activity index.

Trade Name: MabThera 500 mg concentrate for solution for infusion

Roche (Hungary) Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Hungary

137

JPRN-UMIN000000512

2006/10/01

03/11/2006

Efficacy of tacrolimus in rheumatoid arthritis patients who have been treated unsuccessfully with infliximab and methotrexate

Rheumatoid Arthritis

If the score of DAS28 is under 3.2 in rheumatoid arthritis patients who have received infliximab and methotrexate, doses of methotrexate will reduced to 2mg/w. When the score of DAS28 increses, tacrolimus will be administered instead of methotrexate. Period of observation is 32 weeks.
If the score of DAS28 is over 3.2 in rheumatoid arthritis patients who have received infliximab and methotrexate, tacrolimus will be administered. Period of observation is 32 weeks.

Rheumatosurgery, Osaka City University Medical School

NULL

Complete: follow-up complete

Not applicable

Male and Female

Not applicable

Japan

138

NCT01308255
(ClinicalTrials.gov)

September 2006

3/3/2011

Infliximab as Induction Therapy in Early Rheumatoid Arthritis (IDEA)

A Multi-centre Randomised Double Blind Placebo Controlled Study Comparing Two Regimens of Combination Therapy in Early DMARD Naive Rheumatoid Arthritis.

Rheumatoid Arthritis

Drug: Infliximab;Drug: Methylprednisolone;Drug: Methotrexate;Dietary Supplement: Folic acid

University of Leeds

NULL

Completed

18 Years

80 Years

All

112

Phase 4

United Kingdom

139

NCT00732875
(ClinicalTrials.gov)

August 2006

8/8/2008

A Trial of Anti-TNF Chimeric Monoclonal Antibody (cA2) in Korean Patients With Active Rheumatoid Arthritis Despite Methorexate (Extension Part)(Study P05645)(COMPLETED)

A Placebo-controlled, Double-blinded, Randomized Clinical Trial of Anti-TNF Chimeric Monoclonal Antibody (cA2) in Korean Patients With Active Rheumatoid Arthritis Despite Methotrexate Treatment (Open-label Extension Part)

Arthritis, Rheumatoid

Biological: Infliximab + methotrexate (MTX)

Merck Sharp & Dohme Corp.

NULL

Completed

18 Years

75 Years

All

Phase 3

NULL

140

EUCTR2005-001889-13-NL
(EUCTR)

13/07/2006

20/04/2006

Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - RE3

Integrated Therapeutics Group, Inc. - A subsidiary of Schering-Plough Corp.

NULL

Not Recruiting

Female: yes
Male: yes

315

Phase 3

France;Portugal;Belgium;Denmark;Austria;Germany;Netherlands;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

141

EUCTR2005-001889-13-DK
(EUCTR)

04/05/2006

16/03/2006

Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - RE3

Trade Name: Remicade

Integrated Therapeutics Group, Inc. - A subsidiary of Schering-Plough Corp.

NULL

Not Recruiting

Female: yes
Male: yes

315

Portugal;Germany;Netherlands;Belgium;Denmark;France;Greece;Sweden

142

EUCTR2005-001889-13-GR
(EUCTR)

02/05/2006

23/05/2006

Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - RE3

Adult subjects with a diganosis of Rheumatoid Arthritis presenting with a disease flare after an initial response to infliximab.

Integrated Therapeutics Group, Inc. - A subsidiary of Schering-Plough Corp.

NULL

Not Recruiting

Female: yes
Male: yes

315

Phase 3

France;Portugal;Greece;Belgium;Denmark;Austria;Germany;Netherlands;Sweden

143

EUCTR2005-001633-14-SE
(EUCTR)

11/04/2006

27/02/2006

Randomised, multi-center, open-label, parallel-group study comparing adalimumab (Humira[R]) 40 mg s.c. eow versus infliximab (Remicade[R]) 3 mg/kg i.v. every 6. week in RA patients with unsustainable clinical response to infliximab 3 mg/kg every 8. week - The SWITCH Study

Rheumatoid arthritis

Trade Name: Humira
Product Name: Humira
Trade Name: Remicade
Product Name: Remicade

Hvidovre Hospital, Dept. Rheumatology

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

112

Denmark;Sweden

144

EUCTR2005-001889-13-PT
(EUCTR)

07/04/2006

17/01/2006

Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - Re3

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: infliximab

Schering Plough Research Institute, a Division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

315

Portugal;Germany;Netherlands;Denmark;Belgium;France;Greece;Sweden

145

EUCTR2005-005013-37-GB
(EUCTR)

06/04/2006

20/01/2006

A multi-centre randomised double dummy double blind study comparing two regimens of combination induction therapy in early DMARD naive Rheumatoid Arthritis: The IDEA study (Infliximab as Induction Therapy in Early Rheumatoid Arthritis) - IDEA

Early Rheumatoid Arthritis

University of Leeds

NULL

Not Recruiting

Female: yes
Male: yes

112

Phase 4

United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

146

EUCTR2005-001889-13-BE
(EUCTR)

06/03/2006

19/12/2005

Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - Re3

Schering Plough Research Institute, a Division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

315

Phase 3

France;Portugal;Belgium;Denmark;Austria;Germany;Netherlands;Sweden

147

NCT00394589
(ClinicalTrials.gov)

March 2006

31/10/2006

Re³ (Re-Cube: Retain Remicade® Response)(Study P04249AM3)

Randomised Controlled Trial Evaluating Strategies to Optimize Disease Activity Control in RA Patients Treated With Infliximab in Clinical Practice.

Rheumatoid Arthritis

Drug: Infliximab Control;Drug: Infliximab Increased Frequency;Drug: Infliximab Increased Dose

Merck Sharp & Dohme Corp.

Integrated Therapeutics Group

Terminated

18 Years

N/A

All

Phase 3

Austria;Belgium;Denmark;France;Germany;Netherlands;Sweden;Turkey

148

NCT00724243
(ClinicalTrials.gov)

January 2006

25/7/2008

Safety and Effectiveness of Infliximab in Slovakia When Used for Rheumatoid Arthritis (Study P04741)(COMPLETED)

Remicade Treatment Registry in Rheumatoid Arthritis I

Rheumatoid Arthritis

Drug: Infliximab

Merck Sharp & Dohme Corp.

NULL

Completed

N/A

All

N/A

Slovakia

149

EUCTR2005-004530-40-AT
(EUCTR)

30/12/2005

25/11/2005

Induction of remission in RA patients at low disease activity by additional Infliximab-therapy

Patients with a diagnose of rheumatoid arthritis according to ACR-criteria at least 1 year (max. 10 years) prior to start of therapy with active disease: DAS 28 between 2,8 and 3,5 and a change in DAS 28 score <0.6 during the last 6 weeks before inclusion.

Trade Name: Remicade
Product Name: Remicade

AESCA Pharma Ges.m.b.H

NULL

Not Recruiting

Female: yes
Male: yes

160

Austria

150

NCT00705289
(ClinicalTrials.gov)

December 2005

23/6/2008

A Study to Observe Characteristics of Rheumatoid Arthritis in Patients Using Infliximab (Study P04250)

Epidemiology, Correlation and Predictive Value of Disease Activity and Biomarkers in RA Patients Initiated on Infliximab in Clinical Practice

Rheumatoid Arthritis

Biological: Infliximab

Merck Sharp & Dohme Corp.

NULL

Completed

N/A

All

728

N/A

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

151

EUCTR2005-001889-13-SE
(EUCTR)

24/11/2005

13/10/2005

Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - Re3

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: infliximab

Schering-Plough Research Institute, a division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

315

Portugal;Germany;Netherlands;Denmark;Belgium;France;Greece;Sweden

152

EUCTR2005-001889-13-AT
(EUCTR)

15/09/2005

08/11/2005

Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - RE3

Adult subjects with a diganosis of Rheumatoid Arthritis presenting with a disease flare after an initial response to infliximab.

Trade Name: Remicade
Product Name: Remicade

Integrated Therapeutics Group, Inc. - A subsidiary of Schering-Plough Corp.

NULL

Not Recruiting

Female: yes
Male: yes

315

France;Portugal;Greece;Belgium;Denmark;Austria;Germany;Netherlands;Sweden

153

NCT00216177
(ClinicalTrials.gov)

September 2005

20/9/2005

Comparison of Adalimumab and Infliximab Treatment of Rheumatoid Arthritis

Randomised, Multicenter, Open-label, Parallel-group Study Comparing Adalimumab 40 mg s.c. Eow Versus Infliximab 3 mg/kg i.v. Every 6 Weeks in Rheumatoid Arthritis Patients With Unsustainable Clinical Response to Infliximab 3 mg/kg Every 8 Weeks

Rheumatoid Arthritis

Drug: Infliximab;Drug: Adalimumab

Hvidovre University Hospital

University Hospital, Gentofte, Copenhagen

Recruiting

18 Years

80 Years

Both

112

Phase 4

Denmark

154

NCT00691028
(ClinicalTrials.gov)

September 2005

3/6/2008

Efficacy and Safety of Increased Dose of TA-650(Infliximab) in Patients With Rheumatoid Arthritis

Clinical Study to Assess the Efficacy and Safety of Increased Dose of TA-650(Infliximab) in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: TA-650 3 mg/kg;Drug: TA-650 6 mg/kg;Drug: TA-650 10 mg/kg

Mitsubishi Tanabe Pharma Corporation

NULL

Completed

20 Years

75 Years

All

327

Phase 3

NULL

155

EUCTR2005-001633-14-DK
(EUCTR)

17/08/2005

30/06/2005

Randomised, multi-center, open-label, parallel-group study comparing adalimumab (Humira?) 40 mg s.c. eow versus infliximab (Remicade?) 3 mg/kg i.v. every 6. week in RA patients with unsustainable clinical response to infliximab 3 mg/kg every 8. week - The SWITCH Study

Rheumatoid arthritis

Trade Name: Humira
Product Name: Humira
Trade Name: Remicade
Product Name: Remicade

Hvidovre Hospital, Dept. Rheumatology

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

112

Denmark;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

156

NCT00202852
(ClinicalTrials.gov)

June 1, 2005

13/9/2005

A Placebo-Controlled, Double-Blinded, Randomized Trial of Remicade in Korean Patients With Rheumatoid Arthritis Despite Methotrexate (Study P04280)(COMPLETED)

A Placebo-Controlled, Double-Blinded, Randomized Clinical Trial of Anti-TNF Chimeric Monoclonal Antibody (cA2) in Korean Patients With Active Rheumatoid Arthritis Despite Methotrexate

Arthritis, Rheumatoid

Other: Placebo;Drug: MTX;Biological: Infliximab

Merck Sharp & Dohme Corp.

NULL

Completed

18 Years

75 Years

All

143

Phase 3

Korea, Republic of

157

EUCTR2004-000922-59-CZ
(EUCTR)

15/03/2005

Rheumatoid Arthrithis, Nos

Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab

Bristol Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

675

Phase 3

Czech Republic;Denmark;Spain;Sweden

158

EUCTR2004-000922-59-DK
(EUCTR)

02/02/2005

01/12/2004

Rheumatoid Arthrithis, Nos

Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab

Bristol Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

675

Phase 3

Czech Republic;Denmark;Spain;Sweden

159

NCT00095147
(ClinicalTrials.gov)

February 2005

1/11/2004

Abatacept and Infliximab in Combination With Methotrexate in Subjects With Rheumatoid Arthritis

A Phase IIIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Comparative Study of Abatacept or Infliximab in Combination With Methotrexate in Controlling Disease Activity in Subjects With Rheumatoid Arthritis Having an Inadequate Clinical Response to Methotrexate

Rheumatoid Arthritis

Drug: Abatacept (ABA) + Methotrexate (MTX), double-blind (DB);Drug: Infliximab (INF) + MTX, DB;Drug: Placebo (PLA) + MTX, DB;Drug: PLA + MTX switched to ABA+ MTX, DB;Drug: ABA, open-label (OL)

Bristol-Myers Squibb

NULL

Completed

18 Years

75 Years

All

431

Phase 3

United States;Argentina;Australia;Brazil;Canada;Czech Republic;Denmark;Korea, Republic of;Mexico;Peru;Poland;Puerto Rico;Russian Federation;South Africa;Spain;Sweden;Switzerland

160

EUCTR2004-000922-59-ES
(EUCTR)

21/12/2004

18/05/2005

Rheumatoid Arthrithis, Nos

Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab

Bristol Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

675

Phase 3

Czech Republic;Denmark;Spain;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

161

EUCTR2005-000492-18-IT
(EUCTR)

16/12/2004

09/11/2007

Insulin resistance and endothelial dysfunction TNF-Alpha dependent in patients with rheumatoid arthritis or metabolic syndrome

Metabolic Syndrome and Rheumatoid Arthritis
MedDRA version: 6.1;Level: SOC;Classification code 10021428

Trade Name: REMICADE*EV F 100MG+F 2ML
INN or Proposed INN: Infliximab

POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

NULL

Not Recruiting

Female: yes
Male: yes

Italy

162

EUCTR2004-000922-59-SE
(EUCTR)

01/12/2004

13/10/2004

A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled ComparativeStudy of Abatacept or Infliximab in Combination with Methotrexate in ControllingDisease Activity in Subjects with Rheumatoid Arthritis Having an Inadequate ClinicalResponse to Methotrexate.Revised Protocol 1 , incorporating Amendment 02 (v5.0). Pharmacogenomic Amendment 01. Protocol Amendment 03 - Long-Term Extension. Protocol Amendment 05 - Long Term Extension Site Specific (V2.0, Date 23-Dec-2006).

Rheumatoid Arthrithis, Nos

Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab

Bristol Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

660

Phase 3

Czech Republic;Denmark;Spain;Sweden

163

NCT00236028
(ClinicalTrials.gov)

November 2004

7/10/2005

A Safety and Efficacy Study for Infliximab (Remicade) With Methotrexate in Patients With Early Rheumatoid Arthritis

A Randomized, Double-blind, Trial of Anti-TNFa Chimeric Monoclonal Antibody (Infliximab) in Combination With Methotrexate Compared With Methotrexate Alone for the Treatment of Patients With Early Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Infliximab

Centocor, Inc.

NULL

Completed

18 Years

75 Years

Both

607

Phase 3

NULL

164

NCT00099554
(ClinicalTrials.gov)

May 2004

16/12/2004

Effectiveness and Safety of Enbrel® (Etanercept) in Rheumatoid Arthritis Subjects Who Have Failed Remicade® (Infliximab)

A Phase 4, Open-Label, Single Arm, Observational Study Evaluating the Effectiveness and Safety of Enbrel® (Etanercept) 50 mg Once Weekly in Rheumatoid Arthritis Subjects Who Have Failed Remicade® (Infliximab)

Rheumatoid Arthritis

Drug: Etanercept

Amgen

NULL

Completed

18 Years

N/A

Both

200

Phase 4

United States;Canada

165

NCT00725621
(ClinicalTrials.gov)

March 2004

25/7/2008

Real Life Dosing of Remicade for Rheumatoid Arthritis in Austria Monitored Over 9 Infusions (Study P03756)(COMPLETED)

Real Life Dosing Regimen of Remicade in Austria, Monitored Over 9 Consecutive Infusions in Rheumatoid Arthritis Therapy

Rheumatoid Arthritis

Biological: Infliximab

Merck Sharp & Dohme Corp.

Centocor, Inc.

Completed

N/A

All

516

N/A

Austria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

166

NCT00207714
(ClinicalTrials.gov)

November 2003

13/9/2005

An Efficacy and Safety Study of CNTO 148 Subcutaneous Injection Compared With Placebo in Patients With Active Rheumatoid Arthritis

A Randomized, Double-blind, Dose-ranging Trial of CNTO 148 Subcutaneous Injection Compared With Placebo in Subjects With Active Rheumatoid Arthritis Despite Treatment With Methotrexate

Rheumatoid Arthritis

Drug: Golimumab;Drug: MTX;Drug: Placebo;Drug: Infliximab

Centocor, Inc.

Centocor BV

Completed

18 Years

N/A

All

172

Phase 2

NULL

167

NCT00794898
(ClinicalTrials.gov)

July 1, 2003

19/11/2008

Efficacy of Remicade in the Treatment of Active Rheumatoid Arthritis Despite Methotrexate (Study P03027)

Onset of Efficacy of Anti-TNF Chimeric Monoclonal Antibody (Remicade) in the Treatment of Patients With Active Rheumatoid Arthritis Despite Methotrexate Treatment

Arthritis, Rheumatoid

Biological: Infliximab (Remicade)

Merck Sharp & Dohme Corp.

NULL

Completed

18 Years

75 Years

All

Phase 4

NULL

168

NCT00396747
(ClinicalTrials.gov)

June 2003

6/11/2006

A Comparison of Methotrexate Alone or Combined to Infliximab or to Pulse Methylprednisolone in Early Rheumatoid Arthritis: A Magnetic Resonance Imaging Study

Phase IV Study of Early RA: a Randomized Magnetic Resonance Imaging Study Comparing the Effects of Methotrexate Alone or in Combination With Infliximab or Intravenous Pulse Methylprednisolone

Rheumatoid Arthritis

Drug: Infliximab, methylprednisolone, methotrexate;Drug: Methotrexate;Drug: Methotrexate + Methylprednisolone;Drug: Methotrexate + Infliximab

Université Catholique de Louvain

NULL

Completed

18 Years

N/A

Both

Phase 4

Belgium

169

NCT00317538
(ClinicalTrials.gov)

June 2003

21/4/2006

Open-label, Pilot Protocol of Patients With Rheumatoid Arthritis Who Switch to Infliximab After Incomplete Response to Etanercept

Rheumatoid Arthritis

Drug: infliximab, etanercept

Centocor Ortho Biotech Services, L.L.C.

NULL

Completed

18 Years

N/A

Both

Phase 3

NULL

170

NCT00213564
(ClinicalTrials.gov)

April 2003

13/9/2005

Gene Expression Profiling in PBMCs as a Tool for Prediction of Infliximab Responsiveness in Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: response to infliximab associated with methotrexate

University Hospital, Rouen

NULL

Completed

18 Years

N/A

Both

France

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

171

NCT00908089
(ClinicalTrials.gov)

March 2003

22/5/2009

TNF-blocking Therapy in Combination With Disease-modifying Antirheumatic Drugs in Early Rheumatoid Arthritis

Use of TNF-blocking Therapy in Combination With DMARDs in Patients With Early Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Trexan+Salazopyrin+Oxiklorin+prednisolone + infliximab;Drug: Trexan+Salazopyrin+Oxiklorin+prednisolone + placebo

Helsinki University

Seinajoki Central Hospital;Oulu University Hospital;Jyväskylä Central Hospital;Kuopio University Hospital;Satakunta Central Hospital;University of Turku;Rheumatism Foundation Hospital;Orton Invalid Foundation;South Karelia central hospital;Lappi Central Hospital;Central Hospital of Kanta-Hame

Active, not recruiting

18 Years

60 Years

Both

100

Phase 4

Finland

172

NCT00029042
(ClinicalTrials.gov)

January 2002

4/1/2002

Infliximab to Treat Children With Juvenile Rheumatoid Arthritis

A Randomized Double Blind Controlled Intra-Patient Dose Escalation Phase II Trial of Infliximab in Pediatric Patients With Refractory Juvenile Rheumatoid Arthritis

Juvenile Rheumatoid Arthritis

Drug: Infliximab

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NULL

Terminated

N/A

Both

Phase 2

United States

173

NCT00246064
(ClinicalTrials.gov)

December 2001

28/10/2005

The Infliximab Rheumatoid Arthritis Methotrexate Tapering (iRAMT) Protocol

The Infliximab Rheumatoid Arthritis Methotrexate Tapering (iRAMT) Protocol. Tapering Methotrexate in Patients With Rheumatoid Arthritis Beginning Therapy With Infliximab

Arthritis, Rheumatoid

Drug: infliximab

Centocor Ortho Biotech Services, L.L.C.

NULL

Completed

18 Years

80 Years

Both

210

Phase 4

NULL

174

NCT00036387
(ClinicalTrials.gov)

October 2001

9/5/2002

A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Rheumatoid Arthritis.

A Randomized, Double-blind Trial of the Safety of Anti-TNF Chimeric Monoclonal Antibody (Infliximab) in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Rheumatoid Arthritis on Standard Disease-modifying Anti-Rheumatic Drug Background Therapy.

Arthritis, Rheumatoid

Drug: Infliximab

Centocor, Inc.

NULL

Completed

18 Years

N/A

Both

347

Phase 3

United States

175

NCT00036374
(ClinicalTrials.gov)

October 2001

9/5/2002

A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Juvenile Rheumatoid Arthritis

A Randomized, Double-Blind Trial of Anti-TNF Chimeric Monoclonal Antibody (Infliximab) in Combination With Methotrexate for the Treatment of Patients With Polyarticular Juvenile Rheumatoid Arthritis

Rheumatoid Arthritis, Juvenile

Drug: Infliximab

Centocor, Inc.

NULL

Completed

4 Years

18 Years

Both

123

Phase 3

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

176

NCT00006292
(ClinicalTrials.gov)

September 2000

23/9/2000

Infliximab for the Treatment of Early Rheumatoid Arthritis

Randomized Double Blind Active Treatment Controlled Trial of the Anti-TNF-Alpha Antibody Infliximab in Patients With Erosive Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Infliximab

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NULL

Completed

N/A

Both

Phase 2

United States

177

NCT00269867
(ClinicalTrials.gov)

March 1997

22/12/2005

Infliximab Plus Methotrexate for the Treatment of Rheumatoid Arthritis

A Placebo-Controlled, Double-Blinded, Randomized Clinical Trial of Anti-TNF Chimeric Monoclonal Antibody (cA2) in Patients With Active Rheumatoid Arthritis Despite Methotrexate Treatment

Rheumatoid Arthritis

Drug: Placebo;Drug: Infliximab 3 mg/kg;Drug: Infliximab 10 mg/kg

Centocor, Inc.

NULL

Completed

18 Years

75 Years

Both

428

Phase 3

NULL

178

JPRN-JapicCTI-050146

12/10/2005

Clinical Study to assess the efficacy and safety of increased dose of TA-650 in patients with Rheumatoid Arthritis

Rheumatoid Arthritis

Intervention name : TA-650 (Infliximab)
Dosage And administration of the intervention : Intravenous drip infusion

Mitsubishi Tanabe Pharma Corporation

NULL

BOTH

Phase 3

NULL

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2005-004067-30-DE (EUCTR)	05/10/2006	11/05/2006	A Double Blind, Randomized, Placebo Controlled, Multi-Center Trial of Anti-TNFafa Chimeric Monoclonal Antibody (Infliximab, Remicade®) and Azathioprine in Patients Suffering from Systemic Lupus Erythematosus (SLE) with WHO Class V Glomerulonephritis	A Double Blind, Randomized, Placebo Controlled, Multi-Center Trial of Anti-TNFafa Chimeric Monoclonal Antibody (Infliximab, Remicade®) and Azathioprine in Patients Suffering from Systemic Lupus Erythematosus (SLE) with WHO Class V Glomerulonephritis	Systemic Lupus Erythematosus (SLE) with WHO Class V Glomerulonephritis	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Trade Name: Azathioprine Other descriptive name: Azathioprine	Department of Rheumatology, Internal Medicine III, Medical University of Vienna	NULL	Not Recruiting			Female: yes Male: yes	44		Germany;Netherlands;Austria
2	NCT00368264 (ClinicalTrials.gov)	September 2006	23/8/2006	TNF Blockade With Remicade in Active Lupus Nephritis WHO Class V (TRIAL )	A Double Blind, Randomized, Placebo Controlled, Multi-Center Trial of Anti-TNF-alpha Chimeric Monoclonal Antibody (Infliximab) and Azathioprine in Patients Suffering From Systemic Lupus Erythematosus (SLE) With WHO Class V Glomerulonephritis	Lupus Erythematosus, Systemic;Lupus Nephritis	Drug: infliximab;Drug: placebo	Medical University of Vienna	Hospital Hietzing;Medical University of Graz;Charite University, Berlin, Germany;University of Erlangen-Nürnberg;Heinrich-Heine University, Duesseldorf;University Medical Centre Groningen;Leiden University Medical Center;Radboud University	Terminated	18 Years	N/A	Both	1	Phase 2;Phase 3	Austria;Germany;Netherlands
3	EUCTR2005-004067-30-NL (EUCTR)	08/08/2006	20/04/2006	A Double Blind, Randomized, Placebo Controlled, Multi-Center Trial of Anti-TNFafa Chimeric Monoclonal Antibody (Infliximab, Remicade®) and Azathioprine in Patients Suffering from Systemic Lupus Erythematosus (SLE) with WHO Class V Glomerulonephritis	A Double Blind, Randomized, Placebo Controlled, Multi-Center Trial of Anti-TNFafa Chimeric Monoclonal Antibody (Infliximab, Remicade®) and Azathioprine in Patients Suffering from Systemic Lupus Erythematosus (SLE) with WHO Class V Glomerulonephritis	Systemic Lupus Erythematosus (SLE) with WHO Class V Glomerulonephritis	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Trade Name: Azathioprine Other descriptive name: Azathioprine	Department of Rheumatology, Internal Medicine III, Medical University of Vienna	NULL	Not Recruiting			Female: yes Male: yes	44		Germany;Netherlands;Austria
4	EUCTR2005-004067-30-AT (EUCTR)	08/05/2006	31/03/2006	A Double Blind, Randomized, Placebo Controlled, Multi-Center Trial of Anti-TNFafa Chimeric Monoclonal Antibody (Infliximab, Remicade®) and Azathioprine in Patients Suffering from Systemic Lupus Erythematosus (SLE) with WHO Class V Glomerulonephritis	A Double Blind, Randomized, Placebo Controlled, Multi-Center Trial of Anti-TNFafa Chimeric Monoclonal Antibody (Infliximab, Remicade®) and Azathioprine in Patients Suffering from Systemic Lupus Erythematosus (SLE) with WHO Class V Glomerulonephritis	Systemic Lupus Erythematosus (SLE) with WHO Class V Glomerulonephritis	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Trade Name: Azathioprine Other descriptive name: Azathioprine	Department of Rheumatology, Internal Medicine III, Medical University of Vienna	NULL	Not Recruiting			Female: yes Male: yes	44		Germany;Netherlands;Austria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2005-004067-30-DE
(EUCTR)

05/10/2006

11/05/2006

A Double Blind, Randomized, Placebo Controlled, Multi-Center Trial of Anti-TNFafa Chimeric Monoclonal Antibody (Infliximab, Remicade®) and Azathioprine in Patients Suffering from Systemic Lupus Erythematosus (SLE) with WHO Class V Glomerulonephritis

Systemic Lupus Erythematosus (SLE) with WHO Class V Glomerulonephritis

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
Trade Name: Azathioprine
Other descriptive name: Azathioprine

Department of Rheumatology, Internal Medicine III, Medical University of Vienna

NULL

Not Recruiting

Female: yes
Male: yes

Germany;Netherlands;Austria

NCT00368264
(ClinicalTrials.gov)

September 2006

23/8/2006

TNF Blockade With Remicade in Active Lupus Nephritis WHO Class V (TRIAL )

A Double Blind, Randomized, Placebo Controlled, Multi-Center Trial of Anti-TNF-alpha Chimeric Monoclonal Antibody (Infliximab) and Azathioprine in Patients Suffering From Systemic Lupus Erythematosus (SLE) With WHO Class V Glomerulonephritis

Lupus Erythematosus, Systemic;Lupus Nephritis

Drug: infliximab;Drug: placebo

Medical University of Vienna

Hospital Hietzing;Medical University of Graz;Charite University, Berlin, Germany;University of Erlangen-Nürnberg;Heinrich-Heine University, Duesseldorf;University Medical Centre Groningen;Leiden University Medical Center;Radboud University

Terminated

18 Years

N/A

Both

Phase 2;Phase 3

Austria;Germany;Netherlands

EUCTR2005-004067-30-NL
(EUCTR)

08/08/2006

20/04/2006

Systemic Lupus Erythematosus (SLE) with WHO Class V Glomerulonephritis

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
Trade Name: Azathioprine
Other descriptive name: Azathioprine

Department of Rheumatology, Internal Medicine III, Medical University of Vienna

NULL

Not Recruiting

Female: yes
Male: yes

Germany;Netherlands;Austria

EUCTR2005-004067-30-AT
(EUCTR)

08/05/2006

31/03/2006

Systemic Lupus Erythematosus (SLE) with WHO Class V Glomerulonephritis

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
Trade Name: Azathioprine
Other descriptive name: Azathioprine

Department of Rheumatology, Internal Medicine III, Medical University of Vienna

NULL

Not Recruiting

Female: yes
Male: yes

Germany;Netherlands;Austria

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT00033891 (ClinicalTrials.gov)	April 10, 2002	11/4/2002	Infliximab (Remicade ) to Treat Dermatomyositis and Polymyositis	A Randomized, Double-Blind, Placebo-Controlled Trial of Infliximab in Patients With Dermatomyositis and Polymyositis	Dermatomyositis;Polymyositis	Drug: Infliximab	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	NULL	Completed	18 Years	N/A	All	14	Phase 2	United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT00033891
(ClinicalTrials.gov)

April 10, 2002

11/4/2002

Infliximab (Remicade ) to Treat Dermatomyositis and Polymyositis

A Randomized, Double-Blind, Placebo-Controlled Trial of Infliximab in Patients With Dermatomyositis and Polymyositis

Dermatomyositis;Polymyositis

Drug: Infliximab

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NULL

Completed

18 Years

N/A

All

Phase 2

United States

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2019-003964-30-GB (EUCTR)	22/10/2020	31/07/2020	Biologics in refractory vasculitis (BIOVAS): A pragmatic, randomised, double-blind, placebo-controlled, modified-crossover trial of biologic therapy for refractory vasculitis in adults and children.	Biologics in refractory vasculitis (BIOVAS): A pragmatic, randomised, double-blind, placebo-controlled, modified-crossover trial of biologic therapy for refractory primary non-ANCA associated vasculitis in adults and children - Biologics in refractory vasculitis (BIOVAS)	Non-ANCA associated vasculitides: 1.Giant cell arteritis (GCA)2.Takayasu’s arteritis (TA)3.Polyarteritis nodosa (PAN) or cutaneous polyarteritis unrelated to hepatitis B (CPAN)4.Relapsing polychondritis (RP)5.IgA vasculitis (IgAV)6.Cogan’s syndrome7.Non-infective cryoglobulinaemia8.Primary angiitis of central nervous system (PACNS) MedDRA version: 21.1;Level: PT;Classification code 10047115;Term: Vasculitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Infliximab Product Code: N/A INN or Proposed INN: Infliximab Trade Name: Rituximab Product Name: Rituximab INN or Proposed INN: Rituximab Trade Name: Tocilizumab Product Name: Tocilizumab Product Code: N/A INN or Proposed INN: Tocilizumab	Cambridge University Hospitals NHS Foundation Trust	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	140	Phase 2	United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-003964-30-GB
(EUCTR)

22/10/2020

31/07/2020

Biologics in refractory vasculitis (BIOVAS): A pragmatic, randomised, double-blind, placebo-controlled, modified-crossover trial of biologic therapy for refractory vasculitis in adults and children.

Biologics in refractory vasculitis (BIOVAS): A pragmatic, randomised, double-blind, placebo-controlled, modified-crossover trial of biologic therapy for refractory primary non-ANCA associated vasculitis in adults and children - Biologics in refractory vasculitis (BIOVAS)

Non-ANCA associated vasculitides: 1.Giant cell arteritis (GCA)2.Takayasu’s arteritis (TA)3.Polyarteritis nodosa (PAN) or cutaneous polyarteritis unrelated to hepatitis B (CPAN)4.Relapsing polychondritis (RP)5.IgA vasculitis (IgAV)6.Cogan’s syndrome7.Non-infective cryoglobulinaemia8.Primary angiitis of central nervous system (PACNS)
MedDRA version: 21.1;Level: PT;Classification code 10047115;Term: Vasculitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Infliximab
Product Code: N/A
INN or Proposed INN: Infliximab
Trade Name: Rituximab
Product Name: Rituximab
INN or Proposed INN: Rituximab
Trade Name: Tocilizumab
Product Name: Tocilizumab
Product Code: N/A
INN or Proposed INN: Tocilizumab

Cambridge University Hospitals NHS Foundation Trust

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

140

Phase 2

United Kingdom

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT03371095 (ClinicalTrials.gov)	March 15, 2018	7/12/2017	Induction Therapy With Anti-TNFa vs Cyclophosphamide in Severe Behçet Disease	Multicenter, Randomized, Prospective Trial Comparing the Efficacy and Safety of Infliximab to That of Cyclophosphamide in Severe Behçet's Disease. ITAC : Induction Therapy With Anti-TNFa vs Cyclophosphamide in Severe Behçet Disease	Behcet's Disease;Vasculitis	Drug: Infliximab;Drug: Cyclophosphamide	Assistance Publique - Hôpitaux de Paris	NULL	Not yet recruiting	12 Years	N/A	All	52	Phase 3	NULL
2	JPRN-UMIN000025451	2017/04/01	28/12/2016	Clinical studies on discontinuation of infliximab and making the shift to cyclosporine for refractory uveitis of Behcet's disease	Clinical studies on discontinuation of infliximab and making the shift to cyclosporine for refractory uveitis of Behcet's disease - Clinical studies on discontinuation of infliximab and making the shift to cyclosporine for refractory uveitis of Behcet's disease	refractory uveitis of Behcet's disease	Patients with Behcet's disease who has received Infliximab intravenous infusion treatment at 8 week intervals over a long period (over 4 years) and calm eye inflammation, shall be discontinued from infliximab and be changed to cyclosporine A oral administration. For cases in which uveitis can not be suppressed and infliximab is reintroduced, if it is 20% or less, it shall be acceptable. Cyclosporine A is started orally at 5 mg / kg / day orally twice a day from 6 weeks after the final Infiximab administration, the maintenance dose is 3 to 5 mg / kg / day, and if the clinical findings are stabilized, Losing weight little by little is judged by the research doctor . The target trough value should be less than 150 ng / ml. The observation period of cyclosporine administration is one year.	Yokohama City University Hospital	NULL	Pending	20years-old	65years-old	Male and Female	5	Not selected	Japan
3	EUCTR2014-005390-36-GB (EUCTR)	17/02/2016	31/12/2015	BIO BEHCET'S TRIAL	Optimal utilisation of biologic drugs in Behçet’s Disease: a randomised controlled trial of infliximab (IFX) verses alpha interferon (aIFN), with genotyping and metabolomic profiling, towards a stratified medicines approach to treatment. - BIO BEHÇET’S	Behcets Disease MedDRA version: 18.1;Level: LLT;Classification code 10004212;Term: Behcet's disease;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Remicade Product Name: Remicade Product Code: 3400935113276 INN or Proposed INN: infliximab Trade Name: Roferon-A, 3miu Product Name: Roferon-A 3miu Product Code: 8699505952864 INN or Proposed INN: alpha interferon Trade Name: Roferon-A, 4.5miu Product Name: Roferon-A, 4.5miu Product Code: J1081 INN or Proposed INN: alpha interferon Trade Name: Roferon-A, 6miu Product Name: Roferon-A, 6miu Product Code: 2387066 INN or Proposed INN: alpha interferon	The University of Liverpool	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	100	Phase 3	United Kingdom
4	NCT02505568 (ClinicalTrials.gov)	July 22, 2015	29/6/2015	A Study to Evaluate Efficacy and Safety of Infliximab in Participant With Moderate-to-Severe Refractory Intestinal Behcet's Disease	An Interventional, Open-label, Single Arm, Multicenter Study to Evaluate Efficacy and Safety of Infliximab in Subject With Moderate-to-Severe Refractory Intestinal Behcet's Disease	Behcet Disease	Drug: Infliximab	Janssen Korea, Ltd., Korea	NULL	Completed	19 Years	75 Years	All	33	Phase 3	Korea, Republic of
5	NCT02620618 (ClinicalTrials.gov)	January 2013	26/11/2015	Intravitreal Infliximab in Refractory Uveitis in Behcet's Disease: A Safety and Efficacy Clinical Study	Intravitreal Infliximab in Refractory Uveitis in Behcet's Disease: A Safety and Efficacy Clinical Study	Behçet's Disease;Uveitis	Drug: Intravitreal Infliximab	Cairo University	NULL	Completed	N/A	N/A	Both	20	Phase 1;Phase 2	NULL
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	EUCTR2017-002264-41-FR (EUCTR)		19/07/2017	NA	Etude randomisée multicentrique évaluant l’efficacité et la tolérance de l’infliximab comparativement au Cyclophosphamide dans les formes sévères de maladie de Behçet Multicenter, randomized, prospective trial comparing the Efficacy and Safety of Infliximab to that of Cyclophosphamide in severe Behçet's disease - ITAC	Induction Therapy with Anti-TNF vs Cyclophosphamide in severe Behçet disease MedDRA version: 20.0;Level: LLT;Classification code 10004212;Term: Behcet's disease;System Organ Class: 100000017240 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)	NULL	NA			Female: yes Male: yes	52	Phase 2	France

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03371095
(ClinicalTrials.gov)

March 15, 2018

7/12/2017

Induction Therapy With Anti-TNFa vs Cyclophosphamide in Severe Behçet Disease

Multicenter, Randomized, Prospective Trial Comparing the Efficacy and Safety of Infliximab to That of Cyclophosphamide in Severe Behçet's Disease. ITAC : Induction Therapy With Anti-TNFa vs Cyclophosphamide in Severe Behçet Disease

Behcet's Disease;Vasculitis

Drug: Infliximab;Drug: Cyclophosphamide

Assistance Publique - Hôpitaux de Paris

NULL

Not yet recruiting

12 Years

N/A

All

Phase 3

NULL

JPRN-UMIN000025451

2017/04/01

28/12/2016

Clinical studies on discontinuation of infliximab and making the shift to cyclosporine for refractory uveitis of Behcet's disease

Clinical studies on discontinuation of infliximab and making the shift to cyclosporine for refractory uveitis of Behcet's disease - Clinical studies on discontinuation of infliximab and making the shift to cyclosporine for refractory uveitis of Behcet's disease

refractory uveitis of Behcet's disease

Patients with Behcet's disease who has received Infliximab intravenous infusion treatment at 8 week intervals over a long period (over 4 years) and calm eye inflammation, shall be discontinued from infliximab and be changed to cyclosporine A oral administration. For cases in which uveitis can not be suppressed and infliximab is reintroduced, if it is 20% or less, it shall be acceptable. Cyclosporine A is started orally at 5 mg / kg / day orally twice a day from 6 weeks after the final Infiximab administration, the maintenance dose is 3 to 5 mg / kg / day, and if the clinical findings are stabilized, Losing weight little by little is judged by the research doctor . The target trough value should be less than 150 ng / ml. The observation period of cyclosporine administration is one year.

Yokohama City University Hospital

NULL

Pending

20years-old

65years-old

Male and Female

Not selected

Japan

EUCTR2014-005390-36-GB
(EUCTR)

17/02/2016

31/12/2015

BIO BEHCET'S TRIAL

Optimal utilisation of biologic drugs in Behçet’s Disease: a randomised controlled trial of infliximab (IFX) verses alpha interferon (aIFN), with genotyping and metabolomic profiling, towards a stratified medicines approach to treatment. - BIO BEHÇET’S

Behcets Disease
MedDRA version: 18.1;Level: LLT;Classification code 10004212;Term: Behcet's disease;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Remicade
Product Name: Remicade
Product Code: 3400935113276
INN or Proposed INN: infliximab
Trade Name: Roferon-A, 3miu
Product Name: Roferon-A 3miu
Product Code: 8699505952864
INN or Proposed INN: alpha interferon
Trade Name: Roferon-A, 4.5miu
Product Name: Roferon-A, 4.5miu
Product Code: J1081
INN or Proposed INN: alpha interferon
Trade Name: Roferon-A, 6miu
Product Name: Roferon-A, 6miu
Product Code: 2387066
INN or Proposed INN: alpha interferon

The University of Liverpool

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

100

Phase 3

United Kingdom

NCT02505568
(ClinicalTrials.gov)

July 22, 2015

29/6/2015

A Study to Evaluate Efficacy and Safety of Infliximab in Participant With Moderate-to-Severe Refractory Intestinal Behcet's Disease

An Interventional, Open-label, Single Arm, Multicenter Study to Evaluate Efficacy and Safety of Infliximab in Subject With Moderate-to-Severe Refractory Intestinal Behcet's Disease

Behcet Disease

Drug: Infliximab

Janssen Korea, Ltd., Korea

NULL

Completed

19 Years

75 Years

All

Phase 3

Korea, Republic of

NCT02620618
(ClinicalTrials.gov)

January 2013

26/11/2015

Intravitreal Infliximab in Refractory Uveitis in Behcet's Disease: A Safety and Efficacy Clinical Study

Behçet's Disease;Uveitis

Drug: Intravitreal Infliximab

Cairo University

NULL

Completed

N/A

Both

Phase 1;Phase 2

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2017-002264-41-FR
(EUCTR)

19/07/2017

Etude randomisée multicentrique évaluant l’efficacité et la tolérance de l’infliximab comparativement au Cyclophosphamide dans les formes sévères de maladie de Behçet Multicenter, randomized, prospective trial comparing the Efficacy and Safety of Infliximab to that of Cyclophosphamide in severe Behçet's disease - ITAC

Induction Therapy with Anti-TNF vs Cyclophosphamide in severe Behçet disease
MedDRA version: 20.0;Level: LLT;Classification code 10004212;Term: Behcet's disease;System Organ Class: 100000017240 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

NULL

Female: yes
Male: yes

Phase 2

France

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT00325078 (ClinicalTrials.gov)	May 2006	11/5/2006	Infliximab to Treat Crohn'S-like Inflammatory Bowel Disease in Chronic Granulomatous Disease	Tumor Necrosis Factor Alpha Inhibitor (Lnfliximab, Adalimumab) Treatment for Crohn'S-like Inflammatory Bowel Disease in Chronic Granulomatous Disease: A Phase I/II Study Assessing Clinical and Immune Responses to Treatment and Genetic Influences	Chronic Granulomatous Disease;Crohn'S-like IBD;Inflammatory Bowel Disease (IBD)	Drug: Infliximab	National Institute of Allergy and Infectious Diseases (NIAID)	NULL	Terminated	10 Years	N/A	All	40	Phase 1;Phase 2	United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT00325078
(ClinicalTrials.gov)

May 2006

11/5/2006

Infliximab to Treat Crohn'S-like Inflammatory Bowel Disease in Chronic Granulomatous Disease

Tumor Necrosis Factor Alpha Inhibitor (Lnfliximab, Adalimumab) Treatment for Crohn'S-like Inflammatory Bowel Disease in Chronic Granulomatous Disease: A Phase I/II Study Assessing Clinical and Immune Responses to Treatment and Genetic Influences

Chronic Granulomatous Disease;Crohn'S-like IBD;Inflammatory Bowel Disease (IBD)

Drug: Infliximab

National Institute of Allergy and Infectious Diseases (NIAID)

NULL

Terminated

10 Years

N/A

All

Phase 1;Phase 2

United States

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT03704610 (ClinicalTrials.gov)	March 28, 2019	10/10/2018	Efficacy of Remission-induction Regimen With Infliximab for Severe Extrathoracic Sarcoidosis (EFIRTES)	Efficacy of Remission-induction Regimen With Infliximab for Severe Extrathoracic Sarcoidosis (EFIRTES STUDY)	Extrathoracic Sarcoidosis	Drug: Infliximab;Drug: Placebo	Assistance Publique - Hôpitaux de Paris	NULL	Recruiting	18 Years	N/A	All	30	Phase 3	France
2	EUCTR2014-002224-26-NL (EUCTR)	07/05/2015	03/02/2015	Infliximab dosing based on blood concentrations in patients with sarcoidosis: smart dosing	A new dosing strategy of infliximab versus standard dosing in patients with severe sarcoidosis: optimization of treatment - Concentration guided dosing of infliximab in sarcoidosis	Sarcoidosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Remicade Product Name: Remicade	St. Antonius Hospital	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Netherlands
3	EUCTR2011-003630-13-NL (EUCTR)	22/11/2011	07/11/2011	Tracer for the imaging of disease activity in sarcoidosis in the lung	99mTc labelled anti-TNF-alpha for the imaging of disease activity in pulmonary sarcoidosis - TISS	Pulmonary sarcoidosis MedDRA version: 17.0;Level: PT;Classification code 10037430;Term: Pulmonary sarcoidosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: 99mTc-Infliximab Product Code: not applicable INN or Proposed INN: not applicable Other descriptive name: 99m technetium infliximab	Sint Antonius Hospital	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Netherlands
4	NCT00073437 (ClinicalTrials.gov)	October 2003	20/11/2003	A Study of Infliximab in Patients With Sarcoidosis	A Multicenter, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Safety and Efficacy of Infliximab (Remicade?) in Subjects With Chronic Sarcoidosis With Pulmonary Involvement.	Sarcoidosis	Drug: Infliximab	Centocor, Inc.	NULL	Completed	18 Years	N/A	Both	139	Phase 3	United States;Austria;Belgium;France;Germany;Netherlands;Sweden;Switzerland;United Kingdom;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03704610
(ClinicalTrials.gov)

March 28, 2019

10/10/2018

Efficacy of Remission-induction Regimen With Infliximab for Severe Extrathoracic Sarcoidosis (EFIRTES)

Efficacy of Remission-induction Regimen With Infliximab for Severe Extrathoracic Sarcoidosis (EFIRTES STUDY)

Extrathoracic Sarcoidosis

Drug: Infliximab;Drug: Placebo

Assistance Publique - Hôpitaux de Paris

NULL

Recruiting

18 Years

N/A

All

Phase 3

France

EUCTR2014-002224-26-NL
(EUCTR)

07/05/2015

03/02/2015

Infliximab dosing based on blood concentrations in patients with sarcoidosis: smart dosing

A new dosing strategy of infliximab versus standard dosing in patients with severe sarcoidosis: optimization of treatment - Concentration guided dosing of infliximab in sarcoidosis

Sarcoidosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Remicade
Product Name: Remicade

St. Antonius Hospital

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Netherlands

EUCTR2011-003630-13-NL
(EUCTR)

22/11/2011

07/11/2011

Tracer for the imaging of disease activity in sarcoidosis in the lung

99mTc labelled anti-TNF-alpha for the imaging of disease activity in pulmonary sarcoidosis - TISS

Pulmonary sarcoidosis
MedDRA version: 17.0;Level: PT;Classification code 10037430;Term: Pulmonary sarcoidosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Product Name: 99mTc-Infliximab
Product Code: not applicable
INN or Proposed INN: not applicable
Other descriptive name: 99m technetium infliximab

Sint Antonius Hospital

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Netherlands

NCT00073437
(ClinicalTrials.gov)

October 2003

20/11/2003

A Study of Infliximab in Patients With Sarcoidosis

A Multicenter, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Safety and Efficacy of Infliximab (Remicade?) in Subjects With Chronic Sarcoidosis With Pulmonary Involvement.

Sarcoidosis

Drug: Infliximab

Centocor, Inc.

NULL

Completed

18 Years

N/A

Both

139

Phase 3

United States;Austria;Belgium;France;Germany;Netherlands;Sweden;Switzerland;United Kingdom;Italy

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2017-003311-19-DE (EUCTR)	09/01/2018	18/09/2017	Phase IIa proof-of-principle study for the induction treatment of autoimmune hepatitis using infliximabAIH-MAB	Phase IIa proof-of-principle study for the induction treatment of autoimmune hepatitis using infliximabAIH-MAB	Autoimmune Hepatitis (AIH); rare inflammatory liver disease associated with elevated transaminases, elevated Immunoglobulin G, the presence of autoantibodies and interface hepatitis in liver histology. Untreated, AIH progresses to liver fibrosis and cirrhosis with its complications. Historical placebo-controlled studies could show a mortality of around 70% in the placebo-treated group.;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Inflectra (Infliximab)	University Medical Centre Hamburg-Eppendorf	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	12	Phase 2	Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2017-003311-19-DE
(EUCTR)

09/01/2018

18/09/2017

Phase IIa proof-of-principle study for the induction treatment of autoimmune hepatitis using infliximabAIH-MAB

Autoimmune Hepatitis (AIH); rare inflammatory liver disease associated with elevated transaminases, elevated Immunoglobulin G, the presence of autoantibodies and interface hepatitis in liver histology. Untreated, AIH progresses to liver fibrosis and cirrhosis with its complications. Historical placebo-controlled studies could show a mortality of around 70% in the placebo-treated group.;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Inflectra (Infliximab)

University Medical Centre Hamburg-Eppendorf

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Germany

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT04530877 (ClinicalTrials.gov)	December 1, 2020	24/8/2020	Exclusive Enteral Nutrition vs. Infliximab in Chinese CD Patients	Comparative Effectiveness of Exclusive Enteral Nutrition and Infliximab in Chinese Children With Active Crohn's Disease	Crohn's Disease;Exclusive Enteral Nutrition;Infliximab;Mucosal Healing	Biological: Infliximab;Dietary Supplement: Exclusive Enteral Nutrition	Children's Hospital of Fudan University	NULL	Not yet recruiting	1 Year	18 Years	All	80	Phase 4	NULL
2	NCT04646187 (ClinicalTrials.gov)	December 2020	20/11/2020	De-escalation of Anti-TNF Therapy in Inflammatory Bowel Disease	De-escalation of Anti-TNF Therapy in Adolescents and Young Adults With IBD With Tight Faecal Calprotectin and Trough Level Monitoring	Inflammatory Bowel Diseases;Crohn Disease;Colitis, Ulcerative	Biological: Infliximab;Biological: Adalimumab	University Medical Center Groningen	European Crohn´s and Colitis Organisation;Bühlmann Laboratories AG	Not yet recruiting	12 Years	25 Years	All	148	Phase 4	Belgium;Netherlands;Spain
3	EUCTR2020-001811-26-NL (EUCTR)	30/09/2020	08/07/2020	IBD under control with less medication	De-escalation of anti-TNF therapy in adolescents and young adults with IBD with tight faecal calprotectin and trough level monitoring - FREE-study	Crohn's disease, ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Flixabi INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra INN or Proposed INN: INFLIXIMAB Trade Name: Remsima INN or Proposed INN: INFLIXIMAB Trade Name: Zessly INN or Proposed INN: INFLIXIMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Amgevita INN or Proposed INN: ADALIMUMAB Trade Name: Hulio INN or Proposed INN: ADALIMUMAB	University Medical Center Groningen	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 4	Netherlands
4	JPRN-jRCT2031200117	01/09/2020	11/09/2020	A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohns Disease	A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohns Disease	Crohns Disease	Biological: CT-P13 SC (Infliximab) Other: Placebo SC	Ishida Tetsuya	Celltrion	Recruiting	>= 18age old	<= 75age old	Both	600	Phase 3	Austria;Bulgaria;Croatia;Japan;US;Latvia;Czech Republic;France;Poland;Germany;Greece;Hungary;Spain
5	NCT04331639 (ClinicalTrials.gov)	September 2020	23/3/2020	High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Biologic Therapy	Implementation of High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Infliximab or Vedolizumab	Inflammatory Bowel Disease;Crohn Disease;Ulcerative Colitis;Vitamin D Deficiency	Dietary Supplement: vitamin D3	Boston Children's Hospital	NULL	Not yet recruiting	5 Years	25 Years	All	50	Phase 2	NULL
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	NCT04312659 (ClinicalTrials.gov)	July 15, 2020	3/3/2020	A Study of Infliximab in the Treatment of Chinese Children With Crohn's Disease	A Multi-Center Registry Study of Infliximab in the Treatment of Chinese Children With Crohn's Disease	Crohn Disease	Drug: Infliximab	Johnson & Johnson (China) Investment Ltd.	NULL	Recruiting	6 Years	17 Years	All	40		China
7	ChiCTR2000029323	2020-03-01	2020-01-25	Laparoscopic bowel resection combined with infliximab treatment versus infliximab for localized intestinal Crohn's disease: a randomized controlled, open-label trial	Laparoscopic bowel resection combined with infliximab treatment versus infliximab for localized intestinal Crohn's disease: a randomized controlled, open-label trial	Crohn's disease	Experimental group:Laparoscopic bowel resection combined with postoperative Infliximab treatment;Control group:Infliximab;	Renji Hospital, School of Medicine, Shanghai Jiaotong University	NULL	Pending	18	80	Both	Experimental group:30;Control group:30;		China
8	ChiCTR2000029543	2020-02-08	2020-02-03	A Model with serum biomarkers to Predict Infliximab Response in Patients with Crohn's Disease	A Model with serum biomarkers to Predict Infliximab Response in Patients with Crohn's Disease	Crohn's Disease	Gold Standard:Histology pathological examination; SES-CD endoscopy score;Index test:ELISA test for multiple serum cytokines;	The First Hospital Affiliated to Sun Yat sen University	NULL	Recruiting			Both	Target condition:350;Difficult condition:0		China
9	EUCTR2019-001087-30-AT (EUCTR)	28/11/2019	12/09/2019	Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's disease	A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB	Celltrion, Inc	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Japan
10	EUCTR2019-003068-39-NL (EUCTR)	20/11/2019	04/11/2019	In patients with inflammatory bowel disease (IBD) on infliximab (IFX) maintenance treatment, low trough levels of IFX suggest inefficacy of the drug and have consistently been shown to be protective of relapse following withdrawal of IFX. However, up to 30% of these patients will experience a relapse after IFX withdrawal. Pharmacokinetic parameters other than trough levels may predict relapse following drug withdrawal in IBD patients with undetectable IFX trough levels.	Withdrawal of Infliximab in patients with inflammatory bowel disease in remission guided by pharmacokinetics: WINK study - WINK study	Inflammatory Bowel Disease (IBD) Ulcerative colitis Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Infliximab Product Name: Infliximab INN or Proposed INN: INFLIXIMAB	UMC Utrecht	NULL	Not Recruiting			Female: yes Male: yes	30	Phase 4	Netherlands
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
11	NCT04655729 (ClinicalTrials.gov)	November 18, 2019	30/11/2020	Biomarkers to Predict and Monitor Response to Infliximab	Detection of Serum Protein Biomarkers to Predict and Monitor Response to Infliximab Using SOMAscan	Crohn Disease	Drug: Infliximab	Massachusetts General Hospital	The Crohn's and Colitis Foundation	Recruiting	3 Years	20 Years	All	120		United States
12	EUCTR2019-001087-30-DE (EUCTR)	31/10/2019	01/07/2019	Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's disease	A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remsima Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB	Celltrion, Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Czechia;Turkey;Austria;Czech Republic;Hungary;Mexico;Poland;Croatia;Romania;Bulgaria;Germany;Japan
13	EUCTR2019-001087-30-BG (EUCTR)	30/10/2019	24/10/2019	Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's disease	A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remsima Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB	Celltrion, Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	United States;Belarus;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Czechia;Turkey;Austria;Czech Republic;Hungary;Mexico;Brazil;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan
14	NCT03945019 (ClinicalTrials.gov)	October 28, 2019	8/5/2019	CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Crohn's Disease	A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease	Crohn's Disease	Biological: CT-P13 SC (Infliximab);Other: Placebo SC	Celltrion	NULL	Recruiting	18 Years	75 Years	All	600	Phase 3	United States
15	NCT04131504 (ClinicalTrials.gov)	October 16, 2019	16/10/2019	Precision Crohn's Disease Management Utilizing Predictive Protein Panels (ENvISION)	A Multi-Center, Prospective Study to Discover a Companion Diagnostic for Biologics Targeting TNF	Crohn's Disease;IBD	Drug: Infliximab;Drug: Adalimumab	Children's Hospital Medical Center, Cincinnati	The Leona M. and Harry B. Helmsley Charitable Trust	Recruiting	1 Year	22 Years	All	240		United States
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
16	JPRN-jRCT1031190056	30/09/2019	17/07/2019	E6011-CS1 study	Research for medicinal predictive marker on Crohn's disease - E6011-CS1 study	Crohn's disease Crohn's disease;D003424	Study1:Evaluate the disease activity and collect the blood according to the schedule as below. Amount of blood collection should be about 15mL at screening test, after the beginning of the study, about 12.5mL per visit. 1.Adalimumab:At the beginning of the study, after that, 2, 4, 12, 24, 52 weeks after or at the termination 2.Infliximab:At the beginning of the study,after that, 2, 6, 14, 22, 54 weeks after or at the termination 3. Ustekinumab:At the beginning of the study,after that, 2, 8, 20, 32, 56weeks after or at the termination Study2:None.	Nanki Kousaku	EA Pharma Co.,Ltd.(Utilize AMED's funds)	Recruiting	>= 16age old	Not applicable	Both	32	N/A	Japan
17	ChiCTR1900026091	2019-09-19	2019-09-20	Development of a predictive nomogram for primary non-response to infliximab in patients with Crhon's disease	Development of a predictive nomogram for primary non-response to infliximab in patients with Crhon's disease: a multicenter study	Crohn's disease	Case series:infliximab;	The First Affiliated Hospital of Sun Yat-sen University	NULL	Pending	9	58	Both	Case series:343;		China
18	NCT03885713 (ClinicalTrials.gov)	September 10, 2019	4/3/2019	Identification of Predictive Biomarkers for Response to Biologic Therapies in Inflammatory Bowel Disease	Identification of Predictive Biomarkers for Response to Biologic Therapies in Inflammatory Bowel Disease by Proteomic and Mass Cytometry Approaches	Inflammatory Bowel Diseases;Crohn Disease;Ulcerative Colitis	Biological: Infliximab or adalimumab or golimumab or vedolizumab or ustekinumab	Fundación de Investigación Biomédica - Hospital Universitario de La Princesa	NULL	Recruiting	18 Years	N/A	All	180	Phase 4	Spain
19	EUCTR2019-001087-30-PL (EUCTR)	09/09/2019	24/06/2019	Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's disease	A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB	Celltrion, Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	Serbia;Portugal;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Czech Republic;Hungary;Mexico;Brazil;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Japan
20	EUCTR2019-001087-30-GR (EUCTR)	28/08/2019	26/07/2019	Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's disease	A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB	Celltrion, Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	Serbia;Portugal;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Czech Republic;Hungary;Mexico;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
21	EUCTR2019-001087-30-ES (EUCTR)	14/08/2019	10/09/2019	Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's disease	A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB	Celltrion, Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	Serbia;Portugal;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Czech Republic;Hungary;Mexico;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany
22	EUCTR2019-001087-30-CZ (EUCTR)	06/08/2019	06/06/2019	Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's disease	A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease	Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: REMSINA Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB	Celltrion, Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	United States;Belarus;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Czechia;Turkey;Austria;Hungary;Czech Republic;Mexico;Poland;Croatia;Romania;Bulgaria;Germany;Japan
23	EUCTR2018-002064-15-NL (EUCTR)	15/04/2019	15/04/2019	Patient preference model: treatment of perianal fistulas in Crohn's disease	Treatment of Perianal FIstulas in Crohn’s Disease: Surgical closure vs Anti-TNF - PISA II-trial	Perianal fistulas in Crohn's Disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remicade Product Name: Infliximab Trade Name: Humira Product Name: Adalimumab	Academic Medical Center	NULL	Not Recruiting			Female: yes Male: yes	140	Phase 4	Netherlands
24	NCT03884439 (ClinicalTrials.gov)	March 18, 2019	4/3/2019	Infliximab Biosimilar Pfizer Drug Use Investigation (Crohn's Disease or Ulcerative Colitis)	Infliximab BS for Intravenous Drip Infusion 100 mg Pfizer General Investigation (Crohn's Disease or Ulcerative Colitis)	Crohn's Disease;Ulcerative Colitis	Drug: Infliximab [infliximab biosimilar 3]	Pfizer	NULL	Recruiting	N/A	N/A	All	300		Japan
25	NCT04606017 (ClinicalTrials.gov)	January 1, 2019	25/10/2020	Effect of Vitamin D Combined With Calcium Supplementation on Infliximab Response in Patients With Crohn's Disease	Effect of Vitamin D Combined With Calcium Supplementation on Infliximab Response	Crohn Disease;Vitamin D Deficiency;Vitamin D Supplement	Drug: Caltrate Pill	Second Affiliated Hospital of Wenzhou Medical University	NULL	Completed	N/A	N/A	All	70		China
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
26	ChiCTR1800019958	2018-12-16	2018-12-09	Combining infliximab with Hyperbaric Oxygen Therapy in Patients With Perianal Crohn's Disease	Combining infliximab with Hyperbaric Oxygen Therapy in Patients With Perianal Crohn's Disease	Crohn's disease	Case series:Combining infliximab treatmentwith Hyperbaric Oxygen Therapy;	Daping Hospital, Army Medical University (Third Military Medical University)	NULL	Recruiting	18	65	Both	Case series:60;		China
27	NCT03452501 (ClinicalTrials.gov)	August 26, 2018	26/2/2018	Safety and Effectiveness Study of Remsima® in the Treatment of Inflammatory Bowel Diseases Among Saudi Arabia Patients	An Observational, Prospective Cohort Study to Evaluate the Safety and Effectiveness of Remsima® in the Treatment of Inflammatory Bowel Disease Among Saudi Arabia Patients Diagnosed With Crohn's Disease, Ulcerative Colitis, or Fistulizing CD	Inflammatory Bowel Diseases;Crohn Disease;Fistulizing Crohn's Disease;Ulcerative Colitis	Drug: Infliximab	Hikma Pharmaceuticals LLC	NULL	Active, not recruiting	18 Years	N/A	All	150		Saudi Arabia
28	EUCTR2018-001546-33-GB (EUCTR)	11/07/2018	14/05/2018	The effects of switching one drug, used to treat either Ulcerative Colitis (UC) or Crohn’s disease (CD) to another drug, also used to treat UC or Crohn’s disease	IBD Biosimilar to Biosimilar Infliximab Switching Study - iBiSS v1.0	Inflammatory Bowel Disease in particular Crohn's Disease and Ulcerative Colitis MedDRA version: 20.1;Level: PT;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Flixabi Product Name: Flixabi INN or Proposed INN: Infliximab	University Southampton Hospital NHS Foundation Trust	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 4	United Kingdom
29	NCT03662919 (ClinicalTrials.gov)	July 2, 2018	6/9/2018	One-year Persistence to Treatment of Participants Receiving Flixabi or Imraldi: a French Cohort Study	PERFUSE - One-year Persistence to Treatment of Patients Receiving Flixabi or Imraldi: a French Cohort Study	Arthritis, Rheumatoid;Spondylitis, Ankylosing;Arthritis, Psoriatic;Crohn's Disease;Colitis, Ulcerative	Drug: Infliximab;Drug: Adalimumab	Biogen	NULL	Recruiting	6 Years	N/A	All	3000		France
30	EUCTR2014-002311-41-NL (EUCTR)	25/05/2018	18/12/2017	A proSpective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheRapy and infliximab monothErapy in Crohn’s disease patients in sustained steroid-free remission on combination therapy.SPARE	A proSpective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheRapy and infliximab monothErapy in Crohn’s disease patients in sustained steroid-free remission on combination therapy. - GETAID 2014-3 SPARE	Luminal Crohn’s disease patients with steroid free remission for at least 6 months and a combination therapy with infliximab and anti-metabolites for at least 8 months;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: REMICADE Product Name: INFLIXIMAB Trade Name: IMUREL Product Name: azathioprine Trade Name: METHOTREXATE Product Name: METHOTREXATE Trade Name: PURINETHOL Product Name: MERCAPTOPURINE	GETAID	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	300	Phase 4	France;Belgium;Germany;Netherlands;United Kingdom;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
31	NCT03221166 (ClinicalTrials.gov)	February 27, 2018	5/7/2017	Thalidomide Versus Infliximab in New Onset Crohn's Disease With Poor Prognostic Factors	Thalidomide, a Novel Immunological Treatment to Modify the Natural History of Paediatric Crohn's Disease: a New Proposal From a Well-established Paediatric Research Network	Crohn Disease	Drug: Thalidomide;Drug: Infliximab	IRCCS Burlo Garofolo	Centro di Riferimento Oncologico - Aviano;Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia	Terminated	6 Years	17 Years	All	9	Phase 3	Italy
32	NCT03393247 (ClinicalTrials.gov)	June 1, 2017	8/7/2017	The Therapy Effect of Azathioprine Initial or 14 Weeks After Combined With Infliximab on CD	The Therapy Effect of Azathioprine Initial or 14 Weeks After Combined With Infliximab on Crohn Disease:a Randomized, Open Label, Single-center Cohort Study	Crohn Disease	Drug: infliximab and azathioprine combination at week 0;Drug: infliximab and azathioprine combination at week 14	Sixth Affiliated Hospital, Sun Yat-sen University	NULL	Unknown status	14 Years	60 Years	All	160	N/A	China
33	NCT02994836 (ClinicalTrials.gov)	April 21, 2017	24/10/2016	GIS-SUSANTI-TNF-2015 (Anti-TNF Discontinuation )	Anti-TNF Discontinuation in Patients With Inflammatory Bowel Disease: Multicentre, Prospective, Randomized Clinical Trial and Economic Evaluation	Crohn's Disease;Inflammatory Bowel Disease;Ulcerative Colitis	Biological: Anti-TNF: Infliximab (Infusion);Drug: Anti-TNF discontinuation: Physiological saline solution;Biological: Anti-TNF:Adalimumab (Subcutaneus)	Fundación de Investigación Biomédica - Hospital Universitario de La Princesa	NULL	Recruiting	18 Years	N/A	All	194	Phase 4	Spain
34	JPRN-UMIN000026330	2017/02/27	28/02/2017	Efficacy and safety of the biosimilar Infliximab in the patients with Crohn's disease	Efficacy and safety of the biosimilar Infliximab in the patients with Crohn's disease - Efficacy and safety of IFX-BS in CD patients	Crohn disease	Infliximab (5 or 10mg/kg, every 8 weeks, for 12 months) Biosimilar Infliximab (5 or 10mg/kg, every 8 weeks, for 12 months)	University of Toyama	NULL	Complete: follow-up continuing	20years-old	Not applicable	Male and Female	30	Not selected	Japan
35	NCT04272788 (ClinicalTrials.gov)	January 24, 2017	11/2/2020	Association of Breg and Treg With the Clinical Effects of Infliximab in the Treatment of Patients With Crohn's Disease	Association of Breg and Treg With the Clinical Effects of Infliximab in the Treatment of Patients With Crohn's Disease	Crohn Disease	Drug: Infliximab	Second Affiliated Hospital of Wenzhou Medical University	NULL	Completed	18 Years	N/A	All	32		China
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
36	NCT02998827 (ClinicalTrials.gov)	November 2016	24/11/2016	Thalidomide Results in Diminished Ovarian Reserve in Reproductive Age Female IBD Patients		Crohn Disease	Drug: Thalidomide;Drug: infliximab, azathioprine;Other: enteral nutrition	Sixth Affiliated Hospital, Sun Yat-sen University	NULL	Enrolling by invitation	N/A	N/A	Female	90	N/A	NULL
37	EUCTR2016-002061-54-IT (EUCTR)	13/10/2016	15/11/2018	Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases.	Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases.Evaluation of immunogenicity and clinical response - Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®)	Rheumatoid arthritis, seronegative spondylo arthritis,Crohn's Disease, Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10039073;Term: Rheumatoid arthritis;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Classification code 10075634;Term: Acute haemorrhagic ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: REMSIMA - 100 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLANCONCINO (VETRO) - 1 FLACONCINO Product Name: Remsima Product Code: 42942019	UNIVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLI	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 4	Italy
38	EUCTR2014-004904-31-BE (EUCTR)	21/09/2016	29/07/2016	A clinical study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission.	An open-label, multicentre, phase IV study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission.	Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA).;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Remsima (infliximab)	Mundipharma Pharmaceuticals B.V.	NULL	Not Recruiting			Female: yes Male: yes	156	Phase 4	Belgium;Netherlands
39	EUCTR2016-001278-13-FI (EUCTR)	08/06/2016	15/04/2016	Immunologic, genetic and bowel microbes as predictors of the treatment response for TNFalpha-blocking drugs in patients with Crohn’s disease or ulcerative colitis	Immunologic, genetic and microbiomic predictors of the treatment response for TNFalpha-blocking drugs – prospective follow-up cohort of patients with Crohn’s disease or ulcerative colitis - PROSIBD	Ulcerative colitis and Crohn's disease MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.0;Classification code 10013099;Term: Disease Crohns;Classification code 10058815;Term: Crohn's disease acute episode;Classification code 10057035;Term: Crohn's ileocolitis;Classification code 10011405;Term: Crohn's enteritis;Classification code 10011406;Term: Crohn's ileitis;Classification code 10076318;Term: Crohn's disease relapse;Level: PT;Classification code 10011401;Term: Crohn's disease;Classification code 10011402;Term: Crohn's disease (colon);Classification code 10075466;Term: Fistulising Crohn's disease;Classification code 10066678;Term: Acute ulcerative colitis;Classification code 10075465;Term: Fistulizing Crohn's disease;Classification code 10011400;Term: Crohn's colitis;System Organ Class: 10017947 - Gastrointe;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remsima Product Name: Remsima INN or Proposed INN: INFLIXIMAB	Taina Sipponen	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 4	Finland
40	EUCTR2015-004618-10-BE (EUCTR)	19/04/2016	20/11/2015	PhArmaCo-kinetics of InFliximab during treatment Induction	Study of the inter-individual variation of PhArmaCo-kinetics of InFliximab during treatment Induction in patients with Crohn’s disease and Ulcerative Colitis	Patients with Crohn disease or Ulcerative Colitis which need biotherapy (antibody against TNF-a);Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remsima INN or Proposed INN: INFLIXIMAB Other descriptive name: Remsima Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Remicade Trade Name: Inflectra INN or Proposed INN: INFLIXIMAB Other descriptive name: Inflectra	CUB- Hopital Erasme	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes		Phase 4	Belgium
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
41	EUCTR2012-002702-51-NO (EUCTR)	07/03/2016	03/02/2016	Discontinuation of biologic therapy (infliximab) in patients with Crohn’s disease during sustained complete absence of disease activity: A Nordic multi-center, double blinded, randomized, placebo controlled study	Discontinuation of infliximab therapy in patients with Crohn’s disease during sustained complete remission: A Nordic multi-center, double blinded, randomized, placebo controlled study - STOP IT	Patients with Crohn's disease with absence of disease activity during biologic therapy (infliximab) MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Remsima Product Name: Remsima Trade Name: Inflectra Product Name: Inflectra Product Code: EMEA/H/C/002778	Department of medical gastroenterology, Herlev Hospital	NULL	Not Recruiting			Female: yes Male: yes	136	Phase 4	Finland;Denmark;Norway;Sweden
42	ChiCTR1800020305	2016-01-01	2018-12-23	A follow-up study for infliximab or combine with azathioprine in the treatment of Crohn's disease	Infliximab or combine with azathioprine in the treatment of Crohn's disease and relationship with ATI	crohn's disease;K50.900	Group 2:infliximab + azathioprine;Group 1:infliximab alone;	Department of Gastroenterology, Nanfang Hospital, Southern Medical University	NULL	Recruiting	12	80	Both	Group 2:41;Group 1:45;		China
43	EUCTR2014-002311-41-DE (EUCTR)	25/11/2015	21/08/2015	A proSpective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheRapy and infliximab monothErapy in Crohn’s disease patients in sustained steroid-free remission on combination therapy	A proSpective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheRapy and infliximab monothErapy in Crohn’s disease patients in sustained steroid-free remission on combination therapy - SPARE	Luminal Crohn’s disease patients with steroid free remission for at least 6 months and a combination therapy with infliximab and anti-metabolites for at least 8 months;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]	Trade Name: REMICADE Product Name: INFLIXIMAB Trade Name: IMUREL Product Name: azathioprine Trade Name: METHOTREXATE Product Name: METHOTREXATE Trade Name: PURINETHOL Product Name: MERCAPTOPURINE	GETAID	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	300	Phase 4	France;Australia;Netherlands;Germany;United Kingdom;Sweden
44	EUCTR2012-002702-51-FI (EUCTR)	12/10/2015	30/09/2015	Discontinuation of biologic therapy (infliximab) in patients with Crohn’s disease during sustained complete absence of disease activity: A Nordic multi-center, double blinded, randomized, placebo controlled study	Discontinuation of infliximab therapy in patients with Crohn’s disease during sustained complete remission: A Nordic multi-center, double blinded, randomized, placebo controlled study - STOP IT	Patients with Crohn's disease with absence of disease activity during biologic therapy (infliximab) MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Remsima Product Name: Remsima INN or Proposed INN: INFLIXIMAB	Department of medical gastroenterology, Herlev Hospital	NULL	Not Recruiting			Female: yes Male: yes	5	Phase 4	Finland;Denmark;Norway;Sweden
45	NCT02177071 (ClinicalTrials.gov)	October 9, 2015	26/6/2014	A proSpective Randomized Controlled Trial comParing infliximAb-antimetabolites Combination Therapy to Anti-metabolites monotheRapy and Infliximab monothErapy in Crohn's Disease Patients in Sustained Steroid-free Remission on Combination Therapy	A proSpective Randomized Controlled Trial comParing infliximAb-antimetabolites Combination Therapy to Anti-metabolites monotheRapy and Infliximab monothErapy in Crohn's Disease Patients in Sustained Steroid-free Remission on Combination Therapy	Crohn's Disease	Drug: INFLIXIMAB;Drug: AZATHIOPRINE;Drug: MERCAPTOPURINE;Drug: Methotrexate	Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives	Saint-Louis Hospital, Paris, France	Active, not recruiting	18 Years	65 Years	All	211	Phase 4	Australia;Belgium;France
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
46	NCT02847884 (ClinicalTrials.gov)	October 2015	30/11/2015	IDeaL Pilot Study - Infliximab Dose to Level: Pilot Study	IDeaL Pilot Study - Infliximab Dose to Level: Pilot Study	Inflammatory Bowel Disease;Crohn's Disease	Biological: Infliximab	University of Alberta	The Hospital for Sick Children;The Children's Hospital of Winnipeg;Alberta Children's Hospital;Provincial Health Services Authority;Children's Hospital of Eastern Ontario	Completed	2 Years	17 Years	All	28		Canada
47	EUCTR2015-001954-14-NL (EUCTR)	14/09/2015	25/08/2015	Efficacy and safety of Infliximab-biosimilar (Inflectra) compared to Infliximab-innovator (Remicade) in patients with inflammatory bowel disease in remission: the SIMILAR Trial”	SIMILAR Trial: Santeon InflixMab biosimILAr ResearchA randomized, controlled, double blind, phase 4 noninferiority trial to assess efficacy of Infliximab-biosimilar (Inflectra) compared to Infliximab-innovator (Remicade) in patients with inflammatory bowel disease in remission. - SIMILAR Trial: Santeon InflixMab biosimILAr Research	ulcerative colitis and Crohn’s disease MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Inflectra 100 mg powder for concentrate for solution for infusion Product Name: Inflectra 100 mg powder for concentrate for solution for infusion Trade Name: Remicade 100 mg powder for concentrate for solution for infusion. Product Name: Remicade 100 mg powder for concentrate for solution for infusion. Product Code: EMEA/H/C/000240	Santeon	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes		Phase 4	Netherlands
48	NCT02522169 (ClinicalTrials.gov)	September 2015	3/5/2015	TOPIT; Trough Level Optimized Pediatric Inflammatory Bowel Disease Therapy: A Multicenter Study Comparing Effectiveness of Trough Level Optimized Infliximab Maintenance Therapy With Standard Dosing Regimen of Pediatric Patients With Crohn's Disease	Verbessertes Therapiemanagement für pädiatrische CED-Patienten Mit Chronisch-entzündlicher Darmerkrankung: Eine Randomisierte Multizentrische Studie, Welche Die Effektivität Einer Talspiegel-gesteuerten Infliximab-Erhaltungsphase Mit Dem herkömmlichen Dosierungsregime Vergleicht Trough Level Optimized Pediatric Inflammatory Bowel Disease Therapy: A Randomized Multicenter Study Comparing Effectiveness of Trough Level Optimized Infliximab Maintenance Therapy With Standard Dosing Regimen of Pediatric Patients With Crohn's Disease	Pediatric Crohns Disease	Drug: Infliximab	Klinikum Westbrandenburg GmbH	NULL	Not yet recruiting	6 Years	17 Years	Both	120	N/A	NULL
49	EUCTR2014-002311-41-SE (EUCTR)	21/08/2015	01/07/2015	A prospective randomized controlled study comparing continuing treatment with an anti-TNF antibody (infliximab) and an antimetabolite to contiuing with a single agent, either with the anti-TNF antibody or the anti-metabolite in Crohn’s disease in patients without clinical sympthoms and without steroids on combination therapy	A proSpective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheRapy and infliximab monothErapy in Crohn’s disease patients in sustained steroid-free remission on combination therapy	Crohn´s disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Imurel 25 mg Product Name: Imurel INN or Proposed INN: AZATHIOPRINE Other descriptive name: AZATHIOPRINE Trade Name: Puri-Nethol 50 mg Product Name: Puri-Nethol INN or Proposed INN: MERCAPTOPURINE Trade Name: Metoject Product Name: Metotrexat INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE DISODIUM Trade Name: Remsima Product Name: Remsima INN or Proposed INN: INFLIXIMAB	GETAID	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	225	Phase 4	France;Netherlands;Germany;United Kingdom;Sweden
50	EUCTR2012-002702-51-SE (EUCTR)	10/08/2015	10/06/2015	Discontinuation of biologic therapy (infliximab) in patients with Crohn’s disease during sustained complete absence of disease activity: A Nordic multi-center, double blinded, randomized, placebo controlled study	Discontinuation of infliximab therapy in patients with Crohn’s disease during sustained complete remission: A Nordic multi-center, double blinded, randomized, placebo controlled study - STOP IT	Patients with Crohn's disease with absence of disease activity during biologic therapy (infliximab) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Remsima Product Name: Remsima	Department of medical gastroenterology S, Odense University Hospital	NULL	Not Recruiting			Female: yes Male: yes	136	Phase 4	Finland;Denmark;Norway;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
51	NCT02452151 (ClinicalTrials.gov)	August 2015	20/5/2015	Efficacy and Safety of Infliximab-biosimilar (Inflectra) Compared to Infliximab-innovator (Remicade) in Patients With Inflammatory Bowel Disease in Remission: the SIMILAR Trial	Santeon InflixMab biosimILAr Research A Randomized, Controlled, Double Blind, Phase 4 Noninferiority Trial to Assess Efficacy of Infliximab-biosimilar (Inflectra) Compared to Infliximab-innovator (Remicade) in Patients With Inflammatory Bowel Disease in Remission.	Colitis, Ulcerative;Crohn's Disease	Drug: Infliximab-Biosimilar;Drug: Infliximab-Innovator	Onze Lieve Vrouwe Gasthuis	Santeon	Not yet recruiting	18 Years	N/A	Both	300	Phase 4	NULL
52	EUCTR2014-002311-41-GB (EUCTR)	14/07/2015	30/06/2015	A prospective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheraPy and infliximab monothErapy in Crohn's disease patients in sustained steroid-free remission on combination therapy	A proSpective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheRapy and infliximab monothErapy in Crohn’s disease patients in sustained steroid-free remission on combination therapy (SPARE) - SPARE	Luminal Crohn's disease patients in steroid free remission for at least 6 months and on combination therapy with infliximab and antimetabolites for at least 1 year MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]	Trade Name: Remicade Product Name: INFLIXIMAB Trade Name: Imuran Product Name: Azathioprine Trade Name: Methotrexate Product Name: Methotrexate Trade Name: Mercaptopurine Product Name: Mercaptopurine	University of Edinburgh	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	300		France;Belgium;Germany;United Kingdom;Sweden
53	NCT02269358 (ClinicalTrials.gov)	July 2015	30/9/2014	Salvage Therapy With High/Low Methotrexate for Loss of Response to Infliximab Dose Escalation	Phase 4, Open Lable Non Randomized un Controlled Study. Salvage Therapy With High/Low Methotrexate for Loss of Response to Infliximab Dose Escalation	Crohn's Disease	Drug: METHOTREXATE	Prof. Arie Levine	NULL	Completed	8 Years	18 Years	All	22	Phase 4	Israel
54	EUCTR2014-004904-31-NL (EUCTR)	19/05/2015	26/01/2015	A clinical study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission.	An open-label, multicentre, phase IV study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission.	Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA).;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Remsima (infliximab)	Mundipharma Pharmaceuticals B.V.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes		Phase 4	Netherlands
55	NCT02413047 (ClinicalTrials.gov)	May 2015	6/3/2015	Evaluate if Response to Infliximab or Adalimumab May be Regained With an Immunomodulator	A Pilot Study to Evaluate if Response to Infliximab or Adalimumab May be Regained With the Addition of an Immunomodulator	Inflammatory Bowel Disease;Ulcerative Colitis;Crohn's Disease	Drug: Azathioprine;Drug: 6 mercaptopurine;Drug: Methotrexate	Indiana University	NULL	Terminated	18 Years	80 Years	All	3	N/A	United States
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
56	NCT02539368 (ClinicalTrials.gov)	April 22, 2015	22/7/2015	Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Inflammatory Bowel Disease	POST-MARKETING OBSERVATIONAL COHORT STUDY OF PATIENTS WITH INFLAMMATORY BOWEL DISEASE (IBD) TREATED WITH CT-P13 IN USUAL CLINICAL PRACTICE (CONNECT-IBD)	Inflammatory Bowel Diseases;Ulcerative Colitis;Crohn's Disease	Drug: CT-P13;Drug: Remicade	Pfizer	Hospira, now a wholly owned subsidiary of Pfizer	Completed	18 Years	N/A	All	2565		Belgium;Czechia;Finland;France;Germany;Greece;Hungary;Italy;Netherlands;Portugal;Slovakia;Spain;United Kingdom;Czech Republic;Ireland
57	EUCTR2014-005702-37-NL (EUCTR)	08/04/2015	12/02/2015	Early infliximab use in kids with Crohn's disease (TISKids)	Top-Down Infliximab Study in Kids with Crohn's disease (TISKids) - Top-down Infliximab in Kids with Crohn's disease (TISKids)	Crohn's disease;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Inflectra INN or Proposed INN: INFLIXIMAB Other descriptive name: Inflectra	Erasmus Medical Center	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	100		Netherlands
58	NCT02517684 (ClinicalTrials.gov)	April 2015	1/7/2015	Top-down Infliximab Study in Kids With Crohn's Disease	Top-down Infliximab Study in Kids With Crohn's Disease	Crohn's Disease	Drug: Infliximab;Drug: Prednisolone;Other: Exclusive enteral nutrition;Drug: Azathioprine	Erasmus Medical Center	ZonMw: The Netherlands Organisation for Health Research and Development;Hospira, now a wholly owned subsidiary of Pfizer	Active, not recruiting	3 Years	17 Years	All	100	Phase 4	Belgium;Finland;Netherlands;Denmark;Italy;Poland
59	NCT02453607 (ClinicalTrials.gov)	November 17, 2014	21/5/2015	The Impact of 6MP Metabolite Levels on Infliximab Pharmacokinetics and Anti-infliximab Antibodies in Crohn's Disease	The Impact of 6MP Metabolite Levels on Infliximab Pharmacokinetics and Anti-infliximab Antibodies in Crohn's Disease	Inflammatory Bowel Disease;Crohn's Disease	Drug: Infliximab;Drug: thiopurine	Ernest Seidman	University of Toronto;University of Calgary;University of Alberta	Recruiting	18 Years	70 Years	All	225	N/A	Canada
60	EUCTR2013-004497-10-RO (EUCTR)	31/10/2014	02/06/2014	Demonstrating the non-inferiority in efficacy and safety of CT-P13 compared to Remicade in patients with active Crohn's Disease.	A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess the Safety of CT-P13 Compared to Remicade in Patients With Active Crohn’s Disease	Active Crohn's Disease MedDRA version: 17.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: REMSIMA Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: REMICADE INN or Proposed INN: INFLIXIMAB	Celltrion, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	214	Phase 3	United States;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Denmark;Netherlands;Germany;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
61	NCT02148640 (ClinicalTrials.gov)	October 2014	23/5/2014	The NOR-SWITCH Study	A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SWITCHING FROM INNOVATOR INFLIXIMAB TO BIOSIMILAR INFLIXIMAB COMPARED WITH CONTINUED TREATMENT WITH INNOVATOR INFLIXIMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS, SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, ULCERATIVE COLITIS, CROHN'S DISEASE AND CHRONIC PLAQUE PSORIASIS THE NOR-SWITCH STUDY	Rheumatoid Arthritis;Spondyloarthritis;Psoriatic Arthritis;Ulcerative Colitis;Crohn's Disease;Psoriasis Chronic	Drug: Innovator infliximab;Drug: Biosimilar infliximab	Diakonhjemmet Hospital	South-Eastern Norway Regional Health Authority	Completed	18 Years	N/A	All	482	Phase 4	Norway
62	EUCTR2013-004497-10-DK (EUCTR)	11/09/2014	02/06/2014	Demonstrating the non-inferiority in efficacy and safety of CT-P13 compared to Remicade in patients with active Crohn's Disease.	A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess the Safety of CT-P13 Compared to Remicade in Patients With Active Crohn’s Disease	Active Crohn's Disease MedDRA version: 18.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: REMSIMA Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: REMICADE INN or Proposed INN: INFLIXIMAB	Celltrion, Inc.	NULL	Not Recruiting			Female: yes Male: yes	214	Phase 3	United States;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Denmark;Netherlands;Germany;Korea, Republic of
63	NCT02332356 (ClinicalTrials.gov)	September 2014	4/1/2015	Therapeutic Optimization Study Based on MR Enterocolonography in Patients With Crohn's Disease	Therapeutic Optimization Study Based on MR Enterocolonography in Patients With Crohn's Disease	Crohn Disease	Drug: azathioprine or adalimumab and infliximab	Tokyo Medical and Dental University	NULL	Recruiting	16 Years	65 Years	All	100	Phase 3	Japan
64	EUCTR2013-005629-21-HU (EUCTR)	14/08/2014	11/06/2014	Diagnostic use of 99mTecnetium labeled infliximab in Crohn’s disease	Diagnostic use of 99mTecnetium labeled infliximab in Crohn’s disease	Crohn’s disease MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remicade Product Name: Infliximab (Remicade): 100 mg of lyophilized infliximab INN or Proposed INN: INFLIXIMAB	First Department of Medicine, University of Szeged	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Hungary
65	EUCTR2014-002056-40-NO (EUCTR)	12/08/2014	13/06/2014	A study to evaluate the safety and efficacy of switching from regular infliximab to biosimilar infliximab in patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn's disease and psoriasis	A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SWITCHING FROM INNOVATOR INFLIXIMAB TO BIOSIMILAR INFLIXIMAB COMPARED WITH CONTINUED TREATMENT WITH INNOVATOR INFLIXIMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS, SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, ULCERATIVE COLITIS, CROHN’S DISEASEAND CHRONIC PLAQUE PSORIASISTHE NOR-SWITCH STUDY - NOR_SWITCH	Rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn’s disease and chronic plaque psoriasis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 18.0;Level: LLT;Classification code 10071117;Term: Plaque psoriasis;System Organ Class: 100000004858 MedDRA version: 18.0;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 18.0;Classification code 10045365;Term: Ulcerative colitis;Classification code 10002556;Term: Ankylosing spondylitis;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Remicade 100 mg pulver til konsentrat til infusjonsvæske, oppløsning Trade Name: Remsima 100 mg pulver til konsentrat til infusjonsvæske, oppløsning	Diakonhjemmet Hospital AS	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Norway
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
66	EUCTR2014-002311-41-FR (EUCTR)	12/08/2014	22/06/2015	A proSpective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheRapy and infliximab monothErapy in Crohn’s disease patients in sustained steroid-free remission on combination therapy.SPARE	A proSpective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheRapy and infliximab monothErapy in Crohn’s disease patients in sustained steroid-free remission on combination therapy. - GETAID 2014-3 SPARE	Luminal Crohn’s disease patients with steroid free remission for at least 6 months and a combination therapy with infliximab and anti-metabolites for at least 1 year;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]	Trade Name: REMICADE Product Name: INFLIXIMAB Trade Name: IMUREL Product Name: azathioprine Trade Name: METHOTREXATE Product Name: METHOTREXATE Trade Name: PURINETHOL Product Name: MERCAPTOPURINE	GETAID	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	300		France;United Kingdom;Sweden
67	EUCTR2013-004497-10-NL (EUCTR)	06/08/2014	03/06/2014	Demonstrating the non-inferiority in efficacy and safety of CT-P13 compared to Remicade in patients with active Crohn's Disease.	A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess the Safety of CT-P13 Compared to Remicade in Patients With Active Crohn’s Disease	Active Crohn's Disease MedDRA version: 19.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: REMSIMA Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: REMICADE INN or Proposed INN: INFLIXIMAB	Celltrion, Inc.	NULL	Not Recruiting			Female: yes Male: yes	214	Phase 3	United States;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Denmark;Netherlands;Germany;Korea, Republic of
68	JPRN-UMIN000014006	2014/08/01	31/07/2014	Exploratory study of relation between efficacy and serum infliximab level, and predictors of response to infliximab dose escalation in patients with crohn's disease		Crohn's disease	dose escalation of infliximab	IBD Center, Sapporo Kosei General Hospital	NULL	Recruiting	18years-old	Not applicable	Male and Female	20	Not selected	Japan
69	EUCTR2013-004497-10-IT (EUCTR)	01/08/2014	27/05/2014	Demonstrating the non-inferiority in efficacy and safety of CT-P13 compared to Remicade in patients with active Crohn's Disease.	A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess the Safety of CT-P13 Compared to Remicade in Patients With Active Crohn’s Disease	Active Crohn's Disease MedDRA version: 17.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: REMSIMA Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: REMICADE INN or Proposed INN: INFLIXIMAB	Celltrion, Inc.	NULL	Not Recruiting			Female: yes Male: yes	214	Phase 3	United States;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Denmark;Netherlands;Germany;Korea, Republic of
70	EUCTR2013-004497-10-ES (EUCTR)	25/07/2014	27/05/2014	Demonstrating the non-inferiority in efficacy and safety of CT-P13 compared to Remicade in patients with active Crohn's Disease.	A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess the Safety of CT-P13 Compared to Remicade in Patients With Active Crohn´s Disease	Active Crohn's Disease MedDRA version: 17.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: REMSIMA Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: REMICADE INN or Proposed INN: INFLIXIMAB	Celltrion, Inc.	NULL	Not Recruiting			Female: yes Male: yes	214	Phase 3	United States;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Denmark;Netherlands;Germany;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
71	EUCTR2013-004497-10-BE (EUCTR)	16/07/2014	12/05/2014	Demonstrating the non-inferiority in efficacy and safety of CT-P13 compared to Remicade in patients with active Crohn's Disease.	A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess the Safety of CT-P13 Compared to Remicade in Patients With Active Crohn’s Disease	Active Crohn's Disease MedDRA version: 18.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: REMSIMA Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: REMICADE INN or Proposed INN: INFLIXIMAB	Celltrion, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	214	Phase 3	United States;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Denmark;Netherlands;Germany;Korea, Republic of
72	EUCTR2013-004497-10-HU (EUCTR)	02/07/2014	22/05/2014	Demonstrating the non-inferiority in efficacy and safety of CT-P13 compared to Remicade in patients with active Crohn's Disease.	A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess the Safety of CT-P13 Compared to Remicade in Patients With Active Crohn’s Disease	Active Crohn's Disease MedDRA version: 17.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: REMSIMA Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: REMICADE INN or Proposed INN: INFLIXIMAB	Celltrion, Inc.	NULL	Not Recruiting			Female: yes Male: yes	214	Phase 3	United States;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Denmark;Netherlands;Germany;Korea, Republic of
73	EUCTR2013-001029-17-NL (EUCTR)	01/04/2014	17/05/2013	Dose reduction of infliximab in Crohn’s disease, based on serum infliximab concentration	Efficacy and safety of trough level-based dose reduction during infliximab maintenance treatment in Crohn’s disease - REDIX	Crohn's disease MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remicade Product Name: Infliximab	Academic Medical Center	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Netherlands
74	NCT01960426 (ClinicalTrials.gov)	April 2014	25/9/2013	Evaluation of Health Costs and Resource Utilization	A Randomized Evaluation of Health Costs and Resource Utilization Comparing Testing-Based Therapy to Empiric Dose Intensification for the Management of Inflammatory Bowel Disease.	Ulcerative Colitis;Crohn's Disease	Other: Measurement of drug (Adalimumab/Infliximab);Other: Intensify treatment with the existing drug	University of Western Ontario, Canada	Prometheus Laboratories	Terminated	18 Years	N/A	Both	51	Phase 4	United States
75	EUCTR2013-002651-15-NL (EUCTR)	03/03/2014	18/09/2013	Adjusting the amount of medication (infliximab) in patients suffering from inflammatory bowel disease, using medication levels in blood.	Adjusting infliximab dose in IBD patients in remission, based on infliximab trough levels: the study on Infliximab Levels in IBD patients Steering Treatment, the ILIST pilot - ILIST-study	Crohns diseaseUlcerative colitis MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remicade (infliximab) Product Name: infliximab	Zon MW	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes		Phase 4	Netherlands
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
76	NCT02088944 (ClinicalTrials.gov)	March 2014	13/3/2014	a Single-center Registered Clinical Research of Chinese Patients With Moderate to Severe Crohn's Disease		Serological C Reactive Protein or Erythrocyte Sedimentation Rate	Drug: Infliximab	Nanfang Hospital of Southern Medical University	NULL	Not yet recruiting	18 Years	75 Years	Both	142	N/A	NULL
77	NCT02060318 (ClinicalTrials.gov)	February 11, 2014	10/2/2014	Regulatory T-cells and Crohn's Disease	The Effect of Infliximab Therapy in Crohn Patients on Regulatory T-cells	Crohn Disease	Drug: Infliximab	Hvidovre University Hospital	NULL	Completed	18 Years	N/A	All	47	N/A	Denmark
78	JPRN-UMIN000012790	2014/02/01	01/02/2014	Prospective Pilot study of Infliximab Dose-intensification determined by Capsule Endoscopic Evaluation of Small Intestinal Involvements in Patients with Crohn's Disease		Crohn's disease	dose intensification of 10mg/kg infliximab with additional treatment with thiopurines in case of aggravation at 6 months	Saitama Medical center	NULL	Complete: follow-up complete	20years-old	65years-old	Male and Female	20	Not selected	Japan
79	EUCTR2011-001332-29-AT (EUCTR)	02/12/2013	07/11/2013	The degradation and elimination of Infliximab	Pharmacokinetics of Infliximab	Inflammatory bowel disease (Ulcerative Colitis, Crohn's disease) MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Remicade	Universitätsklinik für Innere Medizin III, Klinische Abteilung für Gastroenterologie und Hepatologie	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Austria
80	EUCTR2012-000645-13-BE (EUCTR)	09/09/2013	16/07/2013	Infliximab as firsdt treatment instead of second line treatment in Crohns disease	Infliximab Top-down Study in Kids with Crohn’s disease - ITSKIDS	Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remicade	ErasmusMC	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	90		Belgium;Netherlands
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
81	NCT02073526 (ClinicalTrials.gov)	May 2013	9/1/2014	Anti-TNF-alpha Trough Level Measurements in Inflammatory Bowel Disease	Anti-TNF-alpha Trough Level Measurements in Inflammatory Bowel Disease	Inflammatory Bowel Disease;Crohn's Disease;Ulcerative Colitis	Drug: Infliximab, adalimumab, certolizumab pegol	Oslo University Hospital	NULL	Completed	18 Years	N/A	Both	1230	N/A	Norway
82	JPRN-UMIN000010524	2013/03/29	17/04/2013	Optimization of adalimumab switch therapy for loss of response with infliximab in Crohn's disease-OASISstudy		Crohn's disease	Adalimubab is administered continuously starting with 160 mg, then 80 mg after 2 weeks and 40 mg from 2 weeks onwards. Continous administration of azathioprine concomitantly with adalimubab at the initial dose of 160 mg, then 80 mg after 2 weeks and 40 mg from 2 weeks onwards. The target dose for azathioprine is 2.0-2.5mg/kg/day and the dose is increased at the discretion of the attending physician.	Tokyo Medical & Dental University Gastroenterology	NULL	Complete: follow-up complete	15years-old	Not applicable	Male and Female	20	Not selected	Japan
83	NCT01804166 (ClinicalTrials.gov)	March 21, 2013	1/2/2013	A Research Study to Bank Samples for Future Evaluation to Identify Biomarkers That Predispose Crohn's Disease and Ulcerative Colitis Patients to Develop Hepatosplenic T-Cell Lymphoma (HSTCL)	A Research Study to Bank Samples for Future Evaluation to Identify Biomarkers That Predispose Crohn's Disease and Ulcerative Colitis Patients to Develop Hepatosplenic T-Cell Lymphoma (HSTCL)	Hepatosplenic T-Cell Lymphoma	Drug: Infliximab;Drug: Golimumab	Janssen Scientific Affairs, LLC	NULL	Completed	N/A	N/A	All	1	Phase 4	United States
84	NCT01802593 (ClinicalTrials.gov)	February 2013	24/12/2012	Comparison of 2 Immunomodulator Withdrawal Schemes for Infliximab Monotherapy in Active Pediatric Crohn's Disease After Thiopurine Failure	Phase 4, Open Label Multicenter Randomized Controlled Trial. Comparison of 2 Immunomodulator Withdrawal Schemes for Infliximab Monotherapy in Active Pediatric Crohn's Disease After Immunomodulator Failure	Crohn's Disease	Drug: AZATHIOPRINE or METHOTREXATE	Prof. Arie Levine	NULL	Terminated	6 Years	18 Years	Both	20	Phase 4	Israel
85	NCT01880307 (ClinicalTrials.gov)	January 2013	7/6/2013	Infliximab Top-down in Pediatric Crohn	Infliximab Top-down Study in Kids With Crohn's Disease	Crohn's Disease	Drug: Azathioprine;Drug: Infliximab;Drug: Prednisolon	Erasmus Medical Center	University of Roma La Sapienza;University Hospital, Brussels	Terminated	3 Years	17 Years	Both	13	Phase 4	Italy;Netherlands
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
86	NCT01752790 (ClinicalTrials.gov)	December 2012	12/12/2012	Efficacy and Safety of Top-down Therapy in Pediatric Crohn's Disease	Efficacy and Safety of Infliximab as First-line Therapy in Pediatric Crohn's Disease: a Randomized, Controlled, Open-label Trial	Pediatric Crohn's Disease	Drug: Top-down;Drug: Step-up	University of Roma La Sapienza	NULL	Withdrawn	6 Years	18 Years	Both	0	Phase 4	Italy
87	NCT01349920 (ClinicalTrials.gov)	November 28, 2012	5/5/2011	Biomarkers of Intestinal Mucosal Healing in Crohn's Disease (P08143)	An Open Label Study to Discover Biomarkers of Intestinal Mucosal Healing in Crohn's Disease (CD)	Crohn Disease	Drug: Infliximab	Merck Sharp & Dohme Corp.	NULL	Completed	18 Years	60 Years	All	15		Moldova, Republic of;United Kingdom
88	NCT01817426 (ClinicalTrials.gov)	November 2012	29/8/2012	Discontinuation of Infliximab Therapy in Patients With Crohn's Disease During Sustained Complete Remission	Discontinuation of Infliximab Therapy in Patients With Crohn's Disease During Sustained Complete Remission: A Multi-center, Double Blinded, Randomized, Placebo Controlled Study	Crohn Disease	Drug: Infliximab;Other: Placebo	Copenhagen University Hospital at Herlev	NULL	Recruiting	18 Years	N/A	Both	136	Phase 4	Denmark
89	EUCTR2012-000645-13-NL (EUCTR)	17/10/2012	12/07/2012	Infliximab as first treatment instead of second line treatment in Crohns disease	Infliximab Top-down Study in Kids with Crohn’s disease - ITSKIDS	Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remicade	ErasmusMC	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	90		Belgium;Netherlands;Italy
90	EUCTR2011-006084-22-GB (EUCTR)	04/10/2012	15/08/2012	Usefulness of the measurement of blood levels of infliximab and adalimumab in inflammatory bowel disease patients in predicting response to treatment	Utilising drug levels and anti-drug antibodies to predict response to treatment in patients with Inflammatory Bowel Disease - Trough levels of anti-TNF agents in inflammatory bowel disease	Inflammatory bowel disease MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remicade Product Name: Infliximab INN or Proposed INN: Infliximab Trade Name: Humira Product Name: adalimumab INN or Proposed INN: Adalimumab	Royal Liverpool University Hospital	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	0		United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
91	EUCTR2012-002702-51-DK (EUCTR)	24/09/2012	01/08/2012	Discontinuation of biologic therapy (infliximab) in patients with Crohn’s disease during sustained complete absence of disease activity: A Nordic multi-center, double blinded, randomized, placebo controlled study	Discontinuation of infliximab therapy in patients with Crohn’s disease during sustained complete remission: A Nordic multi-center, double blinded, randomized, placebo controlled study - STOP IT	Patients with Crohn's disease with absence of disease activity during biologic therapy (infliximab) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Remsima Product Name: Remsima	Department of medical gastroenterology S, Odense University Hospital	NULL	Not Recruiting			Female: yes Male: yes	136	Phase 4	Finland;Denmark;Norway;Sweden
92	JPRN-UMIN000015297	2012/09/19	01/10/2014	The feasibility study of accelated infliximab infusion from initial administration	The feasibility study of accelated infliximab infusion from initial administration - The feasibility study of accelated infliximab infusion from initial administration	patient in whom infliximab is indicated(rheumatoid arthritis, Crohn's disease, Ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis)	Administration of intravenous infliximab infusion with 60 min accelated procedure for patients who are already successfully treated with usual 2hr infuion without infusion reaction. The tolerable patient continue to receive more five treatment with 60min procedure.	Chiba University Hospital	NULL	Recruiting	20years-old	70years-old	Male and Female	54	Phase 2	Japan
93	EUCTR2011-003038-14-NL (EUCTR)	21/06/2012	31/05/2012	A RANDOMIZED CONTROLLED TRIAL INVESTIGATING TAILORED TREATMENT WITH INFLIXIMAB FOR ACTIVE LUMINAL CROHN'S DISEASE	A RANDOMIZED CONTROLLED TRIAL INVESTIGATING TAILORED TREATMENT WITH INFLIXIMAB FOR ACTIVE LUMINAL CROHN'S DISEASE - TAILORIX	Luminal active Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Trade Name: INFLIXIMAB Product Name: INFLIXIMAB INN or Proposed INN: INFLIXIMAB	GETAID	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120		Netherlands
94	JPRN-UMIN000007806	2012/06/01	01/05/2012	The feasibility study of accelated infliximab infusion during maintenance phase		patient in whom infliximab is indicated(rheumatoid arthritis, Crohn's disease, Ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis)	Administration of intravenous infliximab infusion with 60 min accelated procedure for patients who are already successfully treated with usual 2hr infuion without infusion reaction. The tolerable patient continue to receive more five treatment with 60min procedure.	Chiba University Hospital	NULL	Complete: follow-up complete	Not applicable	Not applicable	Male and Female	54	Phase 2	Japan
95	NCT01442025 (ClinicalTrials.gov)	June 2012	20/9/2011	Study Investigating Tailored Treatment With Infliximab for Active Crohn's Disease	A Randomized Controlled Trial Investigating Tailored Treatment With Infliximab for Active Luminal Crohn's Disease	Crohn's Disease	Drug: Infliximab	Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives	NULL	Completed	18 Years	N/A	Both	121	Phase 4	France
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
96	NCT01181765 (ClinicalTrials.gov)	June 2012	12/8/2010	The Efficacy of Open Label Infliximab for the Induction and Maintenance of Mucosal Healing in Small Bowel Crohn's Disease Assessed Through Wireless Camera Endoscopy	The Efficacy of Open Label Infliximab for the Induction and Maintenance of Mucosal Healing in Small Bowel Crohn's Disease Assessed Through Wireless Camera Endoscopy (the ICE Study)	Crohn's Disease	Biological: Infliximab 5 mg/kg body weight infused over 2 hours	Janssen Inc.	NULL	Completed	18 Years	N/A	Both	1	Phase 4	Canada
97	JPRN-UMIN000008043	2012/05/01	28/05/2012	The influence of medication for Crohn's disease on serological response to the influenza vaccination	The influence of medication for Crohn's disease on serological response to the influenza vaccination - Influence of Crohn's disease medication on influenza vaccination	Crohn's disease	Influenza Vaccination to Crohn's disease patients treated with Infliximab Influenza Vaccination to Crohn's disease patients treated with Elemental diet Influenza Vaccination to patients with upper-alimentary tract disorders (Disease-control)	The Jikei University School of MedicineDivision of Gastroenterology and Hepatology	NULL	Complete: follow-up complete	16years-old	60years-old	Male and Female	150	Phase 4	Japan
98	EUCTR2011-003038-14-BE (EUCTR)	30/03/2012	03/01/2012	A RANDOMIZED CONTROLLED TRIAL INVESTIGATING TAILORED TREATMENT WITH INFLIXIMAB FOR ACTIVE LUMINAL CROHN'S DISEASE	A RANDOMIZED CONTROLLED TRIAL INVESTIGATING TAILORED TREATMENT WITH INFLIXIMAB FOR ACTIVE LUMINAL CROHN'S DISEASE - TAILORIX	Luminal active Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Trade Name: INFLIXIMAB Product Name: INFLIXIMAB INN or Proposed INN: INFLIXIMAB	GETAID	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120		Belgium;Netherlands
99	JPRN-UMIN000007343	2012/02/01	21/02/2012	The study of the effectiveness of anti-TNF antibody maintenance treatment combined with elemental diet for Crohn's disease patients	The study of the effectiveness of anti-TNF antibody maintenance treatment combined with elemental diet for Crohn's disease patients - The study of the effectiveness of anti-TNF antibody maintenance treatment combined with elemental diet for Crohn's disease patients	Crohn's disease	Patients in monotherapy group receive; 1) intravenous infusion of infliximab (10mg/kg) at every 8 weeks (dose escalation of anti-TNF antibody), or 2) intravenous infusion of infliximab (5mg/kg) at week 0, 2, and 6 and then every 8 weeks, or subcutaneous injection of adalimumab at week 0 (160mg), 2 (80mg) and then every 2 weeks (40mg) (first time or switch of anti-TNF antibody). Patients in combination therapy group take half the amount of their daily allowance of calories (900-1,200kcal) by elemental diet and the remaining half by usual unrestricted meals, in addition to above anti-TNF antibody therapy.	Tohoku University Graduate School of Medicine (Tohoku University Hospital)	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	90	Not applicable	Japan
100	JPRN-UMIN000006889	2012/01/01	01/01/2012	Evaluation of Concomitant Infliximab and Granulocyte/ Monocyte Adsorption Apheresis in Crohn's disease Patients who lose Response to 5mg/kg/dose Infliximab Therapy		Crohn's disease	Repeat 3 sets of the concomitant therapy with IFX and GMA. Each set is consisted from a single 5mg/kg/dose of infliximab infusion plus 3 times of weekly GMA at 5, 6, and 7 weeks after IFX infusion. Repeat 3 infusions of the 10mg/kg/dose infliximab in 8 weeks interval.	Department of Lower Gastroenterology, Hyogo College of Medicine	NULL	Complete: follow-up complete	16years-old	75years-old	Male and Female	50	Phase 4	Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
101	EUCTR2008-005237-30-SE (EUCTR)	14/12/2011	16/08/2011	A Multicenter, Prospective, Long-term Registry of children with Crohn's Disease	A Multicenter, Prospective, Long-term Registry of Pediatric Patients with Crohn's Disease - DEVELOP	Pediatric patients with a confirmed diagnosis of CD aged 6 years to lessthan 17 years of age at the time of enrollment MedDRA version: 14.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remicade INN or Proposed INN: INFLIXIMAB	Janssen Biologics BV	NULL	Not Recruiting			Female: yes Male: yes	4000		Hungary;Germany;United Kingdom;Netherlands;Belgium;France;Italy;United States;Sweden
102	NCT01438151 (ClinicalTrials.gov)	December 2011	20/9/2011	Understanding the Relationship Between Infliximab Levels to Clinical Response of Remicade in Crohn's Disease	Association of Serum Infliximab and Antibodies Toward Infliximab (ATI) to Clinical Outcomes in Crohn's Disease	Crohn's Disease	Drug: Remicade	Shradha Agarwal	Prometheus Laboratories	Terminated	7 Years	N/A	All	11	N/A	United States
103	JPRN-UMIN000006232	2011/10/01	01/09/2011	Evaluation of efficacy of high dose infliximab with azathiopurine add-on therapy for patients with Crohn's disease refractory to low dose infliximab		Crohn's disease	treatment with high dose infliximab and azathiopurine(6MP can be used in case of refractory patients to azatioupurine) treatment with only high dose infliximab	Saitama Medical University	NULL	Complete: follow-up complete	15years-old	70years-old	Male and Female	40	Not selected	Japan
104	JPRN-UMIN000005689	2011/09/01	31/05/2011	GMA (Granulocyte and Monocyte Adsorption) early combined with azathioprine vs Infliximab plus azathioprine for induction of remission in active Crohn's disease : an open randomized trial		Crohn's disease	Patients in the combination therapy of GMA with azathioprine receive intensive GMA (twice per week, total 10 sessions) and oral azathioprine. Patients in the combination therapy of Infliximab and azathioprine receive infusion of IFX (at week 0, 2, 6) and oral azathioprine.	Department of Gastroenterology and Hepatology, Kyoto University Hospital	NULL	Complete: follow-up complete	12years-old	75years-old	Male and Female	60	Not applicable	Japan
105	EUCTR2010-018431-18-CZ (EUCTR)	08/08/2011	19/05/2011	A Multicenter Trial Comparing REMICADE (infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence	Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE® (infliximab) and Placebo in the Prevention of Recurrence in Crohn’s Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence - PREVENT	Crohn’s disease (CD) MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remicade Product Name: REMICADE INN or Proposed INN: INFLIXIMAB Other descriptive name: n/a	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	290		Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
106	EUCTR2010-018431-18-HU (EUCTR)	14/07/2011	13/05/2011	A Multicenter Trial Comparing REMICADE (infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence	Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE® (infliximab) and Placebo in the Prevention of Recurrence in Crohn’s Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence - PREVENT	Crohn’s disease (CD) MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remicade Product Name: REMICADE INN or Proposed INN: INFLIXIMAB Other descriptive name: n/a	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	290		Austria;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand
107	EUCTR2011-002061-38-BE (EUCTR)	29/06/2011	08/06/2011	Treating patients with infliximab based on their trough levels	A randomised prospective trough level monitoring study with real-time therapeutic adaptations: Trough level Adapted infliXImab Treatment scheme (TAXIT). - TAXIT	2) Crohn's disease and ulcerative colitis MedDRA version: 13.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 13.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Remicade Product Name: Remicade Product Code: Remicade INN or Proposed INN: INFLIXIMAB	Katholieke Universiteit Leuven	NULL	Not Recruiting			Female: yes Male: yes		Phase 4	Belgium
108	JPRN-UMIN000005251	2011/06/01	01/06/2011	A prospective open-label study to investigate the efficacy and safety of methotrexate in Crohn's disease patients who lost response or showed intolerance to infliximab		Crohn's disease	Administration of oral methotrexate 15mg divided after breakfast and dinner weekly for 16 weeks.If remission(CDAI<150) cannot be obtained at week 8, the dose of methotrexate can be increased to 25mg weekly.	Department of Gastroenterology and Hepatology, Tokyo Medical and Dental University	NULL	Complete: follow-up complete	16years-old	Not applicable	Male and Female	14	Not selected	Japan
109	NCT01355614 (ClinicalTrials.gov)	June 2011	16/5/2011	A Phase II Efficacy Study in Fistulizing Crohn's Disease Patients	A Multi-center, Randomized, Double-blind, Active Controlled Study to Assess Efficacy, Safety and Tolerability of the Anti-IL13 Monoclonal Antibody QAX576 in the Treatment of Perianal Fistulas in Patients Suffering From Crohn's Disease	Crohn's Disease	Drug: QAX576;Drug: Infliximab	Novartis Pharmaceuticals	NULL	Completed	18 Years	N/A	All	10	Phase 2	Germany;Switzerland
110	NCT01346826 (ClinicalTrials.gov)	May 2011	2/5/2011	Safety of Accelerated Infliximab Infusions in Patients With Inflammatory Bowel Disease (IBD)	Safety of Accelerated Infliximab Infusions in Patients With Inflammatory Bowel Disease: A Prospective, Randomized, Double-Blind, Controlled Trial	Crohn's Disease;Ulcerative Colitis	Drug: Standard 2 hours-infusion;Drug: Accelerated 1 hour-infusion;Drug: Accelerated 30 minutes-infusion	Asan Medical Center	NULL	Completed	16 Years	80 Years	Both	145	Phase 4	Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
111	NCT01338740 (ClinicalTrials.gov)	April 2011	18/4/2011	Switching From Adalimumab to Infliximab	Prospective Study to Assess the Efficacy of Switching to Infliximab in Moderately to Severely Active Chrohn's Disease Patients With Primary Non-response or Loss of Response to Adalimumab	Crohn's Disease	Drug: Adalimumab and Infliximab	University Hospital, Ghent	Abbott	Recruiting	18 Years	75 Years	Both	40	N/A	Belgium
112	EUCTR2010-019973-13-DE (EUCTR)	14/01/2011	30/09/2010	A Phase II Efficacy Study in Fistulizing Crohn's Disease Patients	A multi-center, randomized, double-blind, active controlled study to assess efficacy, safety and tolerability of the anti-IL13 monoclonal antibody QAX576 in the treatment of perianal fistulas in patients suffering from Crohn’s disease	Treatment of perianal fistulas in patients suffering from Crohn's Disease. MedDRA version: 14.0;Level: PT;Classification code 10016717;Term: Fistula;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 14.0;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders	Product Code: QAX576 Trade Name: Remicade INN or Proposed INN: INFLIXIMAB	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	23	Phase 2	Germany;Switzerland
113	EUCTR2010-018431-18-IT (EUCTR)	03/12/2010	10/01/2011	Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE (infliximab) and Placebo in the Prevention of Recurrence in Crohn’s Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence - PREVENT	Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE (infliximab) and Placebo in the Prevention of Recurrence in Crohn’s Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence - PREVENT	Crohn`s disease (DS) MedDRA version: 9.1;Level: LLT;Classification code 10011401	Trade Name: REMICADE INN or Proposed INN: INFLIXIMAB	CENTOCOR	NULL	Not Recruiting			Female: yes Male: yes	290		France;Czech Republic;Hungary;Belgium;Austria;Netherlands;Germany;United Kingdom;Italy
114	NCT01266785 (ClinicalTrials.gov)	December 2010	23/12/2010	Infliximab, Regulatory T Cells, IL2 and Crohn's Disease	Analysis of Relationship Between Infliximab Treatment Response, Regulatory T Cells, and Interleukin-2 in Crohn's Disease	Crohn's Disease	Drug: Infliximab	Oregon Health and Science University	Centocor, Inc.	Withdrawn	18 Years	70 Years	All	0	N/A	United States
115	EUCTR2010-018431-18-BE (EUCTR)	19/11/2010	28/07/2010	A Multicenter Trial Comparing REMICADE (infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence	Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE® (infliximab) and Placebo in the Prevention of Recurrence in Crohn’s Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence - PREVENT	Crohn’s disease (CD) MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remicade Product Name: REMICADE INN or Proposed INN: INFLIXIMAB Other descriptive name: n/a	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	290		Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Australia;Denmark;Netherlands;Germany;New Zealand
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
116	NCT01190839 (ClinicalTrials.gov)	November 2010	12/8/2010	A Multicenter Trial Comparing REMICADE (Infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease (CD) Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence	Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE (Infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection Who Are at Increased Risk of Recurrence	Crohn's Disease	Biological: Infliximab;Drug: Placebo	Janssen Biotech, Inc.	NULL	Terminated	18 Years	99 Years	All	297	Phase 3	United States;Australia;Austria;Belgium;Canada;Czech Republic;France;Germany;Hungary;Israel;Netherlands;New Zealand;Poland;United Kingdom;Denmark;Spain
117	EUCTR2010-018431-18-NL (EUCTR)	28/10/2010	20/09/2010	A Multicenter Trial Comparing REMICADE (infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence	Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE® (infliximab) and Placebo in the Prevention of Recurrence in Crohn’s Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence - PREVENT	Crohn’s disease (CD) MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remicade Product Name: REMICADE INN or Proposed INN: INFLIXIMAB Other descriptive name: n/a	Janssen Biologics B.V.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	290		Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand
118	JPRN-UMIN000005761	2010/10/27	13/06/2011	The Study for Efficacy and Safety of Adalimumab for Crohn's Disease with Loss of Response to Infliximab		Crohn's Disease patient as following 1)or 2) 1)the patient who treated with IFX infusion of interval every 4-6 weeks. 2)the patient who could not keep to treat with IFX due to side effect or ineffectiveness.	Adalimumab (HUMIRA 40mg for SC Injection) Inject SC 160mg on Day 1, then inject SC 80 mg on Day 15, and inject SC 40 mg every other week, beginning on Day 29.	Kenji Watanabe	NULL	Complete: follow-up complete	Not applicable	Not applicable	Male and Female	50	Not selected	Japan
119	EUCTR2010-018431-18-FR (EUCTR)	15/09/2010	09/07/2010	Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE® (infliximab) and Placebo in the Prevention of Recurrence in Crohn’s Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence - PREVENT	Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE® (infliximab) and Placebo in the Prevention of Recurrence in Crohn’s Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence - PREVENT	Crohn’s disease (CD) MedDRA version: 12.1;Level: LLT;Classification code 10011401;Term: Crohn's disease	Trade Name: Remicade Product Name: REMICADE INN or Proposed INN: INFLIXIMAB	Centocor BV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	290		Hungary;Czech Republic;United Kingdom;Germany;Netherlands;France;Italy;Austria
120	EUCTR2010-018431-18-DE (EUCTR)	23/08/2010	24/06/2010	A Multicenter Trial Comparing REMICADE (infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence	Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE® (infliximab) and Placebo in the Prevention of Recurrence in Crohn’s Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence - PREVENT	Crohn’s disease (CD) MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remicade Product Name: REMICADE INN or Proposed INN: INFLIXIMAB Other descriptive name: n/a	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	290		Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Germany;Netherlands;New Zealand
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
121	EUCTR2010-018431-18-GB (EUCTR)	16/08/2010	06/07/2010	A Multicenter Trial Comparing REMICADE (infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence	Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE® (infliximab) and Placebo in the Prevention of Recurrence in Crohn’s Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence - PREVENT	Crohn’s disease (CD) MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	290	Phase 3	Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand
122	EUCTR2010-018431-18-AT (EUCTR)	06/08/2010	05/07/2010	A Multicenter Trial Comparing REMICADE (infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence	Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE® (infliximab) and Placebo in the Prevention of Recurrence in Crohn’s Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence - PREVENT	Crohn’s disease (CD) MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remicade Product Name: REMICADE INN or Proposed INN: INFLIXIMAB Other descriptive name: n/a	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	290		Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Germany;Netherlands;New Zealand
123	NCT00988832 (ClinicalTrials.gov)	February 2010	1/10/2009	An Audit of Patients With Crohn's Disease Treated With Infliximab (P06066)	A UK Retrospective Audit of Patients With Crohn's Disease Treated With Infliximab	Crohn's Disease	Biological: Infliximab	Merck Sharp & Dohme Corp.	NULL	Completed	18 Years	N/A	All	380	N/A	United Kingdom
124	NCT01548014 (ClinicalTrials.gov)	January 2010	17/2/2012	The Effect of a Probiotic Preparation (VSL#3) Plus Infliximab in Children With Crohn's Disease	Reduction in Frequency of Infliximab Administration From q 8 Weeks to q 12 Weeks in Children With Crohn's Disease Receiving Probiotic VSL#3 Supplementation: A Pilot Study	Crohn's Disease	Dietary Supplement: VSL#3	Samsung Medical Center	NULL	Recruiting	13 Years	17 Years	Both	1	Phase 3	Korea, Republic of
125	JPRN-UMIN000010293	2009/12/19	21/03/2013	Parallel-group, multicenter, comparative study on the usefulness of nutrition therapy for patients with Crohn's disease Infliximab maintenance therapy		Crohn's disease	Infliximab maintenance therapy for 48 weeks in, Racol daily nutritional interventions during the study period as a target intake of 800kcal per day, in the implementation group nutrition therapy is used in conjunction with a diet and Racol. In the group of non-nutritional therapy is carried out aggressive nutritional intervention is not performed, and only the normal diet	Graduate School of Medical Sciences, Kyushu University	Oita Red Cross HospitalTakano Hospital	Recruiting	20years-old	Not applicable	Male and Female	80	Not applicable	Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
126	EUCTR2008-005237-30-NL (EUCTR)	01/12/2009	18/08/2009	A Multicenter, Prospective, Long-term Registry of children with Crohn's Disease or Ulcerative Colitis	A Multicenter, Prospective, Long-term Registry of Pediatric Patients with Crohn's Disease or Ulcerative Colitis - DEVELOP	Pediatric patients with a confirmed diagnosis of CD or UC . MedDRA version: 18.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Remsima and Inflectra	Janssen Biologics B.V.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	6000		United States;Canada;Netherlands;Sweden
127	NCT01661257 (ClinicalTrials.gov)	October 2009	7/8/2012	Expression of TIM-3 and Correlation With Disease Activity in Pediatric Crohn's Disease With Anti TNF-a Therapy	Expression of T-cell Immunoglobulin- and Mucin-domain-containing Molecule 3 (TIM-3)and Correlation With Disease Activity in Pediatric Crohn's Disease With Anti TNF-a Therapy	Crohn's Disease	Drug: Infliximab	Samsung Medical Center	NULL	Completed	13 Years	17 Years	Both	20	Phase 3	Korea, Republic of
128	NCT02322008 (ClinicalTrials.gov)	September 2009	17/12/2014	Anti-TNF Therapy in Danish Patients With Inflammatory Bowel Diseases in Clinical Practice	Anti-TNF Therapy in Danish Patients With Inflammatory Bowel Diseases in Clinical Practice	Crohn's Disease;Ulcerative Colitis;Inflammatory Bowel Disease	Biological: infliximab and adalimumab	Regionshospitalet Viborg, Skive	NULL	Completed	18 Years	N/A	Both	1035	N/A	NULL
129	EUCTR2008-005688-32-CZ (EUCTR)	02/07/2009	05/01/2009	Biological therapy in the prevention of Crohn`s disease recurrence after resection in ileocecal region.	Biological therapy in the prevention of Crohn`s disease recurrence after resection in ileocecal region.	Prevention of Crohn`s disease recurrence after surgery in ileocecal region by postoperative application of infliximab (four infusions). MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease		Univeristy Hospital Na Bulovce	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	50	Phase 3	Czech Republic
130	EUCTR2006-004784-58-GB (EUCTR)	03/06/2009	30/04/2009	An Open Label, Prospective, Multi-Center Trial on the Effect of Anti-TNF Chimeric Monoclonal Antibody (Infliximab, Remicade) on Inflammatory and Fibrous Lesions in Patients with Intestinal Crohn's Diesease. ACTIF Trial. - Effect of Infliximab on MRI lesions in Crohn's - ACTIF study	An Open Label, Prospective, Multi-Center Trial on the Effect of Anti-TNF Chimeric Monoclonal Antibody (Infliximab, Remicade) on Inflammatory and Fibrous Lesions in Patients with Intestinal Crohn's Diesease. ACTIF Trial. - Effect of Infliximab on MRI lesions in Crohn's - ACTIF study	Crohn's disease MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab	University of Leuven Hospitals	NULL	Not Recruiting			Female: yes Male: yes	25	Phase 4	France;Belgium;Germany;United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
131	NCT00851565 (ClinicalTrials.gov)	June 2009	24/2/2009	Use of Combined Measurements of Serum Infliximab and Anti-infliximab Antibodies in the Treatment of Patients With Crohns Disease Failing Infliximab Therapy	Use of Combined Measurements of Serum Infliximab and Anti-infliximab Antibodies in the Treatment of Patients With Crohns Disease Failing Infliximab Therapy	Crohn's Disease	Procedure: Measurement of serum infliximab and anti-infliximab antibodies;Procedure: Treatment according to current standards without knowledge of serum infliximab and anti-infliximab Ab status	Copenhagen University Hospital at Herlev	Aase and Ejnar Danielsens Foundation;Beckett Foundation;the Danish Biotechnology Program;Danish Colitis-Crohn Society;Danish Medical Association Research Fund;Frode V. Nyegaard and wife’s Foundation;Health Science Research Foundation of Region of Copenhagen;Herlev Hospital Research Council;Lundbeck Foundation;P. Carl Petersens Fund;Biomonitor A/S;Prometheus Inc.;The Danish Institute for Health Services Research	Active, not recruiting	18 Years	N/A	Both	120	Phase 4	Denmark
132	JPRN-UMIN000002604	2009/05/01	01/11/2009	Combined therapy of infliximab with surgery in maintenance of remission in Crohn's disease		Crohn's disease	Patients are randomly divided into two groups, groups treated with or without infliximab by staffs of Keio Clinical Research Center at 2 to 4 weeks after surgery. Patients receive infliximab 5 mg/kg at 0, 2, 6 weeks, followed by every 8 weeks for 2 years. Alternatively, patients continue to receive infliximab with intervals of 8 weeks if they received infliximab within 8 weeks from the time point 0. Patients without infliximab receive maintenance therapy without immunomodulators.	Clinical Research Group of inflammatory bowel disease in Japan	NULL	Complete: follow-up complete	18years-old	Not applicable	Male and Female	100	Phase 4	Japan
133	EUCTR2008-007519-34-SE (EUCTR)	17/04/2009	02/03/2009	Feasibility of Accelerated infliximab infusions - Safety and Tolerability in patients wit IBD. FAST - FAST VERSION	Feasibility of Accelerated infliximab infusions - Safety and Tolerability in patients wit IBD. FAST - FAST VERSION	This is a open label, prospective, multicenter trial in patients recieving one hour infusions of infliximab (i.e. Remicade)as part of their daily practice. Main objective: Is to assess the tolerability of Remicade with an infusionsrate of 30 minutes.Patients: eligible patients are those with intestinal fistulas Mb Crohn disease or Ulcerative colitis/IBD. or patietns with	Trade Name: Remicade	University of Leuven Hospitals, Division of Gastroenterology	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	200		Sweden
134	EUCTR2008-006484-36-IT (EUCTR)	16/04/2009	24/04/2009	MULTICENTER COMPARATIVE STUDY BETWEEN NUTRITIONAL THERAPY ALONE ANDANTI-TNF-alpha MONOCLONAL ANTIBODY IN INDUCING AND MAINTAINING REMISSION INPEDIATRIC CROHN`S DISEASE: A RANDOMIZED CONTROLLED TRIAL - NUTRITION AND BIOLOGICS IN CROHN`S DISEASE	MULTICENTER COMPARATIVE STUDY BETWEEN NUTRITIONAL THERAPY ALONE ANDANTI-TNF-alpha MONOCLONAL ANTIBODY IN INDUCING AND MAINTAINING REMISSION INPEDIATRIC CROHN`S DISEASE: A RANDOMIZED CONTROLLED TRIAL - NUTRITION AND BIOLOGICS IN CROHN`S DISEASE	Moderate-to-severe active Crohn`sdisease. MedDRA version: 9.1;Level: LLT;Classification code 10011398;Term: Crohn's	Trade Name: REMICADE INN or Proposed INN: INFLIXIMAB	AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA	NULL	Not Recruiting			Female: yes Male: yes			Italy
135	EUCTR2009-009926-94-DK (EUCTR)	26/03/2009	25/02/2009	Use of combined measurements of serum infliximab and anti-infliximab antibodies in the treatment of patients with Crohns disease failing infliximab therapy	Use of combined measurements of serum infliximab and anti-infliximab antibodies in the treatment of patients with Crohns disease failing infliximab therapy	Patients with Crohns diseases failing treatment with infliximab MedDRA version: 13.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders	Trade Name: Remicade Trade Name: Humira	Department of medical gastroenterology, Herlev Hospital	NULL	Not Recruiting			Female: yes Male: yes		Phase 4	Denmark
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
136	NCT00805766 (ClinicalTrials.gov)	December 2008	9/12/2008	Efficacy and Safety of Increased Dose of TA-650 (Infliximab) in Patients With Crohn's Disease (CD)	Clinical Study to Assess the Efficacy and Safety of Increased Dose of TA-650 in Patients With Crohn's Disease (CD)	Crohn's Disease	Drug: TA-650	Mitsubishi Tanabe Pharma Corporation	NULL	Completed	16 Years	75 Years	All	39	Phase 3	Japan
137	NCT00752622 (ClinicalTrials.gov)	November 2008	12/9/2008	Treatment With Infliximab in a Medical Setting (Study P05587)	Optimization of Treatment With Infliximab in a Medical Setting	Crohn's Disease	Biological: Infliximab 5 mg/kg;Biological: Infliximab 5 mg/kg every 6 weeks;Biological: Infliximab 7 mg/kg every 8 weeks	Merck Sharp & Dohme Corp.	NULL	Terminated	18 Years	N/A	All	100	Phase 4	Canada
138	NCT01559142 (ClinicalTrials.gov)	November 2008	19/3/2012	Efficacy and Safety of Two Regimens of Maintenance Therapy in Children With Crohn Disease	Efficacy and Safety of Induction Therapy With Three Doses of Infliximab in Patients With Crohn Disease Aged 7-17 Years-multicenter Open Study. Efficacy and Safety of Two Regimens of Maintenance Therapy in Patients With Crohn Disease Aged 7-17 Years-multicenter Randomized Study	Crohn Disease	Drug: Infliximab with azathioprine (IIFX + AZA);Drug: Infliximab (IFX alone)	Children's Memorial Health Institute, Poland	NULL	Active, not recruiting	7 Years	17 Years	Both	100	Phase 3	Poland
139	EUCTR2008-004926-18-DE (EUCTR)	30/10/2008	30/10/2008	Comparison of the human TNF-alpha antibody adalimumab with infliximab in induction and maintenance of steroid-free remission in patients with moderate to severe Crohn’s disease - CHAMP	Comparison of the human TNF-alpha antibody adalimumab with infliximab in induction and maintenance of steroid-free remission in patients with moderate to severe Crohn’s disease - CHAMP	Moderate to severe Crohn’s disease	Trade Name: Humira Trade Name: Remicade	IBD Center LMU Munich	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Germany
140	NCT00791557 (ClinicalTrials.gov)	October 2008	13/11/2008	Open Label Study for Adults With Pyoderma Gangrenosum and Inflammatory Bowel Disease	An Open Label Single Center Pilot Study Investigating the Clinical Response and Mechanism of Action of Infliximab in the Treatment of Adults With Inflammatory Bowel Disease Who Have Moderate to Severe Pyoderma Gangrenosum	Pyoderma Gangrenosum;Crohn's Disease;Ulcerative Colitis;Inflammatory Bowel Disease	Drug: Infliximab	University Hospitals Cleveland Medical Center	Centocor, Inc.	Completed	18 Years	75 Years	All	2	N/A	United States
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
141	EUCTR2006-004784-58-FR (EUCTR)	07/07/2008	24/06/2008	An open label, prospective, multicenter trial, on the effect of anti-TNF alpha Chimeric monoclonal antibody (Infliximab, Remicade) on the inflammatory and fibrous lesions in patients with intestinal Crohn's Disease.	An open label, prospective, multicenter trial, on the effect of anti-TNF alpha Chimeric monoclonal antibody (Infliximab, Remicade) on the inflammatory and fibrous lesions in patients with intestinal Crohn's Disease.	Crohn's disease	Trade Name: Selective Immunosuppressive agents Product Name: Remicade 100 mg INN or Proposed INN: infliximab	CHRU de Lille	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	25		United Kingdom;Germany;Belgium;France
142	EUCTR2006-004784-58-DE (EUCTR)	27/05/2008	11/03/2008	Effect of infliximab on inflammatory and fibrous lesions in patients with intestinal Crohn’s disease - ACTIF	Effect of infliximab on inflammatory and fibrous lesions in patients with intestinal Crohn’s disease - ACTIF	Crohn's disease MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease	Trade Name: remicade Product Name: remicade INN or Proposed INN: INFLIXIMAB	University of Leuven	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	25		United Kingdom;Germany;Belgium;France
143	EUCTR2008-001131-35-NL (EUCTR)	14/05/2008	29/05/2008	Azathioprine maintenance treatment versus Infliximab maintenance treatment in Crohn's disease patients in remission: a randomized multicenter trial - Azorix-trial	Azathioprine maintenance treatment versus Infliximab maintenance treatment in Crohn's disease patients in remission: a randomized multicenter trial - Azorix-trial	this study is designed as a multicenter radomized trial comparing azathioprine maintenance treatment to infliximab maintenance treatment in Crohn's disease patients that are in remission for at least 6 months while being treated with a combined therapy of infliximab and azathioprine for at least 6 months	Trade Name: Remicade Product Name: Infliximab Product Code: EU/1/99/116/003 Trade Name: Imuran Product Name: Azathioprine Product Code: RVG 05565	Academic Medical Center, department of Gastroenterology and hepatology	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Netherlands
144	EUCTR2008-001466-93-GB (EUCTR)	30/04/2008	28/03/2008		Trial of adjuvant vitamin D with Infliximab in active Crohn's Disease (IBDVit2). - IBDVit2	Active Crohn's Disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease	Trade Name: Vigantol Oel Product Name: Vigantol Oel TM	Imperial College London	NULL	Not Recruiting			Female: yes Male: yes	40		United Kingdom
145	EUCTR2007-006692-37-GB (EUCTR)	10/04/2008	25/01/2008	The Immunomodulatory Role of Vitamin D in Inflammatory Bowel Disease (IBDVit): IBDVit1 - Trial of Adjuvant Vitamin D with Corticosteroids in Active Crohn’s Disease; IBDVit2 - Trial of Adjuvant Vitamin D with Infliximab in Active Crohn's Disease; IBDVit3 - Trial of Adjuvant Vitamin D with standard maintenance therapy in preventing relapse of Inflammatory Bowel Disease. - IBDVit	The Immunomodulatory Role of Vitamin D in Inflammatory Bowel Disease (IBDVit): IBDVit1 - Trial of Adjuvant Vitamin D with Corticosteroids in Active Crohn’s Disease; IBDVit2 - Trial of Adjuvant Vitamin D with Infliximab in Active Crohn's Disease; IBDVit3 - Trial of Adjuvant Vitamin D with standard maintenance therapy in preventing relapse of Inflammatory Bowel Disease. - IBDVit	IBDVit1 - Active Crohn's Disease IBDVit2 - Active Crohn's Disease IBDVit3 - Crohn's Disease in remission / Ulcerative Colitis in remission MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10045365;Term: Ulcerative colitis		Imperial College London	NULL	Not Recruiting			Female: yes Male: yes	210	Phase 4	United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
146	EUCTR2006-004784-58-BE (EUCTR)	22/06/2007	11/04/2007	Effect of infliximab on inflammatory and fibrous lesions in patients with intestinal Crohn’s disease - ACTIF	Effect of infliximab on inflammatory and fibrous lesions in patients with intestinal Crohn’s disease - ACTIF	Crohn's disease MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease	Trade Name: remicade Product Name: remicade INN or Proposed INN: INFLIXIMAB	University of Leuven	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	25		United Kingdom;Germany;Belgium;France
147	JPRN-UMIN000004427	2007/06/01	01/11/2010	A Prospective Randomized Open Trial to Assess the Efficiency of Infliximab for Crohn's Patients after Intestinal Resection		Crohn's disease	Non-infliximab arm: Conventional medicine is administered, excluding Infliximab, Azathioprine, and 6-Mercaptopurine, to subjects during the study period (for 60 months, maximum). Infliximab arm: Infliximab is administered to subjects during the study period (for 60 months, maximum) together with other conventional medications, such as 5-aminosalicylic acid. Infliximab is administered every 8 weeks to subjects during study period after the start of protocol treatment as a rule. Immunomodulators, such as Azathioprine and 6-Mercaptopurine, are not permitted during the trial.	Lower GI disease, Hyogo College of Medicine	NULL	Complete: follow-up complete	16years-old	65years-old	Male and Female	30	Phase 2;Phase 3	Japan
148	NCT00724529 (ClinicalTrials.gov)	June 2007	25/7/2008	Post Marketing Surveillance of Remicade	Post Marketing Surveillance of Remicade in Inflammatory Bowel Disease (IBD)	Crohn's Disease;Ankylosing Spondylitis	Biological: Infliximab	Janssen Korea, Ltd., Korea	NULL	Completed	N/A	N/A	Both	938		Korea, Republic of
149	NCT00606346 (ClinicalTrials.gov)	May 31, 2007	21/1/2008	A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients With Inflammatory Bowel Disease	A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients With Inflammatory Bowel Disease	Crohn's Disease;Ulcerative Colitis;Indeterminate Colitis;Inflammatory Bowel Diseases	Biological: Anti TNF therapy including infliximab;Drug: No Biologics	Janssen Biotech, Inc.	NULL	Active, not recruiting	1 Month	17 Years	All	4970		United States;Canada
150	NCT00307931 (ClinicalTrials.gov)	April 2007	24/3/2006	Certolizumab Pegol for Treatment of Adult Greek Patients With Moderate to Severe Crohn's Disease Who Failed Infliximab	Certolizumab Pegol in the Treatment of Adult Greek Patients With Moderate to Severe Crohn's Disease Who Have Been Previously Treated Successfully With Infliximab But Who Have Subsequently Lost Response or Developed Intolerance to Infliximab	Crohn's Disease	Biological: Certolizumab pegol	UCB Pharma	NULL	Terminated	18 Years	N/A	All	16	Phase 3	Greece
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
151	NCT00462072 (ClinicalTrials.gov)	March 2007	17/4/2007	Centocor Microarray Study of Patients	Microarray Analysis of Peripheral Blood and Tissues of Patients With Immune Mediated Inflammatory Diseases	Rheumatoid Arthritis;Psoriatic Arthritis;Psoriasis;Crohn's Disease	Drug: Infliximab	University of Rochester	Centocor, Inc.	Completed	12 Years	N/A	All	31	Phase 4	United States
152	EUCTR2006-006632-22-BE (EUCTR)	26/01/2007	19/12/2006	Change from infliximab to adalimumab in patients with Crohn’s disease in remission on infliximab: a randomized comparative case control study. - Infliximab to adalimumab switch trial	Change from infliximab to adalimumab in patients with Crohn’s disease in remission on infliximab: a randomized comparative case control study. - Infliximab to adalimumab switch trial	Luminal Crohns Disease, moderate to severe, refractory to steroids and/or antimetabolitets and controlled with anti-TNF therapy MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease	Trade Name: HUMIRA Trade Name: REMICADE	University of Leuven, Division of Gastroenterology	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Belgium
153	EUCTR2006-002027-16-GR (EUCTR)	12/12/2006	05/09/2006	Certolizumab pegol 400 mg monthly in the treatment of adult Greek patients with moderate to severe Crohn’s Disease, who have been previously treated successfully with infliximab but who have subsequently lost the response or have developed intolerance to infliximab: an open-label, multi-center, single-cohort study to evaluate efficacy, safety and onset of action.	Certolizumab pegol 400 mg monthly in the treatment of adult Greek patients with moderate to severe Crohn’s Disease, who have been previously treated successfully with infliximab but who have subsequently lost the response or have developed intolerance to infliximab: an open-label, multi-center, single-cohort study to evaluate efficacy, safety and onset of action.	Certolizumab pegol in the treatment of adult Greek patients with moderate to severe Crohn’s Disease, who have been previously treated successfully with infliximab but who have subsequently lost the response or have developed intolerance to infliximab	Product Name: certolizumab pegol Product Code: CDP870	UCB AE	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Greece
154	NCT00897312 (ClinicalTrials.gov)	October 2006	9/5/2009	Effect of Biological Therapy on Biomarkers in Patients With Untreated Hepatitis C, Metastatic Melanoma, or Crohn Disease	Title: Evaluation of Systemic IDO Levels After Various Immunotherapeutics	Melanoma	Biological: infliximab;Biological: pegylated interferon alfa;Biological: ticilimumab;Drug: ribavirin;Other: high performance liquid chromatography;Other: laboratory biomarker analysis	Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI)	Terminated	N/A	N/A	Both	7	N/A	NULL
155	EUCTR2005-004104-37-ES (EUCTR)	28/07/2006	11/05/2006	A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a PEGylated Fab' fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab.	A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a PEGylated Fab' fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab.	Patients with Crohn's Disease with prior loss of response or intolerance to infliximab Classification code 10011401	Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol	UCB S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3b	Germany;United Kingdom;Belgium;Spain;Italy;Austria;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
156	EUCTR2005-004104-37-DK (EUCTR)	15/06/2006	04/05/2006	A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a PEGylated Fab' fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab.	A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a PEGylated Fab' fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab.	Patients with Crohn's Disease with prior loss of response or intolerance to infliximab Classification code 10011401	Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol	UCB S.A.	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3b	Spain;Belgium;Austria;Denmark;Germany;Italy;United Kingdom;Sweden
157	EUCTR2005-004104-37-SE (EUCTR)	08/06/2006	21/04/2006	A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a PEGylated Fab' fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab.	A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a PEGylated Fab' fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab.	Patients with Crohn's Disease with prior loss of response or intolerance to infliximab Classification code 10011401	Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol	UCB S.A.	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3b	Germany;United Kingdom;Belgium;Spain;Italy;Austria;Sweden
158	NCT00338650 (ClinicalTrials.gov)	June 2006	19/6/2006	Treatment of the Human Anti-TNF Monoclonal Antibody Adalimumab in Moderate to Severe Crohn's Disease With Previous Exposure to Infliximab (CHOICE)	A Multi-Center, Open-Label Treatment Protocol of the Human Anti-TNF Monoclonal Antibody Adalimumab in Patients With Moderate to Severe Crohn's Disease With Previous Exposure to Infliximab	Crohn's Disease	Drug: adalimumab	Abbott	NULL	Completed	18 Years	75 Years	Both	1000	Phase 3	United States
159	EUCTR2005-004104-37-AT (EUCTR)	24/05/2006	04/04/2006	A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a PEGylated Fab' fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab.	A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a PEGylated Fab' fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab.	Patients with Crohn's Disease with prior loss of response or intolerance to infliximab Classification code 10011401	Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol	UCB S.A.	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3b	Germany;United Kingdom;Belgium;Spain;Italy;Austria;Sweden
160	EUCTR2005-004104-37-DE (EUCTR)	19/05/2006	29/03/2006	A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a PEGylated Fab' fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab.	A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a PEGylated Fab' fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab.	Patients with Crohn's Disease with prior loss of response or intolerance to infliximab Classification code 10011401	Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol	UCB Pharma S.A.	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3b	United Kingdom;Germany;Belgium;Spain;Italy;Austria;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
161	EUCTR2005-004104-37-GB (EUCTR)	17/05/2006	17/03/2006	A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a pegylated Fab fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab.	A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a pegylated Fab fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab.	Patients with Crohn's Disease with prior loss of response or intolerance to infliximab Classification code 10011401		UCB S.A.	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	Spain;Belgium;Denmark;Austria;Germany;Italy;United Kingdom;Sweden
162	NCT00308581 (ClinicalTrials.gov)	April 2006	28/3/2006	Certolizumab in Crohn's Disease Patients With Loss of Response or Intolerance to Infliximab	Phase IIIb Open-label Induction and Double-blind Comparison of 2 Maintenance Schedules Evaluating Clinical Benefit and Tolerability of Certolizumab Pegol in Crohn's Disease Patients With Prior Loss of Response or Intolerance to Infliximab	Crohn's Disease	Biological: Certolizumab pegol;Other: Placebo	UCB Pharma	NULL	Completed	18 Years	N/A	All	539	Phase 3	United States;Austria;Belgium;Canada;Denmark;France;Germany;Italy;Netherlands;Norway;Spain;Sweden;Switzerland;United Kingdom
163	EUCTR2005-004104-37-BE (EUCTR)	23/03/2006	27/01/2006	A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a pegylated Fab fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab.	A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a pegylated Fab fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab.	Patients with Crohn's Disease with prior loss of response or intolerance to infliximab Classification code 10011401	Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol	UCB S.A.	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3b	Germany;United Kingdom;Belgium;Spain;Italy;Austria;Sweden
164	NCT00727298 (ClinicalTrials.gov)	February 2006	30/7/2008	Post Marketing Surveillance Study of Remicade in Patients With Chronic Inflammatory Diseases (P04840)	Post Marketing Surveillance Study of the Labeled Use of Remicade® (Infliximab) in Patients With Chronic Inflammatory Diseases	Arthritis, Rheumatoid;Spondylitis, Ankylosing;Arthritis, Psoriatic;Psoriasis;Crohn's Disease	Biological: Infliximab	Merck Sharp & Dohme Corp.	Centocor, Inc.	Completed	18 Years	N/A	All	4485	N/A	Germany
165	EUCTR2004-002815-10-DE (EUCTR)	12/12/2005	25/04/2005	Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONIC	Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONIC	moderate to severe Crohn’s Disease MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease	Trade Name: Remicade INN or Proposed INN: infliximab Other descriptive name: Chimeric IgG1 monoclonal antibody Trade Name: Imuran INN or Proposed INN: azathioprine Other descriptive name: 6-[(methyl-4-nitro-1H-imidazol-5-yl)thio]-1H-purine	Centocor B.V.	NULL	Not Recruiting			Female: yes Male: yes	500		United Kingdom;Germany;Denmark;Spain;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
166	NCT00571337 (ClinicalTrials.gov)	December 2005	25/7/2007	Stop Infliximab in Patients With Crohn's Disease	Prospective Study of Predictive Factors of Sustained Remission of Crohn's Disease After Stopping Infliximab	Crohn Disease	Drug: Infliximab	Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives	NULL	Completed	18 Years	N/A	Both	126	Phase 3	Belgium;France
167	NCT00132899 (ClinicalTrials.gov)	December 2005	19/8/2005	COMMIT (Combination Of Maintenance Methotrexate-Infliximab Trial)	A Phase III Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Multi-Centre Study to Evaluate the Safety and Efficacy of Infliximab in Combination With Methotrexate for the Long-term Treatment of Crohn's Disease (CD)	Crohn's Disease	Drug: Methotrexate;Drug: Placebo	University of Western Ontario, Canada	Schering-Plough	Completed	18 Years	N/A	Both	128	Phase 3	Canada
168	NCT00252369 (ClinicalTrials.gov)	September 2005	10/11/2005	Treatment of Perianal Crohn's Disease, Combining Medical and Surgical Treatment.	Instillation of Fibrin Glue After Induction of Local Conditions Using Infliximab, in the Treatment of Perianal Crohn's Disease.	Crohn's Disease	Drug: Infliximab;Procedure: Instillation of fibrin glue	Sheba Medical Center	NULL	Terminated	18 Years	90 Years	Both		N/A	Israel
169	EUCTR2004-002815-10-GB (EUCTR)	25/07/2005	26/05/2005	Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONIC	Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONIC	moderate to severe Crohn’s Disease MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease	Trade Name: Remicade INN or Proposed INN: infliximab Other descriptive name: Chimeric IgG1 monoclonal antibody Trade Name: Imuran INN or Proposed INN: azathioprine Other descriptive name: 6-[(methyl-4-nitro-1H-imidazol-5-yl)thio]-1H-purine	Centocor B.V.	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	Spain;Denmark;Austria;Germany;United Kingdom;Sweden
170	EUCTR2004-002815-10-ES (EUCTR)	18/07/2005	16/05/2006	Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONIC	Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONIC	moderate to severe Crohn’s Disease MedDRA version: 7.1;Classification code 10011401	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: infliximab Trade Name: Imuran Product Name: Imuran INN or Proposed INN: azathioprine Other descriptive name: 6-[(methyl-4-nitro-1H-imidazol-5-yl)thio]-1H-purine	Centocor B.V.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	500		United Kingdom;Germany;Denmark;Spain;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
171	EUCTR2004-002815-10-DK (EUCTR)	07/07/2005	10/07/2008	Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONIC	Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONIC	moderate to severe Crohn’s Disease MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease	Trade Name: Remicade INN or Proposed INN: infliximab Other descriptive name: Chimeric IgG1 monoclonal antibody Trade Name: Imuran INN or Proposed INN: azathioprine Other descriptive name: 6-[(methyl-4-nitro-1H-imidazol-5-yl)thio]-1H-purine	Centocor B.V.	NULL	Not Recruiting			Female: yes Male: yes	500		United Kingdom;Germany;Denmark;Spain;Sweden
172	EUCTR2004-002815-10-SE (EUCTR)	24/05/2005	11/04/2005	Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONIC	Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONIC	moderate to severe Crohn’s Disease MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease	Trade Name: Remicade INN or Proposed INN: infliximab Other descriptive name: Chimeric IgG1 monoclonal antibody Trade Name: Imuran INN or Proposed INN: azathioprine Other descriptive name: 6-[(methyl-4-nitro-1H-imidazol-5-yl)thio]-1H-purine	Centocor B.V.	NULL	Not Recruiting			Female: yes Male: yes	500		United Kingdom;Germany;Denmark;Spain;Sweden
173	EUCTR2004-002815-10-AT (EUCTR)	04/05/2005	30/03/2005	Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONIC	Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONIC	moderate to severe Crohn’s Disease MedDRA version: 7.1;Classification code 10011401	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: infliximab Trade Name: Imuran Product Name: Imuran INN or Proposed INN: azathioprine Other descriptive name: 6-[(methyl-4-nitro-1H-imidazol-5-yl)thio]-1H-purine	Centocor B.V.	NULL	Not Recruiting			Female: yes Male: yes	500		Spain;Denmark;Austria;Germany;United Kingdom;Sweden
174	NCT00705471 (ClinicalTrials.gov)	April 2005	23/6/2008	Impact of Infliximab in Fistulizing Crohn's Disease on Health Care Resources (Study P04204)(TERMINATED)	Infliximab Use in Fistulizing Crohn's Disease: Impact on Health Care Resources	Crohn Disease	Biological: Infliximab	Merck Sharp & Dohme Corp.	Centocor, Inc.	Terminated	18 Years	N/A	Both	42	N/A	NULL
175	NCT00094458 (ClinicalTrials.gov)	March 2005	19/10/2004	Trial Comparing Infliximab and Infliximab and Azathioprine in the Treatment of Patients With Crohn's Disease na?ve to Both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Chrohn's Disease: SONIC	Multicenter, Randomized, Double-Blind, Active Controlled Trial Comparing REMICADE? (Infliximab) and REMICADE Plus Azathioprine to Azathioprine in the Treatment of Patients With Crohn's Disease Naive to Both Immunomodulators and Biologic Therapy	Crohn Disease	Biological: infliximab infusion; AZA placebo caps;Other: infliximab (IFX) infusion; azathioprine (AZA) caps;Drug: infliximab (IFX) placebo infusion	Centocor Ortho Biotech Services, L.L.C.	Schering-Plough	Completed	21 Years	99 Years	All	508	Phase 3	United States;Austria;Belgium;Canada;Denmark;France;Germany;Greece;Israel;Netherlands;Norway;Portugal;Spain;Sweden;United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
176	EUCTR2004-002934-20-BE (EUCTR)	22/02/2005	08/07/2005	A Multi-Centre, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease who Have Lost Response or are Intolerant to Infliximab	A Multi-Centre, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease who Have Lost Response or are Intolerant to Infliximab	Crohn's Disease	Trade Name: Humira Product Name: Humira INN or Proposed INN: Adalimumab	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes			Belgium
177	NCT00688636 (ClinicalTrials.gov)	January 2005	29/5/2008	Infliximab for the Prevention of Recurrent Crohn's Disease After Surgery	Infliximab for the Prevention of Recurrent Crohn's Disease After Surgery	Crohn's Disease	Drug: infliximab;Drug: placebo	University of Pittsburgh	Centocor, Inc.	Completed	18 Years	72 Years	All	24	Phase 4	United States
178	NCT00724958 (ClinicalTrials.gov)	December 2004	25/7/2008	Program Extension of Real Life Dosing of Remicade in Austria for Crohn's Disease (Study P04052)(COMPLETED)	Real Life Dosing Regimen of Remicade in Austria in Crohn's Disease - Program Extension	Crohn's Disease	Biological: Infliximab	Merck Sharp & Dohme Corp.	Centocor, Inc.	Completed	N/A	N/A	All	348	N/A	Austria
179	NCT00105300 (ClinicalTrials.gov)	October 2004	11/3/2005	Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease	A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Moderate to Severe Crohn's Disease Who Have Lost Response or Are Intolerant to Infliximab	Crohn's Disease	Drug: Adalimumab	Abbott	NULL	Completed	18 Years	75 Years	Both	300	Phase 3	United States;Belgium;Canada;France
180	NCT00796250 (ClinicalTrials.gov)	November 1, 2003	21/11/2008	Efficacy of Infliximab in the Treatment of Patients Affected by Corticodependent Crohn's Disease (P02732)	Efficacy of Infliximab as Bridging Therapy in the Treatment of Patients Affected by Corticodependent Crohn's Disease Under Standard Treatment With Azathioprine	Crohn's Disease	Biological: Infliximab;Drug: AZA;Drug: Placebo Prednisolone;Drug: Prednisolone;Biological: Placebo Infliximab	Merck Sharp & Dohme Corp.	NULL	Terminated	18 Years	65 Years	All	9	Phase 3	NULL
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
181	NCT00207675 (ClinicalTrials.gov)	February 2003	13/9/2005	A Study of the Safety and Efficacy of Infliximab (Remicade) in Pediatric Patients With Crohn's Disease	A Randomized, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Anti-TNF a Chimeric Monoclonal Antibody (Infliximab, REMICADE) in Pediatric Subjects With Moderate to Severe CROHN'S Disease.	Crohn Disease	Drug: infliximab	Centocor, Inc.	Centocor BV	Completed	6 Years	17 Years	Both	112	Phase 3	NULL
182	NCT00818272 (ClinicalTrials.gov)	December 2002	6/1/2009	Remicade Safety Line (Crohn's Disease)(Study P03288)(COMPLETED)	Remicade Safety Line (Crohn's Disease)	Crohn's Disease	Biological: Remicade (infliximab)	Merck Sharp & Dohme Corp.	Centocor, Inc.	Completed	18 Years	N/A	All	148	N/A	Germany
183	NCT00055536 (ClinicalTrials.gov)	April 2002	4/3/2003	Safety and Efficacy of Natalizumab in Combination With Remicade in the Treatment of Crohn's Disease	A Phase II, Multi-Center, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, and Efficacy of Intravenous Antegren (Natalizumab) in Crohn's Disease Subjects Concurrently Receiving Remicade (Infliximab) and Not in Remission	Crohn's Disease	Drug: natalizumab	Biogen	Elan Pharmaceuticals	Completed	18 Years	N/A	Both	60	Phase 2	United States
184	NCT00261976 (ClinicalTrials.gov)	February 2002	2/12/2005	A Long-term Safety Study of Infliximab (Remicade)	Long-term Safety Follow-up of REMICADE (RESULTS)	Arthritis, Rheumatoid;Crohn Disease;Psoriasis	Drug: Infliximab (Remicade)	Centocor, Inc.	Centocor BV	Completed	N/A	N/A	Both	2971		United States;Argentina;Austria;Belgium;Canada;Denmark;Finland;France;Germany;Hungary;Ireland;Israel;Netherlands;Norway;Poland;Spain;Sweden;Switzerland;United Kingdom
185	NCT00554710 (ClinicalTrials.gov)	May 2001	6/11/2007	Top Down Versus Step Up Strategies in Crohn's Disease	The Ideal Management of Crohn's Disease: Top Down Versus Step Up Strategies. A Prospective Controlled Trial in the Benelux	Crohn's Disease	Drug: infliximab+azathioprine;Drug: methylprednisolone or budesonide	Belgian IBD Research Group	Centocor BV;Schering-Plough	Completed	16 Years	75 Years	Both	129	Phase 4	Belgium
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
186	NCT00207662 (ClinicalTrials.gov)	July 2000	13/9/2005	A Safety and Efficacy Study of Infliximab (Remicade) in Patients With Moderate to Severe Active Crohn's Disease	ACCENT I - A Randomized, Double-blind, Placebo-controlled Trial of Anti-TNFa Chimeric Monoclonal Antibody (Infliximab, Remicade) in the Long-term Treatment of Patients With Moderately to Severely Active Crohn's Disease	Crohn Disease	Drug: infliximab or placebo	Centocor, Inc.	NULL	Completed	18 Years	N/A	Both	580	Phase 3	NULL
187	NCT00207766 (ClinicalTrials.gov)	June 2000	13/9/2005	A Study of the Safety and Efficacy of Infliximab (Remicade) in Subjects With Fistulizing Crohn's Disease	ACCENT II - A Randomized, Double-blind, Placebo-controlled Trial of Anti-TNF Chimeric Monoclonal Antibody (Infliximab, Remicade) in the Long Term Treatment of Patients With Fistulizing CROHN'S Disease	Crohn Disease	Drug: infliximab or placebo	Centocor, Inc.	NULL	Completed	18 Years	N/A	Both	306	Phase 3	NULL
188	NCT00269841 (ClinicalTrials.gov)	May 1996	22/12/2005	An Efficacy and Safety Study of Anti-TNF Monoclonal Antibody in Patients With Fistulizing Crohn's Disease	A Placebo-Controlled, Repeated-Dose Study of Anti-TNF Chimeric Monoclonal Antibody (cA2) in the Treatment of Patients With Enterocutaneous Fistulae as a Complication of Crohn's Disease	Crohn Disease	Drug: Infliximab 10 mg/kg;Drug: Infliximab 5 mg/kg;Drug: Placebo	Centocor, Inc.	NULL	Completed	18 Years	65 Years	Both	94	Phase 3	NULL
189	NCT00269854 (ClinicalTrials.gov)	June 1995	22/12/2005	An Efficacy and Safety Study of Anti-TNF Monoclonal Antibody in Patients With Crohn's Disease	A Placebo-Controlled, Dose-Ranging Study Followed by a Placebo-Controlled, Repeated-Dose Extension of Anti-TNF Chimeric Monoclonal Antibody (cA2) in the Treatment of Patients With Active Crohn's Disease	Crohn Disease	Drug: Infliximab 5 mg/kg;Drug: Infliximab 10 mg/kg;Drug: Infliximab 20 mg/kg;Drug: Placebo	Centocor, Inc.	NULL	Completed	18 Years	65 Years	Both	108	Phase 2;Phase 3	NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT04530877
(ClinicalTrials.gov)

December 1, 2020

24/8/2020

Exclusive Enteral Nutrition vs. Infliximab in Chinese CD Patients

Comparative Effectiveness of Exclusive Enteral Nutrition and Infliximab in Chinese Children With Active Crohn's Disease

Crohn's Disease;Exclusive Enteral Nutrition;Infliximab;Mucosal Healing

Biological: Infliximab;Dietary Supplement: Exclusive Enteral Nutrition

Children's Hospital of Fudan University

NULL

Not yet recruiting

1 Year

18 Years

All

Phase 4

NULL

NCT04646187
(ClinicalTrials.gov)

December 2020

20/11/2020

De-escalation of Anti-TNF Therapy in Inflammatory Bowel Disease

De-escalation of Anti-TNF Therapy in Adolescents and Young Adults With IBD With Tight Faecal Calprotectin and Trough Level Monitoring

Inflammatory Bowel Diseases;Crohn Disease;Colitis, Ulcerative

Biological: Infliximab;Biological: Adalimumab

University Medical Center Groningen

European Crohn´s and Colitis Organisation;Bühlmann Laboratories AG

Not yet recruiting

12 Years

25 Years

All

148

Phase 4

Belgium;Netherlands;Spain

EUCTR2020-001811-26-NL
(EUCTR)

30/09/2020

08/07/2020

IBD under control with less medication

De-escalation of anti-TNF therapy in adolescents and young adults with IBD with tight faecal calprotectin and trough level monitoring - FREE-study

Crohn's disease, ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Flixabi
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
INN or Proposed INN: INFLIXIMAB
Trade Name: Remsima
INN or Proposed INN: INFLIXIMAB
Trade Name: Zessly
INN or Proposed INN: INFLIXIMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Amgevita
INN or Proposed INN: ADALIMUMAB
Trade Name: Hulio
INN or Proposed INN: ADALIMUMAB

University Medical Center Groningen

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 4

Netherlands

JPRN-jRCT2031200117

01/09/2020

11/09/2020

A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohns Disease

Crohns Disease

Biological: CT-P13 SC (Infliximab)
Other: Placebo SC

Ishida Tetsuya

Celltrion

Recruiting

>= 18age old

<= 75age old

Both

600

Phase 3

Austria;Bulgaria;Croatia;Japan;US;Latvia;Czech Republic;France;Poland;Germany;Greece;Hungary;Spain

NCT04331639
(ClinicalTrials.gov)

September 2020

23/3/2020

High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Biologic Therapy

Implementation of High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Infliximab or Vedolizumab

Inflammatory Bowel Disease;Crohn Disease;Ulcerative Colitis;Vitamin D Deficiency

Dietary Supplement: vitamin D3

Boston Children's Hospital

NULL

Not yet recruiting

5 Years

25 Years

All

Phase 2

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT04312659
(ClinicalTrials.gov)

July 15, 2020

3/3/2020

A Study of Infliximab in the Treatment of Chinese Children With Crohn's Disease

A Multi-Center Registry Study of Infliximab in the Treatment of Chinese Children With Crohn's Disease

Crohn Disease

Drug: Infliximab

Johnson & Johnson (China) Investment Ltd.

NULL

Recruiting

6 Years

17 Years

All

China

ChiCTR2000029323

2020-03-01

2020-01-25

Laparoscopic bowel resection combined with infliximab treatment versus infliximab for localized intestinal Crohn's disease: a randomized controlled, open-label trial

Crohn's disease

Experimental group:Laparoscopic bowel resection combined with postoperative Infliximab treatment;Control group:Infliximab;

Renji Hospital, School of Medicine, Shanghai Jiaotong University

NULL

Pending

Both

Experimental group:30;Control group:30;

China

ChiCTR2000029543

2020-02-08

2020-02-03

A Model with serum biomarkers to Predict Infliximab Response in Patients with Crohn's Disease

Crohn's Disease

Gold Standard:Histology pathological examination; SES-CD endoscopy score;Index test:ELISA test for multiple serum cytokines;

The First Hospital Affiliated to Sun Yat sen University

NULL

Recruiting

Both

Target condition:350;Difficult condition:0

China

EUCTR2019-001087-30-AT
(EUCTR)

28/11/2019

12/09/2019

Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's disease

Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB

Celltrion, Inc

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3

United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Japan

EUCTR2019-003068-39-NL
(EUCTR)

20/11/2019

04/11/2019

In patients with inflammatory bowel disease (IBD) on infliximab (IFX) maintenance treatment, low trough levels of IFX suggest inefficacy of the drug and have consistently been shown to be protective of relapse following withdrawal of IFX. However, up to 30% of these patients will experience a relapse after IFX withdrawal. Pharmacokinetic parameters other than trough levels may predict relapse following drug withdrawal in IBD patients with undetectable IFX trough levels.

Withdrawal of Infliximab in patients with inflammatory bowel disease in remission guided by pharmacokinetics: WINK study - WINK study

Inflammatory Bowel Disease (IBD) Ulcerative colitis Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Infliximab
Product Name: Infliximab
INN or Proposed INN: INFLIXIMAB

UMC Utrecht

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT04655729
(ClinicalTrials.gov)

November 18, 2019

30/11/2020

Biomarkers to Predict and Monitor Response to Infliximab

Detection of Serum Protein Biomarkers to Predict and Monitor Response to Infliximab Using SOMAscan

Crohn Disease

Drug: Infliximab

Massachusetts General Hospital

The Crohn's and Colitis Foundation

Recruiting

3 Years

20 Years

All

120

United States

EUCTR2019-001087-30-DE
(EUCTR)

31/10/2019

01/07/2019

Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's disease

Trade Name: Remsima
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB

Celltrion, Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Czechia;Turkey;Austria;Czech Republic;Hungary;Mexico;Poland;Croatia;Romania;Bulgaria;Germany;Japan

EUCTR2019-001087-30-BG
(EUCTR)

30/10/2019

24/10/2019

Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's disease

Celltrion, Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

United States;Belarus;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Czechia;Turkey;Austria;Czech Republic;Hungary;Mexico;Brazil;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan

NCT03945019
(ClinicalTrials.gov)

October 28, 2019

8/5/2019

CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Crohn's Disease

Crohn's Disease

Biological: CT-P13 SC (Infliximab);Other: Placebo SC

Celltrion

NULL

Recruiting

18 Years

75 Years

All

600

Phase 3

United States

NCT04131504
(ClinicalTrials.gov)

October 16, 2019

16/10/2019

Precision Crohn's Disease Management Utilizing Predictive Protein Panels (ENvISION)

A Multi-Center, Prospective Study to Discover a Companion Diagnostic for Biologics Targeting TNF

Crohn's Disease;IBD

Drug: Infliximab;Drug: Adalimumab

Children's Hospital Medical Center, Cincinnati

The Leona M. and Harry B. Helmsley Charitable Trust

Recruiting

1 Year

22 Years

All

240

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

JPRN-jRCT1031190056

30/09/2019

17/07/2019

E6011-CS1 study

Research for medicinal predictive marker on Crohn's disease - E6011-CS1 study

Crohn's disease
Crohn's disease;D003424

Study1:Evaluate the disease activity and collect the blood according to the schedule as below. Amount of blood collection should be about 15mL at screening test, after the beginning of the study, about 12.5mL per visit.

1.Adalimumab:At the beginning of the study, after that, 2, 4, 12, 24, 52 weeks after or at the termination
2.Infliximab:At the beginning of the study,after that, 2, 6, 14, 22, 54 weeks after or at the termination
3. Ustekinumab:At the beginning of the study,after that, 2, 8, 20, 32, 56weeks after or at the termination

Study2:None.

Nanki Kousaku

EA Pharma Co.,Ltd.(Utilize AMED's funds)

Recruiting

>= 16age old

Not applicable

Both

N/A

Japan

ChiCTR1900026091

2019-09-19

2019-09-20

Development of a predictive nomogram for primary non-response to infliximab in patients with Crhon's disease

Development of a predictive nomogram for primary non-response to infliximab in patients with Crhon's disease: a multicenter study

Crohn's disease

Case series:infliximab;

The First Affiliated Hospital of Sun Yat-sen University

NULL

Pending

Both

Case series:343;

China

NCT03885713
(ClinicalTrials.gov)

September 10, 2019

4/3/2019

Identification of Predictive Biomarkers for Response to Biologic Therapies in Inflammatory Bowel Disease

Identification of Predictive Biomarkers for Response to Biologic Therapies in Inflammatory Bowel Disease by Proteomic and Mass Cytometry Approaches

Inflammatory Bowel Diseases;Crohn Disease;Ulcerative Colitis

Biological: Infliximab or adalimumab or golimumab or vedolizumab or ustekinumab

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

NULL

Recruiting

18 Years

N/A

All

180

Phase 4

Spain

EUCTR2019-001087-30-PL
(EUCTR)

09/09/2019

24/06/2019

Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's disease

Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB

Celltrion, Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

Serbia;Portugal;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Czech Republic;Hungary;Mexico;Brazil;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Japan

EUCTR2019-001087-30-GR
(EUCTR)

28/08/2019

26/07/2019

Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's disease

Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB

Celltrion, Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

Serbia;Portugal;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Czech Republic;Hungary;Mexico;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-001087-30-ES
(EUCTR)

14/08/2019

10/09/2019

Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's disease

Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB

Celltrion, Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

Serbia;Portugal;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Czech Republic;Hungary;Mexico;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany

EUCTR2019-001087-30-CZ
(EUCTR)

06/08/2019

06/06/2019

Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's disease

Trade Name: REMSINA
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB

Celltrion, Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

United States;Belarus;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Czechia;Turkey;Austria;Hungary;Czech Republic;Mexico;Poland;Croatia;Romania;Bulgaria;Germany;Japan

EUCTR2018-002064-15-NL
(EUCTR)

15/04/2019

Patient preference model: treatment of perianal fistulas in Crohn's disease

Treatment of Perianal FIstulas in Crohn’s Disease: Surgical closure vs Anti-TNF - PISA II-trial

Perianal fistulas in Crohn's Disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Remicade
Product Name: Infliximab
Trade Name: Humira
Product Name: Adalimumab

Academic Medical Center

NULL

Not Recruiting

Female: yes
Male: yes

140

Phase 4

Netherlands

NCT03884439
(ClinicalTrials.gov)

March 18, 2019

4/3/2019

Infliximab Biosimilar Pfizer Drug Use Investigation (Crohn's Disease or Ulcerative Colitis)

Infliximab BS for Intravenous Drip Infusion 100 mg Pfizer General Investigation (Crohn's Disease or Ulcerative Colitis)

Crohn's Disease;Ulcerative Colitis

Drug: Infliximab [infliximab biosimilar 3]

Pfizer

NULL

Recruiting

N/A

All

300

Japan

NCT04606017
(ClinicalTrials.gov)

January 1, 2019

25/10/2020

Effect of Vitamin D Combined With Calcium Supplementation on Infliximab Response in Patients With Crohn's Disease

Effect of Vitamin D Combined With Calcium Supplementation on Infliximab Response

Crohn Disease;Vitamin D Deficiency;Vitamin D Supplement

Drug: Caltrate Pill

Second Affiliated Hospital of Wenzhou Medical University

NULL

Completed

N/A

All

China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

ChiCTR1800019958

2018-12-16

2018-12-09

Combining infliximab with Hyperbaric Oxygen Therapy in Patients With Perianal Crohn's Disease

Crohn's disease

Case series:Combining infliximab treatmentwith Hyperbaric Oxygen Therapy;

Daping Hospital, Army Medical University (Third Military Medical University)

NULL

Recruiting

Both

Case series:60;

China

NCT03452501
(ClinicalTrials.gov)

August 26, 2018

26/2/2018

Safety and Effectiveness Study of Remsima® in the Treatment of Inflammatory Bowel Diseases Among Saudi Arabia Patients

An Observational, Prospective Cohort Study to Evaluate the Safety and Effectiveness of Remsima® in the Treatment of Inflammatory Bowel Disease Among Saudi Arabia Patients Diagnosed With Crohn's Disease, Ulcerative Colitis, or Fistulizing CD

Inflammatory Bowel Diseases;Crohn Disease;Fistulizing Crohn's Disease;Ulcerative Colitis

Drug: Infliximab

Hikma Pharmaceuticals LLC

NULL

Active, not recruiting

18 Years

N/A

All

150

Saudi Arabia

EUCTR2018-001546-33-GB
(EUCTR)

11/07/2018

14/05/2018

The effects of switching one drug, used to treat either Ulcerative Colitis (UC) or Crohn’s disease (CD) to another drug, also used to treat UC or Crohn’s disease

IBD Biosimilar to Biosimilar Infliximab Switching Study - iBiSS v1.0

Inflammatory Bowel Disease in particular Crohn's Disease and Ulcerative Colitis
MedDRA version: 20.1;Level: PT;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Flixabi
Product Name: Flixabi
INN or Proposed INN: Infliximab

University Southampton Hospital NHS Foundation Trust

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 4

United Kingdom

NCT03662919
(ClinicalTrials.gov)

July 2, 2018

6/9/2018

One-year Persistence to Treatment of Participants Receiving Flixabi or Imraldi: a French Cohort Study

PERFUSE - One-year Persistence to Treatment of Patients Receiving Flixabi or Imraldi: a French Cohort Study

Arthritis, Rheumatoid;Spondylitis, Ankylosing;Arthritis, Psoriatic;Crohn's Disease;Colitis, Ulcerative

Drug: Infliximab;Drug: Adalimumab

Biogen

NULL

Recruiting

6 Years

N/A

All

3000

France

EUCTR2014-002311-41-NL
(EUCTR)

25/05/2018

18/12/2017

A proSpective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheRapy and infliximab monothErapy in Crohn’s disease patients in sustained steroid-free remission on combination therapy.SPARE

Luminal Crohn’s disease patients with steroid free remission for at least 6 months and a combination therapy with infliximab and anti-metabolites for at least 8 months;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: REMICADE
Product Name: INFLIXIMAB
Trade Name: IMUREL
Product Name: azathioprine
Trade Name: METHOTREXATE
Product Name: METHOTREXATE
Trade Name: PURINETHOL
Product Name: MERCAPTOPURINE

GETAID

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

Phase 4

France;Belgium;Germany;Netherlands;United Kingdom;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03221166
(ClinicalTrials.gov)

February 27, 2018

5/7/2017

Thalidomide Versus Infliximab in New Onset Crohn's Disease With Poor Prognostic Factors

Thalidomide, a Novel Immunological Treatment to Modify the Natural History of Paediatric Crohn's Disease: a New Proposal From a Well-established Paediatric Research Network

Crohn Disease

Drug: Thalidomide;Drug: Infliximab

IRCCS Burlo Garofolo

Centro di Riferimento Oncologico - Aviano;Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Terminated

6 Years

17 Years

All

Phase 3

Italy

NCT03393247
(ClinicalTrials.gov)

June 1, 2017

8/7/2017

The Therapy Effect of Azathioprine Initial or 14 Weeks After Combined With Infliximab on CD

The Therapy Effect of Azathioprine Initial or 14 Weeks After Combined With Infliximab on Crohn Disease:a Randomized, Open Label, Single-center Cohort Study

Crohn Disease

Drug: infliximab and azathioprine combination at week 0;Drug: infliximab and azathioprine combination at week 14

Sixth Affiliated Hospital, Sun Yat-sen University

NULL

Unknown status

14 Years

60 Years

All

160

N/A

China

NCT02994836
(ClinicalTrials.gov)

April 21, 2017

24/10/2016

GIS-SUSANTI-TNF-2015 (Anti-TNF Discontinuation )

Anti-TNF Discontinuation in Patients With Inflammatory Bowel Disease: Multicentre, Prospective, Randomized Clinical Trial and Economic Evaluation

Crohn's Disease;Inflammatory Bowel Disease;Ulcerative Colitis

Biological: Anti-TNF: Infliximab (Infusion);Drug: Anti-TNF discontinuation: Physiological saline solution;Biological: Anti-TNF:Adalimumab (Subcutaneus)

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

NULL

Recruiting

18 Years

N/A

All

194

Phase 4

Spain

JPRN-UMIN000026330

2017/02/27

28/02/2017

Efficacy and safety of the biosimilar Infliximab in the patients with Crohn's disease

Efficacy and safety of the biosimilar Infliximab in the patients with Crohn's disease - Efficacy and safety of IFX-BS in CD patients

Crohn disease

Infliximab (5 or 10mg/kg, every 8 weeks, for 12 months)
Biosimilar Infliximab (5 or 10mg/kg, every 8 weeks, for 12 months)

University of Toyama

NULL

Complete: follow-up continuing

20years-old

Not applicable

Male and Female

Not selected

Japan

NCT04272788
(ClinicalTrials.gov)

January 24, 2017

11/2/2020

Association of Breg and Treg With the Clinical Effects of Infliximab in the Treatment of Patients With Crohn's Disease

Crohn Disease

Drug: Infliximab

Second Affiliated Hospital of Wenzhou Medical University

NULL

Completed

18 Years

N/A

All

China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT02998827
(ClinicalTrials.gov)

November 2016

24/11/2016

Thalidomide Results in Diminished Ovarian Reserve in Reproductive Age Female IBD Patients

Crohn Disease

Drug: Thalidomide;Drug: infliximab, azathioprine;Other: enteral nutrition

Sixth Affiliated Hospital, Sun Yat-sen University

NULL

Enrolling by invitation

N/A

Female

N/A

NULL

EUCTR2016-002061-54-IT
(EUCTR)

13/10/2016

15/11/2018

Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases.

Trade Name: REMSIMA - 100 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLANCONCINO (VETRO) - 1 FLACONCINO
Product Name: Remsima
Product Code: 42942019

UNIVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLI

NULL

Not Recruiting

Female: yes
Male: yes

250

Phase 4

Italy

EUCTR2014-004904-31-BE
(EUCTR)

21/09/2016

29/07/2016

Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA).;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Remsima (infliximab)

Mundipharma Pharmaceuticals B.V.

NULL

Not Recruiting

Female: yes
Male: yes

156

Phase 4

Belgium;Netherlands

EUCTR2016-001278-13-FI
(EUCTR)

08/06/2016

15/04/2016

Immunologic, genetic and bowel microbes as predictors of the treatment response for TNFalpha-blocking drugs in patients with Crohn’s disease or ulcerative colitis

Immunologic, genetic and microbiomic predictors of the treatment response for TNFalpha-blocking drugs – prospective follow-up cohort of patients with Crohn’s disease or ulcerative colitis - PROSIBD

Ulcerative colitis and Crohn's disease
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.0;Classification code 10013099;Term: Disease Crohns;Classification code 10058815;Term: Crohn's disease acute episode;Classification code 10057035;Term: Crohn's ileocolitis;Classification code 10011405;Term: Crohn's enteritis;Classification code 10011406;Term: Crohn's ileitis;Classification code 10076318;Term: Crohn's disease relapse;Level: PT;Classification code 10011401;Term: Crohn's disease;Classification code 10011402;Term: Crohn's disease (colon);Classification code 10075466;Term: Fistulising Crohn's disease;Classification code 10066678;Term: Acute ulcerative colitis;Classification code 10075465;Term: Fistulizing Crohn's disease;Classification code 10011400;Term: Crohn's colitis;System Organ Class: 10017947 - Gastrointe;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Remsima
Product Name: Remsima
INN or Proposed INN: INFLIXIMAB

Taina Sipponen

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 4

Finland

EUCTR2015-004618-10-BE
(EUCTR)

19/04/2016

20/11/2015

PhArmaCo-kinetics of InFliximab during treatment Induction

Study of the inter-individual variation of PhArmaCo-kinetics of InFliximab during treatment Induction in patients with Crohn’s disease and Ulcerative Colitis

Patients with Crohn disease or Ulcerative Colitis which need biotherapy (antibody against TNF-a);Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Remsima
INN or Proposed INN: INFLIXIMAB
Other descriptive name: Remsima
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Other descriptive name: Remicade
Trade Name: Inflectra
INN or Proposed INN: INFLIXIMAB
Other descriptive name: Inflectra

CUB- Hopital Erasme

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Belgium

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2012-002702-51-NO
(EUCTR)

07/03/2016

03/02/2016

Discontinuation of biologic therapy (infliximab) in patients with Crohn’s disease during sustained complete absence of disease activity: A Nordic multi-center, double blinded, randomized, placebo controlled study

Discontinuation of infliximab therapy in patients with Crohn’s disease during sustained complete remission: A Nordic multi-center, double blinded, randomized, placebo controlled study - STOP IT

Patients with Crohn's disease with absence of disease activity during biologic therapy (infliximab)
MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Remsima
Product Name: Remsima
Trade Name: Inflectra
Product Name: Inflectra
Product Code: EMEA/H/C/002778

Department of medical gastroenterology, Herlev Hospital

NULL

Not Recruiting

Female: yes
Male: yes

136

Phase 4

Finland;Denmark;Norway;Sweden

ChiCTR1800020305

2016-01-01

2018-12-23

A follow-up study for infliximab or combine with azathioprine in the treatment of Crohn's disease

Infliximab or combine with azathioprine in the treatment of Crohn's disease and relationship with ATI

crohn's disease;K50.900

Group 2:infliximab + azathioprine;Group 1:infliximab alone;

Department of Gastroenterology, Nanfang Hospital, Southern Medical University

NULL

Recruiting

Both

Group 2:41;Group 1:45;

China

EUCTR2014-002311-41-DE
(EUCTR)

25/11/2015

21/08/2015

Trade Name: REMICADE
Product Name: INFLIXIMAB
Trade Name: IMUREL
Product Name: azathioprine
Trade Name: METHOTREXATE
Product Name: METHOTREXATE
Trade Name: PURINETHOL
Product Name: MERCAPTOPURINE

GETAID

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

Phase 4

France;Australia;Netherlands;Germany;United Kingdom;Sweden

EUCTR2012-002702-51-FI
(EUCTR)

12/10/2015

30/09/2015

Discontinuation of infliximab therapy in patients with Crohn’s disease during sustained complete remission: A Nordic multi-center, double blinded, randomized, placebo controlled study - STOP IT

Patients with Crohn's disease with absence of disease activity during biologic therapy (infliximab)
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Remsima
Product Name: Remsima
INN or Proposed INN: INFLIXIMAB

Department of medical gastroenterology, Herlev Hospital

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Finland;Denmark;Norway;Sweden

NCT02177071
(ClinicalTrials.gov)

October 9, 2015

26/6/2014

A proSpective Randomized Controlled Trial comParing infliximAb-antimetabolites Combination Therapy to Anti-metabolites monotheRapy and Infliximab monothErapy in Crohn's Disease Patients in Sustained Steroid-free Remission on Combination Therapy

Crohn's Disease

Drug: INFLIXIMAB;Drug: AZATHIOPRINE;Drug: MERCAPTOPURINE;Drug: Methotrexate

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Saint-Louis Hospital, Paris, France

Active, not recruiting

18 Years

65 Years

All

211

Phase 4

Australia;Belgium;France

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT02847884
(ClinicalTrials.gov)

October 2015

30/11/2015

IDeaL Pilot Study - Infliximab Dose to Level: Pilot Study

Inflammatory Bowel Disease;Crohn's Disease

Biological: Infliximab

University of Alberta

The Hospital for Sick Children;The Children's Hospital of Winnipeg;Alberta Children's Hospital;Provincial Health Services Authority;Children's Hospital of Eastern Ontario

Completed

2 Years

17 Years

All

Canada

EUCTR2015-001954-14-NL
(EUCTR)

14/09/2015

25/08/2015

Efficacy and safety of Infliximab-biosimilar (Inflectra) compared to Infliximab-innovator (Remicade) in patients with inflammatory bowel disease in remission: the SIMILAR Trial”

SIMILAR Trial: Santeon InflixMab biosimILAr ResearchA randomized, controlled, double blind, phase 4 noninferiority trial to assess efficacy of Infliximab-biosimilar (Inflectra) compared to Infliximab-innovator (Remicade) in patients with inflammatory bowel disease in remission. - SIMILAR Trial: Santeon InflixMab biosimILAr Research

ulcerative colitis and Crohn’s disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Inflectra 100 mg powder for concentrate for solution for infusion
Product Name: Inflectra 100 mg powder for concentrate for solution for infusion
Trade Name: Remicade 100 mg powder for concentrate for solution for infusion.
Product Name: Remicade 100 mg powder for concentrate for solution for infusion.
Product Code: EMEA/H/C/000240

Santeon

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Netherlands

NCT02522169
(ClinicalTrials.gov)

September 2015

3/5/2015

TOPIT; Trough Level Optimized Pediatric Inflammatory Bowel Disease Therapy: A Multicenter Study Comparing Effectiveness of Trough Level Optimized Infliximab Maintenance Therapy With Standard Dosing Regimen of Pediatric Patients With Crohn's Disease

Verbessertes Therapiemanagement für pädiatrische CED-Patienten Mit Chronisch-entzündlicher Darmerkrankung: Eine Randomisierte Multizentrische Studie, Welche Die Effektivität Einer Talspiegel-gesteuerten Infliximab-Erhaltungsphase Mit Dem herkömmlichen Dosierungsregime Vergleicht Trough Level Optimized Pediatric Inflammatory Bowel Disease Therapy: A Randomized Multicenter Study Comparing Effectiveness of Trough Level Optimized Infliximab Maintenance Therapy With Standard Dosing Regimen of Pediatric Patients With Crohn's Disease

Pediatric Crohns Disease

Drug: Infliximab

Klinikum Westbrandenburg GmbH

NULL

Not yet recruiting

6 Years

17 Years

Both

120

N/A

NULL

EUCTR2014-002311-41-SE
(EUCTR)

21/08/2015

01/07/2015

A prospective randomized controlled study comparing continuing treatment with an anti-TNF antibody (infliximab) and an antimetabolite to contiuing with a single agent, either with the anti-TNF antibody or the anti-metabolite in Crohn’s disease in patients without clinical sympthoms and without steroids on combination therapy

Crohn´s disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Imurel 25 mg
Product Name: Imurel
INN or Proposed INN: AZATHIOPRINE
Other descriptive name: AZATHIOPRINE
Trade Name: Puri-Nethol 50 mg
Product Name: Puri-Nethol
INN or Proposed INN: MERCAPTOPURINE
Trade Name: Metoject
Product Name: Metotrexat
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE DISODIUM
Trade Name: Remsima
Product Name: Remsima
INN or Proposed INN: INFLIXIMAB

GETAID

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

225

Phase 4

France;Netherlands;Germany;United Kingdom;Sweden

EUCTR2012-002702-51-SE
(EUCTR)

10/08/2015

10/06/2015

Discontinuation of infliximab therapy in patients with Crohn’s disease during sustained complete remission: A Nordic multi-center, double blinded, randomized, placebo controlled study - STOP IT

Patients with Crohn's disease with absence of disease activity during biologic therapy (infliximab)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Remsima
Product Name: Remsima

Department of medical gastroenterology S, Odense University Hospital

NULL

Not Recruiting

Female: yes
Male: yes

136

Phase 4

Finland;Denmark;Norway;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT02452151
(ClinicalTrials.gov)

August 2015

20/5/2015

Efficacy and Safety of Infliximab-biosimilar (Inflectra) Compared to Infliximab-innovator (Remicade) in Patients With Inflammatory Bowel Disease in Remission: the SIMILAR Trial

Santeon InflixMab biosimILAr Research A Randomized, Controlled, Double Blind, Phase 4 Noninferiority Trial to Assess Efficacy of Infliximab-biosimilar (Inflectra) Compared to Infliximab-innovator (Remicade) in Patients With Inflammatory Bowel Disease in Remission.

Colitis, Ulcerative;Crohn's Disease

Drug: Infliximab-Biosimilar;Drug: Infliximab-Innovator

Onze Lieve Vrouwe Gasthuis

Santeon

Not yet recruiting

18 Years

N/A

Both

300

Phase 4

NULL

EUCTR2014-002311-41-GB
(EUCTR)

14/07/2015

30/06/2015

A prospective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheraPy and infliximab monothErapy in Crohn's disease patients in sustained steroid-free remission on combination therapy

Luminal Crohn's disease patients in steroid free remission for at least 6 months and on combination therapy with infliximab and antimetabolites for at least 1 year
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

Trade Name: Remicade
Product Name: INFLIXIMAB
Trade Name: Imuran
Product Name: Azathioprine
Trade Name: Methotrexate
Product Name: Methotrexate
Trade Name: Mercaptopurine
Product Name: Mercaptopurine

University of Edinburgh

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

France;Belgium;Germany;United Kingdom;Sweden

NCT02269358
(ClinicalTrials.gov)

July 2015

30/9/2014

Salvage Therapy With High/Low Methotrexate for Loss of Response to Infliximab Dose Escalation

Phase 4, Open Lable Non Randomized un Controlled Study. Salvage Therapy With High/Low Methotrexate for Loss of Response to Infliximab Dose Escalation

Crohn's Disease

Drug: METHOTREXATE

Prof. Arie Levine

NULL

Completed

8 Years

18 Years

All

Phase 4

Israel

EUCTR2014-004904-31-NL
(EUCTR)

19/05/2015

26/01/2015

Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA).;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Remsima (infliximab)

Mundipharma Pharmaceuticals B.V.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Netherlands

NCT02413047
(ClinicalTrials.gov)

May 2015

6/3/2015

Evaluate if Response to Infliximab or Adalimumab May be Regained With an Immunomodulator

A Pilot Study to Evaluate if Response to Infliximab or Adalimumab May be Regained With the Addition of an Immunomodulator

Inflammatory Bowel Disease;Ulcerative Colitis;Crohn's Disease

Drug: Azathioprine;Drug: 6 mercaptopurine;Drug: Methotrexate

Indiana University

NULL

Terminated

18 Years

80 Years

All

N/A

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT02539368
(ClinicalTrials.gov)

April 22, 2015

22/7/2015

Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Inflammatory Bowel Disease

POST-MARKETING OBSERVATIONAL COHORT STUDY OF PATIENTS WITH INFLAMMATORY BOWEL DISEASE (IBD) TREATED WITH CT-P13 IN USUAL CLINICAL PRACTICE (CONNECT-IBD)

Inflammatory Bowel Diseases;Ulcerative Colitis;Crohn's Disease

Drug: CT-P13;Drug: Remicade

Pfizer

Hospira, now a wholly owned subsidiary of Pfizer

Completed

18 Years

N/A

All

2565

Belgium;Czechia;Finland;France;Germany;Greece;Hungary;Italy;Netherlands;Portugal;Slovakia;Spain;United Kingdom;Czech Republic;Ireland

EUCTR2014-005702-37-NL
(EUCTR)

08/04/2015

12/02/2015

Early infliximab use in kids with Crohn's disease (TISKids)

Top-Down Infliximab Study in Kids with Crohn's disease (TISKids) - Top-down Infliximab in Kids with Crohn's disease (TISKids)

Crohn's disease;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Inflectra
INN or Proposed INN: INFLIXIMAB
Other descriptive name: Inflectra

Erasmus Medical Center

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

100

Netherlands

NCT02517684
(ClinicalTrials.gov)

April 2015

1/7/2015

Top-down Infliximab Study in Kids With Crohn's Disease

Crohn's Disease

Drug: Infliximab;Drug: Prednisolone;Other: Exclusive enteral nutrition;Drug: Azathioprine

Erasmus Medical Center

ZonMw: The Netherlands Organisation for Health Research and Development;Hospira, now a wholly owned subsidiary of Pfizer

Active, not recruiting

3 Years

17 Years

All

100

Phase 4

Belgium;Finland;Netherlands;Denmark;Italy;Poland

NCT02453607
(ClinicalTrials.gov)

November 17, 2014

21/5/2015

The Impact of 6MP Metabolite Levels on Infliximab Pharmacokinetics and Anti-infliximab Antibodies in Crohn's Disease

Inflammatory Bowel Disease;Crohn's Disease

Drug: Infliximab;Drug: thiopurine

Ernest Seidman

University of Toronto;University of Calgary;University of Alberta

Recruiting

18 Years

70 Years

All

225

N/A

Canada

EUCTR2013-004497-10-RO
(EUCTR)

31/10/2014

02/06/2014

Demonstrating the non-inferiority in efficacy and safety of CT-P13 compared to Remicade in patients with active Crohn's Disease.

A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess the Safety of CT-P13 Compared to Remicade in Patients With Active Crohn’s Disease

Active Crohn's Disease
MedDRA version: 17.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: REMSIMA
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: REMICADE
INN or Proposed INN: INFLIXIMAB

Celltrion, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

214

Phase 3

United States;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Denmark;Netherlands;Germany;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT02148640
(ClinicalTrials.gov)

October 2014

23/5/2014

The NOR-SWITCH Study

Rheumatoid Arthritis;Spondyloarthritis;Psoriatic Arthritis;Ulcerative Colitis;Crohn's Disease;Psoriasis Chronic

Drug: Innovator infliximab;Drug: Biosimilar infliximab

Diakonhjemmet Hospital

South-Eastern Norway Regional Health Authority

Completed

18 Years

N/A

All

482

Phase 4

Norway

EUCTR2013-004497-10-DK
(EUCTR)

11/09/2014

02/06/2014

Demonstrating the non-inferiority in efficacy and safety of CT-P13 compared to Remicade in patients with active Crohn's Disease.

A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess the Safety of CT-P13 Compared to Remicade in Patients With Active Crohn’s Disease

Active Crohn's Disease
MedDRA version: 18.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: REMSIMA
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: REMICADE
INN or Proposed INN: INFLIXIMAB

Celltrion, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

214

Phase 3

United States;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Denmark;Netherlands;Germany;Korea, Republic of

NCT02332356
(ClinicalTrials.gov)

September 2014

4/1/2015

Therapeutic Optimization Study Based on MR Enterocolonography in Patients With Crohn's Disease

Crohn Disease

Drug: azathioprine or adalimumab and infliximab

Tokyo Medical and Dental University

NULL

Recruiting

16 Years

65 Years

All

100

Phase 3

Japan

EUCTR2013-005629-21-HU
(EUCTR)

14/08/2014

11/06/2014

Diagnostic use of 99mTecnetium labeled infliximab in Crohn’s disease

Crohn’s disease
MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Remicade
Product Name: Infliximab (Remicade): 100 mg of lyophilized infliximab
INN or Proposed INN: INFLIXIMAB

First Department of Medicine, University of Szeged

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Hungary

EUCTR2014-002056-40-NO
(EUCTR)

12/08/2014

13/06/2014

A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SWITCHING FROM INNOVATOR INFLIXIMAB TO BIOSIMILAR INFLIXIMAB COMPARED WITH CONTINUED TREATMENT WITH INNOVATOR INFLIXIMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS, SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, ULCERATIVE COLITIS, CROHN’S DISEASEAND CHRONIC PLAQUE PSORIASISTHE NOR-SWITCH STUDY - NOR_SWITCH

Trade Name: Remicade 100 mg pulver til konsentrat til infusjonsvæske, oppløsning
Trade Name: Remsima 100 mg pulver til konsentrat til infusjonsvæske, oppløsning

Diakonhjemmet Hospital AS

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Norway

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2014-002311-41-FR
(EUCTR)

12/08/2014

22/06/2015

Luminal Crohn’s disease patients with steroid free remission for at least 6 months and a combination therapy with infliximab and anti-metabolites for at least 1 year;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

Trade Name: REMICADE
Product Name: INFLIXIMAB
Trade Name: IMUREL
Product Name: azathioprine
Trade Name: METHOTREXATE
Product Name: METHOTREXATE
Trade Name: PURINETHOL
Product Name: MERCAPTOPURINE

GETAID

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

France;United Kingdom;Sweden

EUCTR2013-004497-10-NL
(EUCTR)

06/08/2014

03/06/2014

Demonstrating the non-inferiority in efficacy and safety of CT-P13 compared to Remicade in patients with active Crohn's Disease.

A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess the Safety of CT-P13 Compared to Remicade in Patients With Active Crohn’s Disease

Active Crohn's Disease
MedDRA version: 19.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: REMSIMA
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: REMICADE
INN or Proposed INN: INFLIXIMAB

Celltrion, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

214

Phase 3

United States;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Denmark;Netherlands;Germany;Korea, Republic of

JPRN-UMIN000014006

2014/08/01

31/07/2014

Exploratory study of relation between efficacy and serum infliximab level, and predictors of response to infliximab dose escalation in patients with crohn's disease

Crohn's disease

dose escalation of infliximab

IBD Center, Sapporo Kosei General Hospital

NULL

Recruiting

18years-old

Not applicable

Male and Female

Not selected

Japan

EUCTR2013-004497-10-IT
(EUCTR)

01/08/2014

27/05/2014

Demonstrating the non-inferiority in efficacy and safety of CT-P13 compared to Remicade in patients with active Crohn's Disease.

A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess the Safety of CT-P13 Compared to Remicade in Patients With Active Crohn’s Disease

Trade Name: REMSIMA
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: REMICADE
INN or Proposed INN: INFLIXIMAB

Celltrion, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

214

Phase 3

United States;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Denmark;Netherlands;Germany;Korea, Republic of

EUCTR2013-004497-10-ES
(EUCTR)

25/07/2014

27/05/2014

Demonstrating the non-inferiority in efficacy and safety of CT-P13 compared to Remicade in patients with active Crohn's Disease.

A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess the Safety of CT-P13 Compared to Remicade in Patients With Active Crohn´s Disease

Trade Name: REMSIMA
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: REMICADE
INN or Proposed INN: INFLIXIMAB

Celltrion, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

214

Phase 3

United States;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Denmark;Netherlands;Germany;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2013-004497-10-BE
(EUCTR)

16/07/2014

12/05/2014

Demonstrating the non-inferiority in efficacy and safety of CT-P13 compared to Remicade in patients with active Crohn's Disease.

A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess the Safety of CT-P13 Compared to Remicade in Patients With Active Crohn’s Disease

Trade Name: REMSIMA
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: REMICADE
INN or Proposed INN: INFLIXIMAB

Celltrion, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

214

Phase 3

United States;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Denmark;Netherlands;Germany;Korea, Republic of

EUCTR2013-004497-10-HU
(EUCTR)

02/07/2014

22/05/2014

Demonstrating the non-inferiority in efficacy and safety of CT-P13 compared to Remicade in patients with active Crohn's Disease.

A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess the Safety of CT-P13 Compared to Remicade in Patients With Active Crohn’s Disease

Active Crohn's Disease
MedDRA version: 17.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: REMSIMA
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: REMICADE
INN or Proposed INN: INFLIXIMAB

Celltrion, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

214

Phase 3

United States;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Denmark;Netherlands;Germany;Korea, Republic of

EUCTR2013-001029-17-NL
(EUCTR)

01/04/2014

17/05/2013

Dose reduction of infliximab in Crohn’s disease, based on serum infliximab concentration

Efficacy and safety of trough level-based dose reduction during infliximab maintenance treatment in Crohn’s disease - REDIX

Crohn's disease
MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Remicade
Product Name: Infliximab

Academic Medical Center

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Netherlands

NCT01960426
(ClinicalTrials.gov)

April 2014

25/9/2013

Evaluation of Health Costs and Resource Utilization

A Randomized Evaluation of Health Costs and Resource Utilization Comparing Testing-Based Therapy to Empiric Dose Intensification for the Management of Inflammatory Bowel Disease.

Ulcerative Colitis;Crohn's Disease

Other: Measurement of drug (Adalimumab/Infliximab);Other: Intensify treatment with the existing drug

University of Western Ontario, Canada

Prometheus Laboratories

Terminated

18 Years

N/A

Both

Phase 4

United States

EUCTR2013-002651-15-NL
(EUCTR)

03/03/2014

18/09/2013

Adjusting the amount of medication (infliximab) in patients suffering from inflammatory bowel disease, using medication levels in blood.

Adjusting infliximab dose in IBD patients in remission, based on infliximab trough levels: the study on Infliximab Levels in IBD patients Steering Treatment, the ILIST pilot - ILIST-study

Crohns diseaseUlcerative colitis
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Remicade (infliximab)
Product Name: infliximab

Zon MW

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT02088944
(ClinicalTrials.gov)

March 2014

13/3/2014

a Single-center Registered Clinical Research of Chinese Patients With Moderate to Severe Crohn's Disease

Serological C Reactive Protein or Erythrocyte Sedimentation Rate

Drug: Infliximab

Nanfang Hospital of Southern Medical University

NULL

Not yet recruiting

18 Years

75 Years

Both

142

N/A

NULL

NCT02060318
(ClinicalTrials.gov)

February 11, 2014

10/2/2014

Regulatory T-cells and Crohn's Disease

The Effect of Infliximab Therapy in Crohn Patients on Regulatory T-cells

Crohn Disease

Drug: Infliximab

Hvidovre University Hospital

NULL

Completed

18 Years

N/A

All

N/A

Denmark

JPRN-UMIN000012790

2014/02/01

01/02/2014

Prospective Pilot study of Infliximab Dose-intensification determined by Capsule Endoscopic Evaluation of Small Intestinal Involvements in Patients with Crohn's Disease

Crohn's disease

dose intensification of 10mg/kg infliximab with additional treatment with thiopurines in case of aggravation at 6 months

Saitama Medical center

NULL

Complete: follow-up complete

20years-old

65years-old

Male and Female

Not selected

Japan

EUCTR2011-001332-29-AT
(EUCTR)

02/12/2013

07/11/2013

The degradation and elimination of Infliximab

Pharmacokinetics of Infliximab

Inflammatory bowel disease (Ulcerative Colitis, Crohn's disease)
MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
Other descriptive name: Remicade

Universitätsklinik für Innere Medizin III, Klinische Abteilung für Gastroenterologie und Hepatologie

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Austria

EUCTR2012-000645-13-BE
(EUCTR)

09/09/2013

16/07/2013

Infliximab as firsdt treatment instead of second line treatment in Crohns disease

Infliximab Top-down Study in Kids with Crohn’s disease - ITSKIDS

Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Remicade

ErasmusMC

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Belgium;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT02073526
(ClinicalTrials.gov)

May 2013

9/1/2014

Anti-TNF-alpha Trough Level Measurements in Inflammatory Bowel Disease

Inflammatory Bowel Disease;Crohn's Disease;Ulcerative Colitis

Drug: Infliximab, adalimumab, certolizumab pegol

Oslo University Hospital

NULL

Completed

18 Years

N/A

Both

1230

N/A

Norway

JPRN-UMIN000010524

2013/03/29

17/04/2013

Optimization of adalimumab switch therapy for loss of response with infliximab in Crohn's disease-OASISstudy

Crohn's disease

Adalimubab is administered continuously starting with 160 mg, then 80 mg after 2 weeks and 40 mg from 2 weeks onwards.
Continous administration of azathioprine concomitantly with adalimubab at the initial dose of 160 mg, then 80 mg after 2 weeks and 40 mg from 2 weeks onwards. The target dose for azathioprine is 2.0-2.5mg/kg/day and the dose is increased at the discretion of the attending physician.

Tokyo Medical & Dental University Gastroenterology

NULL

Complete: follow-up complete

15years-old

Not applicable

Male and Female

Not selected

Japan

NCT01804166
(ClinicalTrials.gov)

March 21, 2013

1/2/2013

A Research Study to Bank Samples for Future Evaluation to Identify Biomarkers That Predispose Crohn's Disease and Ulcerative Colitis Patients to Develop Hepatosplenic T-Cell Lymphoma (HSTCL)

Hepatosplenic T-Cell Lymphoma

Drug: Infliximab;Drug: Golimumab

Janssen Scientific Affairs, LLC

NULL

Completed

N/A

All

Phase 4

United States

NCT01802593
(ClinicalTrials.gov)

February 2013

24/12/2012

Comparison of 2 Immunomodulator Withdrawal Schemes for Infliximab Monotherapy in Active Pediatric Crohn's Disease After Thiopurine Failure

Phase 4, Open Label Multicenter Randomized Controlled Trial. Comparison of 2 Immunomodulator Withdrawal Schemes for Infliximab Monotherapy in Active Pediatric Crohn's Disease After Immunomodulator Failure

Crohn's Disease

Drug: AZATHIOPRINE or METHOTREXATE

Prof. Arie Levine

NULL

Terminated

6 Years

18 Years

Both

Phase 4

Israel

NCT01880307
(ClinicalTrials.gov)

January 2013

7/6/2013

Infliximab Top-down in Pediatric Crohn

Infliximab Top-down Study in Kids With Crohn's Disease

Crohn's Disease

Drug: Azathioprine;Drug: Infliximab;Drug: Prednisolon

Erasmus Medical Center

University of Roma La Sapienza;University Hospital, Brussels

Terminated

3 Years

17 Years

Both

Phase 4

Italy;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT01752790
(ClinicalTrials.gov)

December 2012

12/12/2012

Efficacy and Safety of Top-down Therapy in Pediatric Crohn's Disease

Efficacy and Safety of Infliximab as First-line Therapy in Pediatric Crohn's Disease: a Randomized, Controlled, Open-label Trial

Pediatric Crohn's Disease

Drug: Top-down;Drug: Step-up

University of Roma La Sapienza

NULL

Withdrawn

6 Years

18 Years

Both

Phase 4

Italy

NCT01349920
(ClinicalTrials.gov)

November 28, 2012

5/5/2011

Biomarkers of Intestinal Mucosal Healing in Crohn's Disease (P08143)

An Open Label Study to Discover Biomarkers of Intestinal Mucosal Healing in Crohn's Disease (CD)

Crohn Disease

Drug: Infliximab

Merck Sharp & Dohme Corp.

NULL

Completed

18 Years

60 Years

All

Moldova, Republic of;United Kingdom

NCT01817426
(ClinicalTrials.gov)

November 2012

29/8/2012

Discontinuation of Infliximab Therapy in Patients With Crohn's Disease During Sustained Complete Remission

Discontinuation of Infliximab Therapy in Patients With Crohn's Disease During Sustained Complete Remission: A Multi-center, Double Blinded, Randomized, Placebo Controlled Study

Crohn Disease

Drug: Infliximab;Other: Placebo

Copenhagen University Hospital at Herlev

NULL

Recruiting

18 Years

N/A

Both

136

Phase 4

Denmark

EUCTR2012-000645-13-NL
(EUCTR)

17/10/2012

12/07/2012

Infliximab as first treatment instead of second line treatment in Crohns disease

Infliximab Top-down Study in Kids with Crohn’s disease - ITSKIDS

Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Remicade

ErasmusMC

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Belgium;Netherlands;Italy

EUCTR2011-006084-22-GB
(EUCTR)

04/10/2012

15/08/2012

Usefulness of the measurement of blood levels of infliximab and adalimumab in inflammatory bowel disease patients in predicting response to treatment

Utilising drug levels and anti-drug antibodies to predict response to treatment in patients with Inflammatory Bowel Disease - Trough levels of anti-TNF agents in inflammatory bowel disease

Inflammatory bowel disease
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Remicade
Product Name: Infliximab
INN or Proposed INN: Infliximab
Trade Name: Humira
Product Name: adalimumab
INN or Proposed INN: Adalimumab

Royal Liverpool University Hospital

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2012-002702-51-DK
(EUCTR)

24/09/2012

01/08/2012

Discontinuation of infliximab therapy in patients with Crohn’s disease during sustained complete remission: A Nordic multi-center, double blinded, randomized, placebo controlled study - STOP IT

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Remsima
Product Name: Remsima

Department of medical gastroenterology S, Odense University Hospital

NULL

Not Recruiting

Female: yes
Male: yes

136

Phase 4

Finland;Denmark;Norway;Sweden

JPRN-UMIN000015297

2012/09/19

01/10/2014

The feasibility study of accelated infliximab infusion from initial administration

The feasibility study of accelated infliximab infusion from initial administration - The feasibility study of accelated infliximab infusion from initial administration

patient in whom infliximab is indicated(rheumatoid arthritis, Crohn's disease, Ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis)

Chiba University Hospital

NULL

Recruiting

20years-old

70years-old

Male and Female

Phase 2

Japan

EUCTR2011-003038-14-NL
(EUCTR)

21/06/2012

31/05/2012

A RANDOMIZED CONTROLLED TRIAL INVESTIGATING TAILORED TREATMENT WITH INFLIXIMAB FOR ACTIVE LUMINAL CROHN'S DISEASE

A RANDOMIZED CONTROLLED TRIAL INVESTIGATING TAILORED TREATMENT WITH INFLIXIMAB FOR ACTIVE LUMINAL CROHN'S DISEASE - TAILORIX

Luminal active Crohn's Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

Trade Name: INFLIXIMAB
Product Name: INFLIXIMAB
INN or Proposed INN: INFLIXIMAB

GETAID

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

120

Netherlands

JPRN-UMIN000007806

2012/06/01

01/05/2012

The feasibility study of accelated infliximab infusion during maintenance phase

patient in whom infliximab is indicated(rheumatoid arthritis, Crohn's disease, Ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis)

Chiba University Hospital

NULL

Complete: follow-up complete

Not applicable

Male and Female

Phase 2

Japan

NCT01442025
(ClinicalTrials.gov)

June 2012

20/9/2011

Study Investigating Tailored Treatment With Infliximab for Active Crohn's Disease

A Randomized Controlled Trial Investigating Tailored Treatment With Infliximab for Active Luminal Crohn's Disease

Crohn's Disease

Drug: Infliximab

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

NULL

Completed

18 Years

N/A

Both

121

Phase 4

France

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT01181765
(ClinicalTrials.gov)

June 2012

12/8/2010

The Efficacy of Open Label Infliximab for the Induction and Maintenance of Mucosal Healing in Small Bowel Crohn's Disease Assessed Through Wireless Camera Endoscopy

The Efficacy of Open Label Infliximab for the Induction and Maintenance of Mucosal Healing in Small Bowel Crohn's Disease Assessed Through Wireless Camera Endoscopy (the ICE Study)

Crohn's Disease

Biological: Infliximab 5 mg/kg body weight infused over 2 hours

Janssen Inc.

NULL

Completed

18 Years

N/A

Both

Phase 4

Canada

JPRN-UMIN000008043

2012/05/01

28/05/2012

The influence of medication for Crohn's disease on serological response to the influenza vaccination

The influence of medication for Crohn's disease on serological response to the influenza vaccination - Influence of Crohn's disease medication on influenza vaccination

Crohn's disease

Influenza Vaccination to Crohn's disease patients treated with Infliximab

Influenza Vaccination to Crohn's disease patients treated with Elemental diet
Influenza Vaccination to patients with upper-alimentary tract disorders (Disease-control)

The Jikei University School of MedicineDivision of Gastroenterology and Hepatology

NULL

Complete: follow-up complete

16years-old

60years-old

Male and Female

150

Phase 4

Japan

EUCTR2011-003038-14-BE
(EUCTR)

30/03/2012

03/01/2012

A RANDOMIZED CONTROLLED TRIAL INVESTIGATING TAILORED TREATMENT WITH INFLIXIMAB FOR ACTIVE LUMINAL CROHN'S DISEASE

A RANDOMIZED CONTROLLED TRIAL INVESTIGATING TAILORED TREATMENT WITH INFLIXIMAB FOR ACTIVE LUMINAL CROHN'S DISEASE - TAILORIX

Trade Name: INFLIXIMAB
Product Name: INFLIXIMAB
INN or Proposed INN: INFLIXIMAB

GETAID

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

120

Belgium;Netherlands

JPRN-UMIN000007343

2012/02/01

21/02/2012

The study of the effectiveness of anti-TNF antibody maintenance treatment combined with elemental diet for Crohn's disease patients

The study of the effectiveness of anti-TNF antibody maintenance treatment combined with elemental diet for Crohn's disease patients - The study of the effectiveness of anti-TNF antibody maintenance treatment combined with elemental diet for Crohn's disease patients

Crohn's disease

Patients in monotherapy group receive; 1) intravenous infusion of infliximab (10mg/kg) at every 8 weeks (dose escalation of anti-TNF antibody), or 2) intravenous infusion of infliximab (5mg/kg) at week 0, 2, and 6 and then every 8 weeks, or subcutaneous injection of adalimumab at week 0 (160mg), 2 (80mg) and then every 2 weeks (40mg) (first time or switch of anti-TNF antibody).
Patients in combination therapy group take half the amount of their daily allowance of calories (900-1,200kcal) by elemental diet and the remaining half by usual unrestricted meals, in addition to above anti-TNF antibody therapy.

Tohoku University Graduate School of Medicine (Tohoku University Hospital)

NULL

Complete: follow-up complete

20years-old

Not applicable

Male and Female

Not applicable

Japan

100

JPRN-UMIN000006889

2012/01/01

01/01/2012

Evaluation of Concomitant Infliximab and Granulocyte/ Monocyte Adsorption Apheresis in Crohn's disease Patients who lose Response to 5mg/kg/dose Infliximab Therapy

Crohn's disease

Repeat 3 sets of the concomitant therapy with IFX and GMA. Each set is consisted from a single 5mg/kg/dose of infliximab infusion plus 3 times of weekly GMA at 5, 6, and 7 weeks after IFX infusion.
Repeat 3 infusions of the 10mg/kg/dose infliximab in 8 weeks interval.

Department of Lower Gastroenterology, Hyogo College of Medicine

NULL

Complete: follow-up complete

16years-old

75years-old

Male and Female

Phase 4

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

101

EUCTR2008-005237-30-SE
(EUCTR)

14/12/2011

16/08/2011

A Multicenter, Prospective, Long-term Registry of children with Crohn's Disease

A Multicenter, Prospective, Long-term Registry of Pediatric Patients with Crohn's Disease - DEVELOP

Pediatric patients with a confirmed diagnosis of CD aged 6 years to lessthan 17 years of age at the time of enrollment
MedDRA version: 14.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB

Janssen Biologics BV

NULL

Not Recruiting

Female: yes
Male: yes

4000

Hungary;Germany;United Kingdom;Netherlands;Belgium;France;Italy;United States;Sweden

102

NCT01438151
(ClinicalTrials.gov)

December 2011

20/9/2011

Understanding the Relationship Between Infliximab Levels to Clinical Response of Remicade in Crohn's Disease

Association of Serum Infliximab and Antibodies Toward Infliximab (ATI) to Clinical Outcomes in Crohn's Disease

Crohn's Disease

Drug: Remicade

Shradha Agarwal

Prometheus Laboratories

Terminated

7 Years

N/A

All

N/A

United States

103

JPRN-UMIN000006232

2011/10/01

01/09/2011

Evaluation of efficacy of high dose infliximab with azathiopurine add-on therapy for patients with Crohn's disease refractory to low dose infliximab

Crohn's disease

treatment with high dose infliximab and azathiopurine(6MP can be used in case of refractory patients to azatioupurine)
treatment with only high dose infliximab

Saitama Medical University

NULL

Complete: follow-up complete

15years-old

70years-old

Male and Female

Not selected

Japan

104

JPRN-UMIN000005689

2011/09/01

31/05/2011

GMA (Granulocyte and Monocyte Adsorption) early combined with azathioprine vs Infliximab plus azathioprine for induction of remission in active Crohn's disease : an open randomized trial

Crohn's disease

Patients in the combination therapy of GMA with azathioprine receive intensive GMA (twice per week, total 10 sessions) and oral azathioprine.
Patients in the combination therapy of Infliximab and azathioprine receive infusion of IFX (at week 0, 2, 6) and oral azathioprine.

Department of Gastroenterology and Hepatology, Kyoto University Hospital

NULL

Complete: follow-up complete

12years-old

75years-old

Male and Female

Not applicable

Japan

105

EUCTR2010-018431-18-CZ
(EUCTR)

08/08/2011

19/05/2011

A Multicenter Trial Comparing REMICADE (infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence

Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE® (infliximab) and Placebo in the Prevention of Recurrence in Crohn’s Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence - PREVENT

Crohn’s disease (CD)
MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Remicade
Product Name: REMICADE
INN or Proposed INN: INFLIXIMAB
Other descriptive name: n/a

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

290

Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

106

EUCTR2010-018431-18-HU
(EUCTR)

14/07/2011

13/05/2011

A Multicenter Trial Comparing REMICADE (infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence

Trade Name: Remicade
Product Name: REMICADE
INN or Proposed INN: INFLIXIMAB
Other descriptive name: n/a

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

290

Austria;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand

107

EUCTR2011-002061-38-BE
(EUCTR)

29/06/2011

08/06/2011

Treating patients with infliximab based on their trough levels

A randomised prospective trough level monitoring study with real-time therapeutic adaptations: Trough level Adapted infliXImab Treatment scheme (TAXIT). - TAXIT

2) Crohn's disease and ulcerative colitis
MedDRA version: 13.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 13.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Remicade
Product Name: Remicade
Product Code: Remicade
INN or Proposed INN: INFLIXIMAB

Katholieke Universiteit Leuven

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Belgium

108

JPRN-UMIN000005251

2011/06/01

01/06/2011

A prospective open-label study to investigate the efficacy and safety of methotrexate in Crohn's disease patients who lost response or showed intolerance to infliximab

Crohn's disease

Administration of oral methotrexate 15mg divided after breakfast and dinner weekly for 16 weeks.If remission(CDAI<150) cannot be obtained at week 8, the dose of methotrexate can be increased to 25mg weekly.

Department of Gastroenterology and Hepatology, Tokyo Medical and Dental University

NULL

Complete: follow-up complete

16years-old

Not applicable

Male and Female

Not selected

Japan

109

NCT01355614
(ClinicalTrials.gov)

June 2011

16/5/2011

A Phase II Efficacy Study in Fistulizing Crohn's Disease Patients

A Multi-center, Randomized, Double-blind, Active Controlled Study to Assess Efficacy, Safety and Tolerability of the Anti-IL13 Monoclonal Antibody QAX576 in the Treatment of Perianal Fistulas in Patients Suffering From Crohn's Disease

Crohn's Disease

Drug: QAX576;Drug: Infliximab

Novartis Pharmaceuticals

NULL

Completed

18 Years

N/A

All

Phase 2

Germany;Switzerland

110

NCT01346826
(ClinicalTrials.gov)

May 2011

2/5/2011

Safety of Accelerated Infliximab Infusions in Patients With Inflammatory Bowel Disease (IBD)

Safety of Accelerated Infliximab Infusions in Patients With Inflammatory Bowel Disease: A Prospective, Randomized, Double-Blind, Controlled Trial

Crohn's Disease;Ulcerative Colitis

Drug: Standard 2 hours-infusion;Drug: Accelerated 1 hour-infusion;Drug: Accelerated 30 minutes-infusion

Asan Medical Center

NULL

Completed

16 Years

80 Years

Both

145

Phase 4

Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

111

NCT01338740
(ClinicalTrials.gov)

April 2011

18/4/2011

Switching From Adalimumab to Infliximab

Prospective Study to Assess the Efficacy of Switching to Infliximab in Moderately to Severely Active Chrohn's Disease Patients With Primary Non-response or Loss of Response to Adalimumab

Crohn's Disease

Drug: Adalimumab and Infliximab

University Hospital, Ghent

Abbott

Recruiting

18 Years

75 Years

Both

N/A

Belgium

112

EUCTR2010-019973-13-DE
(EUCTR)

14/01/2011

30/09/2010

A Phase II Efficacy Study in Fistulizing Crohn's Disease Patients

A multi-center, randomized, double-blind, active controlled study to assess efficacy, safety and tolerability of the anti-IL13 monoclonal antibody QAX576 in the treatment of perianal fistulas in patients suffering from Crohn’s disease

Treatment of perianal fistulas in patients suffering from Crohn's Disease.
MedDRA version: 14.0;Level: PT;Classification code 10016717;Term: Fistula;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 14.0;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders

Product Code: QAX576
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB

Novartis Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Germany;Switzerland

113

EUCTR2010-018431-18-IT
(EUCTR)

03/12/2010

10/01/2011

Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE (infliximab) and Placebo in the Prevention of Recurrence in Crohn’s Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence - PREVENT

Crohn`s disease (DS)
MedDRA version: 9.1;Level: LLT;Classification code 10011401

Trade Name: REMICADE
INN or Proposed INN: INFLIXIMAB

CENTOCOR

NULL

Not Recruiting

Female: yes
Male: yes

290

France;Czech Republic;Hungary;Belgium;Austria;Netherlands;Germany;United Kingdom;Italy

114

NCT01266785
(ClinicalTrials.gov)

December 2010

23/12/2010

Infliximab, Regulatory T Cells, IL2 and Crohn's Disease

Analysis of Relationship Between Infliximab Treatment Response, Regulatory T Cells, and Interleukin-2 in Crohn's Disease

Crohn's Disease

Drug: Infliximab

Oregon Health and Science University

Centocor, Inc.

Withdrawn

18 Years

70 Years

All

N/A

United States

115

EUCTR2010-018431-18-BE
(EUCTR)

19/11/2010

28/07/2010

A Multicenter Trial Comparing REMICADE (infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence

Trade Name: Remicade
Product Name: REMICADE
INN or Proposed INN: INFLIXIMAB
Other descriptive name: n/a

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

290

Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Australia;Denmark;Netherlands;Germany;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

116

NCT01190839
(ClinicalTrials.gov)

November 2010

12/8/2010

A Multicenter Trial Comparing REMICADE (Infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease (CD) Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence

Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE (Infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection Who Are at Increased Risk of Recurrence

Crohn's Disease

Biological: Infliximab;Drug: Placebo

Janssen Biotech, Inc.

NULL

Terminated

18 Years

99 Years

All

297

Phase 3

United States;Australia;Austria;Belgium;Canada;Czech Republic;France;Germany;Hungary;Israel;Netherlands;New Zealand;Poland;United Kingdom;Denmark;Spain

117

EUCTR2010-018431-18-NL
(EUCTR)

28/10/2010

20/09/2010

A Multicenter Trial Comparing REMICADE (infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence

Trade Name: Remicade
Product Name: REMICADE
INN or Proposed INN: INFLIXIMAB
Other descriptive name: n/a

Janssen Biologics B.V.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

290

Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand

118

JPRN-UMIN000005761

2010/10/27

13/06/2011

The Study for Efficacy and Safety of Adalimumab for Crohn's Disease with Loss of Response to Infliximab

Crohn's Disease patient as following 1)or 2) 1)the patient who treated with IFX infusion of interval every 4-6 weeks. 2)the patient who could not keep to treat with IFX due to side effect or ineffectiveness.

Adalimumab (HUMIRA 40mg for SC Injection)

Inject SC 160mg on Day 1, then inject SC 80 mg on Day 15, and inject SC 40 mg every other week, beginning on Day 29.

Kenji Watanabe

NULL

Complete: follow-up complete

Not applicable

Male and Female

Not selected

Japan

119

EUCTR2010-018431-18-FR
(EUCTR)

15/09/2010

09/07/2010

Crohn’s disease (CD)
MedDRA version: 12.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Trade Name: Remicade
Product Name: REMICADE
INN or Proposed INN: INFLIXIMAB

Centocor BV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

290

Hungary;Czech Republic;United Kingdom;Germany;Netherlands;France;Italy;Austria

120

EUCTR2010-018431-18-DE
(EUCTR)

23/08/2010

24/06/2010

A Multicenter Trial Comparing REMICADE (infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence

Trade Name: Remicade
Product Name: REMICADE
INN or Proposed INN: INFLIXIMAB
Other descriptive name: n/a

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

290

Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Germany;Netherlands;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

121

EUCTR2010-018431-18-GB
(EUCTR)

16/08/2010

06/07/2010

A Multicenter Trial Comparing REMICADE (infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence

Crohn’s disease (CD)
MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

290

Phase 3

Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand

122

EUCTR2010-018431-18-AT
(EUCTR)

06/08/2010

05/07/2010

A Multicenter Trial Comparing REMICADE (infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence

Crohn’s disease (CD)
MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Remicade
Product Name: REMICADE
INN or Proposed INN: INFLIXIMAB
Other descriptive name: n/a

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

290

Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Germany;Netherlands;New Zealand

123

NCT00988832
(ClinicalTrials.gov)

February 2010

1/10/2009

An Audit of Patients With Crohn's Disease Treated With Infliximab (P06066)

A UK Retrospective Audit of Patients With Crohn's Disease Treated With Infliximab

Crohn's Disease

Biological: Infliximab

Merck Sharp & Dohme Corp.

NULL

Completed

18 Years

N/A

All

380

N/A

United Kingdom

124

NCT01548014
(ClinicalTrials.gov)

January 2010

17/2/2012

The Effect of a Probiotic Preparation (VSL#3) Plus Infliximab in Children With Crohn's Disease

Reduction in Frequency of Infliximab Administration From q 8 Weeks to q 12 Weeks in Children With Crohn's Disease Receiving Probiotic VSL#3 Supplementation: A Pilot Study

Crohn's Disease

Dietary Supplement: VSL#3

Samsung Medical Center

NULL

Recruiting

13 Years

17 Years

Both

Phase 3

Korea, Republic of

125

JPRN-UMIN000010293

2009/12/19

21/03/2013

Parallel-group, multicenter, comparative study on the usefulness of nutrition therapy for patients with Crohn's disease Infliximab maintenance therapy

Crohn's disease

Infliximab maintenance therapy for 48 weeks in, Racol daily nutritional interventions during the study period as a target intake of 800kcal per day, in the implementation group nutrition therapy is used in conjunction with a diet and Racol.
In the group of non-nutritional therapy is carried out aggressive nutritional intervention is not performed, and only the normal diet

Graduate School of Medical Sciences, Kyushu University

Oita Red Cross HospitalTakano Hospital

Recruiting

20years-old

Not applicable

Male and Female

Not applicable

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

126

EUCTR2008-005237-30-NL
(EUCTR)

01/12/2009

18/08/2009

A Multicenter, Prospective, Long-term Registry of children with Crohn's Disease or Ulcerative Colitis

A Multicenter, Prospective, Long-term Registry of Pediatric Patients with Crohn's Disease or Ulcerative Colitis - DEVELOP

Pediatric patients with a confirmed diagnosis of CD or UC .
MedDRA version: 18.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Other descriptive name: Remsima and Inflectra

Janssen Biologics B.V.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

6000

United States;Canada;Netherlands;Sweden

127

NCT01661257
(ClinicalTrials.gov)

October 2009

7/8/2012

Expression of TIM-3 and Correlation With Disease Activity in Pediatric Crohn's Disease With Anti TNF-a Therapy

Expression of T-cell Immunoglobulin- and Mucin-domain-containing Molecule 3 (TIM-3)and Correlation With Disease Activity in Pediatric Crohn's Disease With Anti TNF-a Therapy

Crohn's Disease

Drug: Infliximab

Samsung Medical Center

NULL

Completed

13 Years

17 Years

Both

Phase 3

Korea, Republic of

128

NCT02322008
(ClinicalTrials.gov)

September 2009

17/12/2014

Anti-TNF Therapy in Danish Patients With Inflammatory Bowel Diseases in Clinical Practice

Crohn's Disease;Ulcerative Colitis;Inflammatory Bowel Disease

Biological: infliximab and adalimumab

Regionshospitalet Viborg, Skive

NULL

Completed

18 Years

N/A

Both

1035

N/A

NULL

129

EUCTR2008-005688-32-CZ
(EUCTR)

02/07/2009

05/01/2009

Biological therapy in the prevention of Crohn`s disease recurrence after resection in ileocecal region.

Prevention of Crohn`s disease recurrence after surgery in ileocecal region by postoperative application of infliximab (four infusions).
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Univeristy Hospital Na Bulovce

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

Czech Republic

130

EUCTR2006-004784-58-GB
(EUCTR)

03/06/2009

30/04/2009

An Open Label, Prospective, Multi-Center Trial on the Effect of Anti-TNF Chimeric Monoclonal Antibody (Infliximab, Remicade) on Inflammatory and Fibrous Lesions in Patients with Intestinal Crohn's Diesease. ACTIF Trial. - Effect of Infliximab on MRI lesions in Crohn's - ACTIF study

Crohn's disease
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab

University of Leuven Hospitals

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

France;Belgium;Germany;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

131

NCT00851565
(ClinicalTrials.gov)

June 2009

24/2/2009

Use of Combined Measurements of Serum Infliximab and Anti-infliximab Antibodies in the Treatment of Patients With Crohns Disease Failing Infliximab Therapy

Crohn's Disease

Procedure: Measurement of serum infliximab and anti-infliximab antibodies;Procedure: Treatment according to current standards without knowledge of serum infliximab and anti-infliximab Ab status

Copenhagen University Hospital at Herlev

Aase and Ejnar Danielsens Foundation;Beckett Foundation;the Danish Biotechnology Program;Danish Colitis-Crohn Society;Danish Medical Association Research Fund;Frode V. Nyegaard and wife’s Foundation;Health Science Research Foundation of Region of Copenhagen;Herlev Hospital Research Council;Lundbeck Foundation;P. Carl Petersens Fund;Biomonitor A/S;Prometheus Inc.;The Danish Institute for Health Services Research

Active, not recruiting

18 Years

N/A

Both

120

Phase 4

Denmark

132

JPRN-UMIN000002604

2009/05/01

01/11/2009

Combined therapy of infliximab with surgery in maintenance of remission in Crohn's disease

Crohn's disease

Patients are randomly divided into two groups, groups treated with or without infliximab by staffs of Keio Clinical Research Center at 2 to 4 weeks after surgery.
Patients receive infliximab 5 mg/kg at 0, 2, 6 weeks, followed by every 8 weeks for 2 years. Alternatively, patients continue to receive infliximab with intervals of 8 weeks if they received infliximab within 8 weeks from the time point 0.
Patients without infliximab receive maintenance therapy without immunomodulators.

Clinical Research Group of inflammatory bowel disease in Japan

NULL

Complete: follow-up complete

18years-old

Not applicable

Male and Female

100

Phase 4

Japan

133

EUCTR2008-007519-34-SE
(EUCTR)

17/04/2009

02/03/2009

Feasibility of Accelerated infliximab infusions - Safety and Tolerability in patients wit IBD. FAST - FAST VERSION

This is a open label, prospective, multicenter trial in patients recieving one hour infusions of infliximab (i.e. Remicade)as part of their daily practice. Main objective: Is to assess the tolerability of Remicade with an infusionsrate of 30 minutes.Patients: eligible patients are those with intestinal fistulas Mb Crohn disease or Ulcerative colitis/IBD. or patietns with

Trade Name: Remicade

University of Leuven Hospitals, Division of Gastroenterology

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

Sweden

134

EUCTR2008-006484-36-IT
(EUCTR)

16/04/2009

24/04/2009

MULTICENTER COMPARATIVE STUDY BETWEEN NUTRITIONAL THERAPY ALONE ANDANTI-TNF-alpha MONOCLONAL ANTIBODY IN INDUCING AND MAINTAINING REMISSION INPEDIATRIC CROHN`S DISEASE: A RANDOMIZED CONTROLLED TRIAL - NUTRITION AND BIOLOGICS IN CROHN`S DISEASE

Moderate-to-severe active Crohn`sdisease.
MedDRA version: 9.1;Level: LLT;Classification code 10011398;Term: Crohn's

Trade Name: REMICADE
INN or Proposed INN: INFLIXIMAB

AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA

NULL

Not Recruiting

Female: yes
Male: yes

Italy

135

EUCTR2009-009926-94-DK
(EUCTR)

26/03/2009

25/02/2009

Use of combined measurements of serum infliximab and anti-infliximab antibodies in the treatment of patients with Crohns disease failing infliximab therapy

Patients with Crohns diseases failing treatment with infliximab
MedDRA version: 13.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders

Trade Name: Remicade
Trade Name: Humira

Department of medical gastroenterology, Herlev Hospital

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Denmark

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

136

NCT00805766
(ClinicalTrials.gov)

December 2008

9/12/2008

Efficacy and Safety of Increased Dose of TA-650 (Infliximab) in Patients With Crohn's Disease (CD)

Clinical Study to Assess the Efficacy and Safety of Increased Dose of TA-650 in Patients With Crohn's Disease (CD)

Crohn's Disease

Drug: TA-650

Mitsubishi Tanabe Pharma Corporation

NULL

Completed

16 Years

75 Years

All

Phase 3

Japan

137

NCT00752622
(ClinicalTrials.gov)

November 2008

12/9/2008

Treatment With Infliximab in a Medical Setting (Study P05587)

Optimization of Treatment With Infliximab in a Medical Setting

Crohn's Disease

Biological: Infliximab 5 mg/kg;Biological: Infliximab 5 mg/kg every 6 weeks;Biological: Infliximab 7 mg/kg every 8 weeks

Merck Sharp & Dohme Corp.

NULL

Terminated

18 Years

N/A

All

100

Phase 4

Canada

138

NCT01559142
(ClinicalTrials.gov)

November 2008

19/3/2012

Efficacy and Safety of Two Regimens of Maintenance Therapy in Children With Crohn Disease

Efficacy and Safety of Induction Therapy With Three Doses of Infliximab in Patients With Crohn Disease Aged 7-17 Years-multicenter Open Study. Efficacy and Safety of Two Regimens of Maintenance Therapy in Patients With Crohn Disease Aged 7-17 Years-multicenter Randomized Study

Crohn Disease

Drug: Infliximab with azathioprine (IIFX + AZA);Drug: Infliximab (IFX alone)

Children's Memorial Health Institute, Poland

NULL

Active, not recruiting

7 Years

17 Years

Both

100

Phase 3

Poland

139

EUCTR2008-004926-18-DE
(EUCTR)

30/10/2008

Comparison of the human TNF-alpha antibody adalimumab with infliximab in induction and maintenance of steroid-free remission in patients with moderate to severe Crohn’s disease - CHAMP

Moderate to severe Crohn’s disease

Trade Name: Humira
Trade Name: Remicade

IBD Center LMU Munich

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Germany

140

NCT00791557
(ClinicalTrials.gov)

October 2008

13/11/2008

Open Label Study for Adults With Pyoderma Gangrenosum and Inflammatory Bowel Disease

An Open Label Single Center Pilot Study Investigating the Clinical Response and Mechanism of Action of Infliximab in the Treatment of Adults With Inflammatory Bowel Disease Who Have Moderate to Severe Pyoderma Gangrenosum

Pyoderma Gangrenosum;Crohn's Disease;Ulcerative Colitis;Inflammatory Bowel Disease

Drug: Infliximab

University Hospitals Cleveland Medical Center

Centocor, Inc.

Completed

18 Years

75 Years

All

N/A

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

141

EUCTR2006-004784-58-FR
(EUCTR)

07/07/2008

24/06/2008

An open label, prospective, multicenter trial, on the effect of anti-TNF alpha Chimeric monoclonal antibody (Infliximab, Remicade) on the inflammatory and fibrous lesions in patients with intestinal Crohn's Disease.

Crohn's disease

Trade Name: Selective Immunosuppressive agents
Product Name: Remicade 100 mg
INN or Proposed INN: infliximab

CHRU de Lille

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

United Kingdom;Germany;Belgium;France

142

EUCTR2006-004784-58-DE
(EUCTR)

27/05/2008

11/03/2008

Effect of infliximab on inflammatory and fibrous lesions in patients with intestinal Crohn’s disease - ACTIF

Crohn's disease
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Trade Name: remicade
Product Name: remicade
INN or Proposed INN: INFLIXIMAB

University of Leuven

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

United Kingdom;Germany;Belgium;France

143

EUCTR2008-001131-35-NL
(EUCTR)

14/05/2008

29/05/2008

Azathioprine maintenance treatment versus Infliximab maintenance treatment in Crohn's disease patients in remission: a randomized multicenter trial - Azorix-trial

this study is designed as a multicenter radomized trial comparing azathioprine maintenance treatment to infliximab maintenance treatment in Crohn's disease patients that are in remission for at least 6 months while being treated with a combined therapy of infliximab and azathioprine for at least 6 months

Trade Name: Remicade
Product Name: Infliximab
Product Code: EU/1/99/116/003
Trade Name: Imuran
Product Name: Azathioprine
Product Code: RVG 05565

Academic Medical Center, department of Gastroenterology and hepatology

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Netherlands

144

EUCTR2008-001466-93-GB
(EUCTR)

30/04/2008

28/03/2008

Trial of adjuvant vitamin D with Infliximab in active Crohn's Disease (IBDVit2). - IBDVit2

Active Crohn's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Trade Name: Vigantol Oel
Product Name: Vigantol Oel TM

Imperial College London

NULL

Not Recruiting

Female: yes
Male: yes

United Kingdom

145

EUCTR2007-006692-37-GB
(EUCTR)

10/04/2008

25/01/2008

The Immunomodulatory Role of Vitamin D in Inflammatory Bowel Disease (IBDVit): IBDVit1 - Trial of Adjuvant Vitamin D with Corticosteroids in Active Crohn’s Disease; IBDVit2 - Trial of Adjuvant Vitamin D with Infliximab in Active Crohn's Disease; IBDVit3 - Trial of Adjuvant Vitamin D with standard maintenance therapy in preventing relapse of Inflammatory Bowel Disease. - IBDVit

IBDVit1 - Active Crohn's Disease IBDVit2 - Active Crohn's Disease IBDVit3 - Crohn's Disease in remission / Ulcerative Colitis in remission
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
MedDRA version: 9.1;Classification code 10045365;Term: Ulcerative colitis

Imperial College London

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 4

United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

146

EUCTR2006-004784-58-BE
(EUCTR)

22/06/2007

11/04/2007

Effect of infliximab on inflammatory and fibrous lesions in patients with intestinal Crohn’s disease - ACTIF

Crohn's disease
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Trade Name: remicade
Product Name: remicade
INN or Proposed INN: INFLIXIMAB

University of Leuven

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

United Kingdom;Germany;Belgium;France

147

JPRN-UMIN000004427

2007/06/01

01/11/2010

A Prospective Randomized Open Trial to Assess the Efficiency of Infliximab for Crohn's Patients after Intestinal Resection

Crohn's disease

Non-infliximab arm:
Conventional medicine is administered, excluding Infliximab, Azathioprine, and 6-Mercaptopurine, to subjects during the study period (for 60 months, maximum).

Infliximab arm:
Infliximab is administered to subjects during the study period (for 60 months, maximum) together with other conventional medications, such as 5-aminosalicylic acid. Infliximab is administered every 8 weeks to subjects during study period after the start of protocol treatment as a rule. Immunomodulators, such as Azathioprine and 6-Mercaptopurine, are not permitted during the trial.

Lower GI disease, Hyogo College of Medicine

NULL

Complete: follow-up complete

16years-old

65years-old

Male and Female

Phase 2;Phase 3

Japan

148

NCT00724529
(ClinicalTrials.gov)

June 2007

25/7/2008

Post Marketing Surveillance of Remicade

Post Marketing Surveillance of Remicade in Inflammatory Bowel Disease (IBD)

Crohn's Disease;Ankylosing Spondylitis

Biological: Infliximab

Janssen Korea, Ltd., Korea

NULL

Completed

N/A

Both

938

Korea, Republic of

149

NCT00606346
(ClinicalTrials.gov)

May 31, 2007

21/1/2008

A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients With Inflammatory Bowel Disease

Crohn's Disease;Ulcerative Colitis;Indeterminate Colitis;Inflammatory Bowel Diseases

Biological: Anti TNF therapy including infliximab;Drug: No Biologics

Janssen Biotech, Inc.

NULL

Active, not recruiting

1 Month

17 Years

All

4970

United States;Canada

150

NCT00307931
(ClinicalTrials.gov)

April 2007

24/3/2006

Certolizumab Pegol for Treatment of Adult Greek Patients With Moderate to Severe Crohn's Disease Who Failed Infliximab

Certolizumab Pegol in the Treatment of Adult Greek Patients With Moderate to Severe Crohn's Disease Who Have Been Previously Treated Successfully With Infliximab But Who Have Subsequently Lost Response or Developed Intolerance to Infliximab

Crohn's Disease

Biological: Certolizumab pegol

UCB Pharma

NULL

Terminated

18 Years

N/A

All

Phase 3

Greece

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

151

NCT00462072
(ClinicalTrials.gov)

March 2007

17/4/2007

Centocor Microarray Study of Patients

Microarray Analysis of Peripheral Blood and Tissues of Patients With Immune Mediated Inflammatory Diseases

Rheumatoid Arthritis;Psoriatic Arthritis;Psoriasis;Crohn's Disease

Drug: Infliximab

University of Rochester

Centocor, Inc.

Completed

12 Years

N/A

All

Phase 4

United States

152

EUCTR2006-006632-22-BE
(EUCTR)

26/01/2007

19/12/2006

Change from infliximab to adalimumab in patients with Crohn’s disease in remission on infliximab: a randomized comparative case control study. - Infliximab to adalimumab switch trial

Luminal Crohns Disease, moderate to severe, refractory to steroids and/or antimetabolitets and controlled with anti-TNF therapy
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Trade Name: HUMIRA
Trade Name: REMICADE

University of Leuven, Division of Gastroenterology

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Belgium

153

EUCTR2006-002027-16-GR
(EUCTR)

12/12/2006

05/09/2006

Certolizumab pegol 400 mg monthly in the treatment of adult Greek patients with moderate to severe Crohn’s Disease, who have been previously treated successfully with infliximab but who have subsequently lost the response or have developed intolerance to infliximab: an open-label, multi-center, single-cohort study to evaluate efficacy, safety and onset of action.

Certolizumab pegol in the treatment of adult Greek patients with moderate to severe Crohn’s Disease, who have been previously treated successfully with infliximab but who have subsequently lost the response or have developed intolerance to infliximab

Product Name: certolizumab pegol
Product Code: CDP870

UCB AE

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Greece

154

NCT00897312
(ClinicalTrials.gov)

October 2006

9/5/2009

Effect of Biological Therapy on Biomarkers in Patients With Untreated Hepatitis C, Metastatic Melanoma, or Crohn Disease

Title: Evaluation of Systemic IDO Levels After Various Immunotherapeutics

Melanoma

Biological: infliximab;Biological: pegylated interferon alfa;Biological: ticilimumab;Drug: ribavirin;Other: high performance liquid chromatography;Other: laboratory biomarker analysis

Vanderbilt-Ingram Cancer Center

National Cancer Institute (NCI)

Terminated

N/A

Both

N/A

NULL

155

EUCTR2005-004104-37-ES
(EUCTR)

28/07/2006

11/05/2006

A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a PEGylated Fab' fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab.

Patients with Crohn's Disease with prior loss of response or intolerance to infliximab
Classification code 10011401

Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3b

Germany;United Kingdom;Belgium;Spain;Italy;Austria;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

156

EUCTR2005-004104-37-DK
(EUCTR)

15/06/2006

04/05/2006

Patients with Crohn's Disease with prior loss of response or intolerance to infliximab
Classification code 10011401

Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB S.A.

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3b

Spain;Belgium;Austria;Denmark;Germany;Italy;United Kingdom;Sweden

157

EUCTR2005-004104-37-SE
(EUCTR)

08/06/2006

21/04/2006

Patients with Crohn's Disease with prior loss of response or intolerance to infliximab
Classification code 10011401

Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB S.A.

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3b

Germany;United Kingdom;Belgium;Spain;Italy;Austria;Sweden

158

NCT00338650
(ClinicalTrials.gov)

June 2006

19/6/2006

Treatment of the Human Anti-TNF Monoclonal Antibody Adalimumab in Moderate to Severe Crohn's Disease With Previous Exposure to Infliximab (CHOICE)

A Multi-Center, Open-Label Treatment Protocol of the Human Anti-TNF Monoclonal Antibody Adalimumab in Patients With Moderate to Severe Crohn's Disease With Previous Exposure to Infliximab

Crohn's Disease

Drug: adalimumab

Abbott

NULL

Completed

18 Years

75 Years

Both

1000

Phase 3

United States

159

EUCTR2005-004104-37-AT
(EUCTR)

24/05/2006

04/04/2006

Patients with Crohn's Disease with prior loss of response or intolerance to infliximab
Classification code 10011401

Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB S.A.

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3b

Germany;United Kingdom;Belgium;Spain;Italy;Austria;Sweden

160

EUCTR2005-004104-37-DE
(EUCTR)

19/05/2006

29/03/2006

Patients with Crohn's Disease with prior loss of response or intolerance to infliximab
Classification code 10011401

Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB Pharma S.A.

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3b

United Kingdom;Germany;Belgium;Spain;Italy;Austria;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

161

EUCTR2005-004104-37-GB
(EUCTR)

17/05/2006

17/03/2006

A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a pegylated Fab fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab.

Patients with Crohn's Disease with prior loss of response or intolerance to infliximab
Classification code 10011401

UCB S.A.

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3

Spain;Belgium;Denmark;Austria;Germany;Italy;United Kingdom;Sweden

162

NCT00308581
(ClinicalTrials.gov)

April 2006

28/3/2006

Certolizumab in Crohn's Disease Patients With Loss of Response or Intolerance to Infliximab

Phase IIIb Open-label Induction and Double-blind Comparison of 2 Maintenance Schedules Evaluating Clinical Benefit and Tolerability of Certolizumab Pegol in Crohn's Disease Patients With Prior Loss of Response or Intolerance to Infliximab

Crohn's Disease

Biological: Certolizumab pegol;Other: Placebo

UCB Pharma

NULL

Completed

18 Years

N/A

All

539

Phase 3

United States;Austria;Belgium;Canada;Denmark;France;Germany;Italy;Netherlands;Norway;Spain;Sweden;Switzerland;United Kingdom

163

EUCTR2005-004104-37-BE
(EUCTR)

23/03/2006

27/01/2006

A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a pegylated Fab fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab.

Patients with Crohn's Disease with prior loss of response or intolerance to infliximab
Classification code 10011401

Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB S.A.

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3b

Germany;United Kingdom;Belgium;Spain;Italy;Austria;Sweden

164

NCT00727298
(ClinicalTrials.gov)

February 2006

30/7/2008

Post Marketing Surveillance Study of Remicade in Patients With Chronic Inflammatory Diseases (P04840)

Post Marketing Surveillance Study of the Labeled Use of Remicade® (Infliximab) in Patients With Chronic Inflammatory Diseases

Arthritis, Rheumatoid;Spondylitis, Ankylosing;Arthritis, Psoriatic;Psoriasis;Crohn's Disease

Biological: Infliximab

Merck Sharp & Dohme Corp.

Centocor, Inc.

Completed

18 Years

N/A

All

4485

N/A

Germany

165

EUCTR2004-002815-10-DE
(EUCTR)

12/12/2005

25/04/2005

Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONIC

moderate to severe Crohn’s Disease
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Trade Name: Remicade
INN or Proposed INN: infliximab
Other descriptive name: Chimeric IgG1 monoclonal antibody
Trade Name: Imuran
INN or Proposed INN: azathioprine
Other descriptive name: 6-[(methyl-4-nitro-1H-imidazol-5-yl)thio]-1H-purine

Centocor B.V.

NULL

Not Recruiting

Female: yes
Male: yes

500

United Kingdom;Germany;Denmark;Spain;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

166

NCT00571337
(ClinicalTrials.gov)

December 2005

25/7/2007

Stop Infliximab in Patients With Crohn's Disease

Prospective Study of Predictive Factors of Sustained Remission of Crohn's Disease After Stopping Infliximab

Crohn Disease

Drug: Infliximab

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

NULL

Completed

18 Years

N/A

Both

126

Phase 3

Belgium;France

167

NCT00132899
(ClinicalTrials.gov)

December 2005

19/8/2005

COMMIT (Combination Of Maintenance Methotrexate-Infliximab Trial)

A Phase III Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Multi-Centre Study to Evaluate the Safety and Efficacy of Infliximab in Combination With Methotrexate for the Long-term Treatment of Crohn's Disease (CD)

Crohn's Disease

Drug: Methotrexate;Drug: Placebo

University of Western Ontario, Canada

Schering-Plough

Completed

18 Years

N/A

Both

128

Phase 3

Canada

168

NCT00252369
(ClinicalTrials.gov)

September 2005

10/11/2005

Treatment of Perianal Crohn's Disease, Combining Medical and Surgical Treatment.

Instillation of Fibrin Glue After Induction of Local Conditions Using Infliximab, in the Treatment of Perianal Crohn's Disease.

Crohn's Disease

Drug: Infliximab;Procedure: Instillation of fibrin glue

Sheba Medical Center

NULL

Terminated

18 Years

90 Years

Both

N/A

Israel

169

EUCTR2004-002815-10-GB
(EUCTR)

25/07/2005

26/05/2005

moderate to severe Crohn’s Disease
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Centocor B.V.

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 3

Spain;Denmark;Austria;Germany;United Kingdom;Sweden

170

EUCTR2004-002815-10-ES
(EUCTR)

18/07/2005

16/05/2006

moderate to severe Crohn’s Disease
MedDRA version: 7.1;Classification code 10011401

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: infliximab
Trade Name: Imuran
Product Name: Imuran
INN or Proposed INN: azathioprine
Other descriptive name: 6-[(methyl-4-nitro-1H-imidazol-5-yl)thio]-1H-purine

Centocor B.V.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

500

United Kingdom;Germany;Denmark;Spain;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

171

EUCTR2004-002815-10-DK
(EUCTR)

07/07/2005

10/07/2008

moderate to severe Crohn’s Disease
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Centocor B.V.

NULL

Not Recruiting

Female: yes
Male: yes

500

United Kingdom;Germany;Denmark;Spain;Sweden

172

EUCTR2004-002815-10-SE
(EUCTR)

24/05/2005

11/04/2005

moderate to severe Crohn’s Disease
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease

Centocor B.V.

NULL

Not Recruiting

Female: yes
Male: yes

500

United Kingdom;Germany;Denmark;Spain;Sweden

173

EUCTR2004-002815-10-AT
(EUCTR)

04/05/2005

30/03/2005

moderate to severe Crohn’s Disease
MedDRA version: 7.1;Classification code 10011401

Centocor B.V.

NULL

Not Recruiting

Female: yes
Male: yes

500

Spain;Denmark;Austria;Germany;United Kingdom;Sweden

174

NCT00705471
(ClinicalTrials.gov)

April 2005

23/6/2008

Impact of Infliximab in Fistulizing Crohn's Disease on Health Care Resources (Study P04204)(TERMINATED)

Infliximab Use in Fistulizing Crohn's Disease: Impact on Health Care Resources

Crohn Disease

Biological: Infliximab

Merck Sharp & Dohme Corp.

Centocor, Inc.

Terminated

18 Years

N/A

Both

N/A

NULL

175

NCT00094458
(ClinicalTrials.gov)

March 2005

19/10/2004

Trial Comparing Infliximab and Infliximab and Azathioprine in the Treatment of Patients With Crohn's Disease na?ve to Both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Chrohn's Disease: SONIC

Multicenter, Randomized, Double-Blind, Active Controlled Trial Comparing REMICADE? (Infliximab) and REMICADE Plus Azathioprine to Azathioprine in the Treatment of Patients With Crohn's Disease Naive to Both Immunomodulators and Biologic Therapy

Crohn Disease

Biological: infliximab infusion; AZA placebo caps;Other: infliximab (IFX) infusion; azathioprine (AZA) caps;Drug: infliximab (IFX) placebo infusion

Centocor Ortho Biotech Services, L.L.C.

Schering-Plough

Completed

21 Years

99 Years

All

508

Phase 3

United States;Austria;Belgium;Canada;Denmark;France;Germany;Greece;Israel;Netherlands;Norway;Portugal;Spain;Sweden;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

176

EUCTR2004-002934-20-BE
(EUCTR)

22/02/2005

08/07/2005

A Multi-Centre, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease who Have Lost Response or are Intolerant to Infliximab

Crohn's Disease

Trade Name: Humira
Product Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

Belgium

177

NCT00688636
(ClinicalTrials.gov)

January 2005

29/5/2008

Infliximab for the Prevention of Recurrent Crohn's Disease After Surgery

Crohn's Disease

Drug: infliximab;Drug: placebo

University of Pittsburgh

Centocor, Inc.

Completed

18 Years

72 Years

All

Phase 4

United States

178

NCT00724958
(ClinicalTrials.gov)

December 2004

25/7/2008

Program Extension of Real Life Dosing of Remicade in Austria for Crohn's Disease (Study P04052)(COMPLETED)

Real Life Dosing Regimen of Remicade in Austria in Crohn's Disease - Program Extension

Crohn's Disease

Biological: Infliximab

Merck Sharp & Dohme Corp.

Centocor, Inc.

Completed

N/A

All

348

N/A

Austria

179

NCT00105300
(ClinicalTrials.gov)

October 2004

11/3/2005

Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Moderate to Severe Crohn's Disease Who Have Lost Response or Are Intolerant to Infliximab

Crohn's Disease

Drug: Adalimumab

Abbott

NULL

Completed

18 Years

75 Years

Both

300

Phase 3

United States;Belgium;Canada;France

180

NCT00796250
(ClinicalTrials.gov)

November 1, 2003

21/11/2008

Efficacy of Infliximab in the Treatment of Patients Affected by Corticodependent Crohn's Disease (P02732)

Efficacy of Infliximab as Bridging Therapy in the Treatment of Patients Affected by Corticodependent Crohn's Disease Under Standard Treatment With Azathioprine

Crohn's Disease

Biological: Infliximab;Drug: AZA;Drug: Placebo Prednisolone;Drug: Prednisolone;Biological: Placebo Infliximab

Merck Sharp & Dohme Corp.

NULL

Terminated

18 Years

65 Years

All

Phase 3

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

181

NCT00207675
(ClinicalTrials.gov)

February 2003

13/9/2005

A Study of the Safety and Efficacy of Infliximab (Remicade) in Pediatric Patients With Crohn's Disease

A Randomized, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Anti-TNF a Chimeric Monoclonal Antibody (Infliximab, REMICADE) in Pediatric Subjects With Moderate to Severe CROHN'S Disease.

Crohn Disease

Drug: infliximab

Centocor, Inc.

Centocor BV

Completed

6 Years

17 Years

Both

112

Phase 3

NULL

182

NCT00818272
(ClinicalTrials.gov)

December 2002

6/1/2009

Remicade Safety Line (Crohn's Disease)(Study P03288)(COMPLETED)

Remicade Safety Line (Crohn's Disease)

Crohn's Disease

Biological: Remicade (infliximab)

Merck Sharp & Dohme Corp.

Centocor, Inc.

Completed

18 Years

N/A

All

148

N/A

Germany

183

NCT00055536
(ClinicalTrials.gov)

April 2002

4/3/2003

Safety and Efficacy of Natalizumab in Combination With Remicade in the Treatment of Crohn's Disease

A Phase II, Multi-Center, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, and Efficacy of Intravenous Antegren (Natalizumab) in Crohn's Disease Subjects Concurrently Receiving Remicade (Infliximab) and Not in Remission

Crohn's Disease

Drug: natalizumab

Biogen

Elan Pharmaceuticals

Completed

18 Years

N/A

Both

Phase 2

United States

184

NCT00261976
(ClinicalTrials.gov)

February 2002

2/12/2005

A Long-term Safety Study of Infliximab (Remicade)

Long-term Safety Follow-up of REMICADE (RESULTS)

Arthritis, Rheumatoid;Crohn Disease;Psoriasis

Drug: Infliximab (Remicade)

Centocor, Inc.

Centocor BV

Completed

N/A

Both

2971

United States;Argentina;Austria;Belgium;Canada;Denmark;Finland;France;Germany;Hungary;Ireland;Israel;Netherlands;Norway;Poland;Spain;Sweden;Switzerland;United Kingdom

185

NCT00554710
(ClinicalTrials.gov)

May 2001

6/11/2007

Top Down Versus Step Up Strategies in Crohn's Disease

The Ideal Management of Crohn's Disease: Top Down Versus Step Up Strategies. A Prospective Controlled Trial in the Benelux

Crohn's Disease

Drug: infliximab+azathioprine;Drug: methylprednisolone or budesonide

Belgian IBD Research Group

Centocor BV;Schering-Plough

Completed

16 Years

75 Years

Both

129

Phase 4

Belgium

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

186

NCT00207662
(ClinicalTrials.gov)

July 2000

13/9/2005

A Safety and Efficacy Study of Infliximab (Remicade) in Patients With Moderate to Severe Active Crohn's Disease

ACCENT I - A Randomized, Double-blind, Placebo-controlled Trial of Anti-TNFa Chimeric Monoclonal Antibody (Infliximab, Remicade) in the Long-term Treatment of Patients With Moderately to Severely Active Crohn's Disease

Crohn Disease

Drug: infliximab or placebo

Centocor, Inc.

NULL

Completed

18 Years

N/A

Both

580

Phase 3

NULL

187

NCT00207766
(ClinicalTrials.gov)

June 2000

13/9/2005

A Study of the Safety and Efficacy of Infliximab (Remicade) in Subjects With Fistulizing Crohn's Disease

ACCENT II - A Randomized, Double-blind, Placebo-controlled Trial of Anti-TNF Chimeric Monoclonal Antibody (Infliximab, Remicade) in the Long Term Treatment of Patients With Fistulizing CROHN'S Disease

Crohn Disease

Drug: infliximab or placebo

Centocor, Inc.

NULL

Completed

18 Years

N/A

Both

306

Phase 3

NULL

188

NCT00269841
(ClinicalTrials.gov)

May 1996

22/12/2005

An Efficacy and Safety Study of Anti-TNF Monoclonal Antibody in Patients With Fistulizing Crohn's Disease

A Placebo-Controlled, Repeated-Dose Study of Anti-TNF Chimeric Monoclonal Antibody (cA2) in the Treatment of Patients With Enterocutaneous Fistulae as a Complication of Crohn's Disease

Crohn Disease

Drug: Infliximab 10 mg/kg;Drug: Infliximab 5 mg/kg;Drug: Placebo

Centocor, Inc.

NULL

Completed

18 Years

65 Years

Both

Phase 3

NULL

189

NCT00269854
(ClinicalTrials.gov)

June 1995

22/12/2005

An Efficacy and Safety Study of Anti-TNF Monoclonal Antibody in Patients With Crohn's Disease

A Placebo-Controlled, Dose-Ranging Study Followed by a Placebo-Controlled, Repeated-Dose Extension of Anti-TNF Chimeric Monoclonal Antibody (cA2) in the Treatment of Patients With Active Crohn's Disease

Crohn Disease

Drug: Infliximab 5 mg/kg;Drug: Infliximab 10 mg/kg;Drug: Infliximab 20 mg/kg;Drug: Placebo

Centocor, Inc.

NULL

Completed

18 Years

65 Years

Both

108

Phase 2;Phase 3

NULL

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2020-001811-26-NL (EUCTR)	30/09/2020	08/07/2020	IBD under control with less medication	De-escalation of anti-TNF therapy in adolescents and young adults with IBD with tight faecal calprotectin and trough level monitoring - FREE-study	Crohn's disease, ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Flixabi INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra INN or Proposed INN: INFLIXIMAB Trade Name: Remsima INN or Proposed INN: INFLIXIMAB Trade Name: Zessly INN or Proposed INN: INFLIXIMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Amgevita INN or Proposed INN: ADALIMUMAB Trade Name: Hulio INN or Proposed INN: ADALIMUMAB	University Medical Center Groningen	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 4	Netherlands
2	NCT04205643 (ClinicalTrials.gov)	September 2, 2020	18/12/2019	CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Ulcerative Colitis	A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis	Biological: CT-P13 SC (Infliximab);Other: Placebo SC	Celltrion	NULL	Recruiting	18 Years	75 Years	All	615	Phase 3	Poland
3	NCT04331639 (ClinicalTrials.gov)	September 2020	23/3/2020	High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Biologic Therapy	Implementation of High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Infliximab or Vedolizumab	Inflammatory Bowel Disease;Crohn Disease;Ulcerative Colitis;Vitamin D Deficiency	Dietary Supplement: vitamin D3	Boston Children's Hospital	NULL	Not yet recruiting	5 Years	25 Years	All	50	Phase 2	NULL
4	EUCTR2019-004652-11-SI (EUCTR)	28/08/2020	31/08/2020	A Study of Etrolizumab-Based Induction Therapy Combinations Followed by Etrolizumab Maintenance Therapy in Patients with Moderate-To-Severe Ulcerative Colitis	RANDOMIZED, OPEN-LABEL PHASE 3B STUDY OF ETROLIZUMAB BASED INDUCTION THERAPY COMBINATIONS FOLLOWED BY ETROLIZUMAB MAINTENANCE THERAPY IN PATIENTS WITH MODERATE-TO-SEVERE ULCERATIVE COLITIS - Lantana	Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: RO5490261/F04-02 INN or Proposed INN: Etrolizumab Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223 Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: INFLIXIMAB Trade Name: Xeljanz INN or Proposed INN: TOFACITINIB Other descriptive name: TOFACITINIB Trade Name: Xeljanz INN or Proposed INN: TOFACITINIB Other descriptive name: TOFACITINIB Trade Name: Stelara INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: Stelara INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	372	Phase 3	Serbia;United States;Slovakia;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;Switzerland;France;Latvia;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Germany
5	EUCTR2019-003849-15-HR (EUCTR)	05/06/2020	20/11/2020	Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis	A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remsima Product Code: Remsima (CT-P13) INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB	Celltrion, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	615	Phase 3	United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Czechia;Turkey;Austria;Hungary;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	EUCTR2019-003849-15-ES (EUCTR)	12/05/2020	28/02/2020	Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis	A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remsima Product Code: Remsima (CT-P13) INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB	Celltrion, Inc.	NULL	Not Recruiting			Female: yes Male: yes	615	Phase 3	United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany
7	EUCTR2019-003849-15-BG (EUCTR)	03/04/2020	07/02/2020	Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis	A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remsima Product Code: Remsima (CT-P13) INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB	Celltrion, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	615	Phase 3	Serbia;Belarus;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;Italy;France;Czech Republic;Mexico;Poland;Croatia;Peru;South Africa;Bulgaria;Germany;Latvia;Moldova, Republic of
8	EUCTR2019-003849-15-GR (EUCTR)	03/04/2020	02/04/2020	Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis	A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remsima Product Code: Remsima (CT-P13) INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB	Celltrion, Inc.	NULL	Not Recruiting			Female: yes Male: yes	615	Phase 3	United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany
9	EUCTR2019-003849-15-FR (EUCTR)	03/04/2020	03/02/2020	Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis	A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remsima Product Code: Remsima (CT-P13) INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB	Celltrion, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	615	Phase 3	United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany
10	EUCTR2018-003524-36-IE (EUCTR)	25/03/2020	05/11/2019	Randomized, mulitcenter study to investigate how infliximab dosing calculated by a computer compares to the standard dosing during the induction of infliximab in patients with severe colitis ulcerosa.	Randomized, Multicenter Study to Investigate the Efficacy of Dashboard Driven Individualized Dosing of Infliximab Compared To Standard Dosing During the Induction in Patients with Acute Severe Ulcerative Colitis - TITRATE	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remicade Product Name: NA Product Code: NA INN or Proposed INN: INFLIXIMAB Trade Name: Metoject INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE DISODIUM Trade Name: Puri-Nethol INN or Proposed INN: MERCAPTOPURINE Trade Name: Remsima INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra INN or Proposed INN: INFLIXIMAB Trade Name: Flixabi INN or Proposed INN: INFLIXIMAB	UMC Amsterdam location AMC	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	124	Phase 4	Ireland;Netherlands
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
11	EUCTR2019-003849-15-AT (EUCTR)	20/03/2020	06/02/2020	Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis	A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remsima Product Code: Remsima (CT-P13) INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB	Celltrion, Inc.	NULL	Not Recruiting			Female: yes Male: yes	615	Phase 3	United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany
12	EUCTR2019-003068-39-NL (EUCTR)	20/11/2019	04/11/2019	In patients with inflammatory bowel disease (IBD) on infliximab (IFX) maintenance treatment, low trough levels of IFX suggest inefficacy of the drug and have consistently been shown to be protective of relapse following withdrawal of IFX. However, up to 30% of these patients will experience a relapse after IFX withdrawal. Pharmacokinetic parameters other than trough levels may predict relapse following drug withdrawal in IBD patients with undetectable IFX trough levels.	Withdrawal of Infliximab in patients with inflammatory bowel disease in remission guided by pharmacokinetics: WINK study - WINK study	Inflammatory Bowel Disease (IBD) Ulcerative colitis Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Infliximab Product Name: Infliximab INN or Proposed INN: INFLIXIMAB	UMC Utrecht	NULL	Not Recruiting			Female: yes Male: yes	30	Phase 4	Netherlands
13	NCT03885713 (ClinicalTrials.gov)	September 10, 2019	4/3/2019	Identification of Predictive Biomarkers for Response to Biologic Therapies in Inflammatory Bowel Disease	Identification of Predictive Biomarkers for Response to Biologic Therapies in Inflammatory Bowel Disease by Proteomic and Mass Cytometry Approaches	Inflammatory Bowel Diseases;Crohn Disease;Ulcerative Colitis	Biological: Infliximab or adalimumab or golimumab or vedolizumab or ustekinumab	Fundación de Investigación Biomédica - Hospital Universitario de La Princesa	NULL	Recruiting	18 Years	N/A	All	180	Phase 4	Spain
14	NCT03937609 (ClinicalTrials.gov)	September 4, 2019	30/4/2019	TITRATE (inducTIon for acuTe ulceRATivE Colitis)	Randomized, Multicenter Study to Investigate the Efficacy of Dashboard Driven Individualized Dosing of Infliximab Compared To Standard Dosing During the Induction in Patients With Acute Severe Ulcerative Colitis	Colitis, Ulcerative	Drug: Infliximab	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Pfizer	Recruiting	18 Years	N/A	All	120	Phase 4	Netherlands
15	EUCTR2018-003524-36-NL (EUCTR)	25/04/2019	19/11/2018	Randomized, mulitcenter study to investigate how infliximab dosing calculated by a computer compares to the standard dosing during the induction of infliximab in patients with severe colitis ulcerosa.	Randomized, Multicenter Study to Investigate the Efficacy of Dashboard Driven Individualized Dosing of Infliximab Compared To Standard Dosing During the Induction in Patients with Acute Severe Ulcerative Colitis - TITRATE	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		UMC Amsterdam location AMC	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	98	Phase 4	Netherlands
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
16	EUCTR2018-004587-61-NL (EUCTR)	23/04/2019	13/05/2019	Characterization of lipid changes in patients with ulcerative colitis treated with tofactinib or infliximab	Deep profiling of lipid changes in patients with active ulcerative colitis treated with either tofacitinib or infliximab - LIPID	Ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Erasmus Medical Center	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	40	Phase 4	Netherlands
17	NCT03884439 (ClinicalTrials.gov)	March 18, 2019	4/3/2019	Infliximab Biosimilar Pfizer Drug Use Investigation (Crohn's Disease or Ulcerative Colitis)	Infliximab BS for Intravenous Drip Infusion 100 mg Pfizer General Investigation (Crohn's Disease or Ulcerative Colitis)	Crohn's Disease;Ulcerative Colitis	Drug: Infliximab [infliximab biosimilar 3]	Pfizer	NULL	Recruiting	N/A	N/A	All	300		Japan
18	NCT03942861 (ClinicalTrials.gov)	February 21, 2019	25/4/2019	Sonographic Assessment in Severe Ulcerative Colitis Patients Admitted for Intravenous Corticosteroids and Eligible for Infliximab Rescue Therapy; a Prospective Clinician-blinded Observational Study Protocol.	Sonographic Assessment in Severe Ulcerative Colitis Patients Admitted for Intravenous Corticosteroids and Eligible for Infliximab Rescue Therapy; a Prospective Clinician-blinded Observational Study Protocol.	Ulcerative Colitis;Ultrasound Therapy; Complications	Drug: Solu-Medrol	Copenhagen University Hospital at Herlev	NULL	Recruiting	18 Years	70 Years	All	50		Denmark
19	EUCTR2017-004496-31-PL (EUCTR)	30/01/2019	06/12/2018	A Study of the Efficacy and Safety of Golimumab in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Remicade Product Name: Infliximab Product Code: CNTO312 INN or Proposed INN: INFLIXIMAB	Janssen Biologics BV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	125	Phase 3	United States;France;Taiwan;Spain;Brazil;Belgium;Poland;Israel;Netherlands;Italy;Korea, Republic of
20	NCT03679546 (ClinicalTrials.gov)	January 4, 2019	18/9/2018	EFFICACI : EFFicacy of Intravenous Infliximab Versus Vedolizumab After Failure of subCutaneous Anti-TNF in Patients With UlCerative Colitis	EFFICACI : EFFicacy of Intravenous Infliximab Versus Vedolizumab After Failure of subCutaneous Anti-TNF in Patients With UlCerative Colitis : A Double Blinded Randomized Clinical Trial	Ulcerative Colitis	Drug: Infliximab;Drug: Vedolizumab Injection	Rennes University Hospital	NULL	Recruiting	18 Years	75 Years	All	150	Phase 4	France
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
21	NCT03765450 (ClinicalTrials.gov)	December 21, 2018	4/12/2018	Pharmacokinetics of IFX and TNF Concentrations in Serum, Stool, and Colonic Mucosa in Acute Severe Ulcerative Colitis	Pharmacokinetics of Infliximab and Tumor Necrosis Factor Concentrations in Serum, Stool, and Colonic Mucosa in Acute Severe Ulcerative Colitis	Ulcerative Colitis	Drug: Infliximab	Robarts Clinical Trials Inc.	NULL	Recruiting	18 Years	N/A	All	30		United States;Canada
22	EUCTR2017-004496-31-BE (EUCTR)	07/11/2018	25/07/2018	A Study of the Efficacy and Safety of Golimumab in Pediatric Participantswith Moderately to Severely Active Ulcerative Colitis	A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFaMonoclonal Antibody, Administered Subcutaneously in PediatricParticipants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Remicade Product Name: Infliximab INN or Proposed INN: INFLIXIMAB	Janssen Biologics BV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	125	Phase 3	France;United States;Taiwan;Poland;Brazil;Spain;Belgium;Israel;Netherlands;Italy;Korea, Republic of
23	NCT03596645 (ClinicalTrials.gov)	October 29, 2018	13/7/2018	A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis	A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety, and Pharmacokinetics of Golimumab Treatment, a Human Anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis	Colitis, Ulcerative	Drug: Golimumab;Drug: Infliximab	Janssen Research & Development, LLC	NULL	Recruiting	2 Years	17 Years	All	125	Phase 3	United States;Belgium;Brazil;France;Israel;Italy;Korea, Republic of;Netherlands;Poland;Spain;Taiwan
24	EUCTR2017-004496-31-ES (EUCTR)	15/10/2018	28/08/2018	A Study of the Efficacy and Safety of Golimumab in Pediatric Participantswith Moderately to Severely Active Ulcerative Colitis	A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFaMonoclonal Antibody, Administered Subcutaneously in PediatricParticipants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Remicade Product Name: Infliximab INN or Proposed INN: INFLIXIMAB	Janssen Biologics BV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	125	Phase 3	France;United States;Taiwan;Poland;Brazil;Belgium;Spain;Israel;Netherlands;Italy;Korea, Republic of
25	EUCTR2018-002673-21-FR (EUCTR)	04/09/2018	06/07/2018	EFFICACI : EFFicacy of intravenous Infliximab versus vedolizumab after failure of subCutaneous Anti-TNF in patients with UlCerative colitis : A double blinded Randomized Clinical Trial.	EFFICACI : EFFicacy of intravenous Infliximab versus vedolizumab after failure of subCutaneous Anti-TNF in patients with UlCerative colitis : A double blinded Randomized Clinical Trial. - EFFICACI	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Trade Name: Remicade Product Name: infliximab INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Name: infliximab INN or Proposed INN: INFLIXIMAB Trade Name: Flixabi Product Name: infliximab INN or Proposed INN: INFLIXIMAB Trade Name: Remsima Product Name: infliximab INN or Proposed INN: INFLIXIMAB Trade Name: Entyvio Product Name: Vedolizumab Other descriptive name: VEDOLIZUMAB	Centre Hospitalier Universitaire de Rennes	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 4	France
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
26	NCT03452501 (ClinicalTrials.gov)	August 26, 2018	26/2/2018	Safety and Effectiveness Study of Remsima® in the Treatment of Inflammatory Bowel Diseases Among Saudi Arabia Patients	An Observational, Prospective Cohort Study to Evaluate the Safety and Effectiveness of Remsima® in the Treatment of Inflammatory Bowel Disease Among Saudi Arabia Patients Diagnosed With Crohn's Disease, Ulcerative Colitis, or Fistulizing CD	Inflammatory Bowel Diseases;Crohn Disease;Fistulizing Crohn's Disease;Ulcerative Colitis	Drug: Infliximab	Hikma Pharmaceuticals LLC	NULL	Active, not recruiting	18 Years	N/A	All	150		Saudi Arabia
27	EUCTR2017-002108-28-DE (EUCTR)	25/07/2018	27/03/2018	A study to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06687234/placebo as add-on therapy to infliximab in subjects with ulcerative colitis who are not in remission	A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06687234 AS ADD-ON THERAPY TO INFLIXIMAB IN ACTIVE ULCERATIVE COLITIS SUBJECTS WHO ARE NOT IN REMISSION (BUILD UC) - BUILD UC	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Dekavil Product Code: PF-06687234 INN or Proposed INN: PF-06687234 Other descriptive name: F8IL10	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	76	Phase 2	United States;Serbia;Saudi Arabia;Spain;Belgium;Australia;Israel;Germany;Italy;Korea, Republic of
28	EUCTR2018-001546-33-GB (EUCTR)	11/07/2018	14/05/2018	The effects of switching one drug, used to treat either Ulcerative Colitis (UC) or Crohn’s disease (CD) to another drug, also used to treat UC or Crohn’s disease	IBD Biosimilar to Biosimilar Infliximab Switching Study - iBiSS v1.0	Inflammatory Bowel Disease in particular Crohn's Disease and Ulcerative Colitis MedDRA version: 20.1;Level: PT;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Flixabi Product Name: Flixabi INN or Proposed INN: Infliximab	University Southampton Hospital NHS Foundation Trust	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 4	United Kingdom
29	NCT03209232 (ClinicalTrials.gov)	April 16, 2018	1/7/2017	Infliximab Accelerated Induction in Moderate to Severe Pediatric UC	Infliximab Accelerated Induction for Moderate to Severe Ulcerative Colitis in Children (INDUCE) Trial	Ulcerative Colitis	Drug: Infliximab	Schneider Children's Medical Center, Israel	NULL	Recruiting	6 Years	18 Years	All	84	N/A	Israel
30	EUCTR2017-002108-28-ES (EUCTR)	12/04/2018	20/04/2018	A study to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06687234/placebo as add-on therapy to infliximab in subjects with ulcerative colitis who are not in remission	A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06687234 AS ADD-ON THERAPY TO INFLIXIMAB IN ACTIVE ULCERATIVE COLITIS SUBJECTS WHO ARE NOT IN REMISSION (BUILD UC) - BUILD UC	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Dekavil Product Code: PF-06687234 INN or Proposed INN: Dekavil Other descriptive name: F8IL10	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	98	Phase 2	United States;Serbia;Saudi Arabia;Belgium;Spain;Australia;Israel;Germany;Italy;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
31	EUCTR2017-002108-28-BE (EUCTR)	30/03/2018	22/03/2018	A study to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06687234/placebo as add-on therapy to infliximab in subjects with ulcerative colitis who are not in remission	A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06687234 AS ADD-ON THERAPY TO INFLIXIMAB IN ACTIVE ULCERATIVE COLITIS SUBJECTS WHO ARE NOT IN REMISSION (BUILD UC) - BUILD UC	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	76	Phase 2	Serbia;United States;Saudi Arabia;Spain;Belgium;Australia;Israel;Germany;Italy;Korea, Republic of
32	NCT03269695 (ClinicalTrials.gov)	December 20, 2017	30/8/2017	Efficacy, Safety and Tolerability of PF-06687234 as Add-on Therapy to Infliximab in Active UC Subjects Not in Remission.	A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06687234 AS ADD-ON THERAPY TO INFLIXIMAB IN ACTIVE ULCERATIVE COLITIS SUBJECTS WHO ARE NOT IN REMISSION (BUILD UC)	Ulcerative Colitis	Drug: PF-06687234;Drug: Placebo	Pfizer	NULL	Active, not recruiting	18 Years	75 Years	All	20	Phase 2	United States;Australia;Belgium;Germany;Israel;Italy;Korea, Republic of;Saudi Arabia;Serbia;Turkey;Spain
33	JPRN-UMIN000027465	2017/05/29	24/05/2017	Efficacy and safety of the biosimilar Infliximab in the patients with ulcerative colitis	Efficacy and safety of the biosimilar Infliximab in the patients with ulcerative colitis - Efficacy and safety of IFX-BS in UC patients	ulcerative colitis	Infliximab (5mg/kg, every 8 weeks, for 12 months) Biosimilar Infliximab (5mg/kg, every 8 weeks, for 12 months)	University of Toyama	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	20	Not selected	Japan
34	NCT03151525 (ClinicalTrials.gov)	May 8, 2017	8/5/2017	Two Therapeutic Strategies for the Maintenance of Remission in Patients With Ulcerative Colitis	Comparison Between Two Therapeutic Strategies for the Maintenance of Clinical and Endoscopic Remission in Patients With Ulcerative Colitis Treated by Infliximab	Colitis, Ulcerative	Drug: Azathioprine;Drug: Infliximab	Istituto Clinico Humanitas	Agenzia Italiana del Farmaco	Recruiting	18 Years	65 Years	All	100	Phase 4	Italy
35	NCT02994836 (ClinicalTrials.gov)	April 21, 2017	24/10/2016	GIS-SUSANTI-TNF-2015 (Anti-TNF Discontinuation )	Anti-TNF Discontinuation in Patients With Inflammatory Bowel Disease: Multicentre, Prospective, Randomized Clinical Trial and Economic Evaluation	Crohn's Disease;Inflammatory Bowel Disease;Ulcerative Colitis	Biological: Anti-TNF: Infliximab (Infusion);Drug: Anti-TNF discontinuation: Physiological saline solution;Biological: Anti-TNF:Adalimumab (Subcutaneus)	Fundación de Investigación Biomédica - Hospital Universitario de La Princesa	NULL	Recruiting	18 Years	N/A	All	194	Phase 4	Spain
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
36	EUCTR2016-001409-18-NO (EUCTR)	06/12/2016	09/05/2016	A study to evaluate the safety of stopping versus continuing anti TNF therapy in ulcerative colitis patients in remission, and to evaluate the safety and efficacy of restarting anti TNF therapy in patients with disease recurrence	A prospective, open randomized, parallel-group study to evaluate the outcome of discontinuing or continuing anti-tumor necrosis factor treatment in patients with ulcerative colitis in sustained clinical remission. - The Biostop study	Ulcerative colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: 1.Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Simponi INN or Proposed INN: GOLIMUMAB	Helse More og Romsdal Hospital Trust	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes		Phase 4	Norway
37	NCT02425852 (ClinicalTrials.gov)	December 2016	21/4/2015	A Randomized, Multicenter Open Label Study Comparing Early Administration of Azathioprine Plus IFX to Steroids Plus Azathioprine for Acute Severe Colitis	A Randomized, Multicenter Open Label Study Comparing Early Administration of Azathioprine Plus Infliximab to Corticosteroids Plus Azathioprine for Acute Severe Colitis	Ulcerative Colitis	Drug: Azathioprine;Drug: Infliximab;Drug: Prednisolone;Drug: Hydrocortisone	Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives	NULL	Recruiting	18 Years	N/A	All	146	Phase 4	France
38	JPRN-UMIN000024936	2016/11/30	22/11/2016	Efficacy of additional Calcineurin inhibitors in anti TNF-alfa antibody refractory Ulcerative colitis		Ulcerative colitis	patients who received Infliximab continued to treat every 8 week and who received Adalimumab continued to treat every 2 week. Patients received Tacrolimus 0.5mg2Cap par day at day0. Day0 is day of first anti TNF-alfa antibody treat after participate this study. We control Tacrolimus trough levels 3 to 5 mg/ml.	Keio University Gastroenterology and Hepatology	NULL	Recruiting	16years-old	150years-old	Male and Female	30	Not selected	Japan
39	EUCTR2016-002061-54-IT (EUCTR)	13/10/2016	15/11/2018	Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases.	Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases.Evaluation of immunogenicity and clinical response - Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®)	Rheumatoid arthritis, seronegative spondylo arthritis,Crohn's Disease, Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10039073;Term: Rheumatoid arthritis;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Classification code 10075634;Term: Acute haemorrhagic ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: REMSIMA - 100 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLANCONCINO (VETRO) - 1 FLACONCINO Product Name: Remsima Product Code: 42942019	UNIVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLI	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 4	Italy
40	EUCTR2014-004904-31-BE (EUCTR)	21/09/2016	29/07/2016	A clinical study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission.	An open-label, multicentre, phase IV study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission.	Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA).;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Remsima (infliximab)	Mundipharma Pharmaceuticals B.V.	NULL	Not Recruiting			Female: yes Male: yes	156	Phase 4	Belgium;Netherlands
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
41	NCT02770040 (ClinicalTrials.gov)	July 2016	9/5/2016	Optimising Infliximab Induction Therapy for Acute Severe Ulcerative Colitis	PREDICT UC: Optimising Infliximab Induction Therapy for Acute Severe Ulcerative Colitis - A Randomised Controlled Trial	Ulcerative Colitis	Drug: Infliximab	Austin Health	University of Melbourne	Recruiting	18 Years	80 Years	All	138	Phase 4	Australia
42	EUCTR2016-001278-13-FI (EUCTR)	08/06/2016	15/04/2016	Immunologic, genetic and bowel microbes as predictors of the treatment response for TNFalpha-blocking drugs in patients with Crohn’s disease or ulcerative colitis	Immunologic, genetic and microbiomic predictors of the treatment response for TNFalpha-blocking drugs – prospective follow-up cohort of patients with Crohn’s disease or ulcerative colitis - PROSIBD	Ulcerative colitis and Crohn's disease MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.0;Classification code 10013099;Term: Disease Crohns;Classification code 10058815;Term: Crohn's disease acute episode;Classification code 10057035;Term: Crohn's ileocolitis;Classification code 10011405;Term: Crohn's enteritis;Classification code 10011406;Term: Crohn's ileitis;Classification code 10076318;Term: Crohn's disease relapse;Level: PT;Classification code 10011401;Term: Crohn's disease;Classification code 10011402;Term: Crohn's disease (colon);Classification code 10075466;Term: Fistulising Crohn's disease;Classification code 10066678;Term: Acute ulcerative colitis;Classification code 10075465;Term: Fistulizing Crohn's disease;Classification code 10011400;Term: Crohn's colitis;System Organ Class: 10017947 - Gastrointe;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remsima Product Name: Remsima INN or Proposed INN: INFLIXIMAB	Taina Sipponen	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 4	Finland
43	EUCTR2015-004618-10-BE (EUCTR)	19/04/2016	20/11/2015	PhArmaCo-kinetics of InFliximab during treatment Induction	Study of the inter-individual variation of PhArmaCo-kinetics of InFliximab during treatment Induction in patients with Crohn’s disease and Ulcerative Colitis	Patients with Crohn disease or Ulcerative Colitis which need biotherapy (antibody against TNF-a);Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remsima INN or Proposed INN: INFLIXIMAB Other descriptive name: Remsima Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Remicade Trade Name: Inflectra INN or Proposed INN: INFLIXIMAB Other descriptive name: Inflectra	CUB- Hopital Erasme	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes		Phase 4	Belgium
44	EUCTR2015-001954-14-NL (EUCTR)	14/09/2015	25/08/2015	Efficacy and safety of Infliximab-biosimilar (Inflectra) compared to Infliximab-innovator (Remicade) in patients with inflammatory bowel disease in remission: the SIMILAR Trial”	SIMILAR Trial: Santeon InflixMab biosimILAr ResearchA randomized, controlled, double blind, phase 4 noninferiority trial to assess efficacy of Infliximab-biosimilar (Inflectra) compared to Infliximab-innovator (Remicade) in patients with inflammatory bowel disease in remission. - SIMILAR Trial: Santeon InflixMab biosimILAr Research	ulcerative colitis and Crohn’s disease MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Inflectra 100 mg powder for concentrate for solution for infusion Product Name: Inflectra 100 mg powder for concentrate for solution for infusion Trade Name: Remicade 100 mg powder for concentrate for solution for infusion. Product Name: Remicade 100 mg powder for concentrate for solution for infusion. Product Code: EMEA/H/C/000240	Santeon	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes		Phase 4	Netherlands
45	JPRN-UMIN000018745	2015/09/01	01/09/2015	The Efficacy of Enternal Nutrition in Active Ulcerative Colitis Patients with Hypoalbuminemia ,during Infliximab Therapy		ulcerative colitis	Administration of Infliximab and enteral nutrition Administration of Infliximab	Nagoya University Graduate School of Medicine, Department of Gastroentrology and hepatology	NULL	Pending	15years-old	75years-old	Male and Female	40	Not selected	Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
46	EUCTR2014-004904-31-NL (EUCTR)	19/05/2015	26/01/2015	A clinical study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission.	An open-label, multicentre, phase IV study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission.	Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA).;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Remsima (infliximab)	Mundipharma Pharmaceuticals B.V.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes		Phase 4	Netherlands
47	NCT02413047 (ClinicalTrials.gov)	May 2015	6/3/2015	Evaluate if Response to Infliximab or Adalimumab May be Regained With an Immunomodulator	A Pilot Study to Evaluate if Response to Infliximab or Adalimumab May be Regained With the Addition of an Immunomodulator	Inflammatory Bowel Disease;Ulcerative Colitis;Crohn's Disease	Drug: Azathioprine;Drug: 6 mercaptopurine;Drug: Methotrexate	Indiana University	NULL	Terminated	18 Years	80 Years	All	3	N/A	United States
48	NCT02539368 (ClinicalTrials.gov)	April 22, 2015	22/7/2015	Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Inflammatory Bowel Disease	POST-MARKETING OBSERVATIONAL COHORT STUDY OF PATIENTS WITH INFLAMMATORY BOWEL DISEASE (IBD) TREATED WITH CT-P13 IN USUAL CLINICAL PRACTICE (CONNECT-IBD)	Inflammatory Bowel Diseases;Ulcerative Colitis;Crohn's Disease	Drug: CT-P13;Drug: Remicade	Pfizer	Hospira, now a wholly owned subsidiary of Pfizer	Completed	18 Years	N/A	All	2565		Belgium;Czechia;Finland;France;Germany;Greece;Hungary;Italy;Netherlands;Portugal;Slovakia;Spain;United Kingdom;Czech Republic;Ireland
49	EUCTR2013-004282-14-NL (EUCTR)	13/01/2015	04/08/2014	A study of the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in ulcerative colitis patients who have not previously received TNF inhibitors	PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Remicade INN or Proposed INN: INFLIXIMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	720	Phase 3	Portugal;Philippines;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Vietnam;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Netherlands;Germany;Norway;Sweden;Korea, Republic of
50	EUCTR2013-004282-14-PT (EUCTR)	09/01/2015	23/07/2014	A study to evaluate the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in patients with moderate to severe ulcerative colitis who have not previously received TNF inhibitors	PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	390	Phase 3	Portugal;Philippines;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;Vietnam;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Norway;Netherlands;Germany;Korea, Republic of;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
51	NCT02136069 (ClinicalTrials.gov)	December 24, 2014	15/4/2014	A Study Comparing the Efficacy and Safety of Etrolizumab to Infliximab in Participants With Moderate to Severe Ulcerative Colitis Who Are Naïve to Tumor Necrosis Factor (TNF) Inhibitors	Phase III, Randomized, Multicenter Double-Blind, Double Dummy Study to Evaluate the Efficacy and Safety of Etrolizumab Compared With Infliximab in Patients With Moderate to Severe Active Ulcerative Colitis Who Are Naive to TNF Inhibitors	Ulcerative Colitis	Drug: Etrolizumab;Drug: Infliximab;Other: Placebo (IV);Other: Placebo (Injection)	Hoffmann-La Roche	NULL	Completed	18 Years	80 Years	All	397	Phase 3	Austria;Belgium;Canada;Czechia;France;Germany;Hungary;Israel;Italy;Korea, Republic of;Netherlands;Norway;Portugal;Romania;Singapore;South Africa;Spain;Sweden;Switzerland;United Kingdom;Czech Republic;Philippines;Vietnam
52	EUCTR2013-004282-14-BE (EUCTR)	11/12/2014	27/08/2014	A study to evaluate the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in patients with moderate to severe ulcerative colitis who have not previously received TNF inhibitors	PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Remicade INN or Proposed INN: INFLIXIMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	390	Phase 3	Portugal;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Norway;Netherlands;Germany;Korea, Republic of;Sweden
53	EUCTR2013-004282-14-ES (EUCTR)	25/11/2014	06/08/2014	A study of the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in ulcerative colitis patients who have not previously received TNF inhibitors	PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS	Ulcerative Colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Remicade INN or Proposed INN: INFLIXIMAB	Roche Farma S.A. en nombre de F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	720	Phase 3	Portugal;Philippines;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;Vietnam;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Norway;Netherlands;Germany;Korea, Republic of;Sweden
54	EUCTR2013-004282-14-IT (EUCTR)	10/11/2014	16/09/2014	A study of the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in ulcerative colitis patients who have not previously received TNF inhibitors	PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS	Ulcerative Colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Remicade INN or Proposed INN: INFLIXIMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	720	Phase 3	Portugal;Philippines;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;Vietnam;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Norway;Netherlands;Germany;Korea, Republic of;Sweden
55	EUCTR2013-004282-14-DE (EUCTR)	10/11/2014	18/07/2014	A study to evaluate the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in patients with moderate to severe ulcerative colitis who have not previously received TNF inhibitors	PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Remicade INN or Proposed INN: INFLIXIMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	390	Phase 3	Portugal;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Germany;Netherlands;Norway;Sweden;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
56	EUCTR2013-004282-14-HU (EUCTR)	29/10/2014	30/10/2014	A study to evaluate the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in patients with moderate to severe ulcerative colitis who have not previously received TNF inhibitors	PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Remicade INN or Proposed INN: INFLIXIMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	390	Phase 3	Portugal;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;Canada;Belgium;Singapore;Romania;South Africa;Germany;Netherlands;Norway;Sweden;Korea, Republic of
57	EUCTR2013-004282-14-NO (EUCTR)	17/10/2014	04/08/2014	A study of the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in ulcerative colitis patients who have not previously received TNF inhibitors	PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS	Ulcerative Colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Remicade INN or Proposed INN: INFLIXIMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	720	Phase 3	Portugal;Philippines;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Vietnam;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Norway;Germany;Netherlands;Sweden;Korea, Republic of
58	NCT02148640 (ClinicalTrials.gov)	October 2014	23/5/2014	The NOR-SWITCH Study	A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SWITCHING FROM INNOVATOR INFLIXIMAB TO BIOSIMILAR INFLIXIMAB COMPARED WITH CONTINUED TREATMENT WITH INNOVATOR INFLIXIMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS, SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, ULCERATIVE COLITIS, CROHN'S DISEASE AND CHRONIC PLAQUE PSORIASIS THE NOR-SWITCH STUDY	Rheumatoid Arthritis;Spondyloarthritis;Psoriatic Arthritis;Ulcerative Colitis;Crohn's Disease;Psoriasis Chronic	Drug: Innovator infliximab;Drug: Biosimilar infliximab	Diakonhjemmet Hospital	South-Eastern Norway Regional Health Authority	Completed	18 Years	N/A	All	482	Phase 4	Norway
59	EUCTR2013-004282-14-GB (EUCTR)	29/09/2014	15/07/2014	A study to evaluate the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in patients with moderate to severe ulcerative colitis who have not previously received TNF inhibitors	PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Remicade INN or Proposed INN: INFLIXIMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	390	Phase 3	Portugal;Spain;Austria;Israel;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Germany;Netherlands;Norway;Sweden;Korea, Republic of
60	EUCTR2013-004282-14-CZ (EUCTR)	16/09/2014	18/07/2014	A study to evaluate the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in patients with moderate to severe ulcerative colitis who have not previously received TNF inhibitors	PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Remicade INN or Proposed INN: INFLIXIMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	390	Phase 3	Portugal;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Norway;Netherlands;Germany;Korea, Republic of;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
61	JPRN-UMIN000015068	2014/09/05	05/09/2014	An open label randomized controlled trial of GMA and Infliximab in intractable ulcerative colitis		Ulcerative colitis	Infliximab will be administered intravenously at the dose of 5 mg/kg at 0, 2, 6 weeks GMA will be administrated 10 times	Hiroshima University Hospital, Department of Endoscopy	NULL	Enrolling by invitation	20years-old	Not applicable	Male and Female	150	Not applicable	Japan
62	EUCTR2013-004282-14-AT (EUCTR)	03/09/2014	22/07/2014	A study to evaluate the effectiveness (efficacy) and safety of Etrolizumabcompared with Infliximab in patients with moderate to severe ulcerativecolitis who have not previously received TNF inhibitors	PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Remicade INN or Proposed INN: INFLIXIMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	390	Phase 3	Portugal;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Germany;Netherlands;Norway;Sweden;Korea, Republic of
63	EUCTR2014-002056-40-NO (EUCTR)	12/08/2014	13/06/2014	A study to evaluate the safety and efficacy of switching from regular infliximab to biosimilar infliximab in patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn's disease and psoriasis	A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SWITCHING FROM INNOVATOR INFLIXIMAB TO BIOSIMILAR INFLIXIMAB COMPARED WITH CONTINUED TREATMENT WITH INNOVATOR INFLIXIMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS, SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, ULCERATIVE COLITIS, CROHN’S DISEASEAND CHRONIC PLAQUE PSORIASISTHE NOR-SWITCH STUDY - NOR_SWITCH	Rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn’s disease and chronic plaque psoriasis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 18.0;Level: LLT;Classification code 10071117;Term: Plaque psoriasis;System Organ Class: 100000004858 MedDRA version: 18.0;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 18.0;Classification code 10045365;Term: Ulcerative colitis;Classification code 10002556;Term: Ankylosing spondylitis;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Remicade 100 mg pulver til konsentrat til infusjonsvæske, oppløsning Trade Name: Remsima 100 mg pulver til konsentrat til infusjonsvæske, oppløsning	Diakonhjemmet Hospital AS	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Norway
64	EUCTR2013-004282-14-FR (EUCTR)	28/07/2014	22/06/2015	A study of the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in ulcerative colitis patients who have not previously received TNF inhibitors	PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS	Ulcerative Colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Remicade INN or Proposed INN: INFLIXIMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	720	Phase 3	Portugal;Philippines;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;Vietnam;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Norway;Netherlands;Germany;Korea, Republic of;Sweden
65	JPRN-UMIN000014275	2014/06/24	24/06/2014	Efficacy of infliximab for refractory pouchitis with complexed anal fistula		ulcerative colitis	infliximab	Hyogo College of Medicine	NULL	Complete: follow-up complete	Not applicable	Not applicable	Male and Female	10	Phase 1	Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
66	JPRN-UMIN000013716	2014/04/15	15/04/2014	A study of infliximab administration method for tacrolimus-resistant active ulcerative colitis		ulcerative colitis	After administrating tacrolimus and infliximab for 6 weeks,tacrolimus is tapered to 0mg. Infliximab monotherapy	Yokohama City University Medical Center	NULL	Complete: follow-up complete	16years-old	Not applicable	Male and Female	40	Phase 2	Japan
67	NCT01960426 (ClinicalTrials.gov)	April 2014	25/9/2013	Evaluation of Health Costs and Resource Utilization	A Randomized Evaluation of Health Costs and Resource Utilization Comparing Testing-Based Therapy to Empiric Dose Intensification for the Management of Inflammatory Bowel Disease.	Ulcerative Colitis;Crohn's Disease	Other: Measurement of drug (Adalimumab/Infliximab);Other: Intensify treatment with the existing drug	University of Western Ontario, Canada	Prometheus Laboratories	Terminated	18 Years	N/A	Both	51	Phase 4	United States
68	EUCTR2013-002651-15-NL (EUCTR)	03/03/2014	18/09/2013	Adjusting the amount of medication (infliximab) in patients suffering from inflammatory bowel disease, using medication levels in blood.	Adjusting infliximab dose in IBD patients in remission, based on infliximab trough levels: the study on Infliximab Levels in IBD patients Steering Treatment, the ILIST pilot - ILIST-study	Crohns diseaseUlcerative colitis MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remicade (infliximab) Product Name: infliximab	Zon MW	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes		Phase 4	Netherlands
69	JPRN-UMIN000013033	2014/02/01	01/02/2014	Examination of the early clinical and endoscopic views change after infliximab administration in the ulcerative colitis.		Ulcerative colitis	Study start - 14 weeks:5mg/kg of Infliximab for 0.2.6.14 week, respectively ( initial administration day with 0 weeks)	Department of Internal Medicine,Juntendo University	NULL	Pending	20years-old	Not applicable	Male and Female	30	Not selected	Japan
70	EUCTR2011-001332-29-AT (EUCTR)	02/12/2013	07/11/2013	The degradation and elimination of Infliximab	Pharmacokinetics of Infliximab	Inflammatory bowel disease (Ulcerative Colitis, Crohn's disease) MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Remicade	Universitätsklinik für Innere Medizin III, Klinische Abteilung für Gastroenterologie und Hepatologie	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Austria
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
71	NCT01971814 (ClinicalTrials.gov)	November 2013	17/10/2013	Early Serum Infliximab Levels in Severe Ulcerative Colitis.	Early Serum Infliximab Levels in Severe Ulcerative Colitis	Ulcerative Colitis (UC);Inflammatory Bowel Disease	Drug: Infliximab	University of California, San Francisco	NULL	Completed	18 Years	N/A	Both	11	Phase 1	United States
72	JPRN-UMIN000013370	2013/06/07	07/03/2014	Efficacy of infliximab therapy for refractory pouchitis		ulcerative colitis, pouchitis	infliximab	Inflammatory bowel disease center, Hyogo college of medicine	NULL	Complete: follow-up complete	18years-old	80years-old	Male and Female	10	Phase 1	Japan
73	JPRN-UMIN000013371	2013/06/05	07/03/2014	Efficacy of infliximab therapy for arthritis after restorative proctocolectomy in patients with ulcerative colitis		ulcerative colitis	infliximab	Hyogo college of medicine	NULL	Complete: follow-up complete	20years-old	80years-old	Male and Female	10	Not selected	Japan
74	JPRN-UMIN000010612	2013/05/01	01/05/2013	A comparative study of the efficacy of tacrolimus with infliximab in intractable ulcerative colitis		Ulcerative colitis	Tacrolimus will be administered orally for 10 weeks at the trough level of 10-15 ng/ml for the first 2 weeks following that of 5-10 ng/ml for the rest of the study period. Infliximab will be administered intravenously at the dose of 5 mg/kg at 0, 2, 6 weeks.	Department of Internal Medicine, Division of Gastroenterology and Hepatology, Keio University School of Medicine	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	130	Phase 4	Japan
75	NCT02073526 (ClinicalTrials.gov)	May 2013	9/1/2014	Anti-TNF-alpha Trough Level Measurements in Inflammatory Bowel Disease	Anti-TNF-alpha Trough Level Measurements in Inflammatory Bowel Disease	Inflammatory Bowel Disease;Crohn's Disease;Ulcerative Colitis	Drug: Infliximab, adalimumab, certolizumab pegol	Oslo University Hospital	NULL	Completed	18 Years	N/A	Both	1230	N/A	Norway
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
76	NCT01846026 (ClinicalTrials.gov)	April 2013	30/4/2013	Ulcerative Colitis and Vitamin D Supplementation	Immunomodulating and Clinical Effects of Vitamin D on Remission Induction in Patients With Moderate and Severe Ulcerative Colitis, Undergoing Treatment With Infliximab.	Ulcerative Colitis	Drug: Vitamin D;Drug: placebo	University Hospital of North Norway	NULL	Withdrawn	18 Years	N/A	Both	0	Phase 1;Phase 2	Norway
77	NCT01804166 (ClinicalTrials.gov)	March 21, 2013	1/2/2013	A Research Study to Bank Samples for Future Evaluation to Identify Biomarkers That Predispose Crohn's Disease and Ulcerative Colitis Patients to Develop Hepatosplenic T-Cell Lymphoma (HSTCL)	A Research Study to Bank Samples for Future Evaluation to Identify Biomarkers That Predispose Crohn's Disease and Ulcerative Colitis Patients to Develop Hepatosplenic T-Cell Lymphoma (HSTCL)	Hepatosplenic T-Cell Lymphoma	Drug: Infliximab;Drug: Golimumab	Janssen Scientific Affairs, LLC	NULL	Completed	N/A	N/A	All	1	Phase 4	United States
78	EUCTR2011-006084-22-GB (EUCTR)	04/10/2012	15/08/2012	Usefulness of the measurement of blood levels of infliximab and adalimumab in inflammatory bowel disease patients in predicting response to treatment	Utilising drug levels and anti-drug antibodies to predict response to treatment in patients with Inflammatory Bowel Disease - Trough levels of anti-TNF agents in inflammatory bowel disease	Inflammatory bowel disease MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remicade Product Name: Infliximab INN or Proposed INN: Infliximab Trade Name: Humira Product Name: adalimumab INN or Proposed INN: Adalimumab	Royal Liverpool University Hospital	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	0		United Kingdom
79	JPRN-UMIN000015297	2012/09/19	01/10/2014	The feasibility study of accelated infliximab infusion from initial administration	The feasibility study of accelated infliximab infusion from initial administration - The feasibility study of accelated infliximab infusion from initial administration	patient in whom infliximab is indicated(rheumatoid arthritis, Crohn's disease, Ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis)	Administration of intravenous infliximab infusion with 60 min accelated procedure for patients who are already successfully treated with usual 2hr infuion without infusion reaction. The tolerable patient continue to receive more five treatment with 60min procedure.	Chiba University Hospital	NULL	Recruiting	20years-old	70years-old	Male and Female	54	Phase 2	Japan
80	JPRN-UMIN000007806	2012/06/01	01/05/2012	The feasibility study of accelated infliximab infusion during maintenance phase		patient in whom infliximab is indicated(rheumatoid arthritis, Crohn's disease, Ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis)	Administration of intravenous infliximab infusion with 60 min accelated procedure for patients who are already successfully treated with usual 2hr infuion without infusion reaction. The tolerable patient continue to receive more five treatment with 60min procedure.	Chiba University Hospital	NULL	Complete: follow-up complete	Not applicable	Not applicable	Male and Female	54	Phase 2	Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
81	NCT01551290 (ClinicalTrials.gov)	April 2012	7/3/2012	A Study to Evaluate the Effectiveness and Safety of Infliximab in Chinese Patients With Active Ulcerative Colitis	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Infliximab in Chinese Subjects With Active Ulcerative Colitis	Ulcerative Colitis	Drug: Infliximab;Drug: Placebo	Xian-Janssen Pharmaceutical Ltd.	NULL	Completed	18 Years	65 Years	Both	99	Phase 3	China
82	JPRN-UMIN000007341	2012/02/01	21/02/2012	The study of the effectiveness of maintenance treatment with infliximab for ulcerative colitis patients who respond to induction treatment with infliximab	The study of the effectiveness of maintenance treatment with infliximab for ulcerative colitis patients who respond to induction treatment with infliximab - The study of the effectiveness of maintenance treatment with infliximab for ulcerative colitis patients who respond to induction treatment with infliximab	ulcerative colitis	Patients in maintenance group receive intravenous infusion of infliximab (5mg/kg) at week 0, 2, and 6 and then every 8 weeks (up to week 54). Patients in discontinuation group receive intravenous infusion of infliximab (5mg/kg) at week 0, 2, and 6 (not receiving infliximab at week 14, 22, 30, 38, 46 and 54).	Tohoku University Graduate School of Medicine (Tohoku University Hospital)	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	90	Not applicable	Japan
83	JPRN-UMIN000006141	2011/10/01	12/08/2011	Comparative study of Infliximab monotherapy vs combined therapy with azathiopurine for inducing and maintaining clinical remission in steroid-dependent or -resistant ulcerative colitis		ulcerative colitis	Patients in Infliximab monotherapy receive intravenous infusion of IFX at week 0, 2, and 6, and then every 8 weeks (up to week 54). Patients in the combination therapy of Infliximab and azathiopurine receive intravenous infusion of IFX (at week 0, 2, 6, and then every 8 weeks) and oral azathiopurine (up to week 54).	Department of Gastroenterology and Hepatology, Kyoto University Hospital	NULL	Complete: follow-up complete	16years-old	75years-old	Male and Female	50	Not applicable	Japan
84	EUCTR2011-002061-38-BE (EUCTR)	29/06/2011	08/06/2011	Treating patients with infliximab based on their trough levels	A randomised prospective trough level monitoring study with real-time therapeutic adaptations: Trough level Adapted infliXImab Treatment scheme (TAXIT). - TAXIT	2) Crohn's disease and ulcerative colitis MedDRA version: 13.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 13.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Remicade Product Name: Remicade Product Code: Remicade INN or Proposed INN: INFLIXIMAB	Katholieke Universiteit Leuven	NULL	Not Recruiting			Female: yes Male: yes		Phase 4	Belgium
85	NCT01346826 (ClinicalTrials.gov)	May 2011	2/5/2011	Safety of Accelerated Infliximab Infusions in Patients With Inflammatory Bowel Disease (IBD)	Safety of Accelerated Infliximab Infusions in Patients With Inflammatory Bowel Disease: A Prospective, Randomized, Double-Blind, Controlled Trial	Crohn's Disease;Ulcerative Colitis	Drug: Standard 2 hours-infusion;Drug: Accelerated 1 hour-infusion;Drug: Accelerated 30 minutes-infusion	Asan Medical Center	NULL	Completed	16 Years	80 Years	Both	145	Phase 4	Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
86	NCT01408810 (ClinicalTrials.gov)	February 2011	20/7/2011	Evaluation of Histologic and Endoscopic Remission Induced by Infliximab in Moderate to Severe Ulcerative Colitis	Histological and Endoscopic Evaluation of Remission Induced by Infliximab in Moderately to Severely Active Ulcerative Colitis Patients	Ulcerative Colitis	Drug: Infliximab	Grupo de Estudo da Doença Inflamatória Intestinal	NULL	Completed	18 Years	64 Years	Both	21	Phase 4	Portugal
87	EUCTR2009-013890-16-PT (EUCTR)	28/05/2010	21/12/2009	Herica - Histological and Endoscopic evaluation of Remission induced by Infliximab in moderately to severely active ulcerative Colitis Patients - Herica	Herica - Histological and Endoscopic evaluation of Remission induced by Infliximab in moderately to severely active ulcerative Colitis Patients - Herica	This national, multi-centre, open-label pilot study will assess the histologic remission in patients with moderate to severe active ulcerative colitis under infliximab treatment who have had an inadequate response to conventional therapy.Biopsies will be analyzed throughout the study in order to assess histological disease modifying effects in those patients. MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856	Trade Name: Remicade Product Name: Remicade	GEDII - Grupo de Estudo da Doença inflamatória Intestinal	NULL	Not Recruiting			Female: yes Male: yes	20		Portugal
88	EUCTR2008-005237-30-NL (EUCTR)	01/12/2009	18/08/2009	A Multicenter, Prospective, Long-term Registry of children with Crohn's Disease or Ulcerative Colitis	A Multicenter, Prospective, Long-term Registry of Pediatric Patients with Crohn's Disease or Ulcerative Colitis - DEVELOP	Pediatric patients with a confirmed diagnosis of CD or UC . MedDRA version: 18.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Remsima and Inflectra	Janssen Biologics B.V.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	6000		United States;Canada;Netherlands;Sweden
89	NCT00984568 (ClinicalTrials.gov)	November 2009	24/9/2009	Conventional Step-Up Versus Infliximab Monotherapy in Patients With Ulcerative Colitis (P05553)	Conventional Step-Up Versus Infliximab Monotherapy in Patients With Active Moderate to Severe Ulcerative Colitis. A Randomized, Open Label, Prospective, Multicenter Study	Colitis, Ulcerative	Biological: Infliximab;Drug: Prednisolone;Drug: 5-aminosalicylic acid;Drug: Azathioprine	Merck Sharp & Dohme Corp.	NULL	Terminated	18 Years	N/A	All	28	Phase 3	Germany
90	EUCTR2009-015649-21-NO (EUCTR)	21/10/2009	16/09/2009	Immunmodulating and clinical effect of vitamin D onthe induction of remission in the patients with moderate to severe ulcerative colitis under the treatment with Infliximab.	Immunmodulating and clinical effect of vitamin D onthe induction of remission in the patients with moderate to severe ulcerative colitis under the treatment with Infliximab.	Ulcerative colitis	Trade Name: Dekristol Product Name: cholecalciferol Product Code: na	Medical clinic, University Hospital of North Norway	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	200		Norway
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
91	NCT02322008 (ClinicalTrials.gov)	September 2009	17/12/2014	Anti-TNF Therapy in Danish Patients With Inflammatory Bowel Diseases in Clinical Practice	Anti-TNF Therapy in Danish Patients With Inflammatory Bowel Diseases in Clinical Practice	Crohn's Disease;Ulcerative Colitis;Inflammatory Bowel Disease	Biological: infliximab and adalimumab	Regionshospitalet Viborg, Skive	NULL	Completed	18 Years	N/A	Both	1035	N/A	NULL
92	EUCTR2009-010065-23-DE (EUCTR)	17/08/2009	14/04/2009	Conventional Step-Up versus Infliximab Monotherapy in Patients with Active Moderate to Severe Ulcerative Colitis. A Randomized, Open Label, Prospective, Multicenter Study (Phase 3, Protocol No. P05553) - MUNIX	Conventional Step-Up versus Infliximab Monotherapy in Patients with Active Moderate to Severe Ulcerative Colitis. A Randomized, Open Label, Prospective, Multicenter Study (Phase 3, Protocol No. P05553) - MUNIX	Active Moderate to Severe Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders	Trade Name: Remicade INN or Proposed INN: infliximab Other descriptive name: 100 Trade Name: Pentasa 500 mg Retardtabletten Product Name: 5-Aminosalicylic acid (5-ASA) INN or Proposed INN: 5-Aminosalicylic acid Trade Name: Imurek 25mg Filmtabletten INN or Proposed INN: azathioprine Trade Name: Imurek 50mg Filmtabletten INN or Proposed INN: azathioprine Trade Name: Decortin H 1 mg INN or Proposed INN: prednisolone Trade Name: Decortin H 5mg INN or Proposed INN: prednisolone Trade Name: Decortin H 10mg INN or Proposed INN: prednisolone Trade Name: Decortin H 20mg INN or Proposed INN: prednisolone Trade Name: Decortin H 50 mg INN or Proposed INN: prednisolone	Essex Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes		Phase 3	Germany
93	EUCTR2008-007519-34-SE (EUCTR)	17/04/2009	02/03/2009	Feasibility of Accelerated infliximab infusions - Safety and Tolerability in patients wit IBD. FAST - FAST VERSION	Feasibility of Accelerated infliximab infusions - Safety and Tolerability in patients wit IBD. FAST - FAST VERSION	This is a open label, prospective, multicenter trial in patients recieving one hour infusions of infliximab (i.e. Remicade)as part of their daily practice. Main objective: Is to assess the tolerability of Remicade with an infusionsrate of 30 minutes.Patients: eligible patients are those with intestinal fistulas Mb Crohn disease or Ulcerative colitis/IBD. or patietns with	Trade Name: Remicade	University of Leuven Hospitals, Division of Gastroenterology	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	200		Sweden
94	NCT00791557 (ClinicalTrials.gov)	October 2008	13/11/2008	Open Label Study for Adults With Pyoderma Gangrenosum and Inflammatory Bowel Disease	An Open Label Single Center Pilot Study Investigating the Clinical Response and Mechanism of Action of Infliximab in the Treatment of Adults With Inflammatory Bowel Disease Who Have Moderate to Severe Pyoderma Gangrenosum	Pyoderma Gangrenosum;Crohn's Disease;Ulcerative Colitis;Inflammatory Bowel Disease	Drug: Infliximab	University Hospitals Cleveland Medical Center	Centocor, Inc.	Completed	18 Years	75 Years	All	2	N/A	United States
95	EUCTR2008-001968-36-GB (EUCTR)	27/08/2008	15/07/2008	Comparison of infliximab and ciclosporin in steroid resistant ulcerative colitis: a Trial - CONSTRUCT	Comparison of infliximab and ciclosporin in steroid resistant ulcerative colitis: a Trial - CONSTRUCT	Acute severe steroid resistant ulcerative colitis MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders		Swansea University	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 3	United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
96	EUCTR2006-002670-22-GB (EUCTR)	11/06/2008	01/08/2007	Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1). Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS	Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1). Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS	Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis		Schering-Plough Research Institute, a division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Germany;Italy;United Kingdom
97	EUCTR2006-005299-42-BE (EUCTR)	20/05/2008	07/03/2008	A randomized, multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis (CYSIF Study) - CYSIF	A randomized, multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis (CYSIF Study) - CYSIF	- Diagnosis of UC according to Lennard-Jones criteria - Endoscopically demonstrated colorectal lesions localized above the anal margin and extending at least up to 15cm proximally.- Severe acute flare of UC with a Lichtiger Index score > 10.- Refractoriness to high dose intravenous steroid therapy (= 0.8 mg/kg/d of methylprednisolone or equivalent) given for at least 5 days. MedDRA version: 9.1;Level: LLT;Classification code 10045282;Term: UC	Trade Name: REMICADE INN or Proposed INN: INFLIXIMAB INN or Proposed INN: CICLOSPORIN Other descriptive name: SANDINUM INN or Proposed INN: CICLOSPORIN Other descriptive name: NEORAL Trade Name: CYCLOSPORIN Trade Name: CYCLOSPORIN	GETAID	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	100		Finland;Belgium;France;Spain
98	EUCTR2006-005299-42-ES (EUCTR)	19/05/2008	03/03/2008	Estudio multicéntrico abierto randomizado que compara ciclosporina e infliximab para el tratamiento de la colitis ulcerosa grave corticorrefractaria.A randomized multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis - CYSIF	Estudio multicéntrico abierto randomizado que compara ciclosporina e infliximab para el tratamiento de la colitis ulcerosa grave corticorrefractaria.A randomized multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis - CYSIF	Brote grave de colitis ulcerosa (Severe flare of ulcerative colitis)	Trade Name: Sandimmum Product Name: ciclosporina Trade Name: Remicade Product Name: infliximab	GETECCU (Grupo Español para el estudio de la enfermedad de Crohn y la colitis ulcerosa)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	100		Finland;Belgium;France;Spain
99	EUCTR2007-006692-37-GB (EUCTR)	10/04/2008	25/01/2008	The Immunomodulatory Role of Vitamin D in Inflammatory Bowel Disease (IBDVit): IBDVit1 - Trial of Adjuvant Vitamin D with Corticosteroids in Active Crohn’s Disease; IBDVit2 - Trial of Adjuvant Vitamin D with Infliximab in Active Crohn's Disease; IBDVit3 - Trial of Adjuvant Vitamin D with standard maintenance therapy in preventing relapse of Inflammatory Bowel Disease. - IBDVit	The Immunomodulatory Role of Vitamin D in Inflammatory Bowel Disease (IBDVit): IBDVit1 - Trial of Adjuvant Vitamin D with Corticosteroids in Active Crohn’s Disease; IBDVit2 - Trial of Adjuvant Vitamin D with Infliximab in Active Crohn's Disease; IBDVit3 - Trial of Adjuvant Vitamin D with standard maintenance therapy in preventing relapse of Inflammatory Bowel Disease. - IBDVit	IBDVit1 - Active Crohn's Disease IBDVit2 - Active Crohn's Disease IBDVit3 - Crohn's Disease in remission / Ulcerative Colitis in remission MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10045365;Term: Ulcerative colitis		Imperial College London	NULL	Not Recruiting			Female: yes Male: yes	210	Phase 4	United Kingdom
100	EUCTR2007-007702-30-IT (EUCTR)	03/04/2008	08/07/2008	Feasibility and safety of Infliximab enema treatment in patients with active left-sided ulcerative colitis. An open-label, non comparative, pilot study. - ND	Feasibility and safety of Infliximab enema treatment in patients with active left-sided ulcerative colitis. An open-label, non comparative, pilot study. - ND	Ulcerative colitis MedDRA version: 9.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders	Trade Name: REMICADE INN or Proposed INN: INFLIXIMAB	COSMO TECHNOLOGIES LTD	NULL	Not Recruiting			Female: no Male: yes			Italy
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
101	EUCTR2006-005299-42-FI (EUCTR)	25/02/2008	27/12/2007	A randomized, multicentre, open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitisSatunnaistettu, avoin, vertaileva monikeskustutkimus siklosporiinista ja infliximabista kortikosteroidille reagoimattoman vaikean haavaisen paksusuolitulehduksen hoidossa. - CYSIF STUDY	A randomized, multicentre, open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitisSatunnaistettu, avoin, vertaileva monikeskustutkimus siklosporiinista ja infliximabista kortikosteroidille reagoimattoman vaikean haavaisen paksusuolitulehduksen hoidossa. - CYSIF STUDY	Tutkimuksessa verrataan kortikosteroidihoidolle reagoimattoman haavaisen paksusuolitulehduksen hoitoa käyttämällä suonensisäistä siklosporiinihoitoa 2 mg/kg/vrk 7 vrk:n ajan ja siklosporiini (Sandimmun Neoral) 4 mg/kg/vrk suun kautta tämän jälkeen 3 kk:n ajan verrattuna infliximabi (Remicade) 5 mg/kg iv viikoilla 0, 2 ja 6. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Sandimmun 50 mg/ml, infuusiokonsentraatti INN or Proposed INN: CICLOSPORIN Trade Name: Sandimmun Neoral INN or Proposed INN: CICLOSPORIN Trade Name: Remicade 100 mg infuusiokuiva-aine, konsentraattiliuosta varten INN or Proposed INN: INFLIXIMAB	Groupe d'Etude Thérapeutique des Affections Inflammatoires Digestives (G.E.T.A.I.D.)	NULL	Not Recruiting			Female: yes Male: yes	100		France;Finland;Belgium;Spain
102	EUCTR2006-002670-22-SK (EUCTR)	08/02/2008	15/04/2008	Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1). Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS	Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1). Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS	Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis		Schering-Plough Research Institute, a division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Germany;Italy;United Kingdom
103	EUCTR2006-002670-22-IT (EUCTR)	27/11/2007	04/10/2007	Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1) Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-Up of Efficacy and Safety (Part 2)	Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1) Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-Up of Efficacy and Safety (Part 2)	moderately to severely active Ulcerative Colitis MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remicade INN or Proposed INN: Infliximab Trade Name: imuran INN or Proposed INN: azathioprine	SCHERING-PLOUGH	NULL	Not Recruiting			Female: yes Male: yes	600		Portugal;France;Czech Republic;Hungary;Spain;Belgium;Germany;United Kingdom;Italy
104	EUCTR2006-000410-20-NL (EUCTR)	13/11/2007	09/08/2007	A Phase 3, Randomized, Open-label, Parallel-group, Multicenter Trial to Evaluate the Safety and Efficacy of Infliximab (REMICADE®) in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis	A Phase 3, Randomized, Open-label, Parallel-group, Multicenter Trial to Evaluate the Safety and Efficacy of Infliximab (REMICADE®) in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative colitis MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Remicade	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 3	Netherlands;Belgium;Denmark;Italy
105	EUCTR2006-002670-22-DE (EUCTR)	31/10/2007	12/06/2007	Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS	Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS	Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Trade Name: Imuran Product Name: Overencapsulated Azathioprine (Imuran) 50 mg Tablet Product Code: SCH 900050 INN or Proposed INN: azathioprine	Schering-Plough Research Institute, a division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	600		Portugal;Hungary;United Kingdom;Czech Republic;Germany;Belgium;France;Spain;Italy
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
106	EUCTR2006-002670-22-PT (EUCTR)	12/10/2007	20/07/2007	Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS	Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS	Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Trade Name: Imuran Product Name: Overencapsulated Azathioprine (Imuran) 50 mg Tablet Product Code: SCH 900050 INN or Proposed INN: azathioprine	Schering-Plough Research Institute, a division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	600		Hungary;Portugal;United Kingdom;Czech Republic;Germany;Belgium;France;Spain;Italy
107	EUCTR2006-002670-22-ES (EUCTR)	20/09/2007	26/07/2007	Comparación de la eficacia y la seguridad del infliximab, en monoterapia o en combinación con azatioprina, y la azatioprina en monoterapia en la colitis ulcerosa activa de moderada a grave (1.ª parte). Comparación del tratamiento de mantenimiento y el tratamiento intermitente con infliximab en la conservación de la remisión: seguimiento de la eficacia y la seguridad (2.ª parte).	Comparación de la eficacia y la seguridad del infliximab, en monoterapia o en combinación con azatioprina, y la azatioprina en monoterapia en la colitis ulcerosa activa de moderada a grave (1.ª parte). Comparación del tratamiento de mantenimiento y el tratamiento intermitente con infliximab en la conservación de la remisión: seguimiento de la eficacia y la seguridad (2.ª parte).	Colitis Ulcerosa MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis		Schering-Plough Research Institute, a division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	Portugal;France;Czech Republic;Hungary;Slovakia;Belgium;Spain;Germany;Italy;United Kingdom
108	EUCTR2006-002670-22-FR (EUCTR)	07/09/2007	14/06/2007	Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2)	Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2)	Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Trade Name: Imuran Product Name: Azathioprine (Imuran) 50 mg Overencapsulated Tablet Product Code: SCH 900050 INN or Proposed INN: azathioprine	Schering-Plough Research Institute, a division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Germany;Italy;United Kingdom
109	EUCTR2006-002670-22-CZ (EUCTR)	29/08/2007	20/07/2007	Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS	Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS	Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Trade Name: Imuran Product Name: Overencapsulated Azathioprine (Imuran) 50 mg Tablet Product Code: SCH 900050 INN or Proposed INN: azathioprine	Schering-Plough Research Institute, a division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	600		Portugal;Hungary;United Kingdom;Germany;Czech Republic;Belgium;France;Spain;Italy
110	EUCTR2006-000410-20-DK (EUCTR)	13/08/2007	09/01/2007	A Phase 3, Randomized, Open-label, Parallel-group, Multicenter Trial to Evaluate the Safety and Efficacy of Infliximab (REMICADE®) in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis	A Phase 3, Randomized, Open-label, Parallel-group, Multicenter Trial to Evaluate the Safety and Efficacy of Infliximab (REMICADE®) in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative colitis MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Remicade INN or Proposed INN: infliximab	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 3	Netherlands;Belgium;Denmark;Italy
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
111	EUCTR2006-002670-22-HU (EUCTR)	09/08/2007	04/07/2007	Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS	Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS	Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Trade Name: Imuran Product Name: Overencapsulated Azathioprine (Imuran) 50 mg Tablet Product Code: SCH 900050 INN or Proposed INN: azathioprine	Schering-Plough Research Institute, a division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	600		Portugal;Hungary;United Kingdom;Czech Republic;Germany;Belgium;France;Spain;Italy
112	EUCTR2006-000410-20-IT (EUCTR)	02/08/2007	08/08/2007	A Phase 3, Randomized, Open-label, Parallel-group, MulticenterTrial to Evaluate the Safety and Efficacy of Infliximab(REMICADE) in Pediatric Subjects with Moderately to SeverelyActive Ulcerative Colitis - Protocol C0168T72	A Phase 3, Randomized, Open-label, Parallel-group, MulticenterTrial to Evaluate the Safety and Efficacy of Infliximab(REMICADE) in Pediatric Subjects with Moderately to SeverelyActive Ulcerative Colitis - Protocol C0168T72	Moderately to severely active Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative	Trade Name: REMICADE INN or Proposed INN: Infliximab	CENTOCOR	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 3	Netherlands;Belgium;Denmark;Italy
113	EUCTR2006-002670-22-BE (EUCTR)	25/07/2007	15/06/2007	Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1). Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS	Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1). Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS	Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis		Schering-Plough Research Institute, a division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Germany;Italy;United Kingdom
114	NCT00537316 (ClinicalTrials.gov)	July 2007	28/9/2007	Efficacy & Safety of Infliximab Monotherapy Vs Combination Therapy Vs AZA Monotherapy in Ulcerative Colitis (Part 1) Maintenance Vs Intermittent Therapy for Maintaining Remission (Part 2)(Study P04807)	Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1) Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-Up of Efficacy and Safety (Part 2)	Ulcerative Colitis	Biological: Infliximab (IFX);Drug: Azathioprine (AZA);Drug: Placebo to Azathioprine;Drug: Placebo infusion	Merck Sharp & Dohme Corp.	NULL	Terminated	21 Years	N/A	All	242	Phase 3	Argentina;Belgium;Canada;Colombia;Czech Republic;France;Germany;Hungary;Italy;Poland;Portugal;Russian Federation;Spain;Sweden;Switzerland;Ukraine;United Kingdom
115	NCT00705484 (ClinicalTrials.gov)	June 1, 2007	23/6/2008	European Safety Registry in Ulcerative Colitis (P04808)	Ulcerative Colitis European Registry: A Prospective, Observational, Non-interventional, Post-Marketing Safety Surveillance Program	Ulcerative Colitis	Biological: infliximab;Drug: Standard Therapy	Merck Sharp & Dohme Corp.	Centocor, Inc.	Completed	18 Years	N/A	All	2239		Austria;Belgium;Czech Republic;Denmark;France;Germany;Greece;Ireland;Italy;Netherlands;Spain;Sweden;United Kingdom;United States
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
116	NCT00542152 (ClinicalTrials.gov)	June 2007	8/10/2007	Study Comparing Cyclosporine With Infliximab in Steroid-refractory Severe Attacks of Ulcerative Colitis	A Randomized, Multicenter Open Label Study Comparing Cyclosporine With Infliximab in Steroid-refractory Severe Attacks of Ulcerative Colitis	Ulcerative Colitis;Steroid Refractory	Drug: CYCLOSPORINE VS INFLIXIMAB	Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives	NULL	Completed	18 Years	N/A	Both	115	Phase 4	Belgium;Finland;France;Italy;Spain
117	NCT00606346 (ClinicalTrials.gov)	May 31, 2007	21/1/2008	A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients With Inflammatory Bowel Disease	A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients With Inflammatory Bowel Disease	Crohn's Disease;Ulcerative Colitis;Indeterminate Colitis;Inflammatory Bowel Diseases	Biological: Anti TNF therapy including infliximab;Drug: No Biologics	Janssen Biotech, Inc.	NULL	Active, not recruiting	1 Month	17 Years	All	4970		United States;Canada
118	EUCTR2006-005299-42-FR (EUCTR)	16/05/2007	06/03/2007	A randomized, multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis (CYSIF Study) - CYSIF	A randomized, multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis (CYSIF Study) - CYSIF	- Diagnosis of UC according to Lennard-Jones criteria - Endoscopically demonstrated colorectal lesions localized above the anal margin and extending at least up to 15cm proximally.- Severe acute flare of UC with a Lichtiger Index score > 10.- Refractoriness to high dose intravenous steroid therapy (= 0.8 mg/kg/d of methylprednisolone or equivalent) given for at least 5 days. MedDRA version: 9.1;Level: LLT;Classification code 10045282;Term: UC	Trade Name: REMICADE INN or Proposed INN: INFLIXIMAB INN or Proposed INN: CICLOSPORIN Other descriptive name: SANDINUM INN or Proposed INN: CICLOSPORIN Other descriptive name: NEORAL Trade Name: CYCLOSPORIN Trade Name: CYCLOSPORIN	GETAID	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	100		Finland;Belgium;France;Spain
119	EUCTR2006-000410-20-BE (EUCTR)	18/04/2007	11/01/2007	A Phase 3, Randomized, Open-label, Parallel-group, Multicenter Trial to Evaluate the Safety and Efficacy of Infliximab (REMICADE®) in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis	A Phase 3, Randomized, Open-label, Parallel-group, Multicenter Trial to Evaluate the Safety and Efficacy of Infliximab (REMICADE®) in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative colitis MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Remicade INN or Proposed INN: infliximab	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 3	Netherlands;Denmark;Belgium;Italy
120	NCT00336492 (ClinicalTrials.gov)	September 2006	9/6/2006	A Study of the Safety and Efficacy of Infliximab(REMICADE ) in Pediatric Patients With Moderately to SeverelyActive Ulcerative Colitis	A Phase 3, Randomized, Open-label, Parallel-group, Multicenter Trial to Evaluate the Safety and Efficacy of Infliximab (REMICADE?) in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis	Biological: infliximab	Centocor, Inc.	NULL	Completed	6 Years	17 Years	All	60	Phase 3	United States;Belgium;Canada;Denmark;Netherlands
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
121	NCT00207688 (ClinicalTrials.gov)	August 31, 2004	13/9/2005	A Long Term Safety Study of Infliximab (Remicade) in in Ulcerative Colitis Patients	A Multicenter International Study of the Long-term Safety of Infliximab (REMICADE) in Ulcerative Colitis	Ulcerative Colitis	Drug: Infliximab 5 mg/kg;Drug: Infliximab 10 mg/kg;Drug: Placebo	Janssen Research & Development, LLC	Janssen Biologics BV	Completed	N/A	N/A	All	505		New Zealand;Switzerland;United Kingdom;Argentina;Australia;Austria;Belgium;Canada;Czechia;Denmark;France;Germany;Israel;Netherlands;United States;Czech Republic
122	NCT00096655 (ClinicalTrials.gov)	May 2002	12/11/2004	A Safety and Efficacy Study for Infliximab (Remicade) in Patients With Ulcerative Colitis	A Randomized, Placebo-controlled, Double-blind Trial to Evaluate the Safety and Efficacy of Infliximab in Patients With Active Ulcerative Colitis	Ulcerative Colitis	Drug: Infliximab	Centocor, Inc.	NULL	Completed	18 Years	N/A	Both	364	Phase 3	NULL
123	NCT00036439 (ClinicalTrials.gov)	February 2002	10/5/2002	A Safety and Efficacy Study for Infliximab (Remicade) in Patients With Active Ulcerative Colitis	A Randomized, Placebo-controlled, Double-blind Trial to Evaluate the Safety and Efficacy of Infliximab in Patients With Active Ulcerative Colitis	Ulcerative Colitis	Drug: Infliximab	Centocor, Inc.	NULL	Completed	18 Years	N/A	Both	364	Phase 3	United States;Belgium
124	JPRN-JapicCTI-060298		24/08/2006	Clinical study to assess the efficacy and safety of TA-650 in patients with active ulcerative colitis	Clinical study to assess the efficacy and safety of TA-650 in patients with active ulcerative colitis	Ulcerative colitis	Intervention name : TA-650 (Infliximab) Dosage And administration of the intervention : Intravenous drip infusion	Mitsubishi Tanabe Pharma Corporation	NULL		16		BOTH		Phase 3	NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2020-001811-26-NL
(EUCTR)

30/09/2020

08/07/2020

IBD under control with less medication

De-escalation of anti-TNF therapy in adolescents and young adults with IBD with tight faecal calprotectin and trough level monitoring - FREE-study

Crohn's disease, ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

University Medical Center Groningen

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 4

Netherlands

NCT04205643
(ClinicalTrials.gov)

September 2, 2020

18/12/2019

CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Ulcerative Colitis

A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis

Biological: CT-P13 SC (Infliximab);Other: Placebo SC

Celltrion

NULL

Recruiting

18 Years

75 Years

All

615

Phase 3

Poland

NCT04331639
(ClinicalTrials.gov)

September 2020

23/3/2020

High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Biologic Therapy

Implementation of High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Infliximab or Vedolizumab

Inflammatory Bowel Disease;Crohn Disease;Ulcerative Colitis;Vitamin D Deficiency

Dietary Supplement: vitamin D3

Boston Children's Hospital

NULL

Not yet recruiting

5 Years

25 Years

All

Phase 2

NULL

EUCTR2019-004652-11-SI
(EUCTR)

28/08/2020

31/08/2020

A Study of Etrolizumab-Based Induction Therapy Combinations Followed by Etrolizumab Maintenance Therapy in Patients with Moderate-To-Severe Ulcerative Colitis

RANDOMIZED, OPEN-LABEL PHASE 3B STUDY OF ETROLIZUMAB BASED INDUCTION THERAPY COMBINATIONS FOLLOWED BY ETROLIZUMAB MAINTENANCE THERAPY IN PATIENTS WITH MODERATE-TO-SEVERE ULCERATIVE COLITIS - Lantana

Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Etrolizumab
Product Code: RO5490261/F04-02
INN or Proposed INN: Etrolizumab
Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Other descriptive name: INFLIXIMAB
Trade Name: Xeljanz
INN or Proposed INN: TOFACITINIB
Other descriptive name: TOFACITINIB
Trade Name: Xeljanz
INN or Proposed INN: TOFACITINIB
Other descriptive name: TOFACITINIB
Trade Name: Stelara
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

372

Phase 3

Serbia;United States;Slovakia;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;Switzerland;France;Latvia;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Germany

EUCTR2019-003849-15-HR
(EUCTR)

05/06/2020

20/11/2020

Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis

A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis

Moderately to Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Remsima
Product Code: Remsima (CT-P13)
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB

Celltrion, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

615

Phase 3

United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Czechia;Turkey;Austria;Hungary;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-003849-15-ES
(EUCTR)

12/05/2020

28/02/2020

Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis

A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis

Trade Name: Remsima
Product Code: Remsima (CT-P13)
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB

Celltrion, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

615

Phase 3

United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany

EUCTR2019-003849-15-BG
(EUCTR)

03/04/2020

07/02/2020

Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis

A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis

Trade Name: Remsima
Product Code: Remsima (CT-P13)
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB

Celltrion, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

615

Phase 3

Serbia;Belarus;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;Italy;France;Czech Republic;Mexico;Poland;Croatia;Peru;South Africa;Bulgaria;Germany;Latvia;Moldova, Republic of

EUCTR2019-003849-15-GR
(EUCTR)

03/04/2020

02/04/2020

Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis

A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis

Trade Name: Remsima
Product Code: Remsima (CT-P13)
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB

Celltrion, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

615

Phase 3

United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany

EUCTR2019-003849-15-FR
(EUCTR)

03/04/2020

03/02/2020

Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis

A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis

Trade Name: Remsima
Product Code: Remsima (CT-P13)
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB

Celltrion, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

615

Phase 3

United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany

EUCTR2018-003524-36-IE
(EUCTR)

25/03/2020

05/11/2019

Randomized, mulitcenter study to investigate how infliximab dosing calculated by a computer compares to the standard dosing during the induction of infliximab in patients with severe colitis ulcerosa.

Randomized, Multicenter Study to Investigate the Efficacy of Dashboard Driven Individualized Dosing of Infliximab Compared To Standard Dosing During the Induction in Patients with Acute Severe Ulcerative Colitis - TITRATE

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Remicade
Product Name: NA
Product Code: NA
INN or Proposed INN: INFLIXIMAB
Trade Name: Metoject
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE DISODIUM
Trade Name: Puri-Nethol
INN or Proposed INN: MERCAPTOPURINE
Trade Name: Remsima
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
INN or Proposed INN: INFLIXIMAB
Trade Name: Flixabi
INN or Proposed INN: INFLIXIMAB

UMC Amsterdam location AMC

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

124

Phase 4

Ireland;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-003849-15-AT
(EUCTR)

20/03/2020

06/02/2020

Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis

A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis

Trade Name: Remsima
Product Code: Remsima (CT-P13)
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB

Celltrion, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

615

Phase 3

United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany

EUCTR2019-003068-39-NL
(EUCTR)

20/11/2019

04/11/2019

Withdrawal of Infliximab in patients with inflammatory bowel disease in remission guided by pharmacokinetics: WINK study - WINK study

Inflammatory Bowel Disease (IBD) Ulcerative colitis Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Infliximab
Product Name: Infliximab
INN or Proposed INN: INFLIXIMAB

UMC Utrecht

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Netherlands

NCT03885713
(ClinicalTrials.gov)

September 10, 2019

4/3/2019

Identification of Predictive Biomarkers for Response to Biologic Therapies in Inflammatory Bowel Disease

Identification of Predictive Biomarkers for Response to Biologic Therapies in Inflammatory Bowel Disease by Proteomic and Mass Cytometry Approaches

Inflammatory Bowel Diseases;Crohn Disease;Ulcerative Colitis

Biological: Infliximab or adalimumab or golimumab or vedolizumab or ustekinumab

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

NULL

Recruiting

18 Years

N/A

All

180

Phase 4

Spain

NCT03937609
(ClinicalTrials.gov)

September 4, 2019

30/4/2019

TITRATE (inducTIon for acuTe ulceRATivE Colitis)

Colitis, Ulcerative

Drug: Infliximab

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Pfizer

Recruiting

18 Years

N/A

All

120

Phase 4

Netherlands

EUCTR2018-003524-36-NL
(EUCTR)

25/04/2019

19/11/2018

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

UMC Amsterdam location AMC

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2018-004587-61-NL
(EUCTR)

23/04/2019

13/05/2019

Characterization of lipid changes in patients with ulcerative colitis treated with tofactinib or infliximab

Deep profiling of lipid changes in patients with active ulcerative colitis treated with either tofacitinib or infliximab - LIPID

Ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Erasmus Medical Center

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Netherlands

NCT03884439
(ClinicalTrials.gov)

March 18, 2019

4/3/2019

Infliximab Biosimilar Pfizer Drug Use Investigation (Crohn's Disease or Ulcerative Colitis)

Infliximab BS for Intravenous Drip Infusion 100 mg Pfizer General Investigation (Crohn's Disease or Ulcerative Colitis)

Crohn's Disease;Ulcerative Colitis

Drug: Infliximab [infliximab biosimilar 3]

Pfizer

NULL

Recruiting

N/A

All

300

Japan

NCT03942861
(ClinicalTrials.gov)

February 21, 2019

25/4/2019

Sonographic Assessment in Severe Ulcerative Colitis Patients Admitted for Intravenous Corticosteroids and Eligible for Infliximab Rescue Therapy; a Prospective Clinician-blinded Observational Study Protocol.

Ulcerative Colitis;Ultrasound Therapy; Complications

Drug: Solu-Medrol

Copenhagen University Hospital at Herlev

NULL

Recruiting

18 Years

70 Years

All

Denmark

EUCTR2017-004496-31-PL
(EUCTR)

30/01/2019

06/12/2018

A Study of the Efficacy and Safety of Golimumab in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis

A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB
Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB
Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB
Trade Name: Remicade
Product Name: Infliximab
Product Code: CNTO312
INN or Proposed INN: INFLIXIMAB

Janssen Biologics BV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

125

Phase 3

United States;France;Taiwan;Spain;Brazil;Belgium;Poland;Israel;Netherlands;Italy;Korea, Republic of

NCT03679546
(ClinicalTrials.gov)

January 4, 2019

18/9/2018

EFFICACI : EFFicacy of Intravenous Infliximab Versus Vedolizumab After Failure of subCutaneous Anti-TNF in Patients With UlCerative Colitis

EFFICACI : EFFicacy of Intravenous Infliximab Versus Vedolizumab After Failure of subCutaneous Anti-TNF in Patients With UlCerative Colitis : A Double Blinded Randomized Clinical Trial

Ulcerative Colitis

Drug: Infliximab;Drug: Vedolizumab Injection

Rennes University Hospital

NULL

Recruiting

18 Years

75 Years

All

150

Phase 4

France

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03765450
(ClinicalTrials.gov)

December 21, 2018

4/12/2018

Pharmacokinetics of IFX and TNF Concentrations in Serum, Stool, and Colonic Mucosa in Acute Severe Ulcerative Colitis

Pharmacokinetics of Infliximab and Tumor Necrosis Factor Concentrations in Serum, Stool, and Colonic Mucosa in Acute Severe Ulcerative Colitis

Ulcerative Colitis

Drug: Infliximab

Robarts Clinical Trials Inc.

NULL

Recruiting

18 Years

N/A

All

United States;Canada

EUCTR2017-004496-31-BE
(EUCTR)

07/11/2018

25/07/2018

A Study of the Efficacy and Safety of Golimumab in Pediatric Participantswith Moderately to Severely Active Ulcerative Colitis

A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFaMonoclonal Antibody, Administered Subcutaneously in PediatricParticipants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2

Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB
Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB
Trade Name: Remicade
Product Name: Infliximab
INN or Proposed INN: INFLIXIMAB

Janssen Biologics BV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

125

Phase 3

France;United States;Taiwan;Poland;Brazil;Spain;Belgium;Israel;Netherlands;Italy;Korea, Republic of

NCT03596645
(ClinicalTrials.gov)

October 29, 2018

13/7/2018

A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis

A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety, and Pharmacokinetics of Golimumab Treatment, a Human Anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis

Colitis, Ulcerative

Drug: Golimumab;Drug: Infliximab

Janssen Research & Development, LLC

NULL

Recruiting

2 Years

17 Years

All

125

Phase 3

United States;Belgium;Brazil;France;Israel;Italy;Korea, Republic of;Netherlands;Poland;Spain;Taiwan

EUCTR2017-004496-31-ES
(EUCTR)

15/10/2018

28/08/2018

A Study of the Efficacy and Safety of Golimumab in Pediatric Participantswith Moderately to Severely Active Ulcerative Colitis

A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFaMonoclonal Antibody, Administered Subcutaneously in PediatricParticipants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2

Janssen Biologics BV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

125

Phase 3

France;United States;Taiwan;Poland;Brazil;Belgium;Spain;Israel;Netherlands;Italy;Korea, Republic of

EUCTR2018-002673-21-FR
(EUCTR)

04/09/2018

06/07/2018

EFFICACI : EFFicacy of intravenous Infliximab versus vedolizumab after failure of subCutaneous Anti-TNF in patients with UlCerative colitis : A double blinded Randomized Clinical Trial.

EFFICACI : EFFicacy of intravenous Infliximab versus vedolizumab after failure of subCutaneous Anti-TNF in patients with UlCerative colitis : A double blinded Randomized Clinical Trial. - EFFICACI

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

Trade Name: Remicade
Product Name: infliximab
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Name: infliximab
INN or Proposed INN: INFLIXIMAB
Trade Name: Flixabi
Product Name: infliximab
INN or Proposed INN: INFLIXIMAB
Trade Name: Remsima
Product Name: infliximab
INN or Proposed INN: INFLIXIMAB
Trade Name: Entyvio
Product Name: Vedolizumab
Other descriptive name: VEDOLIZUMAB

Centre Hospitalier Universitaire de Rennes

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 4

France

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03452501
(ClinicalTrials.gov)

August 26, 2018

26/2/2018

Safety and Effectiveness Study of Remsima® in the Treatment of Inflammatory Bowel Diseases Among Saudi Arabia Patients

Inflammatory Bowel Diseases;Crohn Disease;Fistulizing Crohn's Disease;Ulcerative Colitis

Drug: Infliximab

Hikma Pharmaceuticals LLC

NULL

Active, not recruiting

18 Years

N/A

All

150

Saudi Arabia

EUCTR2017-002108-28-DE
(EUCTR)

25/07/2018

27/03/2018

A study to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06687234/placebo as add-on therapy to infliximab in subjects with ulcerative colitis who are not in remission

A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06687234 AS ADD-ON THERAPY TO INFLIXIMAB IN ACTIVE ULCERATIVE COLITIS SUBJECTS WHO ARE NOT IN REMISSION (BUILD UC) - BUILD UC

Product Name: Dekavil
Product Code: PF-06687234
INN or Proposed INN: PF-06687234
Other descriptive name: F8IL10

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Serbia;Saudi Arabia;Spain;Belgium;Australia;Israel;Germany;Italy;Korea, Republic of

EUCTR2018-001546-33-GB
(EUCTR)

11/07/2018

14/05/2018

The effects of switching one drug, used to treat either Ulcerative Colitis (UC) or Crohn’s disease (CD) to another drug, also used to treat UC or Crohn’s disease

IBD Biosimilar to Biosimilar Infliximab Switching Study - iBiSS v1.0

Trade Name: Flixabi
Product Name: Flixabi
INN or Proposed INN: Infliximab

University Southampton Hospital NHS Foundation Trust

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 4

United Kingdom

NCT03209232
(ClinicalTrials.gov)

April 16, 2018

1/7/2017

Infliximab Accelerated Induction in Moderate to Severe Pediatric UC

Infliximab Accelerated Induction for Moderate to Severe Ulcerative Colitis in Children (INDUCE) Trial

Ulcerative Colitis

Drug: Infliximab

Schneider Children's Medical Center, Israel

NULL

Recruiting

6 Years

18 Years

All

N/A

Israel

EUCTR2017-002108-28-ES
(EUCTR)

12/04/2018

20/04/2018

A study to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06687234/placebo as add-on therapy to infliximab in subjects with ulcerative colitis who are not in remission

Product Name: Dekavil
Product Code: PF-06687234
INN or Proposed INN: Dekavil
Other descriptive name: F8IL10

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Serbia;Saudi Arabia;Belgium;Spain;Australia;Israel;Germany;Italy;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2017-002108-28-BE
(EUCTR)

30/03/2018

22/03/2018

A study to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06687234/placebo as add-on therapy to infliximab in subjects with ulcerative colitis who are not in remission

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Serbia;United States;Saudi Arabia;Spain;Belgium;Australia;Israel;Germany;Italy;Korea, Republic of

NCT03269695
(ClinicalTrials.gov)

December 20, 2017

30/8/2017

Efficacy, Safety and Tolerability of PF-06687234 as Add-on Therapy to Infliximab in Active UC Subjects Not in Remission.

Ulcerative Colitis

Drug: PF-06687234;Drug: Placebo

Pfizer

NULL

Active, not recruiting

18 Years

75 Years

All

Phase 2

United States;Australia;Belgium;Germany;Israel;Italy;Korea, Republic of;Saudi Arabia;Serbia;Turkey;Spain

JPRN-UMIN000027465

2017/05/29

24/05/2017

Efficacy and safety of the biosimilar Infliximab in the patients with ulcerative colitis

Efficacy and safety of the biosimilar Infliximab in the patients with ulcerative colitis - Efficacy and safety of IFX-BS in UC patients

ulcerative colitis

Infliximab (5mg/kg, every 8 weeks, for 12 months)
Biosimilar Infliximab (5mg/kg, every 8 weeks, for 12 months)

University of Toyama

NULL

Complete: follow-up complete

20years-old

Not applicable

Male and Female

Not selected

Japan

NCT03151525
(ClinicalTrials.gov)

May 8, 2017

8/5/2017

Two Therapeutic Strategies for the Maintenance of Remission in Patients With Ulcerative Colitis

Comparison Between Two Therapeutic Strategies for the Maintenance of Clinical and Endoscopic Remission in Patients With Ulcerative Colitis Treated by Infliximab

Colitis, Ulcerative

Drug: Azathioprine;Drug: Infliximab

Istituto Clinico Humanitas

Agenzia Italiana del Farmaco

Recruiting

18 Years

65 Years

All

100

Phase 4

Italy

NCT02994836
(ClinicalTrials.gov)

April 21, 2017

24/10/2016

GIS-SUSANTI-TNF-2015 (Anti-TNF Discontinuation )

Anti-TNF Discontinuation in Patients With Inflammatory Bowel Disease: Multicentre, Prospective, Randomized Clinical Trial and Economic Evaluation

Crohn's Disease;Inflammatory Bowel Disease;Ulcerative Colitis

Biological: Anti-TNF: Infliximab (Infusion);Drug: Anti-TNF discontinuation: Physiological saline solution;Biological: Anti-TNF:Adalimumab (Subcutaneus)

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

NULL

Recruiting

18 Years

N/A

All

194

Phase 4

Spain

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2016-001409-18-NO
(EUCTR)

06/12/2016

09/05/2016

A study to evaluate the safety of stopping versus continuing anti TNF therapy in ulcerative colitis patients in remission, and to evaluate the safety and efficacy of restarting anti TNF therapy in patients with disease recurrence

A prospective, open randomized, parallel-group study to evaluate the outcome of discontinuing or continuing anti-tumor necrosis factor treatment in patients with ulcerative colitis in sustained clinical remission. - The Biostop study

Ulcerative colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: 1.Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Simponi
INN or Proposed INN: GOLIMUMAB

Helse More og Romsdal Hospital Trust

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Norway

NCT02425852
(ClinicalTrials.gov)

December 2016

21/4/2015

A Randomized, Multicenter Open Label Study Comparing Early Administration of Azathioprine Plus IFX to Steroids Plus Azathioprine for Acute Severe Colitis

A Randomized, Multicenter Open Label Study Comparing Early Administration of Azathioprine Plus Infliximab to Corticosteroids Plus Azathioprine for Acute Severe Colitis

Ulcerative Colitis

Drug: Azathioprine;Drug: Infliximab;Drug: Prednisolone;Drug: Hydrocortisone

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

NULL

Recruiting

18 Years

N/A

All

146

Phase 4

France

JPRN-UMIN000024936

2016/11/30

22/11/2016

Efficacy of additional Calcineurin inhibitors in anti TNF-alfa antibody refractory Ulcerative colitis

Ulcerative colitis

patients who received Infliximab continued to treat every 8 week and who received Adalimumab continued to treat every 2 week. Patients received Tacrolimus 0.5mg2Cap par day at day0. Day0 is day of first anti TNF-alfa antibody treat after participate this study. We control Tacrolimus trough levels 3 to 5 mg/ml.

Keio University Gastroenterology and Hepatology

NULL

Recruiting

16years-old

150years-old

Male and Female

Not selected

Japan

EUCTR2016-002061-54-IT
(EUCTR)

13/10/2016

15/11/2018

Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases.

Trade Name: REMSIMA - 100 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLANCONCINO (VETRO) - 1 FLACONCINO
Product Name: Remsima
Product Code: 42942019

UNIVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLI

NULL

Not Recruiting

Female: yes
Male: yes

250

Phase 4

Italy

EUCTR2014-004904-31-BE
(EUCTR)

21/09/2016

29/07/2016

Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA).;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Remsima (infliximab)

Mundipharma Pharmaceuticals B.V.

NULL

Not Recruiting

Female: yes
Male: yes

156

Phase 4

Belgium;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT02770040
(ClinicalTrials.gov)

July 2016

9/5/2016

Optimising Infliximab Induction Therapy for Acute Severe Ulcerative Colitis

PREDICT UC: Optimising Infliximab Induction Therapy for Acute Severe Ulcerative Colitis - A Randomised Controlled Trial

Ulcerative Colitis

Drug: Infliximab

Austin Health

University of Melbourne

Recruiting

18 Years

80 Years

All

138

Phase 4

Australia

EUCTR2016-001278-13-FI
(EUCTR)

08/06/2016

15/04/2016

Immunologic, genetic and bowel microbes as predictors of the treatment response for TNFalpha-blocking drugs in patients with Crohn’s disease or ulcerative colitis

Trade Name: Remsima
Product Name: Remsima
INN or Proposed INN: INFLIXIMAB

Taina Sipponen

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 4

Finland

EUCTR2015-004618-10-BE
(EUCTR)

19/04/2016

20/11/2015

PhArmaCo-kinetics of InFliximab during treatment Induction

Study of the inter-individual variation of PhArmaCo-kinetics of InFliximab during treatment Induction in patients with Crohn’s disease and Ulcerative Colitis

Patients with Crohn disease or Ulcerative Colitis which need biotherapy (antibody against TNF-a);Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

CUB- Hopital Erasme

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Belgium

EUCTR2015-001954-14-NL
(EUCTR)

14/09/2015

25/08/2015

Efficacy and safety of Infliximab-biosimilar (Inflectra) compared to Infliximab-innovator (Remicade) in patients with inflammatory bowel disease in remission: the SIMILAR Trial”

Santeon

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Netherlands

JPRN-UMIN000018745

2015/09/01

01/09/2015

The Efficacy of Enternal Nutrition in Active Ulcerative Colitis Patients with Hypoalbuminemia ,during Infliximab Therapy

ulcerative colitis

Administration of Infliximab and enteral nutrition
Administration of Infliximab

Nagoya University Graduate School of Medicine, Department of Gastroentrology and hepatology

NULL

Pending

15years-old

75years-old

Male and Female

Not selected

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2014-004904-31-NL
(EUCTR)

19/05/2015

26/01/2015

Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA).;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Remsima (infliximab)

Mundipharma Pharmaceuticals B.V.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Netherlands

NCT02413047
(ClinicalTrials.gov)

May 2015

6/3/2015

Evaluate if Response to Infliximab or Adalimumab May be Regained With an Immunomodulator

A Pilot Study to Evaluate if Response to Infliximab or Adalimumab May be Regained With the Addition of an Immunomodulator

Inflammatory Bowel Disease;Ulcerative Colitis;Crohn's Disease

Drug: Azathioprine;Drug: 6 mercaptopurine;Drug: Methotrexate

Indiana University

NULL

Terminated

18 Years

80 Years

All

N/A

United States

NCT02539368
(ClinicalTrials.gov)

April 22, 2015

22/7/2015

Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Inflammatory Bowel Disease

POST-MARKETING OBSERVATIONAL COHORT STUDY OF PATIENTS WITH INFLAMMATORY BOWEL DISEASE (IBD) TREATED WITH CT-P13 IN USUAL CLINICAL PRACTICE (CONNECT-IBD)

Inflammatory Bowel Diseases;Ulcerative Colitis;Crohn's Disease

Drug: CT-P13;Drug: Remicade

Pfizer

Hospira, now a wholly owned subsidiary of Pfizer

Completed

18 Years

N/A

All

2565

Belgium;Czechia;Finland;France;Germany;Greece;Hungary;Italy;Netherlands;Portugal;Slovakia;Spain;United Kingdom;Czech Republic;Ireland

EUCTR2013-004282-14-NL
(EUCTR)

13/01/2015

04/08/2014

A study of the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in ulcerative colitis patients who have not previously received TNF inhibitors

PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA

Product Name: Etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

720

Phase 3

Portugal;Philippines;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Vietnam;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Netherlands;Germany;Norway;Sweden;Korea, Republic of

EUCTR2013-004282-14-PT
(EUCTR)

09/01/2015

23/07/2014

A study to evaluate the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in patients with moderate to severe ulcerative colitis who have not previously received TNF inhibitors

PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

390

Phase 3

Portugal;Philippines;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;Vietnam;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Norway;Netherlands;Germany;Korea, Republic of;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT02136069
(ClinicalTrials.gov)

December 24, 2014

15/4/2014

A Study Comparing the Efficacy and Safety of Etrolizumab to Infliximab in Participants With Moderate to Severe Ulcerative Colitis Who Are Naïve to Tumor Necrosis Factor (TNF) Inhibitors

Phase III, Randomized, Multicenter Double-Blind, Double Dummy Study to Evaluate the Efficacy and Safety of Etrolizumab Compared With Infliximab in Patients With Moderate to Severe Active Ulcerative Colitis Who Are Naive to TNF Inhibitors

Ulcerative Colitis

Drug: Etrolizumab;Drug: Infliximab;Other: Placebo (IV);Other: Placebo (Injection)

Hoffmann-La Roche

NULL

Completed

18 Years

80 Years

All

397

Phase 3

Austria;Belgium;Canada;Czechia;France;Germany;Hungary;Israel;Italy;Korea, Republic of;Netherlands;Norway;Portugal;Romania;Singapore;South Africa;Spain;Sweden;Switzerland;United Kingdom;Czech Republic;Philippines;Vietnam

EUCTR2013-004282-14-BE
(EUCTR)

11/12/2014

27/08/2014

PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA

Product Name: Etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

390

Phase 3

Portugal;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Norway;Netherlands;Germany;Korea, Republic of;Sweden

EUCTR2013-004282-14-ES
(EUCTR)

25/11/2014

06/08/2014

A study of the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in ulcerative colitis patients who have not previously received TNF inhibitors

Ulcerative Colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB

Roche Farma S.A. en nombre de F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

720

Phase 3

Portugal;Philippines;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;Vietnam;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Norway;Netherlands;Germany;Korea, Republic of;Sweden

EUCTR2013-004282-14-IT
(EUCTR)

10/11/2014

16/09/2014

A study of the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in ulcerative colitis patients who have not previously received TNF inhibitors

Product Name: Etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

720

Phase 3

EUCTR2013-004282-14-DE
(EUCTR)

10/11/2014

18/07/2014

Product Name: Etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

390

Phase 3

Portugal;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Germany;Netherlands;Norway;Sweden;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2013-004282-14-HU
(EUCTR)

29/10/2014

30/10/2014

PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA

Product Name: Etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

390

Phase 3

Portugal;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;Canada;Belgium;Singapore;Romania;South Africa;Germany;Netherlands;Norway;Sweden;Korea, Republic of

EUCTR2013-004282-14-NO
(EUCTR)

17/10/2014

04/08/2014

A study of the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in ulcerative colitis patients who have not previously received TNF inhibitors

Product Name: Etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

720

Phase 3

Portugal;Philippines;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Vietnam;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Norway;Germany;Netherlands;Sweden;Korea, Republic of

NCT02148640
(ClinicalTrials.gov)

October 2014

23/5/2014

The NOR-SWITCH Study

Rheumatoid Arthritis;Spondyloarthritis;Psoriatic Arthritis;Ulcerative Colitis;Crohn's Disease;Psoriasis Chronic

Drug: Innovator infliximab;Drug: Biosimilar infliximab

Diakonhjemmet Hospital

South-Eastern Norway Regional Health Authority

Completed

18 Years

N/A

All

482

Phase 4

Norway

EUCTR2013-004282-14-GB
(EUCTR)

29/09/2014

15/07/2014

PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA

Product Name: Etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

390

Phase 3

Portugal;Spain;Austria;Israel;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Germany;Netherlands;Norway;Sweden;Korea, Republic of

EUCTR2013-004282-14-CZ
(EUCTR)

16/09/2014

18/07/2014

PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA

Product Name: Etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

390

Phase 3

Portugal;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Norway;Netherlands;Germany;Korea, Republic of;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

JPRN-UMIN000015068

2014/09/05

05/09/2014

An open label randomized controlled trial of GMA and Infliximab in intractable ulcerative colitis

Ulcerative colitis

Infliximab will be administered intravenously at the dose of 5 mg/kg at 0, 2, 6 weeks
GMA will be administrated 10 times

Hiroshima University Hospital, Department of Endoscopy

NULL

Enrolling by invitation

20years-old

Not applicable

Male and Female

150

Not applicable

Japan

EUCTR2013-004282-14-AT
(EUCTR)

03/09/2014

22/07/2014

A study to evaluate the effectiveness (efficacy) and safety of Etrolizumabcompared with Infliximab in patients with moderate to severe ulcerativecolitis who have not previously received TNF inhibitors

Product Name: Etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

390

Phase 3

Portugal;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Germany;Netherlands;Norway;Sweden;Korea, Republic of

EUCTR2014-002056-40-NO
(EUCTR)

12/08/2014

13/06/2014

A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SWITCHING FROM INNOVATOR INFLIXIMAB TO BIOSIMILAR INFLIXIMAB COMPARED WITH CONTINUED TREATMENT WITH INNOVATOR INFLIXIMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS, SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, ULCERATIVE COLITIS, CROHN’S DISEASEAND CHRONIC PLAQUE PSORIASISTHE NOR-SWITCH STUDY - NOR_SWITCH

Trade Name: Remicade 100 mg pulver til konsentrat til infusjonsvæske, oppløsning
Trade Name: Remsima 100 mg pulver til konsentrat til infusjonsvæske, oppløsning

Diakonhjemmet Hospital AS

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Norway

EUCTR2013-004282-14-FR
(EUCTR)

28/07/2014

22/06/2015

A study of the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in ulcerative colitis patients who have not previously received TNF inhibitors

Ulcerative Colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

720

Phase 3

JPRN-UMIN000014275

2014/06/24

24/06/2014

Efficacy of infliximab for refractory pouchitis with complexed anal fistula

ulcerative colitis

infliximab

Hyogo College of Medicine

NULL

Complete: follow-up complete

Not applicable

Male and Female

Phase 1

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

JPRN-UMIN000013716

2014/04/15

15/04/2014

A study of infliximab administration method for tacrolimus-resistant active ulcerative colitis

ulcerative colitis

After administrating tacrolimus and infliximab for 6 weeks,tacrolimus is tapered to 0mg.
Infliximab monotherapy

Yokohama City University Medical Center

NULL

Complete: follow-up complete

16years-old

Not applicable

Male and Female

Phase 2

Japan

NCT01960426
(ClinicalTrials.gov)

April 2014

25/9/2013

Evaluation of Health Costs and Resource Utilization

A Randomized Evaluation of Health Costs and Resource Utilization Comparing Testing-Based Therapy to Empiric Dose Intensification for the Management of Inflammatory Bowel Disease.

Ulcerative Colitis;Crohn's Disease

Other: Measurement of drug (Adalimumab/Infliximab);Other: Intensify treatment with the existing drug

University of Western Ontario, Canada

Prometheus Laboratories

Terminated

18 Years

N/A

Both

Phase 4

United States

EUCTR2013-002651-15-NL
(EUCTR)

03/03/2014

18/09/2013

Adjusting the amount of medication (infliximab) in patients suffering from inflammatory bowel disease, using medication levels in blood.

Adjusting infliximab dose in IBD patients in remission, based on infliximab trough levels: the study on Infliximab Levels in IBD patients Steering Treatment, the ILIST pilot - ILIST-study

Trade Name: Remicade (infliximab)
Product Name: infliximab

Zon MW

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Netherlands

JPRN-UMIN000013033

2014/02/01

01/02/2014

Examination of the early clinical and endoscopic views change after infliximab administration in the ulcerative colitis.

Ulcerative colitis

Study start - 14 weeks:5mg/kg of Infliximab for 0.2.6.14 week, respectively ( initial administration day with 0 weeks)

Department of Internal Medicine,Juntendo University

NULL

Pending

20years-old

Not applicable

Male and Female

Not selected

Japan

EUCTR2011-001332-29-AT
(EUCTR)

02/12/2013

07/11/2013

The degradation and elimination of Infliximab

Pharmacokinetics of Infliximab

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
Other descriptive name: Remicade

Universitätsklinik für Innere Medizin III, Klinische Abteilung für Gastroenterologie und Hepatologie

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Austria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT01971814
(ClinicalTrials.gov)

November 2013

17/10/2013

Early Serum Infliximab Levels in Severe Ulcerative Colitis.

Early Serum Infliximab Levels in Severe Ulcerative Colitis

Ulcerative Colitis (UC);Inflammatory Bowel Disease

Drug: Infliximab

University of California, San Francisco

NULL

Completed

18 Years

N/A

Both

Phase 1

United States

JPRN-UMIN000013370

2013/06/07

07/03/2014

Efficacy of infliximab therapy for refractory pouchitis

ulcerative colitis, pouchitis

infliximab

Inflammatory bowel disease center, Hyogo college of medicine

NULL

Complete: follow-up complete

18years-old

80years-old

Male and Female

Phase 1

Japan

JPRN-UMIN000013371

2013/06/05

07/03/2014

Efficacy of infliximab therapy for arthritis after restorative proctocolectomy in patients with ulcerative colitis

ulcerative colitis

infliximab

Hyogo college of medicine

NULL

Complete: follow-up complete

20years-old

80years-old

Male and Female

Not selected

Japan

JPRN-UMIN000010612

2013/05/01

01/05/2013

A comparative study of the efficacy of tacrolimus with infliximab in intractable ulcerative colitis

Ulcerative colitis

Tacrolimus will be administered orally for 10 weeks at the trough level of 10-15 ng/ml for the first 2 weeks following that of 5-10 ng/ml for the rest of the study period.
Infliximab will be administered intravenously at the dose of 5 mg/kg at 0, 2, 6 weeks.

Department of Internal Medicine, Division of Gastroenterology and Hepatology, Keio University School of Medicine

NULL

Complete: follow-up complete

20years-old

Not applicable

Male and Female

130

Phase 4

Japan

NCT02073526
(ClinicalTrials.gov)

May 2013

9/1/2014

Anti-TNF-alpha Trough Level Measurements in Inflammatory Bowel Disease

Inflammatory Bowel Disease;Crohn's Disease;Ulcerative Colitis

Drug: Infliximab, adalimumab, certolizumab pegol

Oslo University Hospital

NULL

Completed

18 Years

N/A

Both

1230

N/A

Norway

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT01846026
(ClinicalTrials.gov)

April 2013

30/4/2013

Ulcerative Colitis and Vitamin D Supplementation

Immunomodulating and Clinical Effects of Vitamin D on Remission Induction in Patients With Moderate and Severe Ulcerative Colitis, Undergoing Treatment With Infliximab.

Ulcerative Colitis

Drug: Vitamin D;Drug: placebo

University Hospital of North Norway

NULL

Withdrawn

18 Years

N/A

Both

Phase 1;Phase 2

Norway

NCT01804166
(ClinicalTrials.gov)

March 21, 2013

1/2/2013

A Research Study to Bank Samples for Future Evaluation to Identify Biomarkers That Predispose Crohn's Disease and Ulcerative Colitis Patients to Develop Hepatosplenic T-Cell Lymphoma (HSTCL)

Hepatosplenic T-Cell Lymphoma

Drug: Infliximab;Drug: Golimumab

Janssen Scientific Affairs, LLC

NULL

Completed

N/A

All

Phase 4

United States

EUCTR2011-006084-22-GB
(EUCTR)

04/10/2012

15/08/2012

Usefulness of the measurement of blood levels of infliximab and adalimumab in inflammatory bowel disease patients in predicting response to treatment

Utilising drug levels and anti-drug antibodies to predict response to treatment in patients with Inflammatory Bowel Disease - Trough levels of anti-TNF agents in inflammatory bowel disease

Trade Name: Remicade
Product Name: Infliximab
INN or Proposed INN: Infliximab
Trade Name: Humira
Product Name: adalimumab
INN or Proposed INN: Adalimumab

Royal Liverpool University Hospital

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

United Kingdom

JPRN-UMIN000015297

2012/09/19

01/10/2014

The feasibility study of accelated infliximab infusion from initial administration

The feasibility study of accelated infliximab infusion from initial administration - The feasibility study of accelated infliximab infusion from initial administration

patient in whom infliximab is indicated(rheumatoid arthritis, Crohn's disease, Ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis)

Chiba University Hospital

NULL

Recruiting

20years-old

70years-old

Male and Female

Phase 2

Japan

JPRN-UMIN000007806

2012/06/01

01/05/2012

The feasibility study of accelated infliximab infusion during maintenance phase

patient in whom infliximab is indicated(rheumatoid arthritis, Crohn's disease, Ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis)

Chiba University Hospital

NULL

Complete: follow-up complete

Not applicable

Male and Female

Phase 2

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT01551290
(ClinicalTrials.gov)

April 2012

7/3/2012

A Study to Evaluate the Effectiveness and Safety of Infliximab in Chinese Patients With Active Ulcerative Colitis

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Infliximab in Chinese Subjects With Active Ulcerative Colitis

Ulcerative Colitis

Drug: Infliximab;Drug: Placebo

Xian-Janssen Pharmaceutical Ltd.

NULL

Completed

18 Years

65 Years

Both

Phase 3

China

JPRN-UMIN000007341

2012/02/01

21/02/2012

The study of the effectiveness of maintenance treatment with infliximab for ulcerative colitis patients who respond to induction treatment with infliximab

The study of the effectiveness of maintenance treatment with infliximab for ulcerative colitis patients who respond to induction treatment with infliximab - The study of the effectiveness of maintenance treatment with infliximab for ulcerative colitis patients who respond to induction treatment with infliximab

ulcerative colitis

Patients in maintenance group receive intravenous infusion of infliximab (5mg/kg) at week 0, 2, and 6 and then every 8 weeks (up to week 54).
Patients in discontinuation group receive intravenous infusion of infliximab (5mg/kg) at week 0, 2, and 6 (not receiving infliximab at week 14, 22, 30, 38, 46 and 54).

Tohoku University Graduate School of Medicine (Tohoku University Hospital)

NULL

Complete: follow-up complete

20years-old

Not applicable

Male and Female

Not applicable

Japan

JPRN-UMIN000006141

2011/10/01

12/08/2011

Comparative study of Infliximab monotherapy vs combined therapy with azathiopurine for inducing and maintaining clinical remission in steroid-dependent or -resistant ulcerative colitis

ulcerative colitis

Patients in Infliximab monotherapy receive intravenous infusion of IFX at week 0, 2, and 6, and then every 8 weeks (up to week 54).
Patients in the combination therapy of Infliximab and azathiopurine receive intravenous infusion of IFX (at week 0, 2, 6, and then every 8 weeks) and oral azathiopurine (up to week 54).

Department of Gastroenterology and Hepatology, Kyoto University Hospital

NULL

Complete: follow-up complete

16years-old

75years-old

Male and Female

Not applicable

Japan

EUCTR2011-002061-38-BE
(EUCTR)

29/06/2011

08/06/2011

Treating patients with infliximab based on their trough levels

A randomised prospective trough level monitoring study with real-time therapeutic adaptations: Trough level Adapted infliXImab Treatment scheme (TAXIT). - TAXIT

Trade Name: Remicade
Product Name: Remicade
Product Code: Remicade
INN or Proposed INN: INFLIXIMAB

Katholieke Universiteit Leuven

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Belgium

NCT01346826
(ClinicalTrials.gov)

May 2011

2/5/2011

Safety of Accelerated Infliximab Infusions in Patients With Inflammatory Bowel Disease (IBD)

Safety of Accelerated Infliximab Infusions in Patients With Inflammatory Bowel Disease: A Prospective, Randomized, Double-Blind, Controlled Trial

Crohn's Disease;Ulcerative Colitis

Drug: Standard 2 hours-infusion;Drug: Accelerated 1 hour-infusion;Drug: Accelerated 30 minutes-infusion

Asan Medical Center

NULL

Completed

16 Years

80 Years

Both

145

Phase 4

Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT01408810
(ClinicalTrials.gov)

February 2011

20/7/2011

Evaluation of Histologic and Endoscopic Remission Induced by Infliximab in Moderate to Severe Ulcerative Colitis

Histological and Endoscopic Evaluation of Remission Induced by Infliximab in Moderately to Severely Active Ulcerative Colitis Patients

Ulcerative Colitis

Drug: Infliximab

Grupo de Estudo da Doença Inflamatória Intestinal

NULL

Completed

18 Years

64 Years

Both

Phase 4

Portugal

EUCTR2009-013890-16-PT
(EUCTR)

28/05/2010

21/12/2009

Herica - Histological and Endoscopic evaluation of Remission induced by Infliximab in moderately to severely active ulcerative Colitis Patients - Herica

This national, multi-centre, open-label pilot study will assess the histologic remission in patients with moderate to severe active ulcerative colitis under infliximab treatment who have had an inadequate response to conventional therapy.Biopsies will be analyzed throughout the study in order to assess histological disease modifying effects in those patients.
MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856

Trade Name: Remicade
Product Name: Remicade

GEDII - Grupo de Estudo da Doença inflamatória Intestinal

NULL

Not Recruiting

Female: yes
Male: yes

Portugal

EUCTR2008-005237-30-NL
(EUCTR)

01/12/2009

18/08/2009

A Multicenter, Prospective, Long-term Registry of children with Crohn's Disease or Ulcerative Colitis

A Multicenter, Prospective, Long-term Registry of Pediatric Patients with Crohn's Disease or Ulcerative Colitis - DEVELOP

Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Other descriptive name: Remsima and Inflectra

Janssen Biologics B.V.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

6000

United States;Canada;Netherlands;Sweden

NCT00984568
(ClinicalTrials.gov)

November 2009

24/9/2009

Conventional Step-Up Versus Infliximab Monotherapy in Patients With Ulcerative Colitis (P05553)

Conventional Step-Up Versus Infliximab Monotherapy in Patients With Active Moderate to Severe Ulcerative Colitis. A Randomized, Open Label, Prospective, Multicenter Study

Colitis, Ulcerative

Biological: Infliximab;Drug: Prednisolone;Drug: 5-aminosalicylic acid;Drug: Azathioprine

Merck Sharp & Dohme Corp.

NULL

Terminated

18 Years

N/A

All

Phase 3

Germany

EUCTR2009-015649-21-NO
(EUCTR)

21/10/2009

16/09/2009

Immunmodulating and clinical effect of vitamin D onthe induction of remission in the patients with moderate to severe ulcerative colitis under the treatment with Infliximab.

Ulcerative colitis

Trade Name: Dekristol
Product Name: cholecalciferol
Product Code: na

Medical clinic, University Hospital of North Norway

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

Norway

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT02322008
(ClinicalTrials.gov)

September 2009

17/12/2014

Anti-TNF Therapy in Danish Patients With Inflammatory Bowel Diseases in Clinical Practice

Crohn's Disease;Ulcerative Colitis;Inflammatory Bowel Disease

Biological: infliximab and adalimumab

Regionshospitalet Viborg, Skive

NULL

Completed

18 Years

N/A

Both

1035

N/A

NULL

EUCTR2009-010065-23-DE
(EUCTR)

17/08/2009

14/04/2009

Conventional Step-Up versus Infliximab Monotherapy in Patients with Active Moderate to Severe Ulcerative Colitis. A Randomized, Open Label, Prospective, Multicenter Study (Phase 3, Protocol No. P05553) - MUNIX

Active Moderate to Severe Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders

Trade Name: Remicade
INN or Proposed INN: infliximab
Other descriptive name: 100
Trade Name: Pentasa 500 mg Retardtabletten
Product Name: 5-Aminosalicylic acid (5-ASA)
INN or Proposed INN: 5-Aminosalicylic acid
Trade Name: Imurek 25mg Filmtabletten
INN or Proposed INN: azathioprine
Trade Name: Imurek 50mg Filmtabletten
INN or Proposed INN: azathioprine
Trade Name: Decortin H 1 mg
INN or Proposed INN: prednisolone
Trade Name: Decortin H 5mg
INN or Proposed INN: prednisolone
Trade Name: Decortin H 10mg
INN or Proposed INN: prednisolone
Trade Name: Decortin H 20mg
INN or Proposed INN: prednisolone
Trade Name: Decortin H 50 mg
INN or Proposed INN: prednisolone

Essex Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Germany

EUCTR2008-007519-34-SE
(EUCTR)

17/04/2009

02/03/2009

Feasibility of Accelerated infliximab infusions - Safety and Tolerability in patients wit IBD. FAST - FAST VERSION

Trade Name: Remicade

University of Leuven Hospitals, Division of Gastroenterology

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

Sweden

NCT00791557
(ClinicalTrials.gov)

October 2008

13/11/2008

Open Label Study for Adults With Pyoderma Gangrenosum and Inflammatory Bowel Disease

Pyoderma Gangrenosum;Crohn's Disease;Ulcerative Colitis;Inflammatory Bowel Disease

Drug: Infliximab

University Hospitals Cleveland Medical Center

Centocor, Inc.

Completed

18 Years

75 Years

All

N/A

United States

EUCTR2008-001968-36-GB
(EUCTR)

27/08/2008

15/07/2008

Comparison of infliximab and ciclosporin in steroid resistant ulcerative colitis: a Trial - CONSTRUCT

Acute severe steroid resistant ulcerative colitis
MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders

Swansea University

NULL

Not Recruiting

Female: yes
Male: yes

250

Phase 3

United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2006-002670-22-GB
(EUCTR)

11/06/2008

01/08/2007

Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1). Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS

Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Schering-Plough Research Institute, a division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3

Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Germany;Italy;United Kingdom

EUCTR2006-005299-42-BE
(EUCTR)

20/05/2008

07/03/2008

A randomized, multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis (CYSIF Study) - CYSIF

- Diagnosis of UC according to Lennard-Jones criteria - Endoscopically demonstrated colorectal lesions localized above the anal margin and extending at least up to 15cm proximally.- Severe acute flare of UC with a Lichtiger Index score > 10.- Refractoriness to high dose intravenous steroid therapy (= 0.8 mg/kg/d of methylprednisolone or equivalent) given for at least 5 days.
MedDRA version: 9.1;Level: LLT;Classification code 10045282;Term: UC

Trade Name: REMICADE
INN or Proposed INN: INFLIXIMAB
INN or Proposed INN: CICLOSPORIN
Other descriptive name: SANDINUM
INN or Proposed INN: CICLOSPORIN
Other descriptive name: NEORAL
Trade Name: CYCLOSPORIN
Trade Name: CYCLOSPORIN

GETAID

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

100

Finland;Belgium;France;Spain

EUCTR2006-005299-42-ES
(EUCTR)

19/05/2008

03/03/2008

Estudio multicéntrico abierto randomizado que compara ciclosporina e infliximab para el tratamiento de la colitis ulcerosa grave corticorrefractaria.A randomized multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis - CYSIF

Brote grave de colitis ulcerosa (Severe flare of ulcerative colitis)

Trade Name: Sandimmum
Product Name: ciclosporina
Trade Name: Remicade
Product Name: infliximab

GETECCU (Grupo Español para el estudio de la enfermedad de Crohn y la colitis ulcerosa)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

100

Finland;Belgium;France;Spain

EUCTR2007-006692-37-GB
(EUCTR)

10/04/2008

25/01/2008

Imperial College London

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 4

United Kingdom

100

EUCTR2007-007702-30-IT
(EUCTR)

03/04/2008

08/07/2008

Feasibility and safety of Infliximab enema treatment in patients with active left-sided ulcerative colitis. An open-label, non comparative, pilot study. - ND

Ulcerative colitis
MedDRA version: 9.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders

Trade Name: REMICADE
INN or Proposed INN: INFLIXIMAB

COSMO TECHNOLOGIES LTD

NULL

Not Recruiting

Female: no
Male: yes

Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

101

EUCTR2006-005299-42-FI
(EUCTR)

25/02/2008

27/12/2007

A randomized, multicentre, open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitisSatunnaistettu, avoin, vertaileva monikeskustutkimus siklosporiinista ja infliximabista kortikosteroidille reagoimattoman vaikean haavaisen paksusuolitulehduksen hoidossa. - CYSIF STUDY

Tutkimuksessa verrataan kortikosteroidihoidolle reagoimattoman haavaisen paksusuolitulehduksen hoitoa käyttämällä suonensisäistä siklosporiinihoitoa 2 mg/kg/vrk 7 vrk:n ajan ja siklosporiini (Sandimmun Neoral) 4 mg/kg/vrk suun kautta tämän jälkeen 3 kk:n ajan verrattuna infliximabi (Remicade) 5 mg/kg iv viikoilla 0, 2 ja 6.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Sandimmun 50 mg/ml, infuusiokonsentraatti
INN or Proposed INN: CICLOSPORIN
Trade Name: Sandimmun Neoral
INN or Proposed INN: CICLOSPORIN
Trade Name: Remicade 100 mg infuusiokuiva-aine, konsentraattiliuosta varten
INN or Proposed INN: INFLIXIMAB

Groupe d'Etude Thérapeutique des Affections Inflammatoires Digestives (G.E.T.A.I.D.)

NULL

Not Recruiting

Female: yes
Male: yes

100

France;Finland;Belgium;Spain

102

EUCTR2006-002670-22-SK
(EUCTR)

08/02/2008

15/04/2008

Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Schering-Plough Research Institute, a division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3

Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Germany;Italy;United Kingdom

103

EUCTR2006-002670-22-IT
(EUCTR)

27/11/2007

04/10/2007

Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1) Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-Up of Efficacy and Safety (Part 2)

moderately to severely active Ulcerative Colitis
MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Remicade
INN or Proposed INN: Infliximab
Trade Name: imuran
INN or Proposed INN: azathioprine

SCHERING-PLOUGH

NULL

Not Recruiting

Female: yes
Male: yes

600

Portugal;France;Czech Republic;Hungary;Spain;Belgium;Germany;United Kingdom;Italy

104

EUCTR2006-000410-20-NL
(EUCTR)

13/11/2007

09/08/2007

A Phase 3, Randomized, Open-label, Parallel-group, Multicenter Trial to Evaluate the Safety and Efficacy of Infliximab (REMICADE®) in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis

Ulcerative colitis
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Remicade

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Netherlands;Belgium;Denmark;Italy

105

EUCTR2006-002670-22-DE
(EUCTR)

31/10/2007

12/06/2007

Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS

Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
Trade Name: Imuran
Product Name: Overencapsulated Azathioprine (Imuran) 50 mg Tablet
Product Code: SCH 900050
INN or Proposed INN: azathioprine

Schering-Plough Research Institute, a division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

600

Portugal;Hungary;United Kingdom;Czech Republic;Germany;Belgium;France;Spain;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

106

EUCTR2006-002670-22-PT
(EUCTR)

12/10/2007

20/07/2007

Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS

Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Schering-Plough Research Institute, a division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

600

Hungary;Portugal;United Kingdom;Czech Republic;Germany;Belgium;France;Spain;Italy

107

EUCTR2006-002670-22-ES
(EUCTR)

20/09/2007

26/07/2007

Comparación de la eficacia y la seguridad del infliximab, en monoterapia o en combinación con azatioprina, y la azatioprina en monoterapia en la colitis ulcerosa activa de moderada a grave (1.ª parte). Comparación del tratamiento de mantenimiento y el tratamiento intermitente con infliximab en la conservación de la remisión: seguimiento de la eficacia y la seguridad (2.ª parte).

Colitis Ulcerosa
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Schering-Plough Research Institute, a division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3

Portugal;France;Czech Republic;Hungary;Slovakia;Belgium;Spain;Germany;Italy;United Kingdom

108

EUCTR2006-002670-22-FR
(EUCTR)

07/09/2007

14/06/2007

Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2)

Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
Trade Name: Imuran
Product Name: Azathioprine (Imuran) 50 mg Overencapsulated Tablet
Product Code: SCH 900050
INN or Proposed INN: azathioprine

Schering-Plough Research Institute, a division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3

Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Germany;Italy;United Kingdom

109

EUCTR2006-002670-22-CZ
(EUCTR)

29/08/2007

20/07/2007

Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS

Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Schering-Plough Research Institute, a division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

600

Portugal;Hungary;United Kingdom;Germany;Czech Republic;Belgium;France;Spain;Italy

110

EUCTR2006-000410-20-DK
(EUCTR)

13/08/2007

09/01/2007

Ulcerative colitis
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Remicade
INN or Proposed INN: infliximab

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Netherlands;Belgium;Denmark;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

111

EUCTR2006-002670-22-HU
(EUCTR)

09/08/2007

04/07/2007

Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS

Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Schering-Plough Research Institute, a division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

600

Portugal;Hungary;United Kingdom;Czech Republic;Germany;Belgium;France;Spain;Italy

112

EUCTR2006-000410-20-IT
(EUCTR)

02/08/2007

08/08/2007

A Phase 3, Randomized, Open-label, Parallel-group, MulticenterTrial to Evaluate the Safety and Efficacy of Infliximab(REMICADE) in Pediatric Subjects with Moderately to SeverelyActive Ulcerative Colitis - Protocol C0168T72

Moderately to severely active Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative

Trade Name: REMICADE
INN or Proposed INN: Infliximab

CENTOCOR

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Netherlands;Belgium;Denmark;Italy

113

EUCTR2006-002670-22-BE
(EUCTR)

25/07/2007

15/06/2007

Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Schering-Plough Research Institute, a division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3

Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Germany;Italy;United Kingdom

114

NCT00537316
(ClinicalTrials.gov)

July 2007

28/9/2007

Efficacy & Safety of Infliximab Monotherapy Vs Combination Therapy Vs AZA Monotherapy in Ulcerative Colitis (Part 1) Maintenance Vs Intermittent Therapy for Maintaining Remission (Part 2)(Study P04807)

Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1) Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-Up of Efficacy and Safety (Part 2)

Ulcerative Colitis

Biological: Infliximab (IFX);Drug: Azathioprine (AZA);Drug: Placebo to Azathioprine;Drug: Placebo infusion

Merck Sharp & Dohme Corp.

NULL

Terminated

21 Years

N/A

All

242

Phase 3

Argentina;Belgium;Canada;Colombia;Czech Republic;France;Germany;Hungary;Italy;Poland;Portugal;Russian Federation;Spain;Sweden;Switzerland;Ukraine;United Kingdom

115

NCT00705484
(ClinicalTrials.gov)

June 1, 2007

23/6/2008

European Safety Registry in Ulcerative Colitis (P04808)

Ulcerative Colitis European Registry: A Prospective, Observational, Non-interventional, Post-Marketing Safety Surveillance Program

Ulcerative Colitis

Biological: infliximab;Drug: Standard Therapy

Merck Sharp & Dohme Corp.

Centocor, Inc.

Completed

18 Years

N/A

All

2239

Austria;Belgium;Czech Republic;Denmark;France;Germany;Greece;Ireland;Italy;Netherlands;Spain;Sweden;United Kingdom;United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

116

NCT00542152
(ClinicalTrials.gov)

June 2007

8/10/2007

Study Comparing Cyclosporine With Infliximab in Steroid-refractory Severe Attacks of Ulcerative Colitis

A Randomized, Multicenter Open Label Study Comparing Cyclosporine With Infliximab in Steroid-refractory Severe Attacks of Ulcerative Colitis

Ulcerative Colitis;Steroid Refractory

Drug: CYCLOSPORINE VS INFLIXIMAB

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

NULL

Completed

18 Years

N/A

Both

115

Phase 4

Belgium;Finland;France;Italy;Spain

117

NCT00606346
(ClinicalTrials.gov)

May 31, 2007

21/1/2008

A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients With Inflammatory Bowel Disease

Crohn's Disease;Ulcerative Colitis;Indeterminate Colitis;Inflammatory Bowel Diseases

Biological: Anti TNF therapy including infliximab;Drug: No Biologics

Janssen Biotech, Inc.

NULL

Active, not recruiting

1 Month

17 Years

All

4970

United States;Canada

118

EUCTR2006-005299-42-FR
(EUCTR)

16/05/2007

06/03/2007

A randomized, multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis (CYSIF Study) - CYSIF

GETAID

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

100

Finland;Belgium;France;Spain

119

EUCTR2006-000410-20-BE
(EUCTR)

18/04/2007

11/01/2007

Ulcerative colitis
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Remicade
INN or Proposed INN: infliximab

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Netherlands;Denmark;Belgium;Italy

120

NCT00336492
(ClinicalTrials.gov)

September 2006

9/6/2006

A Study of the Safety and Efficacy of Infliximab(REMICADE ) in Pediatric Patients With Moderately to SeverelyActive Ulcerative Colitis

A Phase 3, Randomized, Open-label, Parallel-group, Multicenter Trial to Evaluate the Safety and Efficacy of Infliximab (REMICADE?) in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis

Biological: infliximab

Centocor, Inc.

NULL

Completed

6 Years

17 Years

All

Phase 3

United States;Belgium;Canada;Denmark;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

121

NCT00207688
(ClinicalTrials.gov)

August 31, 2004

13/9/2005

A Long Term Safety Study of Infliximab (Remicade) in in Ulcerative Colitis Patients

A Multicenter International Study of the Long-term Safety of Infliximab (REMICADE) in Ulcerative Colitis

Ulcerative Colitis

Drug: Infliximab 5 mg/kg;Drug: Infliximab 10 mg/kg;Drug: Placebo

Janssen Research & Development, LLC

Janssen Biologics BV

Completed

N/A

All

505

New Zealand;Switzerland;United Kingdom;Argentina;Australia;Austria;Belgium;Canada;Czechia;Denmark;France;Germany;Israel;Netherlands;United States;Czech Republic

122

NCT00096655
(ClinicalTrials.gov)

May 2002

12/11/2004

A Safety and Efficacy Study for Infliximab (Remicade) in Patients With Ulcerative Colitis

A Randomized, Placebo-controlled, Double-blind Trial to Evaluate the Safety and Efficacy of Infliximab in Patients With Active Ulcerative Colitis

Ulcerative Colitis

Drug: Infliximab

Centocor, Inc.

NULL

Completed

18 Years

N/A

Both

364

Phase 3

NULL

123

NCT00036439
(ClinicalTrials.gov)

February 2002

10/5/2002

A Safety and Efficacy Study for Infliximab (Remicade) in Patients With Active Ulcerative Colitis

A Randomized, Placebo-controlled, Double-blind Trial to Evaluate the Safety and Efficacy of Infliximab in Patients With Active Ulcerative Colitis

Ulcerative Colitis

Drug: Infliximab

Centocor, Inc.

NULL

Completed

18 Years

N/A

Both

364

Phase 3

United States;Belgium

124

JPRN-JapicCTI-060298

24/08/2006

Clinical study to assess the efficacy and safety of TA-650 in patients with active ulcerative colitis

Ulcerative colitis

Intervention name : TA-650 (Infliximab)
Dosage And administration of the intervention : Intravenous drip infusion

Mitsubishi Tanabe Pharma Corporation

NULL

BOTH

Phase 3

NULL