46. 悪性関節リウマチ Malignant rheumatoid arthritis Clinical trials / Disease details
臨床試験数 : 4,356 / 薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228
| 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 | NCT05379049 (ClinicalTrials.gov) | March 1, 2022 | 7/5/2022 | Therapeutic Response to Tumor Necrosis Factor-alpha (TNF-alpha) Antagonists in Rheumatoid Arthritis. | Evaluation of the Therapeutic Response to TNF-alpha Antagonist (Etanercept, Infliximab, Adalimumab) in Patients With Rheumatoid Arthritis; Using Plasma TNF-alpha as a Competent Biomarker. Single Center Study in Sulaymaniyah/ Iraq | Rheumatoid Arthritis;Inflammatory Arthritis;Ankylosing Spondylitis | Biological: Infliximab: Adalimumab; Etanercept | University of Sulaimani | NULL | Recruiting | 18 Years | N/A | All | 80 | Iraq | |
| 2 | JPRN-jRCTs071200007 | 28/01/2021 | 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 |
| 3 | 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 |
| 4 | 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 | |
| 5 | 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 | ||
| 6 | NCT04779892 (ClinicalTrials.gov) | February 1, 2020 | 26/2/2021 | The Study of Infliximab (CMAB008 and Remicade) in Healthy Subjects to Compare the PK and Safety | The Study of Infliximab (CMAB008 and Remicade) in Healthy Subjects to Compare the PK and Safety | Rheumatoid Arthritis | Drug: Infliximab | Taizhou Mabtech Pharmaceutical Co.,Ltd | NULL | Completed | 18 Years | 45 Years | Male | 90 | Phase 1 | China |
| 7 | 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 | 0 Years | N/A | All | 300 | Japan | |
| 8 | 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 | ||
| 9 | 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 | Terminated | 18 Years | N/A | All | 208 | Phase 4 | Italy |
| 10 | 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 |
| 11 | EUCTR2016-001987-12-IT (EUCTR) | 18/08/2017 | 05/01/2021 | Clinical study aimed to compare tocilizumab to anti-TNF treatment and to discover biomarkers for treatment selection in rheumatoid arthritis patients with inadequate response to a first anti-TNF | 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 - RAFTING | RHEUMATOID ARTHRITIS MedDRA version: 20.0;Level: LLT;Classification code 10037738;Term: R arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10039014;Term: Rh arthritis;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: ROACTEMRA - 20 MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) 4ML 1 FLACONCINO Product Name: Tocilizumab Product Code: [NA] INN or Proposed INN: Tocilizumab Other descriptive name: Tocilizumab Trade Name: ENBREL - 50 MG POLV SOLUZ INIET SOTTOC. POLV. FLAC VETRO SOLV. SIRI. VET. SOLV 1 ML (50 MG/ML) 12 FLAC+12 SIRI. PRE+12 AGHI+12 ADAT PER FLAC+24 TAMP. PRE INIEZ Product Name: etanercept Product Code: [NA] INN or Proposed INN: ETANERCEPT Trade Name: REMICADE - 100 MG POLVERE PER CONCENTRATO PER INFUSIONE ENDOVENOSA 1 FLACONE VETRO 20 ML USO EV Product Name: Infliximab Product Code: [NA] INN or Proposed INN: INFLIXIMAB Trade Name: HUMIRA - 40MG/0.8ML SOLUZ. INIETTABILE- USO SOTTOCUTANEO-FLACONCINO(VETRO) 0.8ML 2 ASTUCCI:1 FLACONCINO+1SIRINGA+1AGO+1ADATT.STERILE-2TAMPONI IMBEVUTI ALCOOL Product Name: Humira Product Code: [NA] INN or Proposed INN: ADALIMUMAB Trade Name: CIMZIA - 200MG-SOLUZIONE INIETTABILE-USO SOTTOCUTANEO-SIRINGA PRERIEMPITA(VETRO) 1ML 6(3X2) SIRINGHE PRERIEMPITE+6(3X2) SALVIETTINE IMBEVUTE DI | SOCIETA' ITALIANA DI REUMATOLOGIA - SIR | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 208 | Phase 4 | Italy | ||
| 12 | 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] | Product Name: NI-071 Product Code: NI-071 INN or Proposed INN: INFLIXIMAB Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Remicade | Nichi-Iko Pharmaceutical Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 585 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Czech Republic;Puerto Rico;Poland;Spain;Ukraine;Russian Federation;United Kingdom | ||
| 13 | 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 | ||
| 14 | 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] | Product Name: NI-071 Product Code: NI-071 INN or Proposed INN: INFLIXIMAB Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Remicade | Nichi-Iko Pharmaceutical Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 585 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Czech Republic;Puerto Rico;Poland;Spain;Ukraine;Russian Federation;United Kingdom | ||
| 15 | 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] | Product Name: NI-071 Product Code: NI-071 INN or Proposed INN: INFLIXIMAB Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Remicade | Nichi-Iko Pharmaceutical Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 585 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Czech Republic;Puerto Rico;Spain;Poland;Ukraine;Russian Federation;United Kingdom | ||
| 16 | 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] | Product Name: NI-071 Product Code: NI-071 INN or Proposed INN: INFLIXIMAB Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Remicade | Nichi-Iko Pharmaceutical Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 585 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Czech Republic;Puerto Rico;Poland;Spain;Ukraine;Russian Federation;United Kingdom | ||
| 17 | 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 | |
| 18 | NCT02990806 (ClinicalTrials.gov) | January 19, 2017 | 21/11/2016 | A Phase 3 Study of NI-071 in Participants 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 | Drug: NI-071;Drug: Remicade | 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 | EUCTR2016-003129-40-IT (EUCTR) | 05/01/2017 | 10/09/2021 | Remission after suspension of TNF alpha therapies in RA | PHASE 4, MULTICENTER RANDOMISED STUDY, AIMED AT EVALUATING THE MAINTENANCE OF REMISSION AFTER 6, 12, 18 AND 24 MONTHS FROM SUSPENSION OF TNF-ALPHA THERAPIES (ADALIMUMAB, ETANERCEPT, INFLIXIMAB, CERTOLIZUMAB PEGOL, GOLIMUMAB) IN RHEUMATOID ARTHRITIS (RA) PATIENTS - NA | RHEUMATOID ARTHRITIS (RA) PATIENTS MedDRA version: 23.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: HUMIRA - 40 MG SOLUZIONE INIETTABILE USO SOTTOCUTANEO 2 SIRINGHE PRERIEMPITE 0.8 ML + 2 TAMPONI IMBEVUTI DI ALCOL IN 1 BLISTER Product Name: HUMIRA (ADALIMUMAB) Product Code: [NA] INN or Proposed INN: ADALIMUMAB Trade Name: CIMZIA - 200MG-SOLUZIONE INIETTABILE-USO SOTTOCUTANEO-SIRINGA PRERIEMPITA(VETRO) 1ML 6(3X2) SIRINGHE PRERIEMPITE+6(3X2) SALVIETTINE IMBEVUTE DI ALCOOL Product Name: CIMZIA (Certolizumab Pegol) Product Code: [NA] INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: ENBREL - 50 MG POLV SOLUZ INIET SOTTOC. POLV. FLAC VETRO SOLV. SIRI. VET. SOLV 1 ML (50 MG/ML) 12 FLAC+12 SIRI. PRE+12 AGHI+12 ADAT PER FLAC+24 TAMP. PRE INIEZ Product Name: ENBREL (Etanercept) Product Code: [-] INN or Proposed INN: ETANERCEPT Trade Name: REMICADE - 100 MG POLVERE PER CONCENTRATO PER INFUSIONE ENDOVENOSA 1 FLACONE VETRO 20 ML USO EV Product Name: REMICADE (INFLIXIMAB) Product Code: [-] INN or Proposed INN: INFLIXIMAB Trade Name: SIMPONI - 50 MG-SOLUZIONE PER INIEZIONE IN PENNA PRERIEMPITA-USO SOTTOCUTANEO-PENNA PRERIEMPITA(VETRO) -0.5 ML 3 (3X1) PENNE PRERIEMPITE | AZIENDA OSPEDALIERO-UNIVERSITARIA PISANA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 4 | Italy | ||
| 20 | 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] | 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 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;Czech Republic;Canada;Poland;Spain;Romania;Australia;Bulgaria;Germany | ||
| 21 | 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 | ||
| 22 | 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 | |
| 23 | 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] | 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 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;Czech Republic;Canada;Poland;Spain;Romania;Australia;Bulgaria;Germany | ||
| 24 | 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 | ||
| 25 | EUCTR2016-002125-11-BG (EUCTR) | 27/10/2016 | 13/10/2016 | 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: 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 Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB | Celltrion, Inc | NULL | Not Recruiting | Female: yes Male: yes | 258 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Estonia;Slovakia;Spain;Ukraine;Lithuania;Russian Federation;Chile;Italy;Czech Republic;Hungary;Mexico;Poland;Belgium;Peru;Bulgaria;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of | ||
| 26 | EUCTR2016-002125-11-CZ (EUCTR) | 17/10/2016 | 21/07/2016 | 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: 19.0;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 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Estonia;Spain;Ukraine;Lithuania;Russian Federation;Czech Republic;Hungary;Poland;South Africa;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of | ||
| 27 | 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 | ||
| 28 | 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 |
| 29 | 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 | ||
| 30 | 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 | ||
| 31 | 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 | ||
| 32 | 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 | ||
| 33 | EUCTR2016-002125-11-LV (EUCTR) | 23/08/2016 | 01/07/2016 | 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: 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 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Estonia;Slovakia;Spain;Ukraine;Lithuania;Russian Federation;Chile;Italy;Czech Republic;Hungary;Mexico;Poland;Belgium;Peru;South Africa;Bulgaria;Latvia;Korea, Republic of;Bosnia and Herzegovina | ||
| 34 | EUCTR2016-002125-11-EE (EUCTR) | 22/08/2016 | 05/07/2016 | 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: 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 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Estonia;Slovakia;Spain;Ukraine;Lithuania;Russian Federation;Chile;Italy;Czech Republic;Hungary;Mexico;Poland;Belgium;Peru;South Africa;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of | ||
| 35 | 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 |
| 36 | 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 | Complete | >= 18age old | Not applicable | Both | 200 | Phase 4 | Japan |
| 37 | NCT02770794 (ClinicalTrials.gov) | April 1, 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 | Completed | 18 Years | N/A | All | 211 | Phase 4 | Japan |
| 38 | JPRN-UMIN000021492 | 2016/03/01 | 20/03/2016 | To investigate the safety of switch from infliximab biosimilar 1 in rheumatoid arthritis patients. | To investigate the safety of switch from infliximab biosimilar 1 in rheumatoid arthritis patients. - Switch from infliximab to 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 |
| 39 | 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 | |
| 40 | 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 |
| 41 | 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 |
| 42 | 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 | ||
| 43 | 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 | ||
| 44 | 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 | ||
| 45 | 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 | |
| 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 | 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 | Clinical outcome in patients with rheumatoid arthritis switched to tumor nesrosis factor blockers after tocilizumab or abatacept - Clinical outcome in patients with RA switched to TNF blocker 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 |
| 48 | 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 | ||
| 49 | 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 | ||
| 50 | 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 | ||
| 51 | 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 |
| 52 | 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 |
| 53 | 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 | ||
| 54 | 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 | Not Recruiting | Female: yes Male: yes | 500 | Phase 4 | Norway | ||
| 55 | 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 | ||
| 56 | 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 | ||
| 57 | 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] | 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 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | 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 | ||
| 58 | 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 | Examination of the clinical remission and functional remission in Infliximab using the increase-in-quantity protocol to TNF-alpha inhibitory drug resistance rheumatoid arthritis - Examination of the clinical remission and functional remission in Infliximab using an increase-in-quantity protocol | 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 |
| 59 | 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 | ||
| 60 | JPRN-UMIN000016844 | 2014/02/07 | 20/03/2015 | The clinical study for seeking strategy how to treat rheumatoid arthritis by TNF Inhibitors | The clinical study for seeking strategy how to treat rheumatoid arthritis by TNF Inhibitors - The aggressive clinical tight control study(TACTICS trial) | 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 |
| 61 | 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 |
| 62 | 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 | ||
| 63 | 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 |
| 64 | 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 | ||
| 65 | 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 | |||
| 66 | 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 |
| 67 | 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 |
| 68 | 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 | |||
| 69 | 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 | ||
| 70 | 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 | ||
| 71 | 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 |
| 72 | 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 | ||||
| 73 | 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 |
| 74 | 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 | 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 - 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 |
| 75 | 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 | |||
| 76 | 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 | |||
| 77 | 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 |
| 78 | 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 |
| 79 | 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 | ||
| 80 | JPRN-UMIN000007806 | 2012/06/01 | 01/05/2012 | The feasibility study of accelated infliximab infusion during maintenance phase | The feasibility study of accelated infliximab infusion during maintenance phase - 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 |
| 81 | 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 | Dose-escalation study of infliximab or methotrexate based on the disease activity in patients with rheumatoid arthritis treated with infliximab - Study of dose-escalation therapy in IFX-treated RA | 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 |
| 82 | 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 |
| 83 | 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 | |||
| 84 | 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 " | "Effect examination of infliximab to the effect insufficient example and the example of effect decrease of the 1st TNF inhibitor in rheumatoid arthritis " - Effect examination of infliximab to an anti-TNF invalid example | 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 |
| 85 | 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. | Prospective research of infliximab treatment in active RA patients refractry to anti-interleukin six receptor monoclonal antibody. - PRISM Study | 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 |
| 86 | 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 | |||
| 87 | 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 |
| 88 | 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 | Not Recruiting | Female: yes Male: yes | 522 | Phase 3 | Portugal;Philippines;Slovakia;Spain;Ukraine;Lithuania;Austria;Chile;Colombia;United Kingdom;Italy;Mexico;Jordan;Poland;Romania;Peru;Bulgaria;Latvia;Bosnia and Herzegovina | ||
| 89 | 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 | |||
| 90 | 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 | |||
| 91 | 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 | |||
| 92 | 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 |
| 93 | 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 | |||
| 94 | 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 | ||
| 95 | 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 | ||||
| 96 | 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 |
| 97 | 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 |
| 98 | EUCTR2010-023880-17-GB (EUCTR) | 31/03/2011 | 25/02/2011 | SWITCH Clinical Trial for Patients with Rheumatoid Arthritis who have failed an initial TNF-blocking drug | SWITCH: 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. - SWITCH | Rheumatoid arthritis in patients who have failed to respond to an initial TNF-blocking drug 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] - Musculoskeletal Diseases [C05] | Trade Name: Mabthera Product Name: Rituximab Product Code: n/a INN or Proposed INN: Rituximab Other descriptive name: Rituxan (US, Canada, Japan), MabThera (rest of the world) Trade Name: Orencia Product Name: Abatacept Product Code: n/a INN or Proposed INN: abatacept Other descriptive name: Orencia Trade Name: Remicade Product Name: Infliximab Product Code: n/a INN or Proposed INN: infliximab Other descriptive name: n/a Trade Name: Enbrel Product Name: Etanercept Product Code: n/a INN or Proposed INN: etanercept Other descriptive name: n/a | University of Leeds | NULL | Not Recruiting | Female: yes Male: yes | 477 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 99 | 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 |
| 100 | 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 | ||
| 101 | 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 | 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 | Not Recruiting | Female: yes Male: yes | 584 | Phase 3 | Portugal;Slovakia;Spain;Lithuania;Austria;Bulgaria;Latvia;Italy;United Kingdom | ||
| 102 | 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 | |||
| 103 | 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 | ||
| 104 | 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 | ||
| 105 | 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 | ||
| 106 | 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 |
| 107 | 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 | |||
| 108 | 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 | |||
| 109 | 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 | |||
| 110 | 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 |
| 111 | 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: A | Universitätsklinkum Erlangen | NULL | Not Recruiting | Female: yes Male: yes | 318 | Phase 3 | Germany | ||
| 112 | 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 | ||||
| 113 | NCT01000441 (ClinicalTrials.gov) | December 23, 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 | Completed | 18 Years | N/A | All | 300 | Phase 4 | France;Monaco |
| 114 | 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 | 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 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | France;Finland;Spain;Austria;Germany;Netherlands;United Kingdom | ||
| 115 | 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 | |||
| 116 | 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) | Comparison of effects between higher dosages of infliximab and switching to other biologics for rheumatoid arthritis patients with less responsiveness to infliximab therapy (cHAMLET) - 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 |
| 117 | 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 |
| 118 | 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 | |||
| 119 | 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 | Not Recruiting | Female: yes Male: yes | 200 | Phase 4 | France;Finland;Spain;Austria;Germany;Netherlands;United Kingdom | ||
| 120 | 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 |
| 121 | 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 | ||
| 122 | 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 | ||||
| 123 | 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 | ||
| 124 | 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 |
| 125 | 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 | ||
| 126 | 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 | ||||
| 127 | 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 | ||
| 128 | 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 |
| 129 | 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 |
| 130 | EUCTR2007-005464-26-GB (EUCTR) | 05/06/2008 | 11/04/2008 | Devlopment of Heart and blood vessel problems in patients with conditions which cause long-term, widespread, inflammation in the body. | The role of inflammatory biomarkers in pathophysiology of cardiovascular dysfunction in systemic inflammatory conditions- Part II - Inflammatory Biomarkers and Cardiovascular Function - Part II | Rheumatoid Arthritis MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 ;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 Product Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL | Kings College London | Guys and St Thomas'NHS Foundation Trust | Not Recruiting | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 131 | 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 |
| 132 | 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 | |
| 133 | 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 |
| 134 | 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 |
| 135 | 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 | Not Recruiting | Female: yes Male: yes | 30 | Phase 3 | Belgium | ||
| 136 | 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 | ||||
| 137 | NCT03414502 (ClinicalTrials.gov) | August 2007 | 2/1/2014 | Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response | Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response | Rheumatoid Arthritis | Drug: Methotrexate;Drug: Abatacept;Drug: Adalimumab;Drug: Azathioprine;Drug: Baricitinib;Drug: Certolizumab;Drug: Etanercept;Drug: Golimumab;Drug: Hydroxychloroquine;Drug: Infliximab;Drug: Leflunomide;Drug: Minocycline;Drug: Rituximab;Drug: Sarilumab;Drug: Sulfasalazine;Drug: Tofacitinib | University of Nebraska | NULL | Recruiting | 19 Years | N/A | All | 400 | Phase 3 | United States |
| 138 | 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 | |||
| 139 | 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 |
| 140 | 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 |
| 141 | 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 | |
| 142 | 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 |
| 143 | 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 |
| 144 | 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 | Trade Name: Remicade INN or Proposed INN: Infliximab | Integrated Therapeutics Group, Inc. - A subsidiary of Schering-Plough Corp. | NULL | Not Recruiting | Female: yes Male: yes | 315 | Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): | Portugal;France;Belgium;Denmark;Austria;Germany;Netherlands;Sweden | ||
| 145 | 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 | |||
| 146 | EUCTR2006-000363-28-GB (EUCTR) | 03/10/2006 | 28/04/2006 | DIFFERENTIATING THE MECHANISM OF ACTION OF ANTI TNF-alpha AGENTS - DATA Study | DIFFERENTIATING THE MECHANISM OF ACTION OF ANTI TNF-alpha AGENTS - DATA Study | Rheumatoid arthritis and Psoriatic arthritis | Trade Name: Remicade Product Name: Infliximab INN or Proposed INN: Infliximab Trade Name: Enbrel Product Name: Etanercept INN or Proposed INN: Etanercept | Greater Glasgow Health Board | Glasgow University | Not Recruiting | Female: yes Male: yes | 40 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 147 | JPRN-UMIN000000512 | 2006/10/01 | 03/11/2006 | Efficacy of tacrolimus in rheumatoid arthritis patients who have been treated unsuccessfully with infliximab and methotrexate | Efficacy of tacrolimus in rheumatoid arthritis patients who have been treated unsuccessfully with infliximab and methotrexate - Combination therapy with Methotrexate, Infliximab, and Tacrolimus (COMMIT project) | 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 |
| 148 | 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 |
| 149 | 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 |
| 150 | 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 | Trade Name: Remicade | Integrated Therapeutics Group, Inc. - A subsidiary of Schering-Plough Corp. | NULL | Not Recruiting | Female: yes Male: yes | 315 | Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): | France;Portugal;Belgium;Denmark;Austria;Germany;Netherlands;Sweden | ||
| 151 | 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 | |||
| 152 | 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. | Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Remicade | Integrated Therapeutics Group, Inc. - A subsidiary of Schering-Plough Corp. | NULL | Not Recruiting | Female: yes Male: yes | 315 | Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): | France;Portugal;Greece;Belgium;Denmark;Austria;Germany;Netherlands;Sweden | ||
| 153 | 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 | |||
| 154 | 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 | |||
| 155 | 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 | Trade Name: Remicade Product Name: Remicade Product Code: Infliximab Trade Name: Mextrex Product Name: Methotrexate Product Code: Mextrex INN or Proposed INN: n/a Other descriptive name: Methotrexate Trade Name: Ferrograd Folic Tablets Product Name: Folic Acid Product Code: Ferrograd INN or Proposed INN: n/a Other descriptive name: Folic Acid Trade Name: Solu-Medrone 2 Gram Product Name: Methylprednisolone Product Code: Solu-Medrone 2 Gram INN or Proposed INN: n/a Other descriptive name: Methylprednisolone Trade Name: Solu-Medrone 2 Gram Product Name: Methylprednisolone Product Code: Solu-Medrone 2 Gram INN or Proposed INN: n/a | University of Leeds | NULL | Not Recruiting | Female: yes Male: yes | 112 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 156 | 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 | 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 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Portugal;Belgium;Denmark;Austria;Germany;Netherlands;Sweden | ||
| 157 | 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 |
| 158 | NCT05051137 (ClinicalTrials.gov) | January 12, 2006 | 10/9/2021 | Real-World Emulation of the SWEFOT Trial | Comparison of Infliximab With Sulfasalazine/Hydroxychloroquine Initiated After Methotrexate by Rheumatoid Arthritis Patients Treated in Clinical Practice (Real-World Emulation of SWEFOT Trial) | Rheumatoid Arthritis | Biological: Infliximab;Drug: Sulfasalazine + Hydroxychloroquine | Karolinska Institutet | Harvard Medical School | Completed | 18 Years | N/A | All | 509 | Sweden | |
| 159 | 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 |
| 160 | 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 | |||
| 161 | 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 |
| 162 | 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 | |||
| 163 | 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 | |||
| 164 | 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 |
| 165 | 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 |
| 166 | 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 | |||
| 167 | 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 |
| 168 | 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 | ||
| 169 | 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 | ||
| 170 | 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 |
| 171 | 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 | Not Recruiting | Female: yes Male: yes | 675 | Phase 3 | Czech Republic;Spain;Denmark;Sweden | ||
| 172 | 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 | ||||
| 173 | 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 | ||
| 174 | 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 |
| 175 | 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 |
| 176 | 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 |
| 177 | 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 |
| 178 | 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 |
| 179 | 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 |
| 180 | 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 |
| 181 | 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 | |
| 182 | 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 |
| 183 | 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 |
| 184 | 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 |
| 185 | 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 |
| 186 | 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 |
| 187 | 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 |
| 188 | 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 |
| 189 | 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 |