96. クローン病 Crohn disease Clinical trials / Disease details


臨床試験数 : 2,400 薬物数 : 1,391 - (DrugBank : 267) / 標的遺伝子数 : 168 - 標的パスウェイ数 : 214

  
225 trials found
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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Recruitment_
Status
Inclusion_
agemin
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agemax
Inclusion_
gender
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PhaseCountries
1EUCTR2020-001811-26-BE
(EUCTR)
18/11/202122/07/2021IBD under control with less medicationDe-escalation of anti-TNF therapy in adolescents and young adults with IBD with tight faecal calprotectin and trough level monitoring - FREE-study Crohn's disease, ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Flixabi
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
INN or Proposed INN: INFLIXIMAB
Trade Name: Remsima
INN or Proposed INN: INFLIXIMAB
Trade Name: Zessly
INN or Proposed INN: INFLIXIMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Amgevita
INN or Proposed INN: ADALIMUMAB
Trade Name: Hulio
INN or Proposed INN: ADALIMUMAB
University Medical Center GroningenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
148Phase 4Belgium;Netherlands
2NCT05057273
(ClinicalTrials.gov)
November 202116/8/2021Safety and Efficacy of Oral BT-11 in Crohn's Disease Patients With Moderate to Severe DiseaseA Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Oral BT-11 in Crohn's Disease Patients With Moderate to Severe DiseaseCrohn's DiseaseDrug: BT-11 (Omilancor);Biological: adalimumabLandos Biopharma Inc.NULLNot yet recruiting18 Years75 YearsAll40Phase 2NULL
3EUCTR2018-004346-42-HU
(EUCTR)
15/10/202131/01/2020A Study of the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn's DiseaseA 52-Week, Multicenter, Randomized, Double-blind, Placebo and Active-Controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants With Moderately to Severely Active Crohn’s Disease (INTREPID Lead-In) - 52-Week Phase 2b/3 Crohn’s Disease Study Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: MEDI2070
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as 'MEDI2070'
Trade Name: Humira®
INN or Proposed INN: ADALIMUMAB
Product Name: Brazikumab
Product Code: MEDI2070
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as 'MEDI2070'
AstraZeneca ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
553Phase 2;Phase 3United States;Czechia;Taiwan;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;South Africa;Germany;China;Korea, Republic of
4NCT05040464
(ClinicalTrials.gov)
August 26, 202126/8/2021Comparison of Azathioprine to Methotrexate in Combination Therapy With Adalimumab in Crohn's Disease: an Open-label Randomized Controlled TrialComparison of Azathioprine to Methotrexate in Combination Therapy With Adalimumab in Crohn's Disease: an Open-label Randomized Controlled TrialCrohn Disease;Azathioprine;MethotrexateDrug: AZA capsules;Drug: MTX;Biological: blood sampleCentre Hospitalier Universitaire, AmiensNULLRecruiting18 YearsN/AAll166Phase 3France
5NCT04643483
(ClinicalTrials.gov)
June 202119/11/2020A Study to Test Efficacy, Safety, and Pharmacokinetics of Certolizumab Pegol in Children and Adolescents With Moderately to Severely Active Crohn's DiseaseA Phase 3, Randomized, Double-Blind, Multicenter Study Including an Active Reference Arm to Evaluate Efficacy, Safety, and Pharmacokinetics of Certolizumab Pegol in Children and Adolescents (6 to 17 Years of Age) With Moderately to Severely Active Crohn's DiseaseCrohn's DiseaseDrug: Certolizumab pegol;Drug: Adalimumab;Drug: PlaceboUCB Biopharma SRLNULLWithdrawn6 Years17 YearsAll0Phase 3NULL
6JPRN-jRCT2031200406
27/03/202110/03/2021A Study of JNJ-64304500 as Add-on Therapy in Participants with Active Crohn's DiseaseA Phase 2a Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Proof-of-Concept Clinical Study to Evaluate the Safety and Efficacy of JNJ-64304500 as Add-on Therapy to Standard of Care Biologic Therapy with Anti-Tumor Necrosis Factor Alpha or Anti-Interleukin 12/23 in Responder Not Remitter Participants with Active Crohn's Disease - DUET Crohn DiseaseGroup 1- Standard of Care (SOC) Biological Therapy: Adalimumab: Participants will receive JNJ-64304500 Dose 1 or matching placebo subcutaneous (SC) injection as induction dose (Week 0) followed by JNJ-64304500 Dose 2 or matching placebo SC injection from Week 2 through Week 10 as maintenance dose in addition to adalimumab or its biosimilar as SOC therapy.

Group 2: SOC Biological Therapy: Ustekinumab: Participants will receive JNJ-64304500 Dose 1 or matching placebo SC injection as induction dose (Week 0) followed by JNJ-64304500 Dose 2 or matching placebo SC injection from Week 2 through Week 10 as maintenance dose in addition to ustekinumab as SOC therapy.
Numaguchi HirotakaNULLNot Recruiting>= 18age old<= 65age oldBoth70Phase 2Canada;France;Germany;Italy;Spain;United States Of America;Japan
7EUCTR2019-002942-19-DK
(EUCTR)
12/03/202105/11/2020Nordic study of treatment strategy in inflammatory bowel diseaseNORDTREATThe Nordic IBD treatment strategy trial – a randomized controlled trial of access to a protein profile Crohn's disease and Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Imurel
INN or Proposed INN: Azathioprine
Trade Name: Puri-nethol
INN or Proposed INN: MERCAPTOPURINE
Region Örebro länNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 4Denmark
8NCT04646187
(ClinicalTrials.gov)
March 11, 202120/11/2020De-escalation of Anti-TNF Therapy in Inflammatory Bowel DiseaseDe-escalation of Anti-TNF Therapy in Adolescents and Young Adults With IBD With Tight Faecal Calprotectin and Trough Level MonitoringInflammatory Bowel Diseases;Crohn Disease;Colitis, UlcerativeBiological: Infliximab;Biological: AdalimumabUniversity Medical Center GroningenEuropean Crohn´s and Colitis Organisation;Bühlmann Laboratories AGRecruiting12 Years25 YearsAll148Phase 4Belgium;Netherlands;Spain
9NCT04655807
(ClinicalTrials.gov)
March 3, 202130/11/2020A Study of JNJ-64304500 as Add-on Therapy in Participants With Active Crohn's DiseaseA Phase 2a Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Proof-of-Concept Clinical Study to Evaluate the Safety and Efficacy of JNJ-64304500 as Add-on Therapy to Standard of Care Biologic Therapy With Anti-Tumor Necrosis Factor Alpha or Anti-Interleukin 12/23 in Responder Not Remitter Participants With Active Crohn's DiseaseCrohn DiseaseDrug: JNJ-64304500;Drug: Placebo;Drug: Adalimumab;Drug: UstekinumabJanssen Research & Development, LLCNULLWithdrawn18 Years65 YearsAll0Phase 2United States;Canada;France;Germany;Italy;Japan;Spain;Sweden
10ChiCTR2000036845
2021-01-012020-08-25A single-center, randomized, controlled study on the effect of proactive therapeutic drug monitoring on the efficacy and cost of adamumab in the treatment of Crohn's diseaseA single-center, randomized, controlled study on the effect of proactive therapeutic drug monitoring on the efficacy and cost of adamumab in the treatment of Crohn's disease Crohn's diseaseProctive treatment drug monitoring group:In the proactive TDM group, adamumab is 160mg at week 0, 80mg at week 2, and 40mg once every two weeks from week 4 until week 8. Adalimumab serum trough concentration is going to be monitored at week 8, 16, 24, 32 and 40 after inclusion: 1.If serum trough concentration=11.7 g/ mL, continue&#;Reactive treatment drug monitoring group:In the reactive TDM group, adamumab is 160mg at week 0, 80mg at week 2, and 40mg once every two weeks from week 4 until week 8. Clinical response is assesed at week 8, 16, 24, 32, and 40 after inclusion: 1.If the clinical response is achieved, continue to administer 40mg once every ;Xinhua Hospital Affiliated to Shanghai Jiaotong University School of MedicineNULLPending1870BothProctive treatment drug monitoring group:60;Reactive treatment drug monitoring group:60;Phase 4China
11EUCTR2020-001811-26-NL
(EUCTR)
30/09/202008/07/2020IBD under control with less medicationDe-escalation of anti-TNF therapy in adolescents and young adults with IBD with tight faecal calprotectin and trough level monitoring - FREE-study Crohn's disease, ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Flixabi
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
INN or Proposed INN: INFLIXIMAB
Trade Name: Remsima
INN or Proposed INN: INFLIXIMAB
Trade Name: Zessly
INN or Proposed INN: INFLIXIMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Amgevita
INN or Proposed INN: ADALIMUMAB
Trade Name: Hulio
INN or Proposed INN: ADALIMUMAB
University Medical Center GroningenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 4Netherlands
12EUCTR2018-004346-42-IT
(EUCTR)
03/09/202024/05/2021An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's DiseaseA 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn's Disease - 52-Week Phase 2b/3 Crohn's Disease Study Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856
MedDRA version: 20.0;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: [Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Huma
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598
Trade Name: Humira®
Product Name: NA
Product Code: [NA]
INN or Proposed INN: ADALIMUMAB
Product Name: Brazikumab
Product Code: [Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Huma
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anticorpo monoclonale umano anti-Interleuchina-23 Immunoglobulina G2 (IgG2); precedentemente denominato MEDI2070 e AMG 139
ALLERGAN LIMITEDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2000Phase 2;Phase 3United States;Czechia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;South Africa;Bulgaria;Germany
13EUCTR2018-004346-42-AT
(EUCTR)
18/06/202021/01/2020A study of the Efficacy and Safety of Brazikumab in Participants with Moderately to Severly Active Crohn's DiseaseA 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease (INTREPID Lead-In) - 52-Week Phase 2b/3 Crohn’s Disease Study Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: MEDI2070
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598
Trade Name: Humira®
INN or Proposed INN: ADALIMUMAB
Product Name: Brazikumab
Product Code: MEDI2070
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139
Astrazeneca ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 2;Phase 3United States;Czechia;Taiwan;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;South Africa;Germany;Korea, Republic of
14EUCTR2018-004346-42-BG
(EUCTR)
28/05/202008/01/2020An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's DiseaseA 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598
Trade Name: Humira®
INN or Proposed INN: ADALIMUMAB
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139
Allergan Ltd.NULLNot RecruitingFemale: yes
Male: yes
2000Phase 2;Phase 3United States;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;South Africa;Bulgaria;Germany
15EUCTR2018-004346-42-RO
(EUCTR)
19/05/202018/03/2022An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's DiseaseA 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598
Trade Name: Humira®
INN or Proposed INN: ADALIMUMAB
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139
Allergan Ltd.NULLNot RecruitingFemale: yes
Male: yes
2000Phase 2;Phase 3United States;Czechia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;South Africa;Germany
16EUCTR2018-004346-42-BE
(EUCTR)
15/04/202003/03/2020An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's DiseaseA 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598
Trade Name: Humira®
INN or Proposed INN: ADALIMUMAB
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139
Allergan Ltd.NULLNot RecruitingFemale: yes
Male: yes
2000Phase 2;Phase 3United States;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;South Africa;Bulgaria;Germany
17EUCTR2018-004346-42-CZ
(EUCTR)
24/03/202022/01/2020A Study of the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn's DiseaseA 52-Week, Multicenter, Randomized, Double-blind, Placebo and Active-Controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants With Moderately to Severely Active Crohn’s Disease (INTREPID Lead-In) - 52-Week Phase 2b/3 Crohn’s Disease Study Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: MEDI2070
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: MEDI2070
Trade Name: Humira®
INN or Proposed INN: ADALIMUMAB
Product Name: Brazikumab
Product Code: MEDI2070
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: MEDI2070
AstraZeneca ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
221Phase 2;Phase 3United States;Czechia;Taiwan;Slovakia;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;South Africa;Germany;China;Korea, Republic of
18EUCTR2018-004346-42-ES
(EUCTR)
26/12/201911/11/2019An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's DiseaseA 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598
Trade Name: Humira®
INN or Proposed INN: ADALIMUMAB
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139
Allergan Ltd.NULLNot RecruitingFemale: yes
Male: yes
2000Phase 2;Phase 3United States;Serbia;Slovakia;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;South Africa;Bulgaria;Germany;Netherlands;Sweden
19NCT03917303
(ClinicalTrials.gov)
December 23, 20195/4/2019Control Crohn Safe TrialControl Crohn Safe With Episodic Adalimumab Monotherapy as First Line Treatment Study.Crohn Disease;Inflammatory Bowel DiseasesDrug: Adalimumab;Drug: standard step-up careMaastricht University Medical CenterMaastricht University;ZonMw: The Netherlands Organisation for Health Research and DevelopmentRecruiting18 Years70 YearsAll158Phase 4Netherlands
20EUCTR2019-003662-40-DE
(EUCTR)
18/12/201922/10/2019Prospective, open-label, single-arm, single-center phase IV clinical trial to evaluate efficacy and safety of the adalimumab biosimilar Amgevita in subjects with moderate to severe active chronic inflammatory bowel diesease (Crohn's disease and ulcerative colitis)Prospective, open-label, single-arm, single-center phase IV clinical trial to evaluate efficacy and safety of the adalimumab biosimilar Amgevita in subjects with moderate to severe active chronic inflammatory bowel diesease (Crohn's disease and ulcerative colitis) - Amgevita de novo in CED
MedDRA version: 20.1;Level: PT;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Amgevita 40 mg Injektionslösung in einer Fertigspritze
INN or Proposed INN: ADALIMUMAB
Trade Name: Amgevita 40 mg Injektionslösung im Fertigpen
INN or Proposed INN: ADALIMUMAB
Universitätsklinikum ErlangenNULLNot RecruitingFemale: yes
Male: yes
82Phase 4Germany
21EUCTR2018-004346-42-DE
(EUCTR)
10/12/201917/06/2019A Study of the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn's DiseaseA 52-Week, Multicenter, Randomized, Double-blind, Placebo and Active-Controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease (INTREPID Lead-In) - 52-Week Phase 2b/3 Crohn’s Disease Study Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: MEDI2070
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as 'MEDI2070'
Trade Name: Humira®
INN or Proposed INN: ADALIMUMAB
Product Name: Brazikumab
Product Code: MEDI2070
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: MEDI2070
AstraZeneca ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
553Phase 2;Phase 3Belgium;Poland;Bulgaria;South Africa;Germany;China;Korea, Republic of;Canada;Hungary;Czech Republic;France;India;Italy;United Kingdom;Russian Federation;Israel;Austria;Ukraine;Spain;Slovakia;Taiwan;Czechia;United States
22EUCTR2018-004346-42-FR
(EUCTR)
05/11/201910/07/2019An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's DiseaseA 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598
Trade Name: Humira®
INN or Proposed INN: ADALIMUMAB
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139
Allergan Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
2000 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Slovakia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;South Africa;Bulgaria;Netherlands;Germany;Sweden
23NCT04131504
(ClinicalTrials.gov)
October 16, 201916/10/2019Precision Crohn's Disease Management Utilizing Predictive Protein Panels (ENvISION)A Multi-Center, Prospective Study to Discover a Companion Diagnostic for Biologics Targeting TNFCrohn's Disease;IBDDrug: Infliximab;Drug: AdalimumabChildren's Hospital Medical Center, CincinnatiThe Leona M. and Harry B. Helmsley Charitable TrustActive, not recruiting1 Year22 YearsAll239United States
24NCT04131322
(ClinicalTrials.gov)
October 10, 201910/10/2019Loss of Response of Adalimumab Biosimilar vs Adalimumab Original, in Inflammatory Bowel Disease.Loss of Response of Adalimumab Biosimilar Compared With the Loss of Response of Adalimumab Original: Controlled, Randomized, Non-inferiority Open Study. ADA-SWITCH StudyCrohn Disease;Ulcerative ColitisDrug: Amgevita 40Mg Solution for Injection;Drug: HUMIRA 40Mg Solution for InjectionFundación Pública Andaluza para la gestión de la Investigación en SevillaNULLTerminated18 YearsN/AAll24Phase 4Spain
25EUCTR2018-004346-42-GB
(EUCTR)
10/09/201930/05/2019An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's DiseaseA 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598
Trade Name: Humira®
INN or Proposed INN: ADALIMUMAB
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139
AstraZeneca ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2000Phase 2;Phase 3United States;Serbia;Czechia;Slovakia;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;South Africa;Bulgaria;Germany;Netherlands;Sweden
26EUCTR2017-004588-11-NL
(EUCTR)
10/09/201910/09/2019Control Crohn Safe Trial: Long term outcome and tolerability of six months adalimumab as initial treatment for newly diagnosed Crohn's disease versus standard step-up treatment.Control Crohn Safe Trial: Long term efficacy and safety of periodic treatment with adalimumab versus standard step-care for newly diagnosed Crohn's disease. - CoCroS trial The chronic inflammatory bowel disease Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: HumiraUniversity MaastrichtNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
158Phase 4Netherlands
27NCT03885713
(ClinicalTrials.gov)
September 10, 20194/3/2019Identification of Predictive Biomarkers for Response to Biologic Therapies in Inflammatory Bowel DiseaseIdentification of Predictive Biomarkers for Response to Biologic Therapies in Inflammatory Bowel Disease by Proteomic and Mass Cytometry ApproachesInflammatory Bowel Diseases;Crohn Disease;Ulcerative ColitisBiological: Infliximab or adalimumab or golimumab or vedolizumab or ustekinumabFundación de Investigación Biomédica - Hospital Universitario de La PrincesaNULLRecruiting18 YearsN/AAll180Phase 4Spain
28NCT04018599
(ClinicalTrials.gov)
July 15, 201911/7/2019Comparison of PK and Tolerability of MSB11022 Administered by AI or PFSA Phase I, Randomized, Open-label, Parallel-group Study to Determine the Pharmacokinetics, Safety, and Tolerability of MSB11022 (Proposed Adalimumab Biosimilar) Following a Single Subcutaneous Injection by an Auto-injector or by a Pre-filled Syringe in Healthy SubjectsRheumatoid Arthritis;Polyarticular Juvenile Idiopathic Arthritis;Psoriatic Arthritis;Ankylosing Spondylitis;Crohn Disease;Ulcerative Colitis;Plaque Psoriasis;Pediatric Plaque Psoriasis;Pediatric Crohns Disease;Hidradenitis Suppurativa;Non-infectious UveitisDrug: 40 mg MSB11022Fresenius Kabi SwissBioSim GmbHPRA Health SciencesCompleted18 Years55 YearsAll216Phase 1United States
29NCT04089514
(ClinicalTrials.gov)
June 30, 201912/9/2019A Real-world Study of Imraldi® UsePan-EU Real-World Experience With Imraldi®Arthritis, Rheumatoid (RA);Axial Spondyloarthritis (axSpA);Arthritis, Psoriatic (PsA);Crohn's Disease (CD);Colitis, Ulcerative (UC)Drug: AdalimumabBiogenNULLCompleted18 YearsN/AAll1000Belgium;Germany;Ireland;Italy;Spain;United Kingdom
30EUCTR2019-000717-37-ES
(EUCTR)
27/06/201928/06/2019Loss of response of the Adalimumba biosimilar compared with the original drugLOSS OF RESPONSE OF THE ADALIMUMAB BIOSIMILAR COMPARED WITH THE LOSS OF RESPONSE OF THE ADALIMUMAB ORIGINAL: CONTROLLED, RANDOMIZED, NON-INFERIORITY OPEN STUDY.ADA-SWITCH Study - ADA-SWITCH Study Inflammatory Bowel Disease: Crohn's Disease and Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: AMGEVITA®
Product Name: AMGEVITA (Adalimumab biosimilar )
Trade Name: HUMIRA ®
Product Name: Humira (adalimumab original)
Fundación Publica Andaluza para la Gestión de Salud en Sevilla (FISEVI)NULLNot RecruitingFemale: yes
Male: yes
136Phase 4Spain
31EUCTR2018-004967-30-GB
(EUCTR)
30/04/201914/01/2019Inflammatory Bowel Disease (IBD) Reference product (Humira-adalimumab) and Biosimilar Product (Imraldi-adalimumab) CroSS over StudyIBD Reference and Biosimilar adalimumab CroSS over Study - iBaSS Crohn’s disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Imraldi
Product Name: Imraldi
INN or Proposed INN: adalimumab
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: adalimumab
University Hospital Southampton NHS Foundation TrustNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 4United Kingdom
32EUCTR2018-002064-15-NL
(EUCTR)
15/04/201915/04/2019Patient preference model: treatment of perianal fistulas in Crohn's diseaseTreatment of Perianal FIstulas in Crohn’s Disease: Surgical closure vs Anti-TNF - PISA II-trial Perianal fistulas in Crohn's Disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Remicade
Product Name: Infliximab
Trade Name: Humira
Product Name: Adalimumab
Academic Medical CenterNULLNot RecruitingFemale: yes
Male: yes
140Phase 4Netherlands
33EUCTR2018-002925-47-ES
(EUCTR)
28/12/201816/11/2018prediction of response to therapy in inflammatory bowel diseaseIdentification of predictive biomarkers for response to biologic therapies in inflammatory bowel disease by proteomic and mass cytometry approaches Inflammatory bowel disease
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Infliximab
INN or Proposed INN: INFLIXIMAB
Trade Name: Golimumab
INN or Proposed INN: GOLIMUMAB
Trade Name: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Vedolizumab
INN or Proposed INN: VEDOLIZUMAB
Other descriptive name: VEDOLIZUMAB
Fundación de Investigación Biomédica del Hospital Universitario de La PrincesaNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
180 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesSpain
34EUCTR2017-004209-41-BE
(EUCTR)
25/10/201821/08/2018A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With BiologicA Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: Humira®
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Serbia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Brazil;Poland;Australia;Bulgaria;Germany;Netherlands;Korea, Republic of
35EUCTR2017-004209-41-DE
(EUCTR)
16/10/201821/06/2018A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With BiologicA Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: Humira®
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Janssen-Cilag International NVNULLNot RecruitingFemale: yes
Male: yes
350Phase 3Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
36EUCTR2017-004209-41-NL
(EUCTR)
01/10/201827/06/2018A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With BiologicA Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: Humira®
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Janssen-Cilag International NVNULLNot RecruitingFemale: yes
Male: yes
350Phase 3Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
37EUCTR2017-004209-41-BG
(EUCTR)
26/09/201819/07/2018A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With BiologicA Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one year Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: Humira®
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
350Phase 3Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
38EUCTR2017-004209-41-IT
(EUCTR)
31/08/201817/06/2021A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With BiologicA Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: [CNTO1275]
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: [CNTO1275]
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Humira®
Product Name: Adalimumab
Product Code: [Adalimumab]
INN or Proposed INN: ADALIMUMAB
Other descriptive name: ADALIMUMAB
JANSSEN CILAG INTERNATIONAL NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
350Phase 3Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
39EUCTR2017-004209-41-CZ
(EUCTR)
27/08/201813/06/2018A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With BiologicA Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: Humira®
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Janssen-Cilag International NVNULLNot RecruitingFemale: yes
Male: yes
350Phase 3Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
40EUCTR2017-004209-41-GB
(EUCTR)
24/08/201822/06/2018A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With BiologicA Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: Humira®
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
350Phase 3Serbia;United States;Czechia;Spain;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
41EUCTR2017-004209-41-PL
(EUCTR)
03/08/201820/06/2018A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With BiologicA Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: Humira®
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
350Phase 3Korea, Republic of;Germany;Netherlands;Bulgaria;Australia;Belgium;Brazil;Poland;Canada;Hungary;Czech Republic;France;Italy;United Kingdom;Russian Federation;Spain;Czechia;United States;Serbia
42EUCTR2017-004209-41-FR
(EUCTR)
30/07/201814/06/2018A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: Humira®
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Serbia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Brazil;Poland;Australia;Bulgaria;Germany;Netherlands;Korea, Republic of
43NCT03662919
(ClinicalTrials.gov)
July 2, 20186/9/2018One-year Persistence to Treatment of Participants Receiving Flixabi or Imraldi: a French Cohort StudyPERFUSE - One-year Persistence to Treatment of Patients Receiving Flixabi or Imraldi: a French Cohort StudyArthritis, Rheumatoid;Spondylitis, Ankylosing;Arthritis, Psoriatic;Crohn's Disease;Colitis, UlcerativeDrug: Infliximab;Drug: AdalimumabBiogenNULLActive, not recruiting6 YearsN/AAll2274France
44EUCTR2017-004209-41-ES
(EUCTR)
21/06/201821/05/2018A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With BiologicA Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: Humira®
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
350Phase 3Serbia;United States;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
45EUCTR2016-000522-18-BE
(EUCTR)
02/05/201808/01/2018Risk stratified randomized controlled trial in paediatric Crohn’s Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively – a treatment strategyRisk stratified randomized controlled trial in paediatric Crohn’s Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively – a treatment strategy - REDUCE-RISKincd-PIBD-TRIAL Pediatric Crohn’s disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: humira
INN or Proposed INN: ADALIMUMAB
Product Name: Imurel
INN or Proposed INN: azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Methotrexate
Product Name: methotrexate
PIBDNetNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
312 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesFrance;Hungary;Czech Republic;Canada;Poland;Belgium;Israel;Netherlands;Germany;Italy;United Kingdom
46EUCTR2016-000522-18-CZ
(EUCTR)
24/04/201825/04/2018Risk stratified randomized controlled trial in paediatric Crohn´s Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively - a treatment strategyRisk stratified randomized controlled trial in paediatric Crohn´s Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively - a treatment strategy - REDUCE-RISK in CD-PIBD-TRIAL Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: Azathioprin
INN or Proposed INN: azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Humira 40 mg injekcní roztok v predplnené injekcní stríkacce
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Methotrexate
Product Name: methotrexate
INN or Proposed INN: methotrexate
Other descriptive name: METHOTREXATE
PIBDNetNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
312Phase 4France;Hungary;Czech Republic;Canada;Poland;Belgium;Israel;Netherlands;Germany;Italy;United Kingdom
47NCT03464136
(ClinicalTrials.gov)
March 29, 20187/3/2018Safety and Efficacy of Adalimumab Versus Ustekinumab for One YearA Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to That of Adalimumab in the Treatment of Biologic Naïve Subjects With Moderately-to-Severely Active Crohn's DiseaseCrohn DiseaseBiological: Placebo for Ustekinumab;Biological: Placebo for Adalimumab;Biological: Ustekinumab (6 mg/kg);Biological: Ustekinumab (90 mg);Biological: Adalimumab (40 mg)Janssen Scientific Affairs, LLCNULLCompleted18 YearsN/AAll386Phase 3United States;Australia;Belgium;Brazil;Bulgaria;Canada;Czechia;France;Germany;Hungary;Italy;Korea, Republic of;Netherlands;Poland;Russian Federation;Serbia;Spain;United Kingdom
48EUCTR2016-000522-18-GB
(EUCTR)
28/03/201805/12/2017Risk-stratified randomised controlled trial in paediatric Crohn's Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively - a treatment strategy.Risk Stratified randomised controlled trial in paediatric Crohn's Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively - a treatment strategy - REDUCE-RISKinCD-PIBD -TRIAL Paediatric Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40mg/0.4ml pre-filled syringe
Product Name: Humira 40mg/0.4ml pre-filled syringe
INN or Proposed INN: ADALIMUMAB
Other descriptive name: SUB20016
Product Name: Azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: Azathioprine
INN or Proposed INN: Azathioprine
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
INN or Proposed INN: Methotrexate
Product Name: Mercaptopurine
INN or Proposed INN: Mercaptopurine
Other descriptive name: 6-Mercaptopurine
PIBD netNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
312 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesFrance;Czech Republic;Canada;Poland;Belgium;Spain;Israel;Netherlands;Germany;Italy;United Kingdom
49NCT03059849
(ClinicalTrials.gov)
February 1, 201813/2/2017Brief Escalation of Adalimumab Treatment for Prevention of Clinical Relapse in IBDBrief Escalation of Adalimumab Treatment for Prevention of Clinical Relapse in IBDCrohn Disease;Ulcerative ColitisDrug: AdalimumabMcMaster UniversityNULLWithdrawn18 Years80 YearsAll0Phase 4NULL
50EUCTR2016-000522-18-NL
(EUCTR)
28/12/201703/07/2017Risk stratified randomized controlled trial in paediatric Crohn's Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively - a treatment strategy.Risk stratified randomized controlled trial in paediatric Crohn's Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively - a treatment strategy. - REDUCE-RISKincd-PIBD-TRIAL Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Humira
Product Name: humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Azathioprine
Product Name: imuran
INN or Proposed INN: azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: methotrexate
Product Name: methotrexate
Product Code: L01BA
INN or Proposed INN: methotrexate
Other descriptive name: METHOTREXATE
PIBDNetNULLNot RecruitingFemale: yes
Male: yes
312Phase 4France;Czechia;Czech Republic;Hungary;Canada;Poland;Belgium;Israel;Germany;Netherlands;United Kingdom;Italy
51NCT03220841
(ClinicalTrials.gov)
October 9, 20176/7/2017Stricture Definition and Treatment (STRIDENT) Drug Therapy StudyStricture Definition and Treatment (STRIDENT) Drug Therapy StudyCrohn Disease;Inflammatory Bowel Diseases;Stricture; BowelDrug: Adalimumab Injection;Drug: Thiopurine;Procedure: Endoscopic balloon dilatationSt Vincent's Hospital MelbourneAustralasian Gastro Intestinal Research Foundation;AbbVieActive, not recruiting18 YearsN/AAll78Phase 4Australia
52NCT02764762
(ClinicalTrials.gov)
June 12, 20175/5/2016Triple Combination Therapy in High Risk Crohn's Disease (CD)An Open-Label, Phase 4 Study to Evaluate the Efficacy and Safety of Triple Combination Therapy With Vedolizumab IV, Adalimumab SC, and Oral Methotrexate in Early Treatment of Subjects With Crohn's Disease Stratified at Higher Risk for Developing ComplicationsCrohn DiseaseDrug: Vedolizumab;Drug: Adalimumab;Drug: MethotrexateTakedaNULLActive, not recruiting18 Years65 YearsAll55Phase 4United States;Canada
53EUCTR2016-000612-14-HR
(EUCTR)
10/05/201707/06/2017BI 695501 versus Humira® in patients with active Crohn’s disease: a randomized, double-blind, multicenter, parallel group, exploratory trial comparing efficacy, endoscopic improvement, safety, and immunogenicity BI 695501 versus Humira® in patients with active Crohn’s disease: a randomized, double-blind, multicenter, parallel group, exploratory trial comparing efficacy, endoscopic improvement, safety, and immunogenicity Moderately to severely active Crohn’s disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Cyltezo
Product Code: BI 695501
INN or Proposed INN: not available
Trade Name: HUMIRA (adalimumab)
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
130Phase 3Belarus;Serbia;United States;Greece;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Czech Republic;European Union;Croatia;Germany;Bosnia and Herzegovina
54NCT03172377
(ClinicalTrials.gov)
May 3, 201729/5/2017Lengthening Adalimumab Dosing Interval in Quiescent Crohn's Disease PatientsLengthening Adalimumab Dosing Interval in Quiescent Crohn's Disease PatientsCrohn Disease in Remission;Crohn DiseaseOther: Lengthening adalimumab dosing intervalRadboud UniversityErasmus Medical CenterActive, not recruiting18 YearsN/AAll174Phase 4Netherlands
55EUCTR2016-000612-14-GR
(EUCTR)
31/03/201702/02/2017BI 695501 versus Humira in patients with active Crohn’s disease: a trial comparing efficacy, endoscopic improvement, safety, and immunogenicity.BI 695501 versus Humira® in patients with active Crohn’s disease: a randomized, double-blind, multicenter, parallel group, non-inferiority trial comparing efficacy, endoscopic improvement, safety, and immunogenicity. Moderately to severely active Crohn’s disease
MedDRA version: 19.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: BI 695501
INN or Proposed INN: not available
Trade Name: HUMIRA (adalimumab)
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Boehringer Ingelheim International GmbHNULLNot Recruiting Female: yes
Male: yes
286 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Serbia;Greece;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Czech Republic;European Union;Croatia;Germany;Bosnia and Herzegovina
56NCT02852694
(ClinicalTrials.gov)
February 28, 20179/6/2016Reduce Risk for Crohn's Disease PatientsRisk-stratified Randomized Controlled Trial in Paediatric Crohn Disease:Methotrexate vs Azathioprine or Adalimumab for Maintaining Remission in Patients at Low or High Risk for Aggressive Disease Course, respectively-a Treatment StrategyCrohn's DiseaseDrug: Methotrexate;Drug: Adalimumab;Drug: Azathioprine / 6 MercaptopurinePIBD-NetEuropean CommissionRecruiting6 Years17 YearsAll312Phase 4France
57EUCTR2016-000522-18-IT
(EUCTR)
24/02/201708/06/2021Comparison of the effectiveness of treatment with an immunosuppressant medication over another or with respect to a biological drug in the maintenance of remission in children suffering from Crohn's Disease.Risk-stratified randomized controlled trial in paediatric Crohn¿s Disease: Methotrexate versus Azathioprine or Adalimumab for mantaining remission in patients at low or at high risk for aggressive disease course, respectively ¿ a treatment strategy - REDUCE-RISKincd-PBID-TRIAL Crohn Disease
MedDRA version: 20.0;Level: LLT;Classification code 10042759;Term: Symptoms involving digestive system;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: METHOTREXATE - 20 MG/0.8 ML SOLUZIONE INIETTABILE 4 SIRINGHE PRERIEMPITE MONOUSO DA 1.25 ML
Product Name: Methotrexate
Product Code: N.A
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: N.A
Trade Name: AZATIOPRINA ASPEN - 50 COMPRESSE
Product Name: Azatioprina
Product Code: N.A
Trade Name: PURINETHOL - 50 MG COMPRESSE25 COMPRESSE
Product Name: Purinethol
UMBERTO I - POLICLINICO DI ROMANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
312Phase 4France;Czechia;Czech Republic;Hungary;Poland;Belgium;Netherlands;Germany;United Kingdom;Italy
58EUCTR2016-000612-14-GB
(EUCTR)
25/01/201729/09/2016BI 695501 versus Humira in patients with active Crohn’s disease: a trial comparing efficacy, endoscopic improvement, safety, and immunogenicity.BI 695501 versus Humira® in patients with active Crohn’s disease: a randomized, double-blind, multicenter, parallel group, exploratory trial comparing efficacy, endoscopic improvement, safety, and immunogenicity. Moderately to severely active Crohn’s disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: BI 695501
INN or Proposed INN: not available
Trade Name: HUMIRA (adalimumab)
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
286Phase 3Serbia;United States;Greece;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Czech Republic;European Union;Croatia;Germany;Bosnia and Herzegovina
59EUCTR2016-003321-42-NL
(EUCTR)
18/01/201708/12/2016Stepwise extention of the adalimumab injection interval in patients with stable Crohn's disease.Lengthening Adalimumab Dosing Interval in quiescent Crohn’s disease patients: the LADI study. Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Humira (adalimumab)
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Radboud University Medical CentreNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 4Netherlands
60EUCTR2016-000612-14-DE
(EUCTR)
18/01/201705/09/2016BI 695501 versus Humira in patients with active Crohn’s disease: a trial comparing efficacy, endoscopic improvement, safety, and immunogenicity.BI 695501 versus Humira® in patients with active Crohn’s disease: a randomized, double-blind, multicenter, parallel group, exploratory trial comparing efficacy, endoscopic improvement, safety, and immunogenicity. Moderately to severely active Crohn’s disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Cyltezo
Product Code: BI 695501
INN or Proposed INN: not available
Trade Name: HUMIRA (adalimumab)
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
130Phase 3Israel;Russian Federation;United Kingdom;Czech Republic;European Union;Croatia;Germany;Bosnia and Herzegovina;Belarus;Serbia;United States;Greece;Ukraine;Turkey
61NCT03261102
(ClinicalTrials.gov)
January 17, 201722/8/2017TDM Guided Early Optimization of ADAL in Crohn's DiseaseTherapeutic Drug Monitoring Guided Early Optimization of Adalimumab in Crohn's Disease; A Randomized Open Label StudyCrohn Disease;Drug Monitoring;Inflammatory Bowel DiseasesBiological: Adalimumabwaqqas.afifAbbVieRecruiting18 YearsN/AAll200N/ACanada
62EUCTR2016-000522-18-DE
(EUCTR)
05/01/201701/08/2016Risk stratified randomized controlled trial in paediatric Crohn's Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively a treatment strategyRisk stratified randomized controlled trial in paediatric Crohn's Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively a treatment strategy - REDUCE-RISK in CD-PIBD-TRIAL Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Product Name: Azathioprin
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Product Name: Methotrexat
INN or Proposed INN: methotrexate
Other descriptive name: METHOTREXATE
PIBD-NetNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
312Phase 3France;Hungary;Czech Republic;Canada;Poland;Belgium;Israel;Netherlands;Germany;Italy;United Kingdom
63EUCTR2016-000612-14-CZ
(EUCTR)
14/12/201624/10/2016 BI 695501 versus Humira in patients with active Crohn’s disease: a trial comparing efficacy, endoscopic improvement, safety, and immunogenicity. BI 695501 versus Humira® in patients with active Crohn’s disease: a randomized, double-blind, multicenter, parallel group, exploratory trial comparing efficacy, endoscopic improvement, safety, and immunogenicity Moderately to severely active Crohn’s disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Cyltezo
Product Code: BI 695501
INN or Proposed INN: not available
Trade Name: HUMIRA (adalimumab)
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Boehringer Ingelheim International GmbHNULLNot Recruiting Female: yes
Male: yes
130 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Belarus;Serbia;Greece;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Czech Republic;European Union;Croatia;Germany;Bosnia and Herzegovina
64JPRN-UMIN000024566
2016/11/0101/11/2016Study on the selection of appropriate patients for the dose escalation of adalimumab in Crohn's disease therapy.Study on the selection of appropriate patients for the dose escalation of adalimumab in Crohn's disease therapy. - Study on the selection of appropriate patients for the dose escalation of adalimumab. Crohn'diseaseDose escalation group
Administration of Adalimumab 80 mg every other week

Non-dose escalation group
Administration of Adalimumab 40 mg every other week
Toho University Medical Center Sakura HospitalNULLComplete: follow-up complete16years-oldNot applicableMale and Female60Not applicableJapan
65JPRN-UMIN000023735
2016/10/3131/10/2016Does changing every other week (eow)- to every week (ew)-injection of adalimumab influence trough and efficacy in patients with Crohn's disease?-Trough of adalimumab evaluation-TRADE studyDoes changing every other week (eow)- to every week (ew)-injection of adalimumab influence trough and efficacy in patients with Crohn's disease?-Trough of adalimumab evaluation-TRADE study - TRADE study Crohn's diseaseEW or EOW injection of adalimumabSaitama Medical Center, Saitama Medical UniversityNULLComplete: follow-up complete15years-old75years-oldMale and Female10Not selectedJapan
66JPRN-UMIN000023871
2016/08/2501/09/2016Comparison of efficacy between adalimumab 80mg every other week vs 40mg every week in Crohn's disease(WAVE-K study)Comparison of efficacy between adalimumab 80mg every other week vs 40mg every week in Crohn's disease(WAVE-K study) - Comparison of efficacy between adalimumab 80mg every other week vs 40mg every week in Crohn's disease(WAVE-K study) Crohn's diseaseAdministration of Adalimumab 80 mg every 2 weeks.
Administration of Adalimumab 40 mg every week.
Fukuoka University Chikushi HospitalNULLComplete: follow-up complete16years-oldNot applicableMale and Female100Not applicableJapan
67JPRN-UMIN000019958
2016/07/0227/11/2015Research for biomarkers of inflammatory bowel disease. - Investigation of the usefulness of LRG for evaluation of disease condition after adalimumab treatments Crohn's disease, ulcerative colitisPatients with Crohn's disease or ulcerative colitis

Adalimumab administration subcutaneously for 52 weeks using the recommended dosing regimens.
Iwate Medical UniversityKochi Medical School HospitalKeio University School of MedicineNULLComplete: follow-up continuing15years-oldNot applicableMale and Female100Not applicableJapan
68JPRN-UMIN000022270
2016/06/3001/07/2016Evaluation of the effects and predictive factors of double dose of adalimumab for the patients with Crohn's diseaseEvaluation of the effects and predictive factors of double dose of adalimumab for the patients with Crohn's disease - ADA2 study Crohn's diseasedouble dose of adalimumabSaitama Medical CenterNULLComplete: follow-up complete15years-old80years-oldMale and Female20Not selectedJapan
69NCT02750800
(ClinicalTrials.gov)
April 7, 201613/4/2016Post-marketing Observational Study to Evaluate the Incremental Impact of AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary (VALUE)Post-marketing Observational Study to Evaluate the Effect of HUMIRA (Adalimumab) Treatment With AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary in a Real-life Setting: VALUERheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis;Psoriasis;Crohn's Disease;Ulcerative ColitisBiological: Adalimumab;Behavioral: AbbVie Care 2.0AbbVieNULLCompleted18 Years99 YearsAll427Hungary
70EUCTR2013-003199-11-BE
(EUCTR)
25/09/201527/07/2015CUREChanging the coUrse of cRohn's disease with an Early use of adalimumab: The CURE study. - CURE Crohn's disease;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]Trade Name: Adalimumab
Product Name: Humira
GETAID - Groupe d'Etude Thérapeutique des Affections Inflammatoires DigestivesNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 4France;Belgium
71NCT02499783
(ClinicalTrials.gov)
August 17, 201514/7/2015Study to Evaluate the Safety and Efficacy of Adalimumab in Chinese Subjects With Moderate to Severe Crohn's DiseaseA Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Adalimumab for the Induction and Maintenance of Clinical Remission in Chinese Patients With Moderately to Severely Active Crohn's Disease and Elevated High-Sensitivity C-reactive ProteinCrohn's DiseaseBiological: adalimumab;Other: placeboAbbVieNULLCompleted18 Years70 YearsAll205Phase 3China
72EUCTR2014-004887-39-PL
(EUCTR)
08/08/201507/07/2015A study comparing the use of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid ArthritisAn Open-labelled, Single-arm, Multicentre Clinical Study to Evaluate the Usability and Safety of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis Subjects with Rheumatoid Arthritis. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), Axial spondyloarthritis without radiographic evidence of AS, psoriasis (Ps), psoriatic arthritis (PsA), and ulcerative colitis (UC).
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 Code: SB5
INN or Proposed INN: ADALIMUMAB
Product Code: SB5
INN or Proposed INN: ADALIMUMAB
Samsung Bioepis Co., LtdNULLNot RecruitingFemale: yes
Male: yes
Poland
73EUCTR2013-004034-15-BE
(EUCTR)
04/06/201505/01/2015A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability ofRepeated Administration of Adalimumab in Subjects with Crohn's DiseaseA Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability ofRepeated Administration of Adalimumab in Subjects with Crohn's Disease Crohn's disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Slovakia;Spain;Ukraine;Austria;Israel;Switzerland;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany
74EUCTR2010-020137-10-LT
(EUCTR)
13/05/201512/03/2015Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM)An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM Crohn's disease
MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Decortin 5 mg
INN or Proposed INN: PREDNISONE
Trade Name: Decortin 20 mg
INN or Proposed INN: PREDNISONE
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden
75EUCTR2013-004034-15-FR
(EUCTR)
07/05/201522/06/2015 A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease Crohn's disease
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
AbbVie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Slovakia;Spain;Ukraine;Austria;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany
76NCT02256462
(ClinicalTrials.gov)
May 1, 201526/9/2014Pediatric Crohn's Disease AdalImumab Level-based Optimization Treatment (PAILOT) TrialPediatric Crohn's Disease AdalImumab Level-based Optimization Treatment (PAILOT) TrialCrohn's DiseaseDrug: AdalimumabSchneider Children's Medical Center, IsraelNULLCompleted6 Years17 YearsAll82Phase 4Israel
77NCT02413047
(ClinicalTrials.gov)
May 20156/3/2015Evaluate if Response to Infliximab or Adalimumab May be Regained With an ImmunomodulatorA Pilot Study to Evaluate if Response to Infliximab or Adalimumab May be Regained With the Addition of an ImmunomodulatorInflammatory Bowel Disease;Ulcerative Colitis;Crohn's DiseaseDrug: Azathioprine;Drug: 6 mercaptopurine;Drug: MethotrexateIndiana UniversityNULLTerminated18 Years80 YearsAll3N/AUnited States
78EUCTR2013-004034-15-IT
(EUCTR)
31/03/201503/10/2014 A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease Crohn's disease
MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
AbbVie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Slovakia;Spain;Ukraine;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany
79NCT03306446
(ClinicalTrials.gov)
March 17, 201521/6/2015Changing the coUrse of cRohn's Disease With an Early Use of AdalimumabChanging the coUrse of cRohn's Disease With an Early Use of AdalimumabCDDrug: Start adalimumab in monotherapyGroupe d'Etude Therapeutique des Affections Inflammatoires DigestivesNULLActive, not recruiting18 Years75 YearsAll203Phase 4Belgium;France
80EUCTR2013-004034-15-DK
(EUCTR)
06/03/201527/10/2014A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability ofRepeated Administration of Adalimumab in Subjects with Crohn's DiseaseA Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability ofRepeated Administration of Adalimumab in Subjects with Crohn's Disease Crohn's disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Slovakia;Spain;Ukraine;Austria;Israel;Switzerland;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany
81EUCTR2013-004034-15-DE
(EUCTR)
09/02/201529/08/2014A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability ofRepeated Administration of Adalimumab in Subjects with Crohn's DiseaseA Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability ofRepeated Administration of Adalimumab in Subjects with Crohn's Disease Crohn's disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Slovakia;Spain;Ukraine;Austria;Israel;Switzerland;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany
82EUCTR2013-004034-15-GB
(EUCTR)
27/01/201529/08/2014 A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease Crohn's disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
AbbVie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Slovakia;Spain;Ukraine;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany
83EUCTR2013-001746-33-FR
(EUCTR)
14/01/201522/06/2015A Blinded Study to Evaluate the Efficacy and Safety of Two Adalimumab Doses in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal UlcerationA Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Two Adalimumab Induction Regimens in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration Crohn's disease
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
AbbVie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;France;Czech Republic;Hungary;European Union;Canada;Belgium;Denmark;Germany;Netherlands
84EUCTR2013-001746-33-BE
(EUCTR)
12/01/201503/04/2014A Blinded Study to Evaluate Higher Versus Standard Adalimumab Doses for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal UlcerationA Multicenter, Randomized, Double-Blind Study to Evaluate Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration Crohn's disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
AbbVie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
600 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany;Netherlands
85JPRN-UMIN000032485
2015/01/0108/05/2018efficacy of early adalimumab or immunomodulator on postoperative remission maintenance in patients with Crohn's diseaseefficacy of early adalimumab or immunomodulator on postoperative remission maintenance in patients with Crohn's disease - postoperative early adalimumab or immunomodulator in CD study Cron's diseaseadalimumab
azathiopurine
Sakura medical center, Toho universityNULLComplete: follow-up complete20years-old70years-oldMale and Female20Not selectedJapan
86EUCTR2013-004034-15-AT
(EUCTR)
11/12/201412/11/2014A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's DiseaseA Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease Crohn's disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Slovakia;Spain;Ukraine;Austria;Israel;Switzerland;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany
87EUCTR2013-004034-15-SK
(EUCTR)
10/12/201413/10/2014 A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease Crohn's disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
AbbVie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Slovakia;Spain;Ukraine;Austria;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany
88NCT02539849
(ClinicalTrials.gov)
December 20144/8/2015Effect of Prebiotic FOS on Intestinal Abundance of Faecalibacterium Prausnitzii in Patients With Crohn´s DiseaseEffect of Prebiotic Fructo-oligosaccharides (FOS) on Intestinal Abundance of Faecalibacterium Prausnitzii in Patients With Crohn´s DiseaseCrohn DiseaseDietary Supplement: FOS;Drug: AdalimumabHospital Universitari Vall d'Hebron Research InstituteAbbVieCompleted18 Years65 YearsAll38N/ASpain
89EUCTR2013-001746-33-NL
(EUCTR)
28/11/201422/04/2014A Blinded Study to Evaluate Higher Versus Standard Adalimumab doses for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal UlcerationA Multicenter, Randomized, Double-Blind Study to Evaluate Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration Crohn's disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
500Phase 3United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Netherlands;Germany
90EUCTR2013-004034-15-ES
(EUCTR)
25/11/201422/09/2014A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability ofRepeated Administration of Adalimumab in Subjects with Crohn's DiseaseA Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability ofRepeated Administration of Adalimumab in Subjects with Crohn's Disease Crohn's disease
MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Slovakia;Spain;Ukraine;Austria;Israel;Switzerland;France;Hungary;Czech Republic;European Union;Canada;Denmark
91EUCTR2013-001746-33-DK
(EUCTR)
23/10/201415/05/2014A Blinded Study to Evaluate Higher Versus Standard Adalimumab doses for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal UlcerationA Multicenter, Randomized, Double-Blind Study to Evaluate Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration Crohn's disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
500Phase 3United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;France;Czech Republic;Hungary;European Union;Canada;Belgium;Denmark;Germany;Netherlands
92EUCTR2013-001746-33-DE
(EUCTR)
08/10/201401/04/2014A Blinded Study to Evaluate Higher Versus Standard Adalimumab doses forInduction and Maintenance Therapy in Subjects with Moderately toSeverely Active Crohn's Disease and Evidence of Mucosal UlcerationA Multicenter, Randomized, Double-Blind Study to Evaluate Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration Crohn's disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
500Phase 3United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany;Netherlands
93EUCTR2013-004034-15-HU
(EUCTR)
07/10/201425/08/2014A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability ofRepeated Administration of Adalimumab in Subjects with Crohn's DiseaseA Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability ofRepeated Administration of Adalimumab in Subjects with Crohn's Disease Crohn's disease
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Slovakia;Spain;Ukraine;Austria;Israel;Switzerland;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany
94EUCTR2013-001746-33-IT
(EUCTR)
09/09/201410/04/2014A Blinded Study to Evaluate the Efficacy and Safety of Two Adalimumab Doses in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal UlcerationA Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Two Adalimumab Induction Regimens in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration Crohn's disease
MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Slovakia;Spain;Austria;Israel;Italy;Switzerland;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany;Netherlands
95NCT02332356
(ClinicalTrials.gov)
September 20144/1/2015Therapeutic Optimization Study Based on MR Enterocolonography in Patients With Crohn's DiseaseTherapeutic Optimization Study Based on MR Enterocolonography in Patients With Crohn's DiseaseCrohn DiseaseDrug: azathioprine or adalimumab and infliximabTokyo Medical and Dental UniversityNULLRecruiting16 Years65 YearsAll100Phase 3Japan
96NCT02185014
(ClinicalTrials.gov)
August 12, 20147/7/2014Open Label Study to Evaluate Long Term Efficacy, Safety and Tolerability of Repeated Dosing in Subjects With Crohn's Disease and Who Participated and Successfully Completed M14-115A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects With Crohn's DiseaseCrohn's DiseaseDrug: AdalimumabAbbVieNULLCompleted18 Years75 YearsAll252Phase 3Austria;Belgium;Canada;Czech Republic;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Netherlands;Poland;Puerto Rico;Romania;Slovakia;Spain;Switzerland;Ukraine;United Kingdom;United States
97EUCTR2013-003199-11-FR
(EUCTR)
12/08/201426/03/2018CURE Changing the coUrse of cRohn’s disease with an Early use of adalimumab: CURE STUDY - CURE Crohn's disease;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]Trade Name: ADALIMUMAB
Product Name: HUMIRA
GETAIDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 4France;Belgium
98EUCTR2013-001746-33-CZ
(EUCTR)
10/07/201415/05/2014A Blinded Study to Evaluate Higher Versus Standard Adalimumab doses for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal UlcerationA Multicenter, Randomized, Double-Blind Study to Evaluate Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration Crohn's disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United States;Slovakia;Spain;Austria;Israel;Switzerland;France;Czech Republic;Hungary;European Union;Canada;Belgium;Denmark;Netherlands
99EUCTR2013-005013-13-PL
(EUCTR)
25/06/201431/03/2014A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate TherapyA Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis.
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]
Product Name: SB5
INN or Proposed INN: ADALIMUMAB
Other descriptive name: SB5
Trade Name: Humira®
Product Name: Humira®
INN or Proposed INN: ADALIMUMAB
Samsung Bioepis Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
490Bosnia and Herzegovina;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;Latvia;United Kingdom;Korea, Republic of
100EUCTR2013-001746-33-ES
(EUCTR)
23/06/201425/04/2014A Blinded Study to Evaluate the Efficacy and Safety of Two Adalimumab Doses in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal UlcerationA Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Two Adalimumab Induction Regimens in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration Crohn's disease
MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
AbbVie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany;Netherlands
101EUCTR2013-001746-33-HU
(EUCTR)
18/06/201423/04/2014A Blinded Study to Evaluate the Efficacy and Safety of Two Adalimumab Doses in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal UlcerationA Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Two Adalimumab Induction Regimens in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration Crohn's disease
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300United States;Slovakia;Spain;Austria;Israel;Switzerland;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Netherlands
102EUCTR2013-001746-33-SK
(EUCTR)
10/06/201415/04/2014A Blinded Study to Evaluate Higher Versus Standard Adalimumab doses for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal UlcerationA Multicenter, Randomized, Double-Blind Study to Evaluate Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration Crohn's disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
500Phase 3Netherlands;Germany;Denmark;Belgium;Canada;European Union;Czech Republic;Hungary;France;Italy;Switzerland;Israel;Austria;Spain;Slovakia;United States
103EUCTR2013-001746-33-AT
(EUCTR)
05/06/201415/05/2014A Blinded Study to Evaluate Higher Versus Standard Adalimumab doses for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal UlcerationA Multicenter, Randomized, Double-Blind Study to Evaluate Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration Crohn's disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: Adalimumab
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
500Phase 3United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;France;Czech Republic;Hungary;European Union;Canada;Belgium;Denmark;Germany;Netherlands
104NCT02148718
(ClinicalTrials.gov)
June 201423/5/2014Rapidity of Response to Adalimumab Treatment in Patients With Crohn´s DiseaseRapidity of Onset of Response to Adalimumab in Luminal Crohn's Disease (RAPIDA Study)Moderate to Severe Crohn's DiseaseBiological: adalimumabAbbVieLaboratorio Echevarne;Pivotal S.L.Completed18 Years75 YearsAll100Phase 4Spain
105NCT02065570
(ClinicalTrials.gov)
May 1, 201417/2/2014Study to Evaluate Efficacy and Safety of Two Drug Regimens in Subjects With Moderate to Severe Crohn's DiseaseA Multicenter, Randomized, Double-Blind Study to Evaluate Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease and Evidence of Mucosal UlcerationCrohn's DiseaseDrug: Adalimumab;Drug: PlaceboAbbVieNULLCompleted18 Years75 YearsAll514Phase 3United States;Austria;Belgium;Canada;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Netherlands;Poland;Puerto Rico;Romania;Slovakia;Spain;Switzerland;Ukraine;United Kingdom;Czech Republic
106EUCTR2013-005013-13-BG
(EUCTR)
28/04/201423/04/2014A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate TherapyA Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis.
MedDRA version: 17.1;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: SB5
INN or Proposed INN: ADALIMUMAB
Other descriptive name: SB5
Trade Name: Humira®
Product Name: Humira®
INN or Proposed INN: ADALIMUMAB
Samsung Bioepis Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
490Phase 3Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina
107EUCTR2013-004781-34-ES
(EUCTR)
16/04/201425/02/2014Rapidity of response to adalimumab treatment in patients with Crohn´s Disease.Rapidity of onset of response to Adalimumab in luminal Crohn's disease. RAPIDA study. Crohn's disease
MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: ADALIMUMAB
INN or Proposed INN: ADALIMUMAB
AbbVie Farmacéutica S.L.U.NULLNot RecruitingFemale: yes
Male: yes
98Phase 4Spain
108EUCTR2013-005013-13-LT
(EUCTR)
08/04/201413/02/2014A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate TherapyA Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis.
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]
Product Name: SB5
INN or Proposed INN: ADALIMUMAB
Other descriptive name: SB5
Trade Name: Humira®
Product Name: Humira®
INN or Proposed INN: ADALIMUMAB
Samsung Bioepis Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
490Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina
109EUCTR2013-005013-13-CZ
(EUCTR)
03/04/201413/02/2014A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate TherapyA Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis.
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] - Immune System Diseases [C20]
Product Name: SB5
INN or Proposed INN: ADALIMUMAB
Other descriptive name: SB5
Trade Name: Humira®
Product Name: Humira®
INN or Proposed INN: ADALIMUMAB
Samsung Bioepis Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
490Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina
110NCT01960426
(ClinicalTrials.gov)
April 201425/9/2013Evaluation of Health Costs and Resource UtilizationA Randomized Evaluation of Health Costs and Resource Utilization Comparing Testing-Based Therapy to Empiric Dose Intensification for the Management of Inflammatory Bowel Disease.Ulcerative Colitis;Crohn's DiseaseOther: Measurement of drug (Adalimumab/Infliximab);Other: Intensify treatment with the existing drugUniversity of Western Ontario, CanadaPrometheus LaboratoriesTerminated18 YearsN/ABoth51Phase 4United States
111NCT01986127
(ClinicalTrials.gov)
February 14, 20149/10/2013Adalimumab Intralesional in Intestinal Strictures of Crohn's Disease PatientsA Randomized, Double-blinded, Placebo-controlled Study on the Effects of Adalimumab Intralesional Intestinal Strictures of Crohn's Disease PatientsCrohn's DiseaseDrug: Adalimumab;Drug: placeboSara VareaHospital Clinic of BarcelonaTerminated18 YearsN/AAll26Phase 3Spain
112NCT02015793
(ClinicalTrials.gov)
December 201313/12/2013Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Two Treatment Modules in Chinese Subjects With Moderate to Severe Crohn's DiseaseA Phase 2, Randomized, Double-Blind, Multicenter Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Two Adalimumab Dosing Regimens in Chinese Subjects With Moderately to Severely Active Crohn's Disease and Elevated High-Sensitivity C-reactive ProteinCrohn's DiseaseBiological: Adalimumab;Biological: Placebo for adalimumabAbbVieNULLCompleted18 Years70 YearsAll30Phase 2China
113EUCTR2012-001723-12-ES
(EUCTR)
07/10/201314/08/2013adalimumab intralesional in intestinal strictures of Crohn's disease patientsA randomized, double-blinded, placebo-controlled study on the effects of adalimumab intralesional intestinal strictures of Crohn's disease patients Crohn disease
MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Fundació Clínic per a la Recerca BiomèdicaNULLNot RecruitingFemale: yes
Male: yes
102Phase 3Spain
114NCT01674413
(ClinicalTrials.gov)
October 201316/8/2012Calprotectin-Directed Humira® Maintenance Therapy (CADHUM)Calprotectin-Directed Humira® Maintenance Therapy, a Double-blind, Double-dummy, Randomized Controlled Trial in Crohn's DiseaseCrohn's DiseaseDrug: Adalimumab;Drug: Adalimumab PRN;Drug: PlaceboPeter HigginsAbbVieWithdrawn18 YearsN/AAll0Phase 3United States
115JPRN-JapicCTI-142426
01/9/2013A Study of Adalimumab After Dose Escalation in Japanese Subjects With Crohn's DiseaseA Multicenter Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Investigate Efficacy, Safety and Pharmacokinetics after Dose Escalation in Japanese Subjects with Crohn's Disease Crohn's DiseaseIntervention name : adalimumab
INN of the intervention : adalimumab
Dosage And administration of the intervention : adalimumab 80mg every other week
Control intervention name : null
AbbVie GKNULL15BOTH28Phase 3NULL
116NCT01958827
(ClinicalTrials.gov)
September 20134/10/2013A Study of Adalimumab After Dose Escalation in Japanese Subjects With Crohn's DiseaseA Multicenter Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Investigate Efficacy, Safety and Pharmacokinetics After Dose Escalation in Japanese Subjects With Crohn's DiseaseCrohn's DiseaseBiological: AdalimumabAbbVieNULLCompleted15 YearsN/AAll28Phase 3Japan
117EUCTR2013-002932-25-NL
(EUCTR)
21/08/201325/07/2013A randomized clinical trial: treatment of perianal fistulas in Crohn's diseaseMultimodal treatment of perianal fistulas in Crohn's disease: seton vs anti-TNF vs advancement plasty - PISA-trial Perianal fistulas in Crohn's Disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Remicade
Product Name: Infliximab
Trade Name: Humira
Product Name: Adalimumab
Academic Medical CenterNULLNot Recruiting Female: yes
Male: yes
126 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesNetherlands
118NCT02073526
(ClinicalTrials.gov)
May 20139/1/2014Anti-TNF-alpha Trough Level Measurements in Inflammatory Bowel DiseaseAnti-TNF-alpha Trough Level Measurements in Inflammatory Bowel DiseaseInflammatory Bowel Disease;Crohn's Disease;Ulcerative ColitisDrug: Infliximab, adalimumab, certolizumab pegolOslo University HospitalNULLCompleted18 YearsN/ABoth1230N/ANorway
119JPRN-UMIN000010524
2013/03/2917/04/2013Optimization of adalimumab switch therapy for loss of response with infliximab in Crohn's disease-OASISstudy Crohn's diseaseAdalimubab is administered continuously starting with 160 mg, then 80 mg after 2 weeks and 40 mg from 2 weeks onwards.
Continous administration of azathioprine concomitantly with adalimubab at the initial dose of 160 mg, then 80 mg after 2 weeks and 40 mg from 2 weeks onwards. The target dose for azathioprine is 2.0-2.5mg/kg/day and the dose is increased at the discretion of the attending physician.
Tokyo Medical & Dental University GastroenterologyNULLComplete: follow-up complete15years-oldNot applicableMale and Female20Not selectedJapan
120NCT01768858
(ClinicalTrials.gov)
February 5, 201314/1/2013Assessment of Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, Crohn's Disease and Ulcerative Colitis Patients´ Adherence Attitudes to Maintenance Therapy With a Scheduled Adalimumab Treatment in Routine Clinical PracticeAssessment of Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, Crohn's Disease and Ulcerative Colitis Patients´ Adherence Attitudes to Maintenance Therapy With a Scheduled Adalimumab Treatment in Routine Clinical PracticeRheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis;Crohn´s Disease;Ulcerative Colitis;Plaque PsoriasisDrug: AdalimumabAbbVieRaffeiner GmbHCompleted18 Years99 YearsAll96Austria
121JPRN-UMIN000009596
2013/01/0121/12/2012Withdrawal of immunomodulator in Crohn's disease treated with adalimumab and immnomodulator : a multicenter randomized trial(Diamond2 study). Crohn`s diseaseWithdrawal of the concomitant immunomodulator (azathioprine or 6-mercaptoprine) while under adalimumab 40 mg/every other week continued treatment.
Non-withdrawal of the concomitant immunomodulator (azathioprine or 6-mercaptoprine) while under adalimumab 40 mg/every other week continued treatment.
Department of Internal Medicine, School of Medicine, Keio UniversityNULLComplete: follow-up complete15years-oldNot applicableMale and Female200Not selectedJapan
122JPRN-UMIN000009284
2012/11/2020/11/2012The Study for Efficacy of Adalimumab Maintenance Therapy Initiated Following Resection of Active Lesions in Crohn's Disease PatientsThe Study for Efficacy of Adalimumab Maintenance Therapy Initiated Following Resection of Active Lesions in Crohn's Disease Patients - The Efficacy of Adalimumab Maintenance Therapy for Post-Operative Crohn's Disease Crohn's disease Patients who has been treated with following surgical removal of active lesions(intestinal resection)adalimumab injected immediately(within 3months) after surgical removal Crohn's disease lesions(intestinal resection). Inject SC 160mg,80mg,40mg in every other week.Sakura Medical Center,Toho universityNULLComplete: follow-up complete18years-old65years-oldMale and Female20Phase 2Japan
123EUCTR2011-006084-22-GB
(EUCTR)
04/10/201215/08/2012Usefulness of the measurement of blood levels of infliximab and adalimumab in inflammatory bowel disease patients in predicting response to treatmentUtilising drug levels and anti-drug antibodies to predict response to treatment in patients with Inflammatory Bowel Disease - Trough levels of anti-TNF agents in inflammatory bowel disease Inflammatory bowel disease
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Remicade
Product Name: Infliximab
INN or Proposed INN: Infliximab
Trade Name: Humira
Product Name: adalimumab
INN or Proposed INN: Adalimumab
Royal Liverpool University HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
0United Kingdom
124NCT01562951
(ClinicalTrials.gov)
October 201213/3/2012Assessment of Mucosal Activity to Improve the Prognosis of Patients With Crohn's Disease Treated With ImmunosuppressantscAlprotectin and hsCRP as Markers of a New Diagnostic-therapeutic strAtegy That Assesses muCosal Activity to individuaLize Treatment and Improve the Prognosis of Patients With Crohn's Disease Treated With ImmunosuppressantsCrohn's Disease;Mucosal InflammationDrug: ADALIMUMAB;Drug: PlaceboGrupo Espanol de Trabajo en Enfermedad de Crohn y Colitis UlcerosaAbbott;TFS Trial Form SupportTerminated18 Years75 YearsBoth15Phase 3Belgium;France;Spain
125NCT01629628
(ClinicalTrials.gov)
July 201219/6/2012Adalimumab for the Management of Post-operative Crohn's Disease (CD)An Investigator Initiated Prospective, Single Center, Randomized, Open Label Study to Assess the Efficacy of Adalimumab for the Maintenance of Remission in Post-operative CD PatientsCrohn DiseaseDrug: Adalimumab;Drug: 6 MercaptopurineTel-Aviv Sourasky Medical CenterAbbottNot yet recruiting18 Years70 YearsBoth100Phase 3Israel
126NCT01564823
(ClinicalTrials.gov)
June 201231/1/2012Adalimumab on Preventing Post-chirurgic Recurrence on Crohn´s DiseaseAdalimumab on Preventing Postoperative Recurrence of Crohn's DiseaseCrohn´s DiseaseDrug: Metronidazole;Drug: Azathioprine;Drug: AdalimumabGrupo Espanol de Trabajo en Enfermedad de Crohn y Colitis UlcerosaEffice Servicios Para la Investigacion S.L.Completed18 YearsN/ABoth86Phase 3Spain
127NCT01556672
(ClinicalTrials.gov)
April 201215/3/2012Adalimumab-psoriasis and Small Bowel LesionsOpen-label Study on Small Bowel Lesions Suggestive of Crohn's Disease in Patients With Moderate to Severe Plaque Psoriasis Treated With AdalimumabPlaque Psoriasis;Crohn's DiseaseDrug: Adalimumab;Device: Capsule endoscopyInnovaderm Research Inc.Abbott;AbbottCompleted18 Years80 YearsBoth100Phase 4Canada
128NCT02450513
(ClinicalTrials.gov)
March 201212/5/2015Adalimumab Trough Concentrations in Crohn's Disease: A Pilot Pharmacokinetic StudyAdalimumab Trough Concentrations in Crohn's Disease: A Pilot Pharmacokinetic StudyCrohn's DiseaseDrug: AdalimumabUniversitaire Ziekenhuizen LeuvenNULLRecruiting18 Years65 YearsBoth30N/ABelgium
129JPRN-UMIN000007343
2012/02/0121/02/2012The study of the effectiveness of anti-TNF antibody maintenance treatment combined with elemental diet for Crohn's disease patientsThe study of the effectiveness of anti-TNF antibody maintenance treatment combined with elemental diet for Crohn's disease patients - The study of the effectiveness of anti-TNF antibody maintenance treatment combined with elemental diet for Crohn's disease patients Crohn's diseasePatients in monotherapy group receive; 1) intravenous infusion of infliximab (10mg/kg) at every 8 weeks (dose escalation of anti-TNF antibody), or 2) intravenous infusion of infliximab (5mg/kg) at week 0, 2, and 6 and then every 8 weeks, or subcutaneous injection of adalimumab at week 0 (160mg), 2 (80mg) and then every 2 weeks (40mg) (first time or switch of anti-TNF antibody).
Patients in combination therapy group take half the amount of their daily allowance of calories (900-1,200kcal) by elemental diet and the remaining half by usual unrestricted meals, in addition to above anti-TNF antibody therapy.
Tohoku University Graduate School of Medicine (Tohoku University Hospital)NULLComplete: follow-up complete20years-oldNot applicableMale and Female90Not applicableJapan
130JPRN-UMIN000006882
2012/02/0101/01/2012Evaluation of Concomitant Adalimumab and Cytapheresis in Patients who lose Response to Adalimumab Therapy Crohn's diseaseAdalimumab therapy (40 mg/dose, every other week) combined with Granulocyte/ Monocyte Apheresis (GMA), once weekly for 5 comsecutive weeks. If responses are noted, GMA is applied for another 5 sessions (once weekly).Department of Lower Gastroenterology, Hyogo College of MedicineHyogo College of Medicine (Hyogo, Japan), Osaka City Univ. (Osaka, Japan), Osaka Medical College (Osaka, Japan), Kyoto Univ. (Kyoto, Japan), Shiga University of Medical Science (Shiga, Japan)Complete: follow-up complete15years-oldNot applicableMale and Female20Phase 4Japan
131EUCTR2010-020137-10-HU
(EUCTR)
12/01/201222/11/2011Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM)An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM Crohn's disease
MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Decortin 5 mg
INN or Proposed INN: PREDNISONE
Trade Name: Decortin 20 mg
INN or Proposed INN: PREDNISONE
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Germany;Netherlands;Sweden
132EUCTR2011-003966-34-ES
(EUCTR)
10/01/201213/10/2011Biomarkers in diagnosis & treatment of patients with Crohn?s disease treated with immunosuppressantsThe ADACAL Study: cAlprotectin and hsCRP as markers of a new Diagnostic-therapeutic strAtegy that assesses muCosal Activity to individuaLize treatment and improve the prognosis of patients with Crohn?s disease treated with immunosuppressants - not applicable Crohn's disease (CD) is an inflammatory disease of the intestines that primarily causes abdominal pain, diarrhea, vomiting, or weight loss.;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU)NULLNot RecruitingFemale: yes
Male: yes
180Spain
133JPRN-UMIN000007514
2012/01/0115/03/2012Phase ll Study of Postoperative Adalimumab Maintenance Therapy for Crohn's Disease Recurrence Crohn's diseaseAdalimumab (HUMIRA 40mg for SC Injection)

Inject SC 160mg on Day 1, then inject SC 80 mg on Day 15, and inject SC 40 mg every other week, beginning on Day 29.
Nagoya University Gradeate School of MedicineDepartment of GastroenterologyNULLComplete: follow-up complete20years-oldNot applicableMale and Female25Phase 2Japan
134EUCTR2011-000885-36-ES
(EUCTR)
26/12/201129/11/2011Adalimub treatment to prevent recurrency post-surgery in Crohn disease.Multicentric, randomized double blind clinical trial and paralell groups to compare Adalimub vs Azatioprina efficacy prevention in Crhon disease post-surgical recurrency after 52 weeks of treatment - APPRECIA Compare efficay of Adalimub vs Azatioprina to prevent surgical intervention in Chron disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Humira
Product Name: Humira
INN or Proposed INN: Adalimumab
Other descriptive name: Adalimumab
Trade Name: Imurel
Product Name: Imurel
INN or Proposed INN: Azatioprina
Other descriptive name: Imurel
Trade Name: Flagyl
Product Name: Flagyl
INN or Proposed INN: Metronidazol
Other descriptive name: Flagyl
GETECCUNULLNot RecruitingFemale: yes
Male: yes
Spain
135EUCTR2011-003966-34-BE
(EUCTR)
06/12/201111/10/2011Biomarkers in diagnosis & treatment of patients with Crohn’s disease treated with immunosuppressants The ADACAL Study: cAlprotectin and hsCRP as markers of a new Diagnostic-therapeutic strAtegy that assesses muCosal Activity to individuaLize treatment and improve the prognosis of patients with Crohn’s disease treated with immunosuppressants Crohn's disease (CD) is an inflammatory disease of the intestines that primarily causes abdominal pain, diarrhea, vomiting, or weight loss.;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU)NULLNot RecruitingFemale: yes
Male: yes
180Phase 3Spain;Belgium
136JPRN-UMIN000007047
2011/11/0110/01/2012Effect of adacolumn and adalimumab combination therapy for the active stage Crohn's diseaseEffect of adacolumn and adalimumab combination therapy for the active stage Crohn's disease - Effect of adacolumn and adalimumab combination therapy for Crohn's disease Crohn's diseaseAdacolumn and adalimumab combination therapy for 10 weeks.
Adalimumab single therapy for remain 94 weeks.
Adacolumn single therapy for 104 weeks.
Yamaguchi University Graduate School of Medicine Department of Gastroenterology and HepatologyNULLComplete: follow-up complete12years-old75years-oldMale and Female40Not applicableJapan
137NCT01338740
(ClinicalTrials.gov)
April 201118/4/2011Switching From Adalimumab to InfliximabProspective Study to Assess the Efficacy of Switching to Infliximab in Moderately to Severely Active Chrohn's Disease Patients With Primary Non-response or Loss of Response to AdalimumabCrohn's DiseaseDrug: Adalimumab and InfliximabUniversity Hospital, GhentAbbottRecruiting18 Years75 YearsBoth40N/ABelgium
138EUCTR2010-020137-10-BE
(EUCTR)
23/03/201104/10/2010Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM)An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM Crohn's disease
MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Decortin 5 mg
INN or Proposed INN: PREDNISONE
Trade Name: Decortin 20 mg
INN or Proposed INN: PREDNISONE
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden
139JPRN-UMIN000005146
2011/03/0125/02/2011Study of Combination Therapy of Adalimumab and an Immunomodulator for Crohn's Disease(Diamond study) Crohn's diseaseAdministration of Adalimumab 160 mg at baseline, 80 mg at 2 weeks and 40 mg every 2 weeks.
In addition to Adalimumab Therapy, co-administration of 25-100mg Azathioprine once a day.Fixed dosage of Azathioprine up to 4 weeks and not increase in dosage later
Department of Internal Medicine, School of Medicine, Keio UniversityNULLComplete: follow-up complete15years-oldNot applicableMale and Female200Phase 4Japan
140NCT01235689
(ClinicalTrials.gov)
February 11, 20114/11/2010Efficacy and Safety of Two Treatment Algorithms in Adults With Moderate to Severe Crohn's DiseaseAn Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects With Moderate to Severe Crohn's DiseaseCrohn's DiseaseBiological: Adalimumab;Drug: Prednisone;Drug: AzathioprineAbbVie (prior sponsor, Abbott)NULLCompleted18 Years75 YearsAll252Phase 3Austria;Belgium;Canada;Czech Republic;France;Germany;Hungary;Israel;Italy;Japan;Lithuania;Netherlands;Poland;Romania;Russian Federation;South Africa;Spain;Sweden;Switzerland;Turkey;Ukraine;United Kingdom
141NCT01275508
(ClinicalTrials.gov)
January 20117/1/2011Safety and Tolerability of FITC-Adalimumab Administration During Confocal Laser Endomicroscopy of the GutProspective, Monocentric, Open-label, Clinical Phase 1 Study to Demonstrate the Safety and Tolerability of FITC-Adalimumab After Single Topical Administration to the Intestinal Mucosa During Endomicroscopy in Patients With Crohn's DiseaseCrohn's DiseaseDrug: FITC-AdalimumabUniversity of Erlangen-Nürnberg Medical SchoolAbbottCompleted18 Years70 YearsBoth25Phase 1/Phase 2Germany
142EUCTR2010-020137-10-NL
(EUCTR)
17/12/201023/12/2010Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM)An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM Crohn's disease
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Decortin 5 mg
INN or Proposed INN: PREDNISONE
Trade Name: Decortin 20 mg
INN or Proposed INN: PREDNISONE
AbbVie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSpain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Netherlands;Germany;Sweden
143EUCTR2010-020137-10-CZ
(EUCTR)
08/11/201004/08/2010Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM)An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM Crohn's disease
MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Decortin 5 mg
INN or Proposed INN: PREDNISONE
Trade Name: Decortin 20 mg
INN or Proposed INN: PREDNISONE
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden
144EUCTR2010-020137-10-IT
(EUCTR)
07/11/201008/11/2010An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn`s Disease. - CALMAn Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn`s Disease. - CALM Crohn`s disease.
MedDRA version: 9.1;Level: LLT;Classification code 10011401
Trade Name: HUMIRA*SC 2SIR+F 40MG 0,8ML+2T
INN or Proposed INN: Adalimumab
Trade Name: Azathioprin-ratiopharm 25 mg
INN or Proposed INN: Azathioprine
Trade Name: Azathioprine - ratiopharm 50 mg
INN or Proposed INN: Azathioprine
Trade Name: Decortin 5 mg
INN or Proposed INN: Prednisone
Trade Name: Decortin 20 mg
INN or Proposed INN: Prednisone
Abbott GmBH & Co. KGNULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Hungary;Czech Republic;Belgium;Spain;Lithuania;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden
145JPRN-UMIN000005761
2010/10/2713/06/2011The Study for Efficacy and Safety of Adalimumab for Crohn's Disease with Loss of Response to Infliximab Crohn's Disease patient as following 1)or 2) 1)the patient who treated with IFX infusion of interval every 4-6 weeks. 2)the patient who could not keep to treat with IFX due to side effect or ineffectiveness.Adalimumab (HUMIRA 40mg for SC Injection)

Inject SC 160mg on Day 1, then inject SC 80 mg on Day 15, and inject SC 40 mg every other week, beginning on Day 29.
Kenji WatanabeNULLComplete: follow-up completeNot applicableNot applicableMale and Female50Not selectedJapan
146JPRN-UMIN000005762
2010/10/2713/06/2011The Study for Efficacy of Adalimumab Conbined Elemental Diet Therapy for Crohn's Disease Crohn's Disease patient who was ineffective for present therapy and who has not been treated with anti TNF alpha antibody.1)Adalimumab (HUMIRA 40mg for SC Injection)

Inject SC 160mg on Day 1, then inject SC 80 mg on Day 15, and inject SC 40 mg every other week, beginning on Day 29.

2)Elental(1 kcal/ml; 80g/300ml)
Kenji WatanabeNULLComplete: follow-up completeNot applicableNot applicableMale and Female40Not selectedJapan
147EUCTR2006-002078-23-IE
(EUCTR)
20/10/201025/09/2006A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease.A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to7).
MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns
Trade Name: Humira
Product Name: Humira pre-filled PEN
Abbott GmbH & Co. KG (Abbott)NULLNot RecruitingFemale: yes
Male: yes
1000Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Greece
148EUCTR2010-020137-10-ES
(EUCTR)
20/10/201020/08/2010Estudio multicéntrico abierto de la eficacia y la seguridad para evaluar dos algoritmos detratamiento en pacientes con enfermedad de Crohn moderada a grave.An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALMEstudio multicéntrico abierto de la eficacia y la seguridad para evaluar dos algoritmos detratamiento en pacientes con enfermedad de Crohn moderada a grave.An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM Enfermedad de Crohn.Crohn's disease
MedDRA version: 12.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: HUMIRA 40 mg solución inyectable en jeringa precargada
INN or Proposed INN: ADALIMUMAB
Other descriptive name: ADALIMUMAB
Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten
Product Name: azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten
Product Name: azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Decortin 5 mg
INN or Proposed INN: PREDNISONE
Trade Name: Decortin 20 mg
INN or Proposed INN: PREDNISONE
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
240Phase 3France;Hungary;Czech Republic;Belgium;Spain;Lithuania;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
149EUCTR2010-020137-10-FR
(EUCTR)
14/10/201023/08/2010An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALMAn Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM Crohn's disease
MedDRA version: 12.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten
Product Name: azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten
Product Name: azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Decortin 5 mg
INN or Proposed INN: PREDNISONE
Trade Name: Decortin 20 mg
INN or Proposed INN: PREDNISONE
Abbott GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Hungary;Czech Republic;Belgium;Spain;Lithuania;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
150EUCTR2010-020137-10-DE
(EUCTR)
05/10/201020/07/2010Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM)An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM Crohn's disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Decortin 5 mg
INN or Proposed INN: PREDNISONE
Trade Name: Decortin 20 mg
INN or Proposed INN: PREDNISONE
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden
151EUCTR2010-020137-10-GB
(EUCTR)
20/09/201019/07/2010 Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM)An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM Crohn's disease
MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Decortin 5 mg
INN or Proposed INN: PREDNISONE
Trade Name: Decortin 20 mg
INN or Proposed INN: PREDNISONE
AbbVie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden
152EUCTR2010-020137-10-AT
(EUCTR)
16/09/201011/08/2010Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM)An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM Crohn's disease
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Decortin 5 mg
INN or Proposed INN: PREDNISONE
Trade Name: Decortin 20 mg
INN or Proposed INN: PREDNISONE
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden
153EUCTR2010-020137-10-SE
(EUCTR)
15/09/201027/07/2010Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM)An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM Crohn's disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten
Product Name: azathioprine
INN or Proposed INN: Azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Decortin 5 mg
INN or Proposed INN: PREDNISONE
Trade Name: Decortin 20 mg
INN or Proposed INN: PREDNISONE
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden
154EUCTR2007-006494-90-GB
(EUCTR)
24/12/200918/06/2009A Multi-center, Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Efficacy and the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Crohn's Disease Who Have Demonstrated a Clinical Response in the M06-806 StudyA Multi-center, Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Efficacy and the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Crohn's Disease Who Have Demonstrated a Clinical Response in the M06-806 Study Crohn's disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
INN or Proposed INN: adalimumab
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
INN or Proposed INN: adalimumab
Abbott GmbH & Co. K.G.NULLNot Recruiting Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noCzech Republic;Belgium;United Kingdom
155NCT02322008
(ClinicalTrials.gov)
September 200917/12/2014Anti-TNF Therapy in Danish Patients With Inflammatory Bowel Diseases in Clinical PracticeAnti-TNF Therapy in Danish Patients With Inflammatory Bowel Diseases in Clinical PracticeCrohn's Disease;Ulcerative Colitis;Inflammatory Bowel DiseaseBiological: infliximab and adalimumabRegionshospitalet Viborg, SkiveNULLCompleted18 YearsN/ABoth1035N/ANULL
156NCT01012570
(ClinicalTrials.gov)
August 200911/11/2009The Effect of Adalimumab on the Bone Microstructure in Crohn's Disease (CD) PatientsCrohn's DiseaseDrug: Application of AdalimumabGerhard RoglerNULLTerminated18 Years65 YearsBoth34Switzerland
157EUCTR2009-011763-37-IT
(EUCTR)
22/07/200916/04/2009THE ANTI-ANGIOGENIC EFFECTS OF ADALIMUMAB INCROHN`S DISEASE - NDTHE ANTI-ANGIOGENIC EFFECTS OF ADALIMUMAB INCROHN`S DISEASE - ND Crohn`s Disease
MedDRA version: 9.1;Level: LLT;Classification code 10038283;Term: Regional enteritis of small intestine with large intestine
INN or Proposed INN: AdalimumabISTITUTO CLINICO HUMANITASNULLNot RecruitingFemale: yes
Male: yes
Italy
158NCT00972218
(ClinicalTrials.gov)
July 200931/8/2009Effectiveness and Safety of Spondylitis Related to Inflammatory Bowel DiseaseEfficacy of Adalimumab (Humira®) in Spondyloarthritis Related to Crohn's DiseaseSpondyloarthritis;Crohn's DiseaseBiological: AdalimumabUniversity of AlbertaAbbottWithdrawn18 YearsN/ABoth0Phase 4Canada
159EUCTR2007-006494-90-CZ
(EUCTR)
11/02/200907/11/2008Efficacy and Long Term Safety of Adalimumab in Pediatric Subjects Who Have Demonstrated Clinical Response in M06-806A Multi-center, Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Efficacy and the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Crohn's Disease Who Have Demonstrated a Clinical Response in the M06-806 Study Crohn's disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
INN or Proposed INN: adalimumab
Trade Name: Humira 20 mg solution for injection in pre-filled syringe
INN or Proposed INN: adalimumab
Trade Name: Humira 40mg/0.8ml solution for injection for paediatric use
INN or Proposed INN: adalimumab
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
100Phase 3United States;Czech Republic;Canada;Belgium;Poland;United Kingdom
160EUCTR2006-004814-41-GB
(EUCTR)
16/01/200907/03/2008A Multicenter, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's DiseaseA Multicenter, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's Disease Moderate to Severe Crohn's Disease
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
INN or Proposed INN: Adalimumab
Trade Name: Humira 40 mg solution for injection in pre-filled pen
INN or Proposed INN: Adalimumab
INN or Proposed INN: Adalimumab
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
184France;Czech Republic;Belgium;Netherlands;Italy;United Kingdom
161EUCTR2004-002163-24-GB
(EUCTR)
08/12/200817/02/2005A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease.A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease. Crohn's DiseaseProduct Name: Humira
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
960Hungary;Spain;Denmark;Germany;Italy;United Kingdom;Sweden
162EUCTR2007-006494-90-BE
(EUCTR)
24/11/200818/08/2008Efficacy and Long Term Safety of Adalimumab in Pediatric Subjects Who Have Demonstrated Clinical Response in M06-806A Multi-center, Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Efficacy and the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Crohn's Disease Who Have Demonstrated a Clinical Response in the M06-806 Study Crohn's disease
MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
INN or Proposed INN: adalimumab
Trade Name: Humira 20 mg solution for injection in pre-filled syringe
INN or Proposed INN: adalimumab
Trade Name: Humira 40mg/0.8ml solution for injection for paediatric use
INN or Proposed INN: adalimumab
Abbvie Deutschland GmbH & Co. K.G.NULLNot RecruitingFemale: yes
Male: yes
100Phase 3United Kingdom;Belgium;United States;Czech Republic;Canada;Poland
163EUCTR2008-004926-18-DE
(EUCTR)
30/10/200830/10/2008Comparison of the human TNF-alpha antibody adalimumab with infliximab in induction and maintenance of steroid-free remission in patients with moderate to severe Crohn’s disease - CHAMPComparison of the human TNF-alpha antibody adalimumab with infliximab in induction and maintenance of steroid-free remission in patients with moderate to severe Crohn’s disease - CHAMP Moderate to severe Crohn’s diseaseTrade Name: Humira
Trade Name: Remicade
IBD Center LMU MunichNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Germany
164NCT00736983
(ClinicalTrials.gov)
September 200815/8/2008Adalimumab in Combination With Ciprofloxacin/Placebo Treatment of Perianal Fistulas in Crohn'sAdalimumab for the Treatment of Perianal Fistulas in Crohn's Disease More Effective Alone or Combined to CiprofloxacinCrohn's Disease With Perianal FistulasDrug: adalimumab;Drug: ciprofloxacinFoundation for Liver ResearchNULLCompleted18 Years70 YearsBoth76Phase 3Netherlands
165EUCTR2006-004814-41-NL
(EUCTR)
24/07/200822/01/2008A Multicenter, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's DiseaseA Multicenter, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's Disease Moderate to Severe Crohn's Disease
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: Humira
INN or Proposed INN: Adalimumab
Trade Name: Humira
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
184United Kingdom;Czech Republic;Netherlands;Belgium;France;Italy
166EUCTR2006-004814-41-IT
(EUCTR)
19/05/200813/03/2008A Multi-center, Double-blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's Disease - NDA Multi-center, Double-blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's Disease - ND Moderate to severe Crohn's disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: HUMIRA
INN or Proposed INN: Adalimumab
Trade Name: HUMIRA
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
184United Kingdom;Czech Republic;Netherlands;Belgium;France;Italy
167NCT00686374
(ClinicalTrials.gov)
May 1, 200827/5/2008Efficacy and Long Term Safety of Adalimumab in Pediatric Subjects Who Have Demonstrated Clinical Response in M06-806A Multi-center, Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Efficacy and the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects With Crohn's Disease Who Have Demonstrated a Clinical Response in the M06-806 StudyCrohn's DiseaseBiological: AdalimumabAbbVie (prior sponsor, Abbott)NULLCompleted7 Years18 YearsAll100Phase 3Belgium;Canada;Czech Republic;Czechia;France;Netherlands;Poland;United Kingdom;United States
168EUCTR2006-004814-41-CZ
(EUCTR)
12/03/200801/06/2007A Multicenter, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's DiseaseA Multicenter, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's Disease Moderate to Severe Crohn's Disease
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: Humira
INN or Proposed INN: Adalimumab
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
184United Kingdom;Czech Republic;Netherlands;Belgium;France;Italy
169EUCTR2006-004814-41-BE
(EUCTR)
21/01/200801/06/2007A Multicenter, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's DiseaseA Multicenter, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's Disease Moderate to Severe Crohn's Disease
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: Humira
INN or Proposed INN: Adalimumab
INN or Proposed INN: Adalimumab
Trade Name: Humira
INN or Proposed INN: Adalimumab
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
184United Kingdom;Czech Republic;Netherlands;Belgium;France;Italy
170NCT00517296
(ClinicalTrials.gov)
January 200815/8/2007Endoscopic Ultrasound (EUS) Guided Treatment With Humira for Crohn's Perianal FistulasEUS Guided Treatment With Humira for Crohn's Perianal FistulasCrohn Disease;Rectal FistulaProcedure: EUA with seton placement if necessary;Drug: adalimumab;Procedure: EUSVanderbilt University Medical CenterNULLCompleted18 YearsN/AAll21Phase 4United States
171EUCTR2006-004814-41-FR
(EUCTR)
07/08/200721/05/2007A Multicenter, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's DiseaseA Multicenter, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's Disease Moderate to Severe Crohn's Disease
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: Humira
INN or Proposed INN: Adalimumab
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
184Phase 3France;Czech Republic;Belgium;Netherlands;Italy;United Kingdom
172NCT01144156
(ClinicalTrials.gov)
July 200713/6/2010Small Bowel Mucosal Healing Induced by Adalimumab in Crohn's Disease Patients as Assessed by Capsule EndoscopySmall Bowel Mucosal Healing Induced by Adalimumab in Crohn's Disease Patients as Assessed by Capsule EndoscopyCrohn's DiseaseDrug: Treatment with AdalimumabRabin Medical CenterAbbottNot yet recruiting18 YearsN/ABoth30N/AIsrael
173NCT00409682
(ClinicalTrials.gov)
April 20078/12/2006Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's DiseaseA Multi-Center, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's DiseaseCrohn's DiseaseBiological: AdalimumabAbbottNULLCompleted6 Years17 YearsAll192Phase 3United States;Belgium;Canada;Czech Republic;France;Netherlands;Poland;United Kingdom;Italy
174JPRN-JapicCTI-070367
01/3/2007A Study of Adalimumab for the Maintenance of Clinical Remission in Japanese Subjects with Crohn's DiseaseA Multi-Center, Randomized, Double-Blind, Placebo-controlled study of Adalimumab for the Maintenance of Clinical Remission in Japanese Subjects with Crohn's Disease Crohn's diseaseIntervention name : adalimumab
INN of the intervention : adalimumab
Dosage And administration of the intervention : Subcutaneous
Control intervention name : Placebo
Dosage And administration of the control intervention : Subcutaneous
Abbott Japan Co., Ltd.Eisai Co., Ltd.1575BOTH80Phase 2-3NULL
175NCT00445432
(ClinicalTrials.gov)
March 20077/3/2007A Study of Adalimumab for the Maintenance of Clinical Remission in Japanese Subjects With Crohn's DiseaseA Multi-Center, Randomized, Double-blind, Placebo-controlled Study of Adalimumab for the Maintenance of Clinical Remission in Japanese Subjects With Crohn's DiseaseCrohn's DiseaseBiological: adalimumab;Other: PlaceboAbbottEisai Co., Ltd.Completed15 Years75 YearsAll82Phase 2/Phase 3Japan
176EUCTR2006-002078-23-GR
(EUCTR)
27/02/200710/10/2006A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease.A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to 7).
MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns
Trade Name: Humira
Product Name: Humira pre-filled PEN
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
1000Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Belgium;Denmark;Netherlands;Norway;Germany;Sweden
177EUCTR2006-002078-23-GB
(EUCTR)
22/02/200709/10/2006A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease.A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to7).
MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns
Trade Name: Humira
Product Name: Humira pre-filled PEN
Abbott GmbH & Co. KG (Abbott)NULLNot RecruitingFemale: yes
Male: yes
1000Portugal;Slovakia;Greece;Finland;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Denmark;Netherlands;Germany;Sweden
178EUCTR2006-002078-23-PT
(EUCTR)
06/02/200701/09/2006A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease.A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to 7).
MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns
Trade Name: Humira
Product Name: Humira pre-filled PEN
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
1000Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Greece
179JPRN-JapicCTI-070366
01/2/2007A Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects with Crohn's DiseaseA Multi-Center, Randomized, Double-blind, Placebo-controlled Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects with Crohn's Disease Crohn's diseaseIntervention name : adalimumab
INN of the intervention : adalimumab
Dosage And administration of the intervention : Subcutaneous
Control intervention name : Placebo
Dosage And administration of the control intervention : Subcutaneous
Abbott Japan Co., Ltd.Eisai Co., Ltd.1575BOTH80Phase 2-3NULL
180NCT00445939
(ClinicalTrials.gov)
February 20077/3/2007A Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects With Crohn's DiseaseA Multi-Center, Randomized, Double-blind, Placebo-controlled Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects With Crohn's DiseaseCrohn's DiseaseBiological: adalimumab;Biological: placeboAbbottAbbott Japan Co.,Ltd;Eisai Co., Ltd.Completed15 Years75 YearsAll90Phase 2/Phase 3Japan
181EUCTR2006-006632-22-BE
(EUCTR)
26/01/200719/12/2006Change from infliximab to adalimumab in patients with Crohn’s disease in remission on infliximab: a randomized comparative case control study. - Infliximab to adalimumab switch trialChange from infliximab to adalimumab in patients with Crohn’s disease in remission on infliximab: a randomized comparative case control study. - Infliximab to adalimumab switch trial Luminal Crohns Disease, moderate to severe, refractory to steroids and/or antimetabolitets and controlled with anti-TNF therapy
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: HUMIRA
Trade Name: REMICADE
University of Leuven, Division of GastroenterologyNULLNot RecruitingFemale: yes
Male: yes
100Phase 4Belgium
182EUCTR2006-002078-23-FI
(EUCTR)
10/01/200731/08/2006A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease.A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to 7).
MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns
Trade Name: Humira
Product Name: Humira pre-filled PEN
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
1000Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Greece
183EUCTR2006-002078-23-SE
(EUCTR)
10/01/200709/10/2006A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease.A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to 7).
MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns
Trade Name: Humira
Product Name: Humira
Product Code: ABT Humira
Product Name: Humira pre-filled PEN
Product Code: ABT Humira
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
1000Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Greece
184NCT00427921
(ClinicalTrials.gov)
January 200726/1/2007Human Anti-TNF Monoclonal Antibody Adalimumab in Canadian Subjects With Moderate to Severe Crohn's Disease (ACCESS)A Multicentre, Open Label, Treatment Protocol of the Human Anti-TNF Monoclonal Antibody Adalimumab in Canadian Subjects With Moderate to Severe Crohn's Disease (ACCESS)Crohn's DiseaseBiological: adalimumabAbbottNULLCompleted18 YearsN/AAll304Phase 3United States
185EUCTR2006-002078-23-DE
(EUCTR)
07/12/200622/09/2006A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease.A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to7).
MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns
Product Name: Humira pre-filled PENAbbott GmbH & Co. KG (Abbott)NULLNot RecruitingFemale: yes
Male: yes
1000Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Greece
186NCT00409617
(ClinicalTrials.gov)
December 20068/12/2006Study of Adalimumab Treatment for Induction and Maintenance of Clinical Remission in Subjects With Crohn's DiseaseA Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Moderate to Severe Crohn's DiseaseCrohn's DiseaseBiological: adalimumabAbbottNULLCompleted18 Years75 YearsAll945Phase 3Austria;Belgium;Czech Republic;Denmark;Finland;France;Germany;Greece;Ireland;Italy;Norway;Portugal;Slovakia;Spain;Sweden;Switzerland;United Kingdom;United States
187EUCTR2006-002078-23-DK
(EUCTR)
24/11/200626/09/2006A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease.A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to 7).
MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns
Trade Name: Humira
Product Name: Humira pre-filled PEN
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
1000Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Greece
188EUCTR2006-002078-23-FR
(EUCTR)
24/11/200629/09/2006A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease.A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to7).
MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns
Trade Name: Humira
INN or Proposed INN: adalimumab
Other descriptive name: ADALIMUMAB
Product Name: Humira pre-filled PEN
INN or Proposed INN: adalimumab
Other descriptive name: ADALIMUMAB
Abbott GmbH & Co. KG (Abbott)NULLNot RecruitingFemale: yes
Male: yes
1000Phase 3Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Belgium;Denmark;Netherlands;Norway;Germany;Sweden
189EUCTR2006-002078-23-ES
(EUCTR)
23/11/200619/06/2013A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease.Estudio multicéntrico abierto, del anticuerpo monoclonal humano anti-TNF Adalimumab, en inducción y mantenimiento de la remisión clínica en sujetos con Enfermedad de Crohn moderada a grave.A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease.Estudio multicéntrico abierto, del anticuerpo monoclonal humano anti-TNF Adalimumab, en inducción y mantenimiento de la remisión clínica en sujetos con Enfermedad de Crohn moderada a grave. Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to 7).Enfermedad de Crohn moderada a grave.
MedDRA version: 16.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856
Trade Name: Humira
Product Name: Humira pre-filled PEN
Trade Name: Humira
Product Name: Humira pre-filled PEN
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
1000Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Denmark;Netherlands;Norway;Germany;Sweden
190EUCTR2006-002078-23-CZ
(EUCTR)
21/11/200621/11/2006A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease.A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to7).
MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns
Trade Name: Humira
Trade Name: Humira
Product Name: Humira pre-filled PEN
Abbott GmbH & Co. KG (Abbott)NULLNot RecruitingFemale: yes
Male: yes
1000Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Denmark;Greece
191EUCTR2005-005291-32-DE
(EUCTR)
24/10/200606/06/2006A Multi-Center, Randomized, Double-Blind, Placebo - Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn's Disease Involving the Colon.A Multi-Center, Randomized, Double-Blind, Placebo - Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn's Disease Involving the Colon. Crohn's Disease
MedDRA version: 8.1;Level: LLT;Classification code 10057035
Product Name: Humira
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
130Germany;Netherlands;Belgium;Italy;Austria;Sweden
192EUCTR2006-002078-23-NO
(EUCTR)
23/10/200622/08/2006A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. - CAREA Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. - CARE Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to7).
MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns
Trade Name: Humira
Product Name: Humira pre-filled PEN
Abbott GmbH & Co. KG (Abbott)NULLNot RecruitingFemale: yes
Male: yes
1000Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden
193EUCTR2006-002078-23-BE
(EUCTR)
16/10/200616/08/2006A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease.A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to7).
MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns
Trade Name: Humira
Product Name: Humira pre-filled PEN
Abbott GmbH & Co. KG (Abbott)NULLNot RecruitingFemale: yes
Male: yes
1000Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Belgium;Denmark;Netherlands;Norway;Germany;Sweden
194EUCTR2006-002078-23-NL
(EUCTR)
12/10/200610/08/2006A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease.A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to7).
MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: adalimumab
Product Name: Humira pre-filled PEN
INN or Proposed INN: adalimumab
Abbott GmbH & Co. KG (Abbott)NULLNot RecruitingFemale: yes
Male: yes
1000Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Belgium;Denmark;Netherlands;Norway;Germany;Sweden
195EUCTR2006-002078-23-AT
(EUCTR)
25/09/200604/10/2006A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease.A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to7).
MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns
Trade Name: Humira
Product Name: Humira pre-filled PEN
Abbott GmbH & Co. KG (Abbott)NULLNot RecruitingFemale: yes
Male: yes
1000Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Greece
196EUCTR2005-005291-32-IT
(EUCTR)
14/09/200613/12/2006A multi-center, randomized, double-blind, placebo-controlled study on the Human Anti-TNF monoclonal antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn s Disease Involving the Colon - NDA multi-center, randomized, double-blind, placebo-controlled study on the Human Anti-TNF monoclonal antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn s Disease Involving the Colon - ND Crohn s disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: HUMIRA*SC 2SIR+F 40MG 0,8ML+2T
INN or Proposed INN: Adalimumab
Abbott GmbH Co.KGNULLNot RecruitingFemale: yes
Male: yes
130Germany;Netherlands;Belgium;Italy;Austria;Sweden
197EUCTR2005-005291-32-NL
(EUCTR)
23/08/200628/06/2006A Multi-Center, Randomized, Double-Blind, Placebo - Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn's Disease Involving the Colon.A Multi-Center, Randomized, Double-Blind, Placebo - Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn's Disease Involving the Colon. Crohn's Disease
MedDRA version: 8.1;Level: LLT;Classification code 10057035
Product Name: Humira
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
130Germany;Netherlands;Belgium;Italy;Austria;Sweden
198NCT00348283
(ClinicalTrials.gov)
August 200630/6/2006Effects of Adalimumab on Mucosal Healing in Subjects With Crohn's Disease Involving the ColonA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects With Crohn's Disease Involving the ColonCrohn's DiseaseBiological: adalimumab;Biological: placeboAbbottNULLCompleted18 Years75 YearsAll135Phase 3United States;Austria;Belgium;Canada;France;Germany;Italy;Netherlands;Sweden
199EUCTR2005-005291-32-SE
(EUCTR)
25/07/200612/06/2006A Multi-Center, Randomized, Double-Blind, Placebo - Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn's Disease Involving the Colon.A Multi-Center, Randomized, Double-Blind, Placebo - Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn's Disease Involving the Colon. Crohn's Disease
MedDRA version: 8.1;Level: LLT;Classification code 10057035
Product Name: Humira
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
130Germany;Netherlands;Belgium;Italy;Austria;Sweden
200EUCTR2005-005291-32-BE
(EUCTR)
20/07/200603/05/2006A Multi-Center, Randomized, Double-Blind, Placebo - Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn's Disease Involving the Colon.A Multi-Center, Randomized, Double-Blind, Placebo - Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn's Disease Involving the Colon. Crohn's Disease
MedDRA version: 8.1;Level: LLT;Classification code 10057035
Product Name: Humira
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
130Germany;Netherlands;Belgium;Italy;Austria;Sweden
201EUCTR2005-005291-32-AT
(EUCTR)
28/06/200628/06/2006A Multi-Center, Randomized, Double-Blind, Placebo - Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn's Disease Involving the Colon.A Multi-Center, Randomized, Double-Blind, Placebo - Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn's Disease Involving the Colon. Crohn's Disease
MedDRA version: 8.1;Level: LLT;Classification code 10057035
Product Name: Humira
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
130Germany;Netherlands;Belgium;Italy;Austria;Sweden
202NCT00338650
(ClinicalTrials.gov)
June 200619/6/2006Treatment of the Human Anti-TNF Monoclonal Antibody Adalimumab in Moderate to Severe Crohn's Disease With Previous Exposure to Infliximab (CHOICE)A Multi-Center, Open-Label Treatment Protocol of the Human Anti-TNF Monoclonal Antibody Adalimumab in Patients With Moderate to Severe Crohn's Disease With Previous Exposure to InfliximabCrohn's DiseaseDrug: adalimumabAbbottNULLCompleted18 Years75 YearsBoth1000Phase 3United States
203EUCTR2004-002163-24-IT
(EUCTR)
28/02/200515/06/2005A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's DiseaseA Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease Crohn's disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: HUMIRA*SC 2SIR+F 40MG 0,8ML+2T
INN or Proposed INN: Adalimumab
Abbott GmBH Co KGNULLNot RecruitingFemale: yes
Male: yes
960Hungary;Spain;Denmark;Germany;United Kingdom;Italy
204EUCTR2004-002934-20-BE
(EUCTR)
22/02/200508/07/2005A Multi-Centre, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease who Have Lost Response or are Intolerant to InfliximabA Multi-Centre, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease who Have Lost Response or are Intolerant to Infliximab Crohn's DiseaseTrade Name: Humira
Product Name: Humira
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
Belgium
205EUCTR2004-002163-24-DE
(EUCTR)
09/02/200525/10/2004A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease.A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease. Crohn's DiseaseProduct Name: Humira
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
960Hungary;United Kingdom;Germany;Denmark;Spain;Italy
206EUCTR2004-002163-24-SE
(EUCTR)
30/12/200412/11/2004A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease.A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease. Crohn's DiseaseTrade Name: Humira
Product Name: Humira
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
960Hungary;Spain;Denmark;Germany;Italy;United Kingdom;Sweden
207EUCTR2004-002163-24-ES
(EUCTR)
17/12/200407/06/2005A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease.Estudio multicéntrico abierto del anticuerpo monoclonal anti-TNF humano Adalimumab para evaluar la seguridad y la tolerabilidad a largo plazo de la administración repetida de Adalimumab en sujetos con enfermedad de Crohn.A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease.Estudio multicéntrico abierto del anticuerpo monoclonal anti-TNF humano Adalimumab para evaluar la seguridad y la tolerabilidad a largo plazo de la administración repetida de Adalimumab en sujetos con enfermedad de Crohn. Crohn's DiseaseTrade Name: Humira
Product Name: Humira
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
960Hungary;Spain;Denmark;Germany;Italy;United Kingdom;Sweden
208EUCTR2004-002163-24-BE
(EUCTR)
25/11/200419/08/2005A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease.A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease. Crohn's DiseaseProduct Name: Humira
INN or Proposed INN: Adalimumab
Abbott GmbH & co. KGNULLNot RecruitingFemale: yes
Male: yes
960Hungary;Spain;Belgium;Denmark;Germany;Italy;United Kingdom;Sweden
209EUCTR2004-002163-24-HU
(EUCTR)
23/11/200413/10/2004A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease.A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease. Crohn's DiseaseTrade Name: Humira
Product Name: Humira
INN or Proposed INN: Adalimumab
Abbott LaboratoriesNULLNot RecruitingFemale: yes
Male: yes
960Hungary;Belgium;Spain;Denmark;Germany;Italy;United Kingdom;Sweden
210EUCTR2004-002163-24-DK
(EUCTR)
16/11/200409/07/2008A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease.A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease. Crohn's DiseaseProduct Name: Humira
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
960Hungary;United Kingdom;Germany;Denmark;Spain;Italy
211NCT00105300
(ClinicalTrials.gov)
October 200411/3/2005Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's DiseaseA Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Moderate to Severe Crohn's Disease Who Have Lost Response or Are Intolerant to InfliximabCrohn's DiseaseDrug: AdalimumabAbbottNULLCompleted18 Years75 YearsBoth300Phase 3United States;Belgium;Canada;France
212NCT00195715
(ClinicalTrials.gov)
September 200413/9/2005Long-term Safety and Tolerability Study of Adalimumab in Subjects With Crohn's DiseaseA Multi Center, Open Label Study of the Human Anti TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Crohn's DiseaseCrohn's DiseaseBiological: AdalimumabAbbottNULLCompleted18 Years75 YearsAll777Phase 3United States;Australia;Belgium;Canada;Denmark;France;Germany;Hungary;Italy;Netherlands;Poland;South Africa;Spain;Sweden;United Kingdom
213NCT00077779
(ClinicalTrials.gov)
July 200312/2/2004Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Crohn's DiseaseA Multi-Center Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Crohn's DiseaseCrohn's DiseaseDrug: AdalimumabAbbottNULLCompleted18 Years75 YearsBoth854Phase 3United States
214NCT00055497
(ClinicalTrials.gov)
August 20023/3/2003Remission in Subjects With Crohn's Disease, 1 Year PhaseA Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Maintenance of Clinical Remission in Subjects With Crohn's DiseaseCrohn's DiseaseBiological: Double-blind (DB) adalimumab placebo;Biological: DB adalimumab 40 mg eow;Biological: DB adalimumab 40 mg ew;Biological: OL adalimumab 40 mgAbbottNULLCompleted18 Years75 YearsAll276Phase 3United States
215NCT01070303
(ClinicalTrials.gov)
August 200216/2/2010Remission in Subjects With Crohn's Disease, Open Label ExtensionA Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Maintenance of Clinical Remission in Subjects With Crohn's Disease, Open Label ExtensionCrohn's DiseaseBiological: Adalimumab 40 mg eow or ewAbbottNULLCompleted18 Years75 YearsAll177Phase 3United States
216NCT00055523
(ClinicalTrials.gov)
April 20024/3/2003A Study of the Human Anti-TNF Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's DiseaseA Phase II Study of the Human Anti-TNF Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's DiseaseCrohn's DiseaseDrug: Adalimumab (D2E7)AbbottNULLCompleted18 Years75 YearsBoth300Phase 2United States
217EUCTR2014-004560-38-Outside-EU/EEA
(EUCTR)
12/11/2014The purpose of this study is to demonstrate the efficacy and safety of adalimumab for the induction of clinical remission in Japanese subjects with Crohn's disease.A Multi-Center, Randomized, Double-blind, Placebo-controlled Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects With Crohn's Disease. Crohn's Disease
MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: Adalimumab
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
Abbott Deutschland GmbH & Co. KGNULLNAFemale: yes
Male: yes
80Japan
218EUCTR2016-000522-18-PL
(EUCTR)
04/04/2018Risk-stratified randomized controlled trial in paediatric Crohn’s Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively – a treatment strategyRisk-stratified randomized controlled trial in paediatric Crohn’s Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively – a treatment strategy Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Humira
Product Name: HUMIRA
INN or Proposed INN: ADALIMUMAB
Trade Name: Azathioprine
INN or Proposed INN: Azathioprine
Trade Name: Methotrexate
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
PIBDnet (Pediatric Inflammatory Bowel Disease Network)NULLNA Female: no
Male: no
312 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesFrance;Hungary;Czech Republic;Canada;Belgium;Poland;Israel;Netherlands;Germany;Italy;United Kingdom
219EUCTR2006-004814-41-Outside-EU/EEA
(EUCTR)
07/02/2012A Multicenter, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's DiseaseA Multicenter, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's Disease Moderate to Severe Crohn's Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
Trade Name: Humira
INN or Proposed INN: Adalimumab
Trade Name: Humira
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNAFemale: yes
Male: yes
184NULL
220EUCTR2018-004346-42-PL
(EUCTR)
01/08/2019An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's DiseaseA 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study Crohn's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598
Trade Name: Humira®
INN or Proposed INN: ADALIMUMAB
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139
AstraZeneca ABNULLNAFemale: yes
Male: yes
2000Phase 2;Phase 3United States;Czechia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;South Africa;Bulgaria;Germany
221EUCTR2007-006494-90-Outside-EU/EEA
(EUCTR)
07/02/2012Efficacy and Long Term Safety of Adalimumab in Pediatric Subjects Who Have Demonstrated Clinical Response in M06-806A Multi-center, Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Efficacy and the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Crohn's Disease Who Have Demonstrated a Clinical Response in the M06-806 Study Crohn's disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
INN or Proposed INN: adalimumab
Trade Name: Humira 20 mg solution for injection in pre-filled syringe
INN or Proposed INN: adalimumab
Trade Name: Humira 40mg/0.8ml solution for injection for paediatric use
INN or Proposed INN: adalimumab
Abbott GmbH & Co. K.G.NULLNAFemale: yes
Male: yes
100Belgium;Canada;Czech Republic;Poland;United Kingdom;United States
222EUCTR2006-002078-23-SK
(EUCTR)
11/09/2006A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's DiseaseA Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease Moderate to severe Crohn´s Disease (Harvey Bradshaw index score greater or equal to 7)Trade Name: HUMIRAAbbott GmbH & Co. KG (Abbott)NULLNot RecruitingFemale: yes
Male: yes
1000Phase 3Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Belgium;Denmark;Netherlands;Norway;Germany;Sweden
223EUCTR2016-000522-18-FR
(EUCTR)
21/06/2016Risk stratified randomized controlled trial in paediatric Crohn’s Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively – a treatment strategyRisk stratified randomized controlled trial in paediatric Crohn’s Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively – a treatment strategy - REDUCE-RISKincd-PIBD-TRIAL Crohn’s disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: humira
INN or Proposed INN: ADALIMUMAB
Product Name: Imurel
INN or Proposed INN: azathioprine
Other descriptive name: AZATHIOPRINE
Trade Name: Methotrexate
Product Name: methotrexate
PIBDNetNULLNAFemale: yes
Male: yes
312Phase 4France;Hungary;Czech Republic;Canada;Poland;Belgium;Israel;Netherlands;Germany;Italy;United Kingdom
224EUCTR2015-004121-13-Outside-EU/EEA
(EUCTR)
17/11/2015A Multicenter Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Investigate Efficacy, Safety and Pharmacokinetics after Dose Escalation in Japanese Subjects with Crohn's DiseaseA Multicenter Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Investigate Efficacy, Safety and Pharmacokinetics after Dose Escalation in Japanese Subjects with Crohn's Disease Crohn's Disease
MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: Adalimumab
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbVie GKNULLNAFemale: yes
Male: yes
28Japan
225EUCTR2014-004531-39-Outside-EU/EEA
(EUCTR)
12/11/2014A Study of Adalimumab for the Maintenance of Clinical Remission in Japanese Subjects With Crohn's Disease.A Multi-Center, Randomized, Double-blind, Placebo-controlled Study of Adalimumab for the Maintenance of Clinical Remission in Japanese Subjects With Crohn's Disease. Crohn's Disease
MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: Adalimumab
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
Abbott Deutschland GmbH & Co. KGNULLNAFemale: yes
Male: yes
80Japan