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

  
75 trials found
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1NCT04643483
(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
2NCT04163016
(ClinicalTrials.gov)
June 19, 202024/10/2019A Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol)A Postmarketing, Multicenter, Longitudinal, Prospective, Pharmacokinetic, Phase 1B Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol)Rheumatoid Arthritis;Psoriatic Arthritis;Crohn's Disease;Axial Spondyloarthritis;Plaque PsoriasisDrug: Pharmacokinetics of certolizumab pegolUCB Biopharma S.P.R.L.NULLRecruiting18 YearsN/AFemale20Phase 1United States;Canada;France;Germany;Netherlands;Spain;Switzerland
3NCT03559660
(ClinicalTrials.gov)
May 20, 20195/6/2018CUP Certolizumab Pegol (CDP-870) in Adults Suffering From Crohn's Disease (CD)Compassionate Use Program Certolizumab Pegol (CDP-870) in Adults Suffering From Crohn's Disease (CD)Crohn's DiseaseDrug: Certolizumab PegolUCB Biopharma S.P.R.L.NULLAvailable18 YearsN/AAllNULL
4NCT03357471
(ClinicalTrials.gov)
November 3, 201723/11/2017Study to Test the Safe and Effective Use of an e-Device for the Self-injection of Certolizumab Pegol Solution by Subjects With Moderate to Severe Active Rheumatoid Arthritis, Active Ankylosing Spondylitis, Active Psoriatic Arthritis, or Moderately to Severely Active Crohn's DiseaseA Multicenter, Open-Label Study to Evaluate the Safe and Effective Use of an Electro-Mechanical Injection Device (E-Device) for the Subcutaneous Self-Injection of Certolizumab Pegol Solution by Subjects With Moderate to Severe Active Rheumatoid Arthritis, Active Ankylosing Spondylitis, Active Psoriatic Arthritis, or Moderately to Severely Active Crohn's DiseaseModerate and Severe Active Rheumatoid Arthritis;Active Psoriatic Arthritis;Active Ankylosing Spondylitis;Moderately to Severely Active Crohn's DiseaseDrug: e-DeviceUCB Biopharma S.P.R.L.NULLCompleted18 YearsN/AAll70Phase 3United States
5NCT02597829
(ClinicalTrials.gov)
November 201527/10/2015Does Clinical Response Correlate With Serum Certolizumab Levels?Does Clinical Response Correlate With Serum Certolizumab Levels? A Prospective Open Label Trial of Adult Patients With Active Crohn's Disease (APOLLO)Crohn's DiseaseDrug: Certolizumab PegolShafran Gastroenterology CenterUCB Pharma;UCB PharmaNot yet recruiting18 Years70 YearsBoth20Phase 4United States
6NCT02154425
(ClinicalTrials.gov)
September 201430/5/2014A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating MothersA Multicenter, Postmarketing Study to Evaluate the Concentration of Certolizumab Pegol in the Breast Milk of Mothers Receiving Treatment With Cimzia® (Certolizumab Pegol)Axial Spondyloarthritis (AxSpA);Non-radiographic Evidence-AxSpA;Ankylosing Spondylitis;Crohn's Disease;Psoriatic Arthritis;Rheumatoid ArthritisProcedure: Breast milk sampling;Biological: Certolizumab PegolUCB BIOSCIENCES, Inc.PPD;ParexelCompleted18 YearsN/AFemale17Phase 1United States;Netherlands;Switzerland;France
7NCT02019602
(ClinicalTrials.gov)
January 201418/12/2013A Multicener, Postmarketing Study Evaluating the Transfer of Cimzia From the Mother to the Infant Via the PlacentaA Multicenter Postmarketing Study to Evaluate the Placental Transfer of Certolizumab Pegol in Pregnant Women Receiving Treatment With Cimzia® (Certolizumab Pegol)Axial Spondyloarthritis (AxSpA);Non-radiographic Evidence-AxSpA;Ankylosing Spondylitis;Crohn's Disease;Psoriatic Arthritis;Rheumatoid ArthritisProcedure: Blood sampling from mother;Procedure: Blood sampling from infant;Procedure: Blood sampling from umbilical cord;Biological: Certolizumab PegolUCB BIOSCIENCES, Inc.PPD;ParexelCompleted18 YearsN/AAll37Phase 1United States;France;Netherlands;Switzerland
8NCT02073526
(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
9NCT01817972
(ClinicalTrials.gov)
March 201319/3/2013Cimzia Versus Cimzia Plus Azathioprine in the Treatment of Active Crohn's DiseaseA Phase III, Randomized, Double-blind Trial in the Comparison of Cimzia Versus Cimzia Plus Azathioprine in the Change in Mean SES-CD (Simple Endoscopic Scores-Crohn's Disease) Scores in the Treatment of Active, Moderate to Severe Crohn's DiseaseCrohn's DiseaseBiological: Certolizumab pegol;Drug: AzathioprineGastroenterology Research of AmericaUCB PharmaNot yet recruiting18 Years70 YearsBoth65Phase 3United States
10EUCTR2009-017998-37-BE
(EUCTR)
08/06/201211/04/2012Scintigraphic detection of tumor necrosis factor with radioactive labeled TNFa-blocker in patients with active rheumatoid arthritis and active axial and peripheric spondyloarthropathy.Scintigraphic detection of tumor necrosis factor with radioactive labeled TNFa-blocker in patients with active rheumatoid arthritis and active axial and peripheric spondyloarthropathy. Patients with an active spondyloarthropathy and with an active rheumatoid arthritis; who were diagnosed according to the classic ACR-criteria (American College of Rheumatology) for rheumatoid arthritis and according the ASAS-criteria (Assessment of SpondyloArthritis international Society) for spondylarthropathy. Patients with an active rheumatoid arthritis or with an active axial and peripheral spondyloarthropathy. Patients with erosive hand arthrosis. Patients with an active Crohn's disease.
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.0;Level: HLT;Classification code 10052775;Term: Spondyloarthropathies;System Organ Class: 100000004859
MedDRA version: 19.0;Classification code 10039078;Term: Rheumatoid arthropathies;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cimzia 200 mg solution for injection
Product Name: Certolizumab pegol
INN or Proposed INN: CERTOLIZUMAB PEGOL
Product Name: 99mTc-S-HYNIC Certolizumab pegol
INN or Proposed INN: CERTOLIZUMAB PEGOL
Ghent University HospitalNULLNot Recruiting Female: yes
Male: yes
36 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noBelgium
11NCT01190410
(ClinicalTrials.gov)
August 201025/8/2010Extension Study to Assess Long Term Safety in Children and Adolescents With Crohn's Disease Receiving Certolizumab PegolAn Open-label, Multicenter Study to Assess the Safety of Certolizumab Pegol in Children and Adolescents With Active Crohn's Disease Who Completed C87035 (NCT00899678) or Who Were Terminated From C87035Crohn's DiseaseDrug: certolizumab pegolUCB PharmaNULLCompleted6 Years17 YearsAll16Phase 2United States;Australia;Canada
12NCT01053559
(ClinicalTrials.gov)
January 201019/1/2010Assessment of Small Bowel Healing in Crohn's Disease Patients Treated With Cimzia Using Wireless Capsule EndoscopyOpen Label Investigator Initiated, Single Site Study of Mucosal Healing in Patients With Small Bowel Crohn's Disease Treated With Certolizumab Pegol (Cimzia) Assessed by Wireless Capsule EndoscopyCrohn's DiseaseDrug: certolizumab pegolShafran Gastroenterology CenterUCB PharmaCompleted18 Years70 YearsBoth15N/AUnited States
13NCT01024647
(ClinicalTrials.gov)
December 20092/12/2009Optimizing Cimzia in Crohn's PatientsOptimizing Response in Crohn's Disease Patients Who Have Insufficient Initial Response or Who Have Loss of Successful Response to Certolizumab Pegol (Cimzia) Induction TherapyCrohn's DiseaseBiological: certolizumab pegolAtlanta Gastroenterology AssociatesUCB PharmaRecruiting18 YearsN/ABoth50Phase 4United States
14NCT00899678
(ClinicalTrials.gov)
April 200929/4/2009The Use of Certolizumab Pegol for Treatment of Active Crohn's Disease in Children and AdolescentsA Phase 2, Open-label, Multicenter Study to Assess the Safety and Efficacy of Certolizumab Pegol in Children and Adolescents With Active Crohn's Disease (NURTURE Study)Crohn's DiseaseDrug: Certolizumab PegolUCB CelltechNULLTerminated6 Years17 YearsAll99Phase 2United States;Australia;Canada;New Zealand
15NCT00844285
(ClinicalTrials.gov)
January 200913/2/2009SECURE, the Cimzia ® Crohn's Disease Post-Marketing RegistryA Non-Interventional Long-term Post-Marketing Registry of Patients Treated With Certolizumab Pegol (Cimzia ®) for Crohn's DiseaseCrohn's DiseaseDrug: CimziaUCB PharmaNULLCompleted18 YearsN/AAll3045United States
16EUCTR2007-002716-26-EE
(EUCTR)
17/12/200811/12/2007A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn’s disease who have participated in study C87085A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn’s disease who have participated in study C87085 Crohn`s disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB CelltechNULLNot RecruitingFemale: yes
Male: yes
200Phase 3Hungary;Finland;Czech Republic;Belgium;Estonia;Italy;Latvia;Austria
17EUCTR2007-001913-41-AT
(EUCTR)
10/09/200818/06/2008A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease.A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease. Crohn's disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB CelltechNULLNot RecruitingFemale: yes
Male: yes
550Phase 3Hungary;Finland;Czech Republic;Germany;Belgium;Estonia;Italy;Latvia;Austria
18EUCTR2007-001913-41-DE
(EUCTR)
27/08/200820/03/2008A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease.A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease. Crohn's disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB CelltechNULLNot RecruitingFemale: yes
Male: yes
550Phase 3Hungary;Finland;Czech Republic;Germany;Belgium;Estonia;Italy;Latvia;Austria
19EUCTR2007-002716-26-AT
(EUCTR)
08/08/200818/06/2008Clinical study to assess the long term safety of certolizumab pegol, administered at weeks 0, 2 and 4 and every 4 weeks thereafter, in patients with Crohn's disease and who participated in a previous study encoded C87085A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn’s disease who have participated in study C87085 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] - Nutritional and Metabolic Diseases [C18]
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB CelltechNULLNot RecruitingFemale: yes
Male: yes
200Phase 3United States;Estonia;Finland;Ukraine;Austria;Israel;Russian Federation;Chile;Italy;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Romania;Australia;Latvia;Germany;New Zealand
20NCT00552344
(ClinicalTrials.gov)
May 200831/10/2007A Study to Evaluate Safety of Long Term Therapy of Certolizumab Pegol Patients With Crohn's DiseaseA Phase IIIb, Multinational, Open-label, follow-on Trial to C87085 Designed to Assess the Long-term Safety of Certolizumab Pegol, a Pegylated Fab' Fragment of a Humanized Anti-TNF-alpha Monoclonal Antibody, Administered at Weeks 0, 2 and 4, and Then Every 4 Weeks Thereafter, in Subjects With Moderately to Severely Active Crohn's Disease Who Have Participated in Study C87085Crohn DiseaseBiological: CimziaUCB BIOSCIENCES GmbHPPDCompleted18 Years75 YearsAll403Phase 3United States;Australia;Austria;Belgium;Brazil;Canada;Czechia;Estonia;Germany;Hungary;Israel;Italy;Latvia;New Zealand;Poland;Romania;Russian Federation;Ukraine;Chile;Czech Republic;Finland
21EUCTR2007-001913-41-CZ
(EUCTR)
14/04/200807/04/2008A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s diseaseA phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease Crohn`s disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB CelltechNULLNot RecruitingFemale: yes
Male: yes
550Phase 3Hungary;Finland;Germany;Czech Republic;Belgium;Estonia;Italy;Latvia;Austria
22EUCTR2007-002716-26-CZ
(EUCTR)
07/04/200807/04/2008A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn’s disease who have participated in study C87085A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn’s disease who have participated in study C87085 Crohn`s disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB CelltechNULLNot RecruitingFemale: yes
Male: yes
200Phase 3Estonia;Hungary;Czech Republic;Finland;Belgium;Austria;Latvia;Italy
23EUCTR2007-001913-41-IT
(EUCTR)
04/03/200812/02/2008A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn?s disease - NDA phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn?s disease - ND Crohn?s disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB CelletechNULLNot RecruitingFemale: yes
Male: yes
500Phase 3Hungary;Finland;Czech Republic;Germany;Belgium;Estonia;Italy;Latvia;Austria
24EUCTR2007-002716-26-IT
(EUCTR)
04/03/200812/02/2008A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti TNF alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn?s disease who have participated in study C87085 - NDA phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti TNF alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn?s disease who have participated in study C87085 - ND Crohn?s disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB CelltechNULLNot RecruitingFemale: yes
Male: yes
200Phase 3Hungary;Finland;Czech Republic;Belgium;Estonia;Italy;Latvia;Austria
25NCT00552058
(ClinicalTrials.gov)
March 200818/10/2007Study to Evaluate Efficacy and Safety of Certolizumab Pegol for Induction of Remission in Patients With Crohn's DiseasePhase IIIb, Multinational, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Certolizumab Pegol, a Pegylated Fab' Fragment of a Humanized Anti-Tumor Necrosis Factor(TNF)-Alpha Monoclonal Antibody, Administered in Subjects With Moderately to Severely Active Crohn's Disease.Crohn DiseaseBiological: certolizumab pegol (CDP870, CZP);Other: PlaceboUCB PharmaNULLCompleted18 Years75 YearsAll439Phase 3United States;Australia;Austria;Belgium;Brazil;Canada;Chile;Czechia;Estonia;Finland;Germany;Hungary;Israel;Italy;Latvia;New Zealand;Poland;Romania;Russian Federation;Ukraine;Czech Republic;Spain
26EUCTR2007-001913-41-EE
(EUCTR)
11/02/200811/12/2007A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s diseaseA phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease Crohn`s disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB CelltechNULLNot RecruitingFemale: yes
Male: yes
550Phase 3Hungary;Finland;Czech Republic;Germany;Belgium;Estonia;Italy;Latvia;Austria
27EUCTR2007-003239-21-FR
(EUCTR)
05/02/200815/01/2008A phase IIIb, open label, randomized, exploratory clinical study exploring efficacy, safety and patients’ satisfaction with Certolizumab pegol treatment in moderate to severe Crohn’s disease when treatment is administered in two different settings : either at hospital or at home - PERFECTA phase IIIb, open label, randomized, exploratory clinical study exploring efficacy, safety and patients’ satisfaction with Certolizumab pegol treatment in moderate to severe Crohn’s disease when treatment is administered in two different settings : either at hospital or at home - PERFECT Crohn's disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol (rINN)
Other descriptive name: Anti TNF humanized antibody Fab fragment-PEG conjugate
UCB PHARMA S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 3France
28EUCTR2007-001913-41-BE
(EUCTR)
23/01/200813/11/2007A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s diseaseA phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease Crohn`s disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB CelltechNULLNot RecruitingFemale: yes
Male: yes
550Phase 3Hungary;Finland;Czech Republic;Germany;Belgium;Estonia;Italy;Latvia;Austria
29EUCTR2007-002716-26-BE
(EUCTR)
22/01/200816/10/2007Clinical study to assess the long term safety of certolizumab pegol,administered at weeks 0, 2 and 4 and every 4 weeks thereafter, inpatients with Crohn's disease and who participated in a previous studyencoded C87085A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti TNF alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn’s disease who have participated in study C87085. 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]
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB CelltechNULLNot RecruitingFemale: yes
Male: yes
500Phase 3United States;Estonia;Finland;Ukraine;Austria;Israel;Russian Federation;Chile;Italy;Hungary;Czech Republic;Canada;Belgium;Poland;Brazil;Romania;Australia;Latvia;Germany;New Zealand
30EUCTR2007-002716-26-LV
(EUCTR)
20/12/200705/11/2007A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn’s disease who have participated in study C87085A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn’s disease who have participated in study C87085 Crohn`s disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB CelltechNULLNot RecruitingFemale: yes
Male: yes
200Phase 3Czech Republic;Estonia;Hungary;Finland;Belgium;Austria;Latvia;Italy
31EUCTR2007-001913-41-LV
(EUCTR)
20/12/200705/11/2007A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s diseaseA phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease Crohn`s disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB CelltechNULLNot RecruitingFemale: yes
Male: yes
500Phase 3Hungary;Finland;Czech Republic;Germany;Belgium;Estonia;Italy;Latvia;Austria
32EUCTR2007-001913-41-HU
(EUCTR)
18/12/200731/10/2007A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease.A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease. Crohn's disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB CelltechNULLNot RecruitingFemale: yes
Male: yes
500Phase 3Finland;Hungary;Czech Republic;Germany;Belgium;Estonia;Italy;Latvia;Austria
33EUCTR2007-002716-26-HU
(EUCTR)
18/12/200731/10/2007Clinical study to assess the long term safety of certolizumab pegol,administered at weeks 0, 2 and 4 and every 4 weeks thereafter, inpatients with Crohn's disease and who participated in a previous studyencoded C87085A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti TNF alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn’s disease who have participated in study C87085. 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]
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB CelltechNULLNot RecruitingFemale: yes
Male: yes
500Phase 3Australia;Latvia;Germany;New Zealand;United States;Estonia;Finland;Ukraine;Austria;Israel;Russian Federation;Chile;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Romania
34EUCTR2007-001913-41-FI
(EUCTR)
12/12/200716/10/2007A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s diseaseA phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease Crohn`s disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB CelltechNULLNot RecruitingFemale: yes
Male: yes
550Phase 3Hungary;Finland;Czech Republic;Germany;Belgium;Estonia;Italy;Latvia;Austria
35EUCTR2007-002716-26-FI
(EUCTR)
12/12/200716/10/2007A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn’s disease who have participated in study C87085A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn’s disease who have participated in study C87085 Crohn`s disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB CelltechNULLNot RecruitingFemale: yes
Male: yes
200Phase 3Hungary;Finland;Czech Republic;Belgium;Estonia;Italy;Latvia;Austria
36NCT00358683
(ClinicalTrials.gov)
November 200728/7/2006A Trial Evaluating Safety of Chronic Therapy With Certolizumab Pegol in Crohn's DiseaseOpen Label Long Term Clinical Trial Evaluating Safety of Chronic Therapy With Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor Alpha (TNF) in Patients Suffering From Crohn's Disease and Having Completed C87055 Study.Crohn's DiseaseDrug: Certolizumab pegolUCB PharmaNULLWithdrawn18 YearsN/ABoth0Phase 3NULL
37EUCTR2006-001729-24-ES
(EUCTR)
01/06/200701/06/2007Ensayo clínico abierto a largo plazo para evaluar la eficacia y seguridad del tratamiento crónico con certolizumab pegol, un fragmento Fab pegilado del anticuerpo humanizado dirigido al factor de necrosis tumoral alfa (TNF), en pacientes afectados por la enfermedad de Crohn que hayan terminado el estudio C87042.Open label long term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy with certolizumab pegol, A PEGylated Fab fragment of humanized antibofy to tumour necrosis factor alpha (TNF) in patients suffering from Crohn's disease and having completed C87042 study.Ensayo clínico abierto a largo plazo para evaluar la eficacia y seguridad del tratamiento crónico con certolizumab pegol, un fragmento Fab pegilado del anticuerpo humanizado dirigido al factor de necrosis tumoral alfa (TNF), en pacientes afectados por la enfermedad de Crohn que hayan terminado el estudio C87042.Open label long term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy with certolizumab pegol, A PEGylated Fab fragment of humanized antibofy to tumour necrosis factor alpha (TNF) in patients suffering from Crohn's disease and having completed C87042 study. Pacientes afectados por la enfermedad de Crohn que hayan terminado el estudio C87042.Patients suffering from Crohn's disease and having completed C87042 study.
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB S.A.NULLNot RecruitingFemale: yes
Male: yes
250United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
38EUCTR2006-001729-24-IT
(EUCTR)
10/05/200726/06/2007Open label long term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy with certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumor necrosis factor alpha (TNF) in patients suffering from Crohn's disease and having completed C87042 study - C87046Open label long term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy with certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumor necrosis factor alpha (TNF) in patients suffering from Crohn's disease and having completed C87042 study - C87046 Patients suffering from Crohn's disease and having completed the C87042 study
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: certolizumab pegol
Product Code: CDP870
UCB PHARMANULLNot RecruitingFemale: yes
Male: yes
600United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
39EUCTR2006-001729-24-NL
(EUCTR)
10/05/200718/04/2007Open label long term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy with certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumor necrosis factor alpha (TNF) in patients suffering from Crohn's disease and having completed C87042 study. - WELCOME 2Open label long term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy with certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumor necrosis factor alpha (TNF) in patients suffering from Crohn's disease and having completed C87042 study. - WELCOME 2 Patients with Crohn's disease and having completed C87042 study.
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB S.A.NULLNot RecruitingFemale: yes
Male: yes
250Sweden;Austria;Italy;Spain;France;Belgium;Netherlands;Germany;United Kingdom
40EUCTR2006-001729-24-AT
(EUCTR)
09/05/200718/12/2006Open label long term clinical trial evaluating efficacy and safety of chronic therapy with certolizumab pegol, a PEGylated Fab fragment of humanised antibody to tumour necrosis factor alpha (TNFa) in patients suffering from Crohn's disease and having completed C87042 study. - WELCOME 2Open label long term clinical trial evaluating efficacy and safety of chronic therapy with certolizumab pegol, a PEGylated Fab fragment of humanised antibody to tumour necrosis factor alpha (TNFa) in patients suffering from Crohn's disease and having completed C87042 study. - WELCOME 2 Patients with Crohn's disease and having completed C87042 study.
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB S.ANULLNot RecruitingFemale: yes
Male: yes
250United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
41EUCTR2006-001729-24-SE
(EUCTR)
25/04/200709/03/2007Open label long term Clinical trial evaluating efficacy and safety of chronic therapy with certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumour necrosis factor alpha (TNFa) in patients suffering from Crohn's disease and having completed C87042 study. - WELCOME 2Open label long term Clinical trial evaluating efficacy and safety of chronic therapy with certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumour necrosis factor alpha (TNFa) in patients suffering from Crohn's disease and having completed C87042 study. - WELCOME 2 Patients with Crohn's disease and having completed C87042 study.
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB Pharma S.A.NULLNot RecruitingFemale: yes
Male: yes
250United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
42EUCTR2005-003977-25-DE
(EUCTR)
13/04/200705/03/2007A phase III B multicentre open label 54 weeks clinical trial evaluating certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumor necrosis factor alpha (TNF alpha) on endoscopic and mucosal healing in patients suffering form active Crohn's disease - MUSICA phase III B multicentre open label 54 weeks clinical trial evaluating certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumor necrosis factor alpha (TNF alpha) on endoscopic and mucosal healing in patients suffering form active Crohn's disease - MUSIC Crohn's disease
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB Pharma S.ANULLNot RecruitingFemale: yes
Male: yes
85Phase 3Germany;Belgium
43NCT00307931
(ClinicalTrials.gov)
April 200724/3/2006Certolizumab Pegol for Treatment of Adult Greek Patients With Moderate to Severe Crohn's Disease Who Failed InfliximabCertolizumab Pegol in the Treatment of Adult Greek Patients With Moderate to Severe Crohn's Disease Who Have Been Previously Treated Successfully With Infliximab But Who Have Subsequently Lost Response or Developed Intolerance to InfliximabCrohn's DiseaseBiological: Certolizumab pegolUCB PharmaNULLTerminated18 YearsN/AAll16Phase 3Greece
44EUCTR2006-001729-24-FR
(EUCTR)
22/02/200722/01/2007Open label long term clinical trial evaluating efficacy and safety of chronic therapy with certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumour necrosis factor alpha (TNFa) in patients suffering from Crohn's disease and having completed C87042 study - WELCOME 2Open label long term clinical trial evaluating efficacy and safety of chronic therapy with certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumour necrosis factor alpha (TNFa) in patients suffering from Crohn's disease and having completed C87042 study - WELCOME 2 Patients with Crohn's disease and having completed C87042 study.
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB S.A.NULLNot RecruitingFemale: yes
Male: yes
605Phase 3France;Spain;Belgium;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
45EUCTR2006-001729-24-GB
(EUCTR)
14/02/200707/12/2006Open label long term clinical trial evaluating efficacy and safety of chronic therapy with certolizumab pegol, a PEGylated Fab fragment of humanised antibody to tumour necrosis factor alpha (TNFa) in patients suffering from Crohn's disease and having completed C87042 study. - WELCOME 2Open label long term clinical trial evaluating efficacy and safety of chronic therapy with certolizumab pegol, a PEGylated Fab fragment of humanised antibody to tumour necrosis factor alpha (TNFa) in patients suffering from Crohn's disease and having completed C87042 study. - WELCOME 2 Patients with Crohn's disease and having completed C87042 study.
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB S.ANULLNot Recruiting Female: yes
Male: yes
605 Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4):France;Spain;Belgium;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
46EUCTR2006-003871-11-DE
(EUCTR)
06/02/200726/10/2006An open-label, multi-center trial to examine the long term safety, efficacy, and corticosteroid-sparing effect of certolizumab pegol in patients with moderate to severe Crohn's disease who have failed tapering of corticosteroids, needed corticosteroids after completion of tapering, or have successfully completed the trial C87059 (COSPAR I). - COSPAR IIAn open-label, multi-center trial to examine the long term safety, efficacy, and corticosteroid-sparing effect of certolizumab pegol in patients with moderate to severe Crohn's disease who have failed tapering of corticosteroids, needed corticosteroids after completion of tapering, or have successfully completed the trial C87059 (COSPAR I). - COSPAR II The trial aims to examine the long term safety, efficacy, and corticosteroid-sparing effect of certolizumab pegol in patients with moderate to severe Crohn's disease who have failed tapering of corticosteroids, needed corticosteroids after completion of tapering, or have successfully completed the trial C87059 (COSPAR I).
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB Pharma S.A.NULLNot RecruitingFemale: yes
Male: yes
352Germany
47EUCTR2005-003977-25-BE
(EUCTR)
31/01/200711/12/2006A phase III B multicentre open label 54 weeks clinical trial evaluating certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumor necrosis factor alpha (TNF alpha) on endoscopic and mucosal healing in patients suffering form active Crohn's disease - MUSICA phase III B multicentre open label 54 weeks clinical trial evaluating certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumor necrosis factor alpha (TNF alpha) on endoscopic and mucosal healing in patients suffering form active Crohn's disease - MUSIC Crohn's disease
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB S.ANULLNot RecruitingFemale: yes
Male: yes
85Phase 3Germany;Belgium
48EUCTR2006-001729-24-DE
(EUCTR)
16/01/200720/11/2006Open label long term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy with certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumor necrosis factor alpha (TNF) in patients suffering from Crohn's disease and having completed C87042 study. - WELCOME 2Open label long term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy with certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumor necrosis factor alpha (TNF) in patients suffering from Crohn's disease and having completed C87042 study. - WELCOME 2 Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy with certolizumab pegol in patients suffering from Crohn's disease and having completed C87042 study.
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB Pharma SANULLNot RecruitingFemale: yes
Male: yes
605United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
49NCT00354367
(ClinicalTrials.gov)
January 200718/7/2006Evaluate Efficacy of Certolizumab in Crohn's Patients With Draining FistulasA Phase IIIB Multicenter, Open Label, Randomized Clinical Trial Evaluating Efficacy of Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor (TNF) in Crohn's Disease Patients With Draining Fistulas.Crohn DiseaseDrug: Certolizumab pegolUCB PharmaNULLWithdrawn18 YearsN/ABoth0Phase 3NULL
50NCT00356408
(ClinicalTrials.gov)
January 200725/7/2006Examining the Long Term Safety, Efficacy, and Corticosteroid-sparing Effect of Certolizumab Pegol in Crohn's DiseaseAn Open-label, Multi-center Trial to Examine the Long Term Safety, Efficacy, and Corticosteroid-sparing Effect of Certolizumab Pegol in Patients With Moderate to Severe Crohn's Disease Previously Enrolled in C87059 (COSPAR I, NCT00349752).Crohn's DiseaseBiological: Certolizumab pegolUCB PharmaNULLCompleted18 YearsN/AAll106Phase 3United States;Canada;Germany
51EUCTR2006-002027-16-GR
(EUCTR)
12/12/200605/09/2006Certolizumab pegol 400 mg monthly in the treatment of adult Greek patients with moderate to severe Crohn’s Disease, who have been previously treated successfully with infliximab but who have subsequently lost the response or have developed intolerance to infliximab: an open-label, multi-center, single-cohort study to evaluate efficacy, safety and onset of action.Certolizumab pegol 400 mg monthly in the treatment of adult Greek patients with moderate to severe Crohn’s Disease, who have been previously treated successfully with infliximab but who have subsequently lost the response or have developed intolerance to infliximab: an open-label, multi-center, single-cohort study to evaluate efficacy, safety and onset of action. Certolizumab pegol in the treatment of adult Greek patients with moderate to severe Crohn’s Disease, who have been previously treated successfully with infliximab but who have subsequently lost the response or have developed intolerance to infliximabProduct Name: certolizumab pegol
Product Code: CDP870
UCB AENULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Greece
52EUCTR2006-003870-88-DE
(EUCTR)
27/11/200629/09/2006A Phase IIIb, multi-center, double-blind, placebo-controlled, randomized trial to examine the corticosteroid-sparing effect of certolizumab pegol in patients with moderate to severe Crohn's disease (COSPAR I). - COSPAR IA Phase IIIb, multi-center, double-blind, placebo-controlled, randomized trial to examine the corticosteroid-sparing effect of certolizumab pegol in patients with moderate to severe Crohn's disease (COSPAR I). - COSPAR I In the present study, the corticosteroid-sparing effect of certolizumab pegol will be assessed in patients with moderate to severe Crohn’s disease who have received initial acute corticosteroid therapy (prednisone or prednisolone) for induction of remission.
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB Pharma S.A.NULLNot RecruitingFemale: yes
Male: yes
352Phase 3Germany
53NCT00349752
(ClinicalTrials.gov)
November 200630/6/2006Corticosteroid Sparing Effect of Certolizumab in Crohn's DiseaseA Phase IIIb Multicenter, Double-blind, Placebo-controlled,Randomized Trial to Examine the Corticosteroid-sparing Effect of Certolizumab Pegol in Patients With Moderate to Severe Crohn's Disease.Crohn's DiseaseBiological: certolizumab pegol 400 mg;Other: PlaceboUCB PharmaNULLTerminated18 YearsN/AAll174Phase 3United States;Canada;Germany;Belgium
54EUCTR2006-001729-24-BE
(EUCTR)
18/10/200601/09/2006Open label long term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy with certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumor necrosis factor alpha (TNF) in patients suffering from Crohn's disease and having completed C87042 study.Open label long term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy with certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumor necrosis factor alpha (TNF) in patients suffering from Crohn's disease and having completed C87042 study. Patients with Crohn's disease and having completed C87042 study.
MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB S.A.NULLNot RecruitingFemale: yes
Male: yes
600United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
55NCT00333788
(ClinicalTrials.gov)
October 20062/6/2006Follow-up to Welcome Study C87042 [NCT00308581] Examining Certolizumab Pegol (CDP870) in Subjects With Crohn's DiseaseOpen Label Long Term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy With Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor Alpha (TNF) in Patients Suffering From Crohn's Disease and Having Completed C87042 Study.Crohn's DiseaseBiological: Certolizumab pegol (CDP870)UCB PharmaNULLCompleted18 YearsN/AAll233Phase 3United States;Austria;Belgium;Canada;France;Germany;Italy;Netherlands;Spain;Sweden;Switzerland;United Kingdom
56EUCTR2005-004104-37-ES
(EUCTR)
28/07/200611/05/2006A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a PEGylated Fab' fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab.A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a PEGylated Fab' fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab. Patients with Crohn's Disease with prior loss of response or intolerance to infliximab
Classification code 10011401
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB S.A.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3Belgium;Spain;Denmark;Austria;Germany;Italy;United Kingdom;Sweden
57EUCTR2005-004104-37-DK
(EUCTR)
15/06/200604/05/2006A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a PEGylated Fab' fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab.A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a PEGylated Fab' fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab. Patients with Crohn's Disease with prior loss of response or intolerance to infliximab
Classification code 10011401
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB S.A.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3Spain;Belgium;Austria;Denmark;Germany;Italy;United Kingdom;Sweden
58EUCTR2005-004104-37-SE
(EUCTR)
08/06/200621/04/2006A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a PEGylated Fab' fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab.A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a PEGylated Fab' fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab. Patients with Crohn's Disease with prior loss of response or intolerance to infliximab
Classification code 10011401
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB S.A.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3Germany;United Kingdom;Belgium;Spain;Italy;Austria;Sweden
59EUCTR2005-004104-37-AT
(EUCTR)
24/05/200604/04/2006A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a PEGylated Fab' fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab.A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a PEGylated Fab' fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab. Patients with Crohn's Disease with prior loss of response or intolerance to infliximab
Classification code 10011401
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB S.A.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3Germany;United Kingdom;Belgium;Spain;Italy;Austria;Sweden
60EUCTR2005-004104-37-DE
(EUCTR)
19/05/200629/03/2006A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a PEGylated Fab' fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab.A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a PEGylated Fab' fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab. Patients with Crohn's Disease with prior loss of response or intolerance to infliximab
Classification code 10011401
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB Pharma S.A.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3United Kingdom;Germany;Belgium;Spain;Italy;Austria;Sweden
61EUCTR2005-004104-37-GB
(EUCTR)
17/05/200617/03/2006A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a pegylated Fab fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab.A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a pegylated Fab fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab. Patients with Crohn's Disease with prior loss of response or intolerance to infliximab
Classification code 10011401
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB S.A.NULLNot 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): noSpain;Belgium;Denmark;Austria;Germany;Italy;United Kingdom;Sweden
62NCT00329550
(ClinicalTrials.gov)
May 200622/5/2006Maintenance Study of Certolizumab Pegol (CZP) in Crohn's DiseaseA 26-week, Multi-center, Open-label Study to Investigate the Efficacy and Safety of CDP870 in Active Crohn's Disease Patients, Who Showed Clinical Efficacy in a Remission Induction Study (Study C87037 [NCT00291668]), at Week 26 After Subcutaneous Administration of CDP870 400 mg From Week 8 Until Week 24 at 4-week IntervalsCrohn's DiseaseBiological: Certolizumab pegol (CZP)UCB Japan Co. Ltd.NULLCompleted16 Years64 YearsAll40Phase 2Japan
63NCT00329420
(ClinicalTrials.gov)
May 200622/5/2006Maintenance Study Including Re-induction Therapy for Patients Who Did Not Show a Clinical Effect in Study C87037 (NCT00291668)A Multi-center, Open-label Study to Investigate the Efficacy and Safety of CDP870 in Active Crohn's Disease Patients, Who Showed no Clinical Efficacy in a Remission Induction Study (Study C87037) But Showed Clinical Efficacy After Additional Remission Induction Therapy Was Applied, at Week 26 After Subcutaneous Administration of CDP870 400 mg From Week 8 Until Week 24 at 4-week IntervalsCrohn's DiseaseBiological: Certolizumab pegolUCB PharmaNULLCompleted16 Years64 YearsAll46Phase 2Japan
64NCT00308581
(ClinicalTrials.gov)
April 200628/3/2006Certolizumab in Crohn's Disease Patients With Loss of Response or Intolerance to InfliximabPhase IIIb Open-label Induction and Double-blind Comparison of 2 Maintenance Schedules Evaluating Clinical Benefit and Tolerability of Certolizumab Pegol in Crohn's Disease Patients With Prior Loss of Response or Intolerance to InfliximabCrohn's DiseaseBiological: Certolizumab pegol;Other: PlaceboUCB PharmaNULLCompleted18 YearsN/AAll539Phase 3United States;Austria;Belgium;Canada;Denmark;France;Germany;Italy;Netherlands;Norway;Spain;Sweden;Switzerland;United Kingdom
65EUCTR2005-004104-37-BE
(EUCTR)
23/03/200627/01/2006A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a pegylated Fab fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab.A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a pegylated Fab fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab. Patients with Crohn's Disease with prior loss of response or intolerance to infliximab
Classification code 10011401
Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB S.A.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3Germany;United Kingdom;Belgium;Spain;Italy;Austria;Sweden
66NCT00291668
(ClinicalTrials.gov)
March 2, 200610/2/2006Clinical Study of CDP870/Certolizumab Pegol in Patients With Active Crohn's DiseaseA Phase II, Multi-center, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study to Assess the Safety and Efficacy of CDP870/Certolizumab Pegol, Dosed Subcutaneously in Patients With Active Crohn's DiseaseCrohn's DiseaseBiological: Certolizumab Pegol;Other: PlaceboUCB PharmaNULLCompleted16 Years65 YearsAll94Phase 2Japan
67NCT00297648
(ClinicalTrials.gov)
February 200627/2/2006Mucosal Healing Study in Crohn's Disease (CD)A Phase IIIB Multicentre Open Label 54 Weeks Clinical Trial Evaluating Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor Alpha (TNFa) on Endoscopic and Mucosal Healing in Patients Suffering From Active Crohn's Disease.Crohn's DiseaseBiological: Certolizumab pegolUCB PharmaNULLCompleted18 YearsN/AAll89Phase 3Belgium;France;Germany
68NCT00160524
(ClinicalTrials.gov)
July 20048/9/2005A follow-on Safety Study of CDP870 in Subjects With Crohn's Disease (CD) Who Have Completed a 26-week Double Blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425]A Phase III Multi-national, Multi-centre, Open Label, Safety Study to Assess the Safety of Chronic Therapy With the Humanised Anti-TNF PEG Conjugate CDP870 400 mg sc, (Dosed 4-weekly), in the Treatment of Patients With Active Crohn's Disease Who Have Previously Completed Studies CDP870-031 or CDP870-032Crohn's DiseaseBiological: Certolizumab Pegol (CDP870)UCB Pharma SANULLCompleted18 YearsN/AAll596Phase 3United States;Australia;Austria;Belarus;Belgium;Bulgaria;Canada;Czechia;Denmark;Estonia;Georgia;Germany;Hong Kong;Hungary;Israel;Italy;Latvia;Lithuania;New Zealand;Norway;Poland;Russian Federation;Serbia;Singapore;Slovenia;South Africa;Spain;Sweden;Ukraine;Czech Republic;Tunisia
69NCT00152425
(ClinicalTrials.gov)
February 20047/9/2005Study to Test the Effect of CDP870 in the Treatment of Crohn's Disease Over 26 Weeks, Comparing CDP870 to a Dummy Drug (Placebo), Following 3 Doses of Active Drug (CDP870).A Phase III Multi-national, Multi-centre, Double-blind Placebo-controlled Parallel Group, 26 Week Study to Assess the Maintenance of Clinical Response to Humanised Anti-TNF PEG Conjugate, CDP870 400 mg sc, (Dosed 4-weekly From Weeks 8 to 24), in the Treatment of Patients With Active Crohn's Disease Who Have Responded to Open Induction Therapy (Dosed at Weeks 0, 2 and 4) With CDP870Crohn's DiseaseDrug: Certolizumab Pegol (CDP870)UCB PharmaNULLCompleted18 YearsN/ABoth392Phase 3NULL
70NCT00160706
(ClinicalTrials.gov)
February 20048/9/2005A follow-on Safety Study in Subjects With Crohn's Disease Who Have Previously Been Withdrawn From the Double-blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] Due to an Exacerbation of Crohn's DiseaseA Phase III Multi-national, Multi-centre, Open Label, Safety Study to Assess the Safety of Re-exposure After a Variable Interval and Subsequent Chronic Therapy With the Humanised Anti-TNF PEG Conjugate CDP870 400 mg sc, (Dosed at Weeks 0, 2 and 4 Then Every 4 Weeks), in the Treatment of Patients With Active Crohn's Disease Who Have Previously Been Withdrawn From Studies CDP870-031 or CDP870-032 Due to an Exacerbation of Crohn's Disease.Crohn's DiseaseBiological: Certolizumab Pegol (CDP870)UCB Pharma SANULLCompleted18 YearsN/AAll310Phase 3United States;Australia;Austria;Belarus;Belgium;Bulgaria;Canada;Czechia;Denmark;Estonia;Germany;Hungary;Israel;Italy;New Zealand;Norway;Poland;Russian Federation;Serbia;Singapore;Slovenia;South Africa;Spain;Ukraine;Czech Republic
71NCT00152490
(ClinicalTrials.gov)
December 20038/9/2005A Study to Test the Effect of CDP870 in the Treatment of Crohn's Disease Over 26 Weeks, Comparing CDP870 to a Dummy Drug (Placebo)A Phase III Multi-national, Multi-centre, Double-blind Placebo-controlled Parallel Group, 26 Week Study to Assess the Safety and Efficacy of the Humanised Anti-TNF PEG Conjugate, CDP870 400 mg sc, (Dosed at Weeks 0, 2, 4 Then 4-weekly to Week 24), in the Treatment of Patients With Active Crohn's DiseaseCrohn's DiseaseDrug: Certolizumab Pegol (CDP870)UCB PharmaNULLCompleted18 YearsN/ABoth604Phase 3NULL
72EUCTR2014-004381-24-Outside-EU/EEA
(EUCTR)
02/03/2015The Use of Certolizumab Pegol for Treatment of Active Crohn's Disease in Children and Adolescents A Phase 2, Open-label, Multicenter Study to Assess the Safety and Efficacy of Certolizumab Pegol in Children and Adolescents With Active Crohn's Disease (NURTURE Study) - NURTURE 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: Cimzia
Product Name: Certolizumab Pegol /Cimzia
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Other descriptive name: Certolizumab Pegol
UCB CelltechNULLNAFemale: yes
Male: yes
100Phase 2United States;Australia;Canada;New Zealand
73EUCTR2014-004354-34-Outside-EU/EEA
(EUCTR)
27/02/2015Maintenance Study of Certolizumab Pegol (CZP) in Crohn’s Disease A 26-week, multi-center, open-label study to investigate the efficacy and safety of CDP870 in active Crohn’s disease patients, who showed clinical efficacy in a remission induction study (Study C87037), at Week 26 after subcutaneous administration of CDP870 400 mg from Week 8 until Week 24 at 4-week intervals 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: Cimzia
Product Name: Certolizumab Pegol /Cimzia
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Other descriptive name: CERTOLIZUMAB PEGOL
UCB Japan Co., Ltd.NULLNAFemale: yes
Male: yes
35Japan
74EUCTR2014-004399-42-Outside-EU/EEA
(EUCTR)
05/03/2015Clinical Study of CDP870/Certolizumab Pegol in Patients With Active Crohn's Disease A Phase II, Multi-center, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study to Assess the Safety and Efficacy of CDP870/Certolizumab Pegol, Dosed Subcutaneously in Patients With Active 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] - Immune System Diseases [C20]
Trade Name: Cimzia
Product Name: Certolizumab Pegol /Cimzia
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Other descriptive name: CERTOLIZUMAB PEGOL
UCB Japan Co., Ltd.NULLNAFemale: yes
Male: yes
100Phase 2Japan
75EUCTR2014-004400-30-Outside-EU/EEA
(EUCTR)
27/02/2015Maintenance Study Including Re-induction Therapy for Patients Who Did Not Show a Clinical Effect in Study C87037 (2014-004399-42) A multi-center, open-label study to investigate the efficacy and safety of CDP870 in active Crohn’s Disease patients, who showed no clinical efficacy in a remission induction study (Study C87037) but showed clinical efficacy after additional remission induction therapy was applied, at Week 26 after subcutaneous administration of CDP870 400 mg from Week 8 until Week 24 at 4-week intervals 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: Cimzia
Product Name: Certolizumab Pegol /Cimzia
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Other descriptive name: CERTOLIZUMAB PEGOL
UCB Japan Co., Ltd.NULLNAFemale: yes
Male: yes
46Japan