Certolizumab pegol (czp) (DrugBank: Certolizumab pegol)
6 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 37 | 膿疱性乾癬（汎発型） | 0 |
| 46 | 悪性関節リウマチ | 11 |
| 96 | クローン病 | 2 |
| 97 | 潰瘍性大腸炎 | 0 |
| 226 | 間質性膀胱炎（ハンナ型） | 0 |
| 271 | 強直性脊椎炎 | 6 |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT02151851 (ClinicalTrials.gov) | July 2014 | 28/5/2014 | A Study of Certolizumab Pegol as Additional Therapy in Chinese Patients With Active Rheumatoid Arthritis | A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel Group, Randomized 24-week Study to Evaluate the Safety and Efficacy of Certolizumab Pegol (CZP) as Additional Medication to Methotrexate in Chinese Subjects With Active Rheumatoid Arthritis Who Have an Incomplete Response to Methotrexate | Rheumatoid Arthritis | Biological: Certolizumab Pegol;Drug: Methotrexate;Other: Placebo | UCB Pharma SA, Belgium | Parexel | Completed | 18 Years | N/A | All | 430 | Phase 3 | China |
| 2 | NCT02293590 (ClinicalTrials.gov) | November 2013 | 30/10/2014 | RICE: Remission by Intra-articular Injection Plus CErtolizumab | An Open Label, Randomised Study to Compare the Efficacy of Certolizumab Pegol (CZP) Plus a Dynamic or Fixed Dose Treatment Strategy in Patients With Rheumatoid Arthritis, a Phase II Study | Rheumatoid Arthritis | Drug: Certolizumab Pegol | Rüdiger B. Müller | UCB Pharma | Completed | 18 Years | N/A | All | 43 | Phase 2 | Switzerland |
| 3 | NCT01500278 (ClinicalTrials.gov) | December 2011 | 22/12/2011 | Study to Assess the Short- and Long-term Efficacy of Certolizumab Pegol Plus Methotrexate Compared to Adalimumab Plus Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis (RA) Inadequately Responding to Methotrexate | A Multicenter, Single-blind, Randomized Parallel-group Study to Assess the Short- and Long-term Efficacy of Certolizumab Pegol Plus Methotrexate Compared to Adalimumab Plus Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis Responding Inadequately to Methotrexate | Rheumatoid Arthritis | Biological: Certolizumab Pegol (CZP);Biological: Adalimumab (ADA);Drug: Methotrexate (MTX) | UCB Pharma SA | Parexel | Completed | 18 Years | N/A | All | 915 | Phase 4 | United States;Australia;Austria;Bulgaria;Canada;Czechia;France;Germany;Greece;Hungary;Ireland;Italy;Mexico;Monaco;Poland;Portugal;Romania;Spain;Switzerland;United Kingdom;Czech Republic |
| 4 | NCT01374971 (ClinicalTrials.gov) | September 2011 | 14/6/2011 | Rheumatoid Arthritis Treatment and Biopsy Study Assessing Certolizumab Pegol (Cimzia) | Open-Label Pre and Post Treatment Arthroscopic Synovial Biopsy Study for the Assessment of Certolizumab Pegol Immunomodulatory Synovial Effects on Select Biomarkers and Gene Expression | Rheumatoid Arthritis | Drug: Certolizumab Pegol (CZP);Procedure: Arthroscopic synovial tissue biopsy | Nathan Wei, MD, FACP, FACR: | University of California, San Diego | Completed | 18 Years | N/A | All | 12 | Phase 3 | United States |
| 5 | EUCTR2009-013758-33-NL (EUCTR) | 10/05/2011 | 16/09/2010 | MULTICENTER STUDY WITH A 16-WEEK DOUBLE-BLIND, PLACEBO-CONTROLLED (DURING THE INITIAL 2 WEEKS) RANDOMIZED PERIOD, FOLLOWED BY A 24-WEEK OPEN LABEL EXTENSION TO ASSESS MAGNETIC RESONANCE IMAGE-VERIFIED EARLY RESPONSE TO CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS | MULTICENTER STUDY WITH A 16-WEEK DOUBLE-BLIND, PLACEBO-CONTROLLED (DURING THE INITIAL 2 WEEKS) RANDOMIZED PERIOD, FOLLOWED BY A 24-WEEK OPEN LABEL EXTENSION TO ASSESS MAGNETIC RESONANCE IMAGE-VERIFIED EARLY RESPONSE TO CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia® Product Name: certolizumab pegol (CZP) Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL | UCB Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 36 | Denmark;Netherlands;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | NCT01235598 (ClinicalTrials.gov) | December 2010 | 4/11/2010 | Magnetic Resonance Image Verified Early Response to Certolizumab Pegol in Subjects With Active Rheumatoid Arthritis (RA) | A 16-week Double-blind, Placebo-controlled (for Initial 2 Weeks) Randomized Period, Followed by a 24-week Open-label Extension to Assess Magnetic Resonance Image (MRI) - Verified Early Response to Certolizumab Pegol in Subjects With Active Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Other: Placebo;Biological: Certolizumab Pegol (CZP) 200 mg;Biological: Certolizumab Pegol (CZP) 400 mg | UCB Pharma | NULL | Completed | 18 Years | N/A | All | 41 | Phase 3 | Denmark;Netherlands;Poland;Sweden |
| 7 | NCT01255761 (ClinicalTrials.gov) | November 2010 | 6/12/2010 | A Comparison of Two Assessment Tools in Predicting Treatment Success of Cimzia in Rheumatoid Arthritis Subjects | Phase 4, Randomized, 52-Week Study To Evaluate Two Assessment Tools To Predict Treatment Success At 52 Weeks Based On A Treatment Decision At Week 12 In Subjects With Moderate To Severe Rheumatoid Arthritis Receiving Cimzia | Rheumatoid Arthritis | Biological: Certolizumab Pegol (CZP) | UCB Pharma | NULL | Completed | 18 Years | N/A | All | 736 | Phase 4 | United States |
| 8 | EUCTR2009-013758-33-DK (EUCTR) | 09/09/2010 | 09/06/2010 | MULTICENTER STUDY WITH A 16-WEEK DOUBLE-BLIND, PLACEBO-CONTROLLED (DURING THE INITIAL 2 WEEKS) RANDOMIZED PERIOD, FOLLOWED BY A 24-WEEK OPEN LABEL EXTENSION TO ASSESS MAGNETIC RESONANCE IMAGE-VERIFIED EARLY RESPONSE TO CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS | MULTICENTER STUDY WITH A 16-WEEK DOUBLE-BLIND, PLACEBO-CONTROLLED (DURING THE INITIAL 2 WEEKS) RANDOMIZED PERIOD, FOLLOWED BY A 24-WEEK OPEN LABEL EXTENSION TO ASSESS MAGNETIC RESONANCE IMAGE-VERIFIED EARLY RESPONSE TO CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia® Product Name: certolizumab pegol (CZP) Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL | UCB Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 36 | Denmark;Netherlands;Sweden | |||
| 9 | EUCTR2009-013758-33-SE (EUCTR) | 17/06/2010 | 22/03/2010 | MULTICENTER STUDY WITH A 16-WEEK DOUBLE-BLIND, PLACEBO-CONTROLLED (DURING THE INITIAL 2 WEEKS) RANDOMIZED PERIOD, FOLLOWED BY A 24-WEEK OPEN LABEL EXTENSION TO ASSESS MAGNETIC RESONANCE IMAGE-VERIFIED EARLY RESPONSE TO CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS | MULTICENTER STUDY WITH A 16-WEEK DOUBLE-BLIND, PLACEBO-CONTROLLED (DURING THE INITIAL 2 WEEKS) RANDOMIZED PERIOD, FOLLOWED BY A 24-WEEK OPEN LABEL EXTENSION TO ASSESS MAGNETIC RESONANCE IMAGE-VERIFIED EARLY RESPONSE TO CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia® Product Name: certolizumab pegol (CZP) Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL | UCB Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 36 | Denmark;Netherlands;Sweden | |||
| 10 | NCT00717236 (ClinicalTrials.gov) | July 2008 | 15/7/2008 | Certolizumab Pegol for the Treatment of Patients With Active Rheumatoid Arthritis | A Phase IIIb Multicenter Study With a 12-week Double-blind, Placebo-controlled, Randomized Period Followed by an Open-label, Extension Phase Evaluating Safety/Efficacy of Certolizumab Pegol Given to Patients With Active Rheumatoid Arthritis. | Rheumatoid Arthritis | Drug: Certolizumab pegol (CZP);Other: Placebo | UCB Pharma | NULL | Completed | 18 Years | N/A | All | 1648 | Phase 3 | United States;Canada;France;Germany;Italy;Netherlands;Spain |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | NCT00160693 (ClinicalTrials.gov) | March 2003 | 6/9/2005 | Open Label Long-Term Safety Study of Certolizumab Pegol (CZP) for Patients With Rheumatoid Arthritis | A Phase III, Multicenter, Open-Label Long-Term Study to Assess the Safety and Tolerability of CDP870 400 mg Subcutaneously Every 4 Weeks, in Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: Certolizumab Pegol | UCB Pharma | NULL | Completed | 18 Years | N/A | All | 402 | Phase 3 | United Kingdom;Austria;Belgium;Czechia;Germany;Ireland;United States;Czech Republic |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT00329550 (ClinicalTrials.gov) | May 2006 | 22/5/2006 | Maintenance 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 [NCT00291668]), at Week 26 After Subcutaneous Administration of CDP870 400 mg From Week 8 Until Week 24 at 4-week Intervals | Crohn's Disease | Biological: Certolizumab pegol (CZP) | UCB Japan Co. Ltd. | NULL | Completed | 16 Years | 64 Years | All | 40 | Phase 2 | Japan |
| 2 | EUCTR2014-004354-34-Outside-EU/EEA (EUCTR) | 27/02/2015 | Maintenance 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. | NULL | NA | Female: yes Male: yes | 35 | Japan |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2009-011719-19-CZ (EUCTR) | 20/07/2010 | 20/07/2010 | PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE AXIAL SPONDYLOARTHRITIS (AXIAL SPA) | PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE AXIAL SPONDYLOARTHRITIS (AXIAL SPA) | axial spondyloarthritis (axial SpA) MedDRA version: 14.1;Level: PT;Classification code 10051265;Term: Spondyloarthropathy;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 14.1;Level: LLT;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Trade Name: Cimzia® Product Name: certolizumab pegol (CZP) Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB BioSciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | France;Hungary;Czech Republic;Belgium;Netherlands;Germany;Italy;United Kingdom | ||
| 2 | EUCTR2009-011719-19-DE (EUCTR) | 19/07/2010 | 17/02/2010 | N/A | PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE AXIAL SPONDYLOARTHRITIS (AXIAL SPA) | axial spondyloarthritis (axial SpA) MedDRA version: 18.1;Level: PT;Classification code 10051265;Term: Spondyloarthropathy;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 18.1;Level: LLT;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Cimzia® Product Name: certolizumab pegol (CZP) Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB BioSciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Italy;France;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Netherlands;United States;United Kingdom | ||
| 3 | EUCTR2009-011719-19-BE (EUCTR) | 02/07/2010 | 23/04/2010 | NA | PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE AXIAL SPONDYLOARTHRITIS (AXIAL SPA) | axial spondyloarthritis (axial SpA) MedDRA version: 16.0;Level: PT;Classification code 10051265;Term: Spondyloarthropathy;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 16.0;Level: LLT;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Cimzia® Product Name: certolizumab pegol (CZP) Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB BioSciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United States;United Kingdom;Italy;France;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Germany;Netherlands | ||
| 4 | EUCTR2009-011719-19-NL (EUCTR) | 29/06/2010 | 06/05/2010 | PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE AXIAL SPONDYLOARTHRITIS (AXIAL SPA) | PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE AXIAL SPONDYLOARTHRITIS (AXIAL SPA) | axial spondyloarthritis (axial SpA) MedDRA version: 14.0;Level: PT;Classification code 10051265;Term: Spondyloarthropathy;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 14.0;Level: LLT;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Trade Name: Cimzia® Product Name: certolizumab pegol (CZP) Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB BioSciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Italy;United Kingdom | ||
| 5 | EUCTR2009-011719-19-HU (EUCTR) | 13/05/2010 | 12/04/2010 | N/A | PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE AXIAL SPONDYLOARTHRITIS (AXIAL SPA) | axial spondyloarthritis (axial SpA) MedDRA version: 16.0;Level: PT;Classification code 10051265;Term: Spondyloarthropathy;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 16.0;Level: LLT;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Cimzia® Product Name: certolizumab pegol (CZP) Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB BioSciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United States;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Germany;Netherlands | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | EUCTR2009-011719-19-FR (EUCTR) | 29/03/2010 | 04/02/2010 | PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE AXIAL SPONDYLOARTHRITIS (AXIAL SPA) | PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE AXIAL SPONDYLOARTHRITIS (AXIAL SPA) | axial spondyloarthritis (axial SpA) MedDRA version: 12.1;Level: LLT;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies MedDRA version: 12.1;Classification code 10051265;Term: Spondyloarthropathy | Trade Name: Cimzia® Product Name: certolizumab pegol (CZP) Product Code: CDP870 INN or Proposed INN: certolizumab pegol | SCHWARZ BIOSCIENCES, GmbH, A Member of the UCB Group of Companies | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | France;Czech Republic;Hungary;Belgium;Netherlands;Germany;Italy;United Kingdom |