46. 悪性関節リウマチ Malignant rheumatoid arthritis Clinical trials / Disease details
臨床試験数 : 4,356 / 薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | JPRN-jRCTs041200048 | 02/10/2020 | 02/10/2020 | Certolizumab Pegol treatment with Reducing and stoppIng MEthotrexate in patients with Rheumatoid Arthritis in stable low disease activity-state | Certolizumab Pegol treatment with Reducing and stoppIng MEthotrexate in patients with Rheumatoid Arthritis in stable low disease activity-state - PRIMERA study | Rheumatoid arthritis | 1) MTX* - Continued group: Continued at a stable dose and interval throughout the cours of the study. Folic acid is continued if concomitantly used. - Withdrawn group: Week 0 to 12 Reduced after registration. The dose of MTX is reduced to half, regardless of the initial dose. Folic acid is continued if concomitantly used. Week 12 to 52 Discontinued if low disease activity was maintained. Folic acid is discontinued if concomitantly used. *The allowable range of adherence is -20% to +20%. 2) CZP and csDMARDs other than MTX Continued at a stable dose and interval throughout the course of the study in both groups. 3) Glucocorticoids Continued at a stable dose up to week 36, and allowedto taper after week 36 in both group. 4) Rescue treatment One or more of the following rescue treatments are performed if the CDAI score was >10 and at the discretion of the investigator and/or upon patient request. - Restoring, restarting, or increasing doses of MTX - Increasing doses of or adding csDMARDs other than MTX. - Increasing doses of or adding glucocorticoids - Drainage of synovial fluid. - Administering an intraarticular injection of corticosteroids, hyaluronic acid, or lidocaine. | Asai Shuji | Kojima Toshihisa | Recruiting | >= 20age old | Not applicable | Both | 114 | N/A | Japan |
| 2 | JPRN-jRCTs071190001 | 29/08/2019 | 02/04/2019 | Continuation of certolizumab pegol with Or Without MTX in RA patients achieving sustained remissioN and low disease activity | Continuation of certolizumab pegol with Or Without MTX in RA patients achieving sustained remissioN and low disease activity - CROWN study | Rheumatoid arthritis | Patients retaining LDA with the combination of CZP and MTX are randomized to two groups consisting of patients who continue MTX at the same doses or discontinue MTX. The effects of both groups are compared 1 year after starting study. Control group combination therapy with subcutaneous CZP (200 mg in every 2 weeks or 400 mg in every 4 weeks) and oral MTX (at the same dose before starting the protocol treatment) given for 52 weeks of the protocol treatment, or until the time of discontinuation. Intervention group monotherapy with CZP (200 mg in every 2 weeks or 400 mg in every 4 weeks) given for 52 weeks of the protocol treatment, or until the time of discontinuation. The discontinuation criteria for the study are as follows: 1) When subjects requested to discontinue the treatment 2) When the principal investigator or subinvestigator considered that the therapy should be discontinued due to adverse (drug) events 3) When a subject turned out not to fulfil the inclusion criteria or meets the exclusion criteria after starting the study 4) When RA relapses, defined as SDAI over 11, were observed at two consecutive visits 5) When the principal investigator or subinvestigator considered continuation of the study is inappropriate for reasons other than above | Miyazaki Yusuke | Tanaka Yoshiya | Recruiting | >= 16age old | Not applicable | Both | 150 | Phase 4 | Japan |
| 3 | NCT03546335 (ClinicalTrials.gov) | October 1, 2018 | 30/4/2018 | Zr-89 Cimzia PET Imaging Rheumatoid Arthritis | Zirconium-89 Certolizumab PET Imaging in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: 89Zr-DFO-CZP | Robert Flavell, MD, PhD | NULL | Suspended | 18 Years | N/A | All | 10 | Phase 1 | United States |
| 4 | EUCTR2011-002067-20-FR (EUCTR) | 13/01/2015 | 23/08/2012 | Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide. | A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - | Moderate to severe rheumatoid arthritis MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 892 | United States;Portugal;Greece;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Australia;Bulgaria;Germany | |||
| 5 | 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 |
| 6 | 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 |
| 7 | EUCTR2011-002067-20-GR (EUCTR) | 10/01/2013 | 13/12/2012 | Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide. | A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - | Moderate to severe rheumatoid arthritis MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 892 | United States;Portugal;Greece;Spain;Ireland;Austria;Switzerland;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany | |||
| 8 | EUCTR2011-002067-20-IT (EUCTR) | 23/08/2012 | 13/09/2012 | Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the EU and a n. of other countries worldwide | A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate | Moderate to severe rheumatoid arthritis MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Humira INN or Proposed INN: ADALIMUMAB | UCB PHARMA SA/NV. | NULL | Not Recruiting | Female: yes Male: yes | 892 | United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany | |||
| 9 | EUCTR2011-002067-20-GB (EUCTR) | 23/07/2012 | 13/03/2012 | Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide. | A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - | Moderate to severe rheumatoid arthritis MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 892 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United States;Portugal;Greece;Spain;Ireland;Austria;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;European Union;Mexico;Canada;Australia;Bulgaria;Germany | ||
| 10 | EUCTR2011-002067-20-PT (EUCTR) | 06/07/2012 | 21/03/2012 | Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide. | A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - | Moderate to severe rheumatoid arthritis MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 892 | Phase 4 | Portugal;United States;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany | ||
| 11 | EUCTR2011-002067-20-BG (EUCTR) | 28/06/2012 | 11/05/2012 | Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide. | A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - | Moderate to severe rheumatoid arthritis MedDRA version: 18.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 892 | Phase 4 | United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany | ||
| 12 | EUCTR2011-002067-20-ES (EUCTR) | 26/06/2012 | 10/05/2012 | Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide. | A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - | Moderate to severe rheumatoid arthritis MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 892 | United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany | |||
| 13 | EUCTR2011-002067-20-AT (EUCTR) | 26/06/2012 | 27/03/2012 | Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide. | A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - | Moderate to severe rheumatoid arthritis MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 892 | United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany | |||
| 14 | EUCTR2011-002067-20-CZ (EUCTR) | 19/06/2012 | 25/04/2012 | Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide. | A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - | Moderate to severe rheumatoid arthritis MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 892 | Phase 4 | United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Australia;Bulgaria;Germany | ||
| 15 | EUCTR2011-002067-20-DE (EUCTR) | 13/06/2012 | 16/02/2012 | Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide. | A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - | Moderate to severe rheumatoid arthritis MedDRA version: 18.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 892 | Phase 4 | Ireland;Austria;Italy;United States;Portugal;Greece;Spain;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany | ||
| 16 | EUCTR2011-002067-20-IE (EUCTR) | 01/06/2012 | 10/04/2012 | Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide. | A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - | Moderate to severe rheumatoid arthritis MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 892 | Phase 4 | United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;European Union;Mexico;Canada;Australia;Bulgaria;Germany | ||
| 17 | EUCTR2011-002067-20-HU (EUCTR) | 30/05/2012 | 20/03/2012 | Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide. | A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - | Moderate to severe rheumatoid arthritis MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 892 | United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany | |||
| 18 | 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 |
| 19 | NCT01451203 (ClinicalTrials.gov) | October 11, 2011 | 25/9/2011 | Efficacy Confirmation Study of CDP870 in Early Rheumatoid Arthritis | A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of CDP870 in Patients With Early-stage Rheumatoid Arthritis Who Are Naïve to Methotrexate and Have Poor Prognostic Factors | Rheumatoid Arthritis | Drug: Placebo;Drug: CZP;Drug: methotrexate (MTX) | Astellas Pharma Inc | UCB Japan Co. Ltd. | Completed | 20 Years | 64 Years | All | 319 | Phase 3 | Japan |
| 20 | 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 |
| 21 | EUCTR2011-000385-35-IT (EUCTR) | 19/08/2011 | 27/02/2012 | MULTICENTER, OPEN LABEL STUDY TO EVALUATE THE PREDICTABILITY OF EARLY RESPONSE TO CERTOLIZUMAB PEGOL (IN COMBINATION WITH METHOTREXATE) AS CONFIRMED AT WEEK 52 IN SUBJECTS WITH MODERATE-SEVERE RHEUMATOID ARTHRITIS (RA): THE CZP-SPEED STUDY | MULTICENTER, OPEN LABEL STUDY TO EVALUATE THE PREDICTABILITY OF EARLY RESPONSE TO CERTOLIZUMAB PEGOL (IN COMBINATION WITH METHOTREXATE) AS CONFIRMED AT WEEK 52 IN SUBJECTS WITH MODERATE-SEVERE RHEUMATOID ARTHRITIS (RA): THE CZP-SPEED STUDY - CZP-SPEED | 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 INN or Proposed INN: CERTOLUZIMAB PEGOL Other descriptive name: NA | UCB PHARMA | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 22 | 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 | |||
| 23 | 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 |
| 24 | 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 |
| 25 | 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 | |||
| 26 | 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 | |||
| 27 | 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 |
| 28 | 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 |