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Sponsors and Collaborators: |
Otsuka Pharmaceutical Co., Ltd. UCB Japan CO., LTD. |
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Information provided by: | Otsuka Pharmaceutical Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT00791921 |
The objectives of this study are to verify the superiority in efficacy (ACR20) and investigate the pharmacokinetics and safety of CDP870 versus placebo without coadministration of MTX in active RA patients in whom MTX cannot be administrated.
Condition | Intervention | Phase |
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Rheumatoid Arthritis |
Drug: Placebo of CDP870 Drug: CDP870 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Trial to Assess the Efficacy, Pharmacokinetics, and Safety of CDP870 Without Coadministration of Mthotrexate (MTX) in Japanese Active Rheumatoid Arthritis (RA) Patients in Whom MTX Cannot be Administrated. |
Estimated Enrollment: | 200 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | March 2011 |
Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Placebo: Placebo Comparator
Placebo of CDP870
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Drug: Placebo of CDP870
Placebo given every 2 weeks until Week22 (SC)
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CDP870 200mg: Experimental
400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks
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Drug: CDP870
400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks until Week22 (SC)
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Ages Eligible for Study: | 20 Years to 74 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects must have active RA disease as defined by:
Exclusion Criteria:
Contact: Drug Information Center | opc_ctr@otsuka.jp |
Japan | |
Recruiting | |
Kanto Region, Japan | |
Recruiting | |
Hokkaido Region, Japan | |
Recruiting | |
Chube Region, Japan | |
Recruiting | |
Kyushuh Region, Japan | |
Recruiting | |
Chugoku Region, Japan | |
Recruiting | |
Shikoku Region, Japan | |
Recruiting | |
Kinki Region, Japan |
Study Chair: | Katsuhisa Saito | OPCJ |
Responsible Party: | Department of Clinical Research and Development, Otsuka Pharmaceutical Co., Ltd. ( Katsuhisa Saito, Senior Operating Officer ) |
Study ID Numbers: | CDP870-275-08-003 |
Study First Received: | November 14, 2008 |
Last Updated: | July 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00791921 History of Changes |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Rheumatoid Arthritis Certolizumab Pegol Cimzia |
Autoimmune Diseases Musculoskeletal Diseases Joint Diseases Arthritis |
Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases |
Autoimmune Diseases Immune System Diseases Musculoskeletal Diseases Joint Diseases |
Arthritis Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases |