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Sponsors and Collaborators: |
UCB no collaborators |
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Information provided by: | UCB |
ClinicalTrials.gov Identifier: | NCT00753454 |
The purpose of this study is to continue to assess the safety of certolizumab pegol in combination with methotrexate.
Condition | Intervention | Phase |
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Rheumatoid Arthritis |
Drug: Certolizumab pegol |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase IIIb, Multi-Center Open-Label, Follow-up Study to Evaluate the Safety and Efficacy of Certolizumab Pegol Administered Concomitantly With Methotrexate in Patients With Active Rheumatoid Arthritis Who Participated in C87077. |
Estimated Enrollment: | 201 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | May 2011 |
Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
CDP870: Experimental
Certolizumab pegol
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Drug: Certolizumab pegol
Liquid certolizumab pegol administered every two weeks as a single injection (400 mg at entry, week 2 & week 4, followed by 200 mg every 2 weeks).
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |
Huntsville, Alabama, United States | |
United States, Arizona | |
Tucson, Arizona, United States | |
United States, Arkansas | |
Little Rock, Arkansas, United States | |
United States, California | |
Palm Desert, California, United States | |
Los Angeles, California, United States | |
United States, Florida | |
Aventura, Florida, United States | |
Sarasota, Florida, United States | |
Gainesville, Florida, United States | |
Clearwater, Florida, United States | |
United States, Illinois | |
Vernon Hills, Illinois, United States | |
United States, Nebraska | |
Lincoln, Nebraska, United States | |
United States, New York | |
Syracuse, New York, United States | |
Albany, New York, United States | |
United States, North Carolina | |
Wilmington, North Carolina, United States | |
Charlotte, North Carolina, United States | |
Monroe, North Carolina, United States | |
United States, Oklahoma | |
Norman, Oklahoma, United States | |
United States, Pennsylvania | |
Duncansville, Pennsylvania, United States | |
United States, South Carolina | |
Simpsonville, South Carolina, United States | |
United States, Texas | |
Tyler, Texas, United States | |
San Antonio, Texas, United States |
Study Director: | UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) |
Responsible Party: | UCB ( Study Director ) |
Study ID Numbers: | C87084, Dose Flex II, Dose Flex Extension Trial |
Study First Received: | June 5, 2008 |
Last Updated: | April 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00753454 History of Changes |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; France: Afssaps - French Health Products Safety Agency |
Rheumatoid Arthritis Joint Disease Arthritis Certolizumab pegol Cimzia |
Immunoglobulin Fab Fragments Antibodies Autoimmune Diseases Immunologic Factors Musculoskeletal Diseases Arthritis |
Joint Diseases Connective Tissue Diseases Arthritis, Rheumatoid Methotrexate Rheumatic Diseases Immunoglobulins |
Immunoglobulin Fab Fragments Autoimmune Diseases Immunologic Factors Immune System Diseases Musculoskeletal Diseases Joint Diseases |
Arthritis Physiological Effects of Drugs Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases Pharmacologic Actions |