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Sponsored by: |
Biogen Idec |
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Information provided by: | Biogen Idec |
ClinicalTrials.gov Identifier: | NCT00810836 |
The purpose of this study is to investigate whether the drug BG00012 can improve the symptoms of rheumatoid arthritis (RA) in patients who are already taking methotrexate for RA, but who still suffer symptoms of RA. The purpose is also to ensure that the combination of methotrexate is safe for patients to take and that any side effects are acceptable to patients with RA.
Condition | Intervention | Phase |
---|---|---|
Rheumatoid Arthritis |
Drug: BG00012 Drug: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2a, Randomised, Double-Blind, Placebo-Controlled, Multicentre Study to Evaluate the Efficacy, Safety and Tolerability of BG00012 When Given With Methotrexate to Subjects With Active RA Who Have Had an Inadequate Response to Conventional Disease-Modifying Anti-Rheumatic Drug Therapy |
Estimated Enrollment: | 150 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
BG00012 480 mg/day
|
Drug: BG00012
oral
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2: Active Comparator
BG00012 720 mg/day
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Drug: BG00012
Oral
|
3: Placebo Comparator |
Drug: placebo
oral placebo
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The study is a double-blind, placebo-controlled study of BG00012 plus methotrexate, versus methotrexate alone, in patients with active RA, who have had an incomplete response to other conventional disease modifying anti-rheumatic (DMARD) therapy.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Other criteria also apply.
Contact: Immunology Department Biogen Idec | immunologyclinicaltrials@biogenidec.com |
Australia | |
Research Site | Recruiting |
Woodville, Australia, SA 5011 | |
Contact: Biogen Idec Immunology Dept immunologyclinicaltrials@biogenidec.com | |
Research Site | Not yet recruiting |
Woolloongabba, Australia, QLD 4102 | |
Contact: Biogen Idec Immunology Dept immunologyclinicaltrials@biogenidec.com | |
Canada | |
Research Site | Not yet recruiting |
Sarnia, Canada, ON N7T 4X3 | |
Contact: Biogen Idec Immunology Dept immunologyclinicaltrials@biogenidec.com | |
Research Site | Recruiting |
Ottawa, Canada | |
Contact: Biogen Idec Immunology Dept immunologyclinicaltrials@biogenidec.com | |
Research Site | Recruiting |
Rothesay, Canada | |
Contact: Biogen Idec Immunology Dept immunologyclinicaltrials@biogenidec.com | |
Research Site | Not yet recruiting |
New Market, Canada | |
Contact: Biogen Idec Immunology Dept immunologyclinicaltrials@biogenidec.com | |
Czech Republic | |
Research Site | Not yet recruiting |
Prague, Czech Republic | |
Contact: Biogen Idec Immunology Dept immunologyclinicaltrials@biogenidec.com | |
Research Site | Not yet recruiting |
Pardubice, Czech Republic | |
Contact: Biogen Idec Immunology Dept immunologyclinicaltrials@biogenidec.com | |
Research Site | Not yet recruiting |
Zlin, Czech Republic | |
Contact: Biogen Idec Immunology Dept immunologyclinicaltrials@biogenidec.com | |
Research Site | Not yet recruiting |
Uh. Hradiste, Czech Republic | |
Contact: Biogen Idec Immunology Dept immunologyclinicaltrials@biogenidec.com | |
India | |
Research Site | Not yet recruiting |
Bangalore, India | |
Contact: BIogen Idec Immunology Dept immunologyclinialtrials@biogenidec.com | |
Research Site | Not yet recruiting |
Bangalore, India | |
Contact: Biogen Idec Immunology Dept immunologyclinicaltrials@biogenidec.com | |
Research Site | Not yet recruiting |
Hyderabaad, India | |
Contact: Biogen Idec Immunology Dept immunologyclinicaltrials@biogenidec.com | |
Research Site | Not yet recruiting |
Lucknow, India | |
Contact: Biogen Idec Immunology Dept immunologyclinialtrials@biogenidec.com | |
Poland | |
Research Site | Not yet recruiting |
Bialystock, Poland | |
Contact: Biogen Idec Immunology Dept immunologyclinicaltrials@biogenidec.com | |
Research Site | Not yet recruiting |
Lublin, Poland | |
Contact: Biogen Idec Immunology Dept immunologyclinicaltrials@biogenidec.com | |
Research Site | Not yet recruiting |
Grodzisk Mazowiecki, Poland | |
Contact: Biogen Idec Immunology Dept immunologyclinicaltrials@biogenidec.com | |
Research Site | Not yet recruiting |
Warsaw, Poland | |
Contact: Biogen Idec Immunology Dept immunologyclinicaltrials@biogenidec.com | |
Research Site | Not yet recruiting |
Poznan, Poland | |
Contact: Biogen Idec Immunology Dept immunologyclinicaltrials@biogenidec.com | |
Slovakia | |
Research Site | Not yet recruiting |
Kosice, Slovakia | |
Contact: Biogen Idec Imunology Dept immunologyclinicaltrials@biogenidec.com | |
Research Site | Not yet recruiting |
Piestany, Slovakia | |
Contact: Biogen Idec Immunology Dept immunologyclinicaltrials@biogenidec.com | |
Research Site | Not yet recruiting |
Bratislava, Slovakia | |
Contact: Biogen Idec Immunology Dept immunologyclinicaltrials@biogenidec.com | |
Research Site | Not yet recruiting |
Banska Bysterica, Slovakia | |
Contact: Biogen Idec Immunology Dept immunologyclinicaltrials@biogenidec.com |
Responsible Party: | Biogen Idec ( Biogen Idec,Immunology department ) |
Study ID Numbers: | 109RA201 |
Study First Received: | December 17, 2008 |
Last Updated: | December 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00810836 History of Changes |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration; Australia: Human Research Ethics Committee; Canada: Health Canada; India: Indian Council of Medical Research; Poland: Ministry of Health; Slovakia: State Institute for Drug Control; Czech Republic: Ethics Committee; Czech Republic: State Institute for Drug Control |
Antimetabolites Autoimmune Diseases Immunologic Factors Joint Diseases Arthritis, Rheumatoid Dimethyl fumarate Rheumatic Diseases Folic Acid Antagonists |
Immunosuppressive Agents Folic Acid Radiation-Sensitizing Agents Musculoskeletal Diseases Arthritis Connective Tissue Diseases Methotrexate Antirheumatic Agents |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Arthritis, Rheumatoid Dimethyl fumarate Reproductive Control Agents Musculoskeletal Diseases Arthritis Therapeutic Uses Abortifacient Agents Connective Tissue Diseases |
Methotrexate Dermatologic Agents Nucleic Acid Synthesis Inhibitors Autoimmune Diseases Immune System Diseases Joint Diseases Enzyme Inhibitors Rheumatic Diseases Abortifacient Agents, Nonsteroidal Folic Acid Antagonists Immunosuppressive Agents Pharmacologic Actions Radiation-Sensitizing Agents Antirheumatic Agents |