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Sponsored by: |
Biogen Idec |
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Information provided by: | Biogen Idec |
ClinicalTrials.gov Identifier: | NCT00292422 |
This Phase 2a study is designed to evaluate the safety and tolerability of multiple subcutaneous (SC) doses of BG9924, administered in a cohort dose-escalation fashion, in patients with active rheumatoid arthritis (RA) who have had an inadequate response to therapy with disease-modifying anti rheumatic drugs (DMARDs) and who may have undergone anti-TNF therapy. This study will assist with dose selection for further planned Phase 2 studies.
Condition | Intervention | Phase |
---|---|---|
Rheumatoid Arthritis |
Drug: BG9924 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Safety/Efficacy Study |
Official Title: | A Randomized, Blinded, Placebo-Controlled, Multicenter, Dose-Escalating Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BG9924 When Given in Combination With Methotrexate to Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to DMARD Therapy |
Enrollment: | 50 |
Study Start Date: | November 2005 |
Study Completion Date: | May 2007 |
Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Subjects will be excluded who meet any of the following criteria regarding treatment with concomitant therapy for RA:
Subjects with any laboratory test result at Screening considered clinically significant (as determined by the Investigator) or
United States, Michigan | |
Fiechtner Research Inc. | |
Lansing, Michigan, United States, 48910 | |
United States, Missouri | |
Arthritis Consultants Inc. | |
St. Louis, Missouri, United States, 63141 | |
United States, Pennsylvania | |
The Arthritis Group | |
Philadelphia, Pennsylvania, United States, 19152 | |
Poland | |
Klinika Reumatologii-Instytut Reumatologiczny | |
Warsawa, Poland, 02-637 | |
Oddzial Reumatologii Wojewodzki Szpital | |
Elblag, Poland, 82-300 | |
Klinika Chorob Tkanki Lacznej-Instytut Reumatologiczny | |
Warsawa, Poland, 02-637 | |
Centrum Leczenia Chorob Cywilizacyjnych | |
Warsawa, Poland, 02-777 | |
Centrum Medyczne SpecjalistycznyGabinet Lekarski | |
Bialystok, Poland, 15-337 | |
Osrodek Badan Klinicznych | |
Lublin, Poland, 20-022 | |
Prakyta Lekarza Rodzinnego "Nasz Lekarz" | |
Torun, Poland, 87-100 |
Study Director: | Evan Beckman, MD | Biogen Idec |
Responsible Party: | Biogen Idec Inc. ( Biogen Idec Medical Director ) |
Study ID Numbers: | 104-RA-201 |
Study First Received: | February 15, 2006 |
Last Updated: | December 26, 2007 |
ClinicalTrials.gov Identifier: | NCT00292422 |
Health Authority: | United States: Food and Drug Administration |
Arthritis, Rheumatoid Methotrexate Antirheumatic Agents |
Folic Acid Autoimmune Diseases Musculoskeletal Diseases Joint Diseases Arthritis |
Connective Tissue Diseases Arthritis, Rheumatoid Methotrexate Rheumatic Diseases |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Immune System Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Reproductive Control Agents |
Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Immunosuppressive Agents Pharmacologic Actions Therapeutic Uses Abortifacient Agents Antirheumatic Agents Dermatologic Agents Nucleic Acid Synthesis Inhibitors |