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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 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Arthritis, Rheumatoid Methotrexate Antirheumatic Agents |
Antimetabolites Autoimmune Diseases Immunologic Factors Joint Diseases Arthritis, Rheumatoid Rheumatic Diseases Folic Acid Antagonists |
Immunosuppressive Agents Folic Acid Musculoskeletal Diseases Arthritis Connective Tissue Diseases Methotrexate Antirheumatic Agents |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Arthritis, Rheumatoid 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 Antirheumatic Agents |