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Sponsored by: |
Rigel Pharmaceuticals |
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Information provided by: | Rigel Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00326339 |
This is a Phase II, multicenter, randomized, double-blind, placebo-controlled, ascending dose, dose ranging study to evaluate up to three doses of R935788 (50 mg bid, 100 mg bid and 150 mg bid). Approximately 180 patients who have had rheumatoid arthritis for a minimum of 12 months and who have been receiving a weekly methotrexate (MTX) dose for a minimum of 6 months will be enrolled into the study.
Condition | Intervention | Phase |
---|---|---|
Rheumatoid Arthritis |
Drug: R788 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 II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose, Dose Ranging Study to Evaluate Up to Three Doses of R935788 in Rheumatoid Arthritis Patients Failing to Respond to Methotrexate |
Enrollment: | 189 |
Study Start Date: | August 2006 |
Study Completion Date: | December 2007 |
Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
R788 50 mg PO bid
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Drug: R788
R788 50 mg, 100 mg, or 150 mg PO bid
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2: Experimental
R788 100 mg PO bid
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Drug: R788
R788 50 mg, 100 mg, or 150 mg PO bid
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3: Experimental
R788 150 mg PO bid
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Drug: R788
R788 50 mg, 100 mg, or 150 mg PO bid
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4: Placebo Comparator
Placebo PO bid
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Drug: Placebo
Placebo PO bid
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The primary objective of this study is to assess the preliminary efficacy of up to three different dosage regimens of R788 as determined by ACR 20 responder rates at 12 weeks The secondary objectives of this study are to assess the safety of up to three different dosage regimens of R788 as determined by ACR 20 responder rates at 12 weeks, and to assess the general clinical and laboratory safety evaluations throughout the study.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Males and females, 18 to 75 years of age, with active RA for at least 12 months (functional class I-III, e.g., not bed or wheelchair-bound) who have been receiving weekly doses of methotrexate (10-25 mg/week) for a minimum of 180 days, and who have been receiving a stable MTX dose of at least 15 mg without any change in route or change in folic acid supplementation for at least 30 days.
Active RA is defined as the presence of (a)6 swollen joints (28 joint count); AND (b)6 tender joints (28 joint count); AND (c) CRP level > ULN for the central reference laboratory. Patient may receive up to 10 mg per day of oral prednisone or steroid equivalent, NSAID therapy, hydroxychloroquine, chloroquine, minocycline, sulfasalazine, and doxycycline. The dose(s) must have been stable for at least 30 days and must not be changed during the washout, screening and treatment periods, unless dictated by tolerability requirements.
Exclusion Criteria:
Any patient who has received any of the following treatments must abide by the indicated washout period:
Study Director: | Elliott Grossbard, M.D. | Rigel Pharmaceuticals |
Principal Investigator: | Michael Weinblatt, M.D. | Brigham and Women's Hospital |
Principal Investigator: | Arthur Kavanaugh, M.D. | University of California, San Diego |
Responsible Party: | Rigel Pharmaceuticals, Inc. ( Elliott Grossbard/SVP Medical Development ) |
Study ID Numbers: | C-935788-006 |
Study First Received: | May 12, 2006 |
Last Updated: | April 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00326339 History of Changes |
Health Authority: | United States: Food and Drug Administration; Mexico: Ministry of Health |
R935788 Rheumatoid Arthritis Syk Kinase |
Autoimmune Diseases Musculoskeletal Diseases Joint Diseases Arthritis |
Connective Tissue Diseases Arthritis, Rheumatoid Methotrexate Rheumatic Diseases |
Autoimmune Diseases Immune System Diseases Musculoskeletal Diseases Joint Diseases |
Arthritis Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases |