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Sponsored by: |
Rigel Pharmaceuticals |
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Information provided by: | Rigel Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00665925 |
The purpose of this study is to determine whether the Spleen Tyrosine Kinase (Syk) inhibitor, R935788 (R788), at a dose of 100 mg, orally, twice-a-day, and/or a dose of of 150 mg, orally, once-a-day is effective in the treatment of Rheumatoid Arthrits in patients who have had an inadequate clinical response to methotrexate.
Condition | Intervention | Phase |
---|---|---|
Rheumatoid Arthritis |
Drug: Fostamatinib disodium (R935788) |
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, Parallel Dose Study of Two Doses of R935788 in Rheumatoid Arthritis Patients Failing to Respond to Methotrexate |
Estimated Enrollment: | 420 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
R788, 100 mg tablet, orally, twice-a-day
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Drug: Fostamatinib disodium (R935788)
100 mg tablet, orally, twice-a-day 150 mg tablet, orally, once-a-day
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2: Experimental
R788, 150 mg tablet, orally, once a day
|
Drug: Fostamatinib disodium (R935788)
100 mg tablet, orally, twice-a-day 150 mg tablet, orally, once-a-day
|
3: Placebo Comparator
Placebo, orally, either once a day, or twice a day
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Drug: Fostamatinib disodium (R935788)
100 mg tablet, orally, twice-a-day 150 mg tablet, orally, once-a-day
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have been receiving weekly methotrexate doses (7.5-25 mg/week) for a minimum of 3 months prior to Day 1 dosing and must be receiving a stable MTX dose, with no change in route, for the previous 6 weeks prior to Day 1 dosing.
`Patients must be receiving a folic or folinic acid supplementation at a stable dose for at least 6 weeks prior to Day 1 dosing.
Exclusion Criteria:
The patient has a history of, or a concurrent, clinically significant illness, medical condition (other than arthritis) or laboratory abnormality that, in the Investigator's opinion, could affect the conduct of the study. Specifically, excluded are patients with the following:
Study Director: | Daniel B Magilavy, MD | Rigel Pharmaceuticals |
Responsible Party: | Rigel Pharmaceuticals, Inc ( Daniel B. Magilavy, MD/Vice President, Clinical Development ) |
Study ID Numbers: | C-935788-010 |
Study First Received: | April 22, 2008 |
Last Updated: | December 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00665925 |
Health Authority: | United States: Food and Drug Administration |
Autoimmune Diseases Musculoskeletal Diseases Joint Diseases Arthritis |
Connective Tissue Diseases Arthritis, Rheumatoid Methotrexate Rheumatic Diseases |
Immune System Diseases |