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Sponsored by: |
Rigel Pharmaceuticals |
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Information provided by: | Rigel Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00665626 |
The purpose of this study is to determine whether the Spleen Tyrosine Kinase (Syk) Inhibitor, R935788 (R788) at a dose of 100 mg, tablet, orally, twice-a-day is effective in the treatment of Rheumatoid Arthritis in patients who have 'failed' a biologic therapy.
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 R935788 in Patients With Rheumatoid Arthritis Who Have Failed at Least One Biologic |
Estimated Enrollment: | 195 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
R935788 100 mg tablet, orally, twice-a-day
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Drug: Fostamatinib disodium (R935788)
R935788 100 mg tablet, orally, twice-a-day
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2: Placebo Comparator
Placebo, orally, twice-a-day
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Drug: Fostamatinib disodium (R935788)
R935788 100 mg tablet, orally, twice-a-day
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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:
Contact: www.taskistudy.com |
Study Director: | Daniel B Magilavy, MD | Rigel Pharmaceuticals |
Responsible Party: | Rigel Pharmaceuticals ( Daniel B. Magilavy, MD ) |
Study ID Numbers: | C-935788-011 |
Study First Received: | April 22, 2008 |
Last Updated: | December 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00665626 |
Health Authority: | United States: Food and Drug Administration |
Autoimmune Diseases Musculoskeletal Diseases Joint Diseases Arthritis |
Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases |
Immune System Diseases |