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Sponsored by: |
Rigel Pharmaceuticals |
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Information provided by: | Rigel Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00805467 |
The purpose of this new research study is to gain additional information about how safe and effective R935788 is over a longer period of time.
Condition | Intervention | Phase |
---|---|---|
Rheumatoid Arthritis |
Drug: Fostamatinib Disodium (R935788) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label, Multicenter Extension Study to Evaluate the Safety of R935788 in Patients With Rheumatoid Arthritis Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 Study |
Estimated Enrollment: | 800 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | October 2011 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
R935788 50 mg tablet, orally, twice-a-day
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Drug: Fostamatinib Disodium (R935788)
50 mg PO BID; 100 mg PO BID; 100 mg PO QD; 150 mg tablet PO QD
|
2: Experimental
R935788 100 mg tablet, orally, twice-a-day
|
Drug: Fostamatinib Disodium (R935788)
50 mg PO BID; 100 mg PO BID; 100 mg PO QD; 150 mg tablet PO QD
|
3: Experimental
R935788 100 mg tablet, orally, once-a-day
|
Drug: Fostamatinib Disodium (R935788)
50 mg PO BID; 100 mg PO BID; 100 mg PO QD; 150 mg tablet PO QD
|
4: Experimental
R935788 150 mg tablet, orally, once-a-day
|
Drug: Fostamatinib Disodium (R935788)
50 mg PO BID; 100 mg PO BID; 100 mg PO QD; 150 mg tablet PO QD
|
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:
United States, California | |
San Diego Arthritis Medical Clinic | |
San Diego, California, United States, 92108, | |
United States, Indiana | |
Memorial Medical Group Clinical Research Inst | |
South Bend, Indiana, United States, 46601, | |
United States, Oklahoma | |
Health Research of Oklahoma | |
Oklahoma City, Oklahoma, United States, 73103, |
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-935788-012 |
Study First Received: | December 5, 2008 |
Last Updated: | December 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00805467 |
Health Authority: | United States: Food and Drug Administration |
RA |
Autoimmune Diseases Musculoskeletal Diseases Joint Diseases Arthritis |
Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases |
Immune System Diseases |