Comparing The Effectiveness And Safety Of 2 Doses Of An Experimental Drug, CP-690,550, To Methotrexate (MTX) In Patients With Rheumatoid Arthritis Who Have Not Previously Received MTX
Status: | Completed |
---|---|
Conditions: | Arthritis, Rheumatoid Arthritis |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 18 - 99 |
Updated: | 4/17/2018 |
Start Date: | January 2010 |
End Date: | March 2013 |
Phase 3 Randomized, Double-blind Study Of The Efficacy And Safety Of 2 Doses Of Cp-690,550 Compared To Methotrexate In Methotrexate Navie Patients With Rheumatoid Arthritis
This study is designed to compare the effectiveness of the experimental drug, CP-690,550, to
methotrexate in preventing joint damage and improving symptoms of rheumatoid arthritis. This
study will also compare the safety of CP-690,550 with methotrexate.
methotrexate in preventing joint damage and improving symptoms of rheumatoid arthritis. This
study will also compare the safety of CP-690,550 with methotrexate.
Inclusion Criteria:
- Adults with moderate to severe RA (Rheumatoid Arthritis) who have not been treated
with methotrexate.
- Diagnosis of RA based on the American College of Rheumatology 1987 revised criteria.
- Active disease as defined by both >=6 tender or painful joints on motion and >= 6
joints swollen; and either an erythrocyte sedimentation rate (ESR) > 28 mm or a
C-reactive protein (CRP) concentration > 7 mg/dL
Exclusion Criteria:
- Blood dyscrasias including confirmed: Hemoglobin <9 g/dL or Hematocrit <30%; White
blood cell count <3.0 x 109/L; Absolute neutrophil count <1.2 x 109/L; Platelet count
<100 x 109/L
- History of any other rheumatic autoimmune disease other than Sjogren's syndrome
- No malignancy or history of malignancy
- History of infection requiring hospitalization, parenteral antimicrobial therapy, or
as otherwise judged clinically significant by the investigator, within the 6 months
prior to the first dose of study drug
- No chronic liver disease, recent or active hepatitis or other contraindication to
methotrexate therapy
We found this trial at
41
sites
171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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96 Jonathan Lucas Street
Charleston, South Carolina 29425
Charleston, South Carolina 29425
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Charleston, South Carolina 29425
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Lynn Health Science Institute Our mission is to provide clinical trials research and health services...
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Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
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