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
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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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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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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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