Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis
Status: | Recruiting |
---|---|
Conditions: | Arthritis, Rheumatoid Arthritis |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 50 - Any |
Updated: | 4/6/2019 |
Start Date: | March 14, 2014 |
End Date: | March 3, 2020 |
Contact: | Pfizer CT.gov Call Center |
Email: | ClinicalTrials.gov_Inquiries@pfizer.com |
Phone: | 1-800-718-1021 |
PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS
This post-marketing study is designed to compare the safety of tofacitinib versus TNF
inhibitor with respect to major cardiovascular adverse events and malignancies, excluding
non-melanoma skin cancers when given to subjects with rheumatoid arthritis. Other safety
events, including non-melanoma skin cancers, hepatic events, infections, and efficacy
parameters will be collected and evaluated in the study.
inhibitor with respect to major cardiovascular adverse events and malignancies, excluding
non-melanoma skin cancers when given to subjects with rheumatoid arthritis. Other safety
events, including non-melanoma skin cancers, hepatic events, infections, and efficacy
parameters will be collected and evaluated in the study.
Inclusion Criteria:
- Moderate to severe rheumatoid arthritis
- Taking methotrexate without adequate control of symptoms
- Have at least one cardiovascular risk factor (eg, current smoker, high blood pressure,
high cholesterol levels, diabetes mellitus, history of heart attack, family history of
coronary heart disease, extra-articular RA disease)
Exclusion Criteria:
- Current or recent infection
- Clinically significant laboratory abnormalities
- Pregnancy
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2845 Capital Avenue Southwest
Battle Creek, Michigan 49015
Battle Creek, Michigan 49015
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Birmingham, Alabama 35294
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U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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2201 Inwood Road
Dallas, Texas 75390
Dallas, Texas 75390
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Borgess Medical Center At Borgess, healing is our calling. This is the place where people...
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