A Study To Evaluate The Safety And Efficacy Of Tofacitinib Modified Release Tablets Compared To Tofacitinib Immediate Release Tablets In Adult Patients With Rheumatoid Arthritis

• Status: Completed
• Trial end date: 2017-03-15
• Target enrollment: 0
• Participant gender: All

Summary

This is a 12 week study that will evaluate the efficacy and safety of the 11 mg tofacitinib modified release tablet taken once a day in patients with rheumatoid arthritis who continue taking methotrexate. Results for the modified release tablets will be compared to the efficacy and safety of the 5 mg tofacitinib immediate release tablets taken twice a day in patients with rheumatoid arthritis who continue taking methotrexate.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Tofacitinib

Criteria

Inclusion Criteria:

• diagnosis of rheumatoid arthritis

• currently taking a stable dose of methotrexate

• no evidence of active or latent or inadequately treated tuberculosis

Exclusion Criteria:

• evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or allergic disease

• clinically significant infections within the past 6 months