Long-Term Effectiveness And Safety Of CP-690,550 For The Treatment Of Rheumatoid Arthritis

• Status: Completed
• Trial end date: 2017-10-26
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the long-term effectiveness and safety of CP-690,550 for the treatment of rheumatoid arthritis. Subjects are eligible for this study only after participating in another "qualifying" study of CP-690,550

A sub-study will be conducted within the A3921024 study, this study will evaluate the immune response to pneumococcal and influenza vaccines in patients receiving CP-690,550

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

Details

• Lead Sponsor: Pfizer
• Treatments: Tofacitinib

Criteria

Inclusion Criteria:

• Subjects who have participated in a randomized "qualifying" study of CP-690,550 for the treatment of rheumatoid arthritis

Vaccine sub-study visit

• Subjects actively participating in Study A3921024 must have completed at least 3 months of continuous 10 mg BID CP-690,550 treatment in A3921024 as defined by >80% compliance with prescribed dose consumption of CP-690,550 over the previous 3 months.

Exclusion Criteria:

• Serious medical conditions that would make treatment with CP-690,550 potentially unsafe

Vaccine sub-study visit

1. Any documented influenza or pneumococcal infection within the last 3 months prior to randomization in this study

2. Received any vaccine within 1 month prior to randomization in this study

3. Received an influenza vaccine within 6 months or a pneumococcal vaccine within 5 years of randomization in this study.