A Phase 2/3 Open-label Extension Study to Evaluate Long-Term Safety and Efficacy With VX-509 in Subjects With Rheumatoid Arthritis

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to evaluate the long-term safety and tolerability of VX-509 in subjects with active rheumatoid arthritis (RA) on DMARD therapy. This study will enroll subjects who completed a previous designated study with VX-509 (e.g., Study VX12-509-103).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vertex Pharmaceuticals Incorporated
• Treatments: Antirheumatic Agents

Criteria

Inclusion Criteria:

• Subjects must have completed the assigned study drug treatment phase of a previous VX-509 study (e.g., Study 103).

• Subjects must voluntarily sign and date the Study 104 informed consent document.

• Subject must be willing and able to comply with the scheduled visits, treatment plan, laboratory tests, contraceptive guidelines, and other study procedures.

Exclusion Criteria:

• Inflammatory and rheumatological disorders other than RA, where arthritis may be a prominent feature.

• History of any clinically significant illness that might, in the opinion of the investigator, confound the results of the study or pose an additional risk in administering study drug(s) to the subject

• History of tuberculosis (TB), regardless of history of antimycobacterial treatment.

• Planned surgery during the study.

• History of alcohol or drug abuse, or excessive alcohol consumption as determined by the investigator, during the previous 12 months before Day 1.

• Pregnant or nursing an infant or with a life partner who is pregnant, nursing, or planning to become pregnant