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

Completed · Phase 2/Phase 3

Conditions studied: Rheumatoid Arthritis

In brief

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).

Key facts

Study ID

NCT01830985

Run by

Vertex Pharmaceuticals Incorporated

People needed

39

Starts

2013-04-01

Expected to finish

2014-07-01

Last updated by the study team

2015-11-20

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Vertex Investigational Site — Upland, California, United States
• Vertex Investigational Site — Fort Lauderdale, Florida, United States
• Vertex Investigational Site — Venice, Florida, United States
• Vertex Investigational Site — West Palm Beach, Florida, United States
• Vertex Investigational Site — Canton, Georgia, United States
• Vertex Investigational Site — Decatur, Georgia, United States
• Vertex Investigational Site — Elizabethtown, Kentucky, United States
• Vertex Investigational Site — Fredrick, Maryland, United States
• Vertex Investigational Site — Lincoln, Nebraska, United States
• Vertex Investigational Site — Rochester, New York, United States
• Vertex Investigational Site — Greensboro, North Carolina, United States
• Vertex Investigational Site — Duncansville, Pennsylvania, United States
• Vertex Investigational Site — Charleston, South Carolina, United States
• Vertex Investigational Site — Memphis, Tennessee, United States
• Vertex Investigational Site — Katy, Texas, United States
• Vertex Investigational Site — San Antonio, Texas, United States
• Vertex Investigational Site — Webster, Texas, United States
• Vertex Investigational Site — Spokane, Washington, United States
• Vertex Investigational Site — Tallinn, Estonia
• Vertex Investigational Site — Vilnius, Lithuania
• Vertex Investigational Site — Pretoria, South Africa
• Vertex Investigational Site — Stellenbosch, South Africa

Full record on ClinicalTrials.gov

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