Status:
COMPLETED
A Phase 2/3 Open-label Extension Study to Evaluate Long-Term Safety and Efficacy With VX-509 in Subjects With Rheumatoid Arthritis
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief 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 p...
Detailed Description
VX-509 is an oral, selective Janus kinase 3 (JAK3) inhibitor being developed by Vertex. In autoimmune diseases, JAK3 is an essential component of the immune signaling cascade. This cascade ultimately ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT01830985
Start Date
April 1 2013
End Date
July 1 2014
Last Update
November 20 2015
Active Locations (22)
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1
Vertex Investigational Site
Upland, California, United States
2
Vertex Investigational Site
Fort Lauderdale, Florida, United States
3
Vertex Investigational Site
Venice, Florida, United States
4
Vertex Investigational Site
West Palm Beach, Florida, United States