A Open-label Extension Study to Evaluate Long-term Safety and Efficacy With VX 509 in Subjects With Rheumatoid Arthritis on Disease-Modifying Antirheumatic Drugs

Phase 1

• Conditions: Rheumatoid Arthritis; MedDRA version: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2012-004342-14-DK
• Lead Sponsor: Vertex Pharmaceuticals Incorporated

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-19
• Last Update Posted: 8 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1.Subjects must have completed the assigned study drug treatment phase of a previous VX 509 study (e.g., Study 103).
2.Subjects must voluntarily sign and date the Study 104 informed consent document.
3.Subject must be willing and able to comply with the scheduled visits, treatment plan, laboratory tests, contraceptive guidelines, and other study procedures.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1.Inflammatory and rheumatological disorders other than RA, where arthritis may be a prominent feature
2.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.
3.History of cancer, except squamous or basal cell cancers of the skin or in situ cancer of the cervix.
4.History of hematologic disorders including neutropenia and thrombocytopenia other than Felty syndrome.
5.History of tuberculosis (TB), regardless of history of antimycobacterial treatment.
6.Acute or chronic active infection requiring systemic antimicrobial treatment with the exception of onychomycosis receiving antifungal medication or acne and rosacea receiving low-dose antibiotics.
7.History of previous osteomyelitis, infected joint, or joint prosthesis.
8.Subjects who are at high risk of developing an infection due to a compromised immune system including poorly controlled diabetes.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified