A Magnetic Resonance Imaging Study and Arthroscopic Biopsy Substudy in Subjects With Active Rheumatoid Arthritis Receiving VX-509, an Oral JAK3 Inhibitor

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The current study is designed to evaluate the safety and efficacy, including MRI imaging, across a range of VX-509 doses in subjects with active rheumatoid arthritis (RA) who have had an inadequate response to disease-modifying antirheumatic drugs (DMARDs).

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

Details

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

Criteria

Inclusion Criteria:

• Male and female subjects 18 to 65 years of age (inclusive)

• Diagnosis of RA

• Swollen joint count of ≥6 out of 66 joints and tender joint count of ≥6 out of 68 joints

• Seropositivity based on either a positive rheumatoid factor or anti cyclic citrullinated peptide antibody at screening -OR- known erosive disease based on previous X-ray report or erosions detected on screening hand and foot X-ray

• Baseline CRP level or Westergren erythrocyte sedimentation rate ≥1.2 × upper limit of normal

• Receiving stable therapy with 1 of the following DMARDs: methotrexate, sulfasalazine, leflunomide, anti-malarial drug, or penicillamine

• Palpable 2+ synovitis of the wrist or ≥2 MCPs in the MRI-designated hand

Exclusion Criteria:

• History or presence of a clinically significant medical disorder other than RA that, in the opinion of the investigator and medical monitor, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.

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

• Planned surgery during the study

• History of alcohol or drug abuse, or excessive alcohol consumption

• History of tuberculosis (TB) infection of any kind (pulmonary or extrapulmonary, active or latent), regardless of history of anti-TB treatment.

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