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

Completed · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

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).

Key facts

Study ID

NCT01754935

Run by

Vertex Pharmaceuticals Incorporated

People needed

43

Starts

2013-01-01

Expected to finish

2014-02-01

Last updated by the study team

2015-05-19

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Vertex Investigational Site — Stanford, California, United States
• 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 — Kansas City, Kansas, United States
• Vertex Investigational Site — Elizabethtown, Kentucky, United States
• Vertex Investigational Site — Frederick, Maryland, United States
• Vertex Investigational Site — Lincoln, Nebraska, United States
• Vertex Investigational Site — Rochester, New York, United States
• Vertex Investigational Site — Greenboro, 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 — Seattle, Washington, United States
• Vertex Investigational Site — Spokane, Washington, United States
• Vertex Investigational Site — Hillerød, Denmark
• Vertex Investigational Site — Hjørring, Denmark
• Vertex Investigational Site — Tallinn, Estonia
• Vertex Investigational Site — Vilnius, Lithuania

Full record on ClinicalTrials.gov

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