24-week Study With Open Label Extension of VX-509, an Oral JAK3 Inhibitor, in Subjects Taking Methotrexate

Completed · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

This study is designed to evaluate the safety and efficacy of VX-509, an oral JAK3 inhibitor, for treatment of subjects with active RA who have had an inadequate response to Methotrexate.

Key facts

Study ID

NCT01590459

Run by

Vertex Pharmaceuticals Incorporated

People needed

359

Starts

2012-04-01

Expected to finish

2014-07-01

Last updated by the study team

2015-11-20

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female subjects, between 18 and 80 years of age (inclusive)
• All subjects must have been diagnosed with RA
• Must have a swollen joint count of ≥6 out of 66 joints and tender joint count of ≥6 out of 68 joints
• Baseline CRP level must be above the upper limit of normal
• All subjects must have been receiving stable MTX coadministered with folic or folinic acid (at least 5 mg/week)
• Subjects may remain on 1 nonsteroidal anti-inflammatory medication during the study (aspirin ≤ 325 mg/day is allowed).
• Subjects must not have received prior treatment with a JAK inhibitor
• Subjects who are on an additional nonbiologic DMARD (e.g., sulfasalazine) must be willing to discontinue that DMARD after signing consent, except for hydroxychloroquine
• Subjects may have received previous therapy with a single TNF inhibitor (e.g., etanercept, adalimumab, infliximab, golimumab, certolizumab pegol)
• Females must have a negative pregnancy test prior to study dosing
• Sexually active subjects and their partners must agree to contraceptive requirements

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.
• Subjects with inflammatory, rheumatological disorders other than RA
• Pregnant or nursing female subjects
• Subjects who have a female partner who is pregnant, nursing, or planning to become pregnant
• Subjects who have planned major surgery (e.g., joint replacement) or procedures during the study
• History of drug abuse or positive drug screen
• History of alcohol 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.

Where it is running

• Vertex Investigational Site — Huntsville, Alabama, United States
• Vertex Investigational Site — Long Beach, California, United States
• Vertex Investigational Site — Tustin, California, United States
• Vertex Investigational Site — Boca Raton, Florida, United States
• Vertex Investigational Site — Daytona Beach, Florida, United States
• Vertex Investigational Site — New Port Richey, Florida, United States
• Vertex Investigational Site — North Miami Beach, Florida, United States
• Vertex Investigational Site — Ocala, Florida, United States
• Vertex Investigational Site — Tampa, Florida, United States
• Vertex Investigational Site — Springfield, Illinois, United States
• Vertex Investigational Site — Wichita, Kansas, United States
• Vertex Investigational Site — Kalamazoo, Michigan, United States
• Vertex Investigational Site — St Louis, Missouri, United States
• Vertex Investigational Site — Omaha, Nebraska, United States
• Vertex Investigational Site — Las Vegas, Nevada, United States
• Vertex Investigational Site — Clifton, New Jersey, United States
• Vertex Investigational Site — Freehold, New Jersey, United States
• Vertex Investigational Site — Brooklyn, New York, United States
• Vertex Investigational Site — Charlotte, North Carolina, United States
• Vertex Investigational Site — Durham, North Carolina, United States
• Vertex Investigational Site — Hickory, North Carolina, United States
• Vertex Investigational Site — Oklahoma City, Oklahoma, United States
• Vertex Investigational Site — Bethlehem, Pennsylvania, United States
• Vertex Investigational Site — Duncansville, Pennsylvania, United States
• Vertex Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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