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

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Vertex Pharmaceuticals Incorporated
• Treatments: Methotrexate

Criteria

Inclusion Criteria:

• 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

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.

• 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.