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



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - 80
Updated:4/21/2016
Start Date:April 2012
End Date:July 2014

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A 24-week, Double-Blind, Randomized, Parallel Group, Placebo-Controlled, Phase 2 Study of Different Doses of VX-509 in Adult Subjects With Active Rheumatoid Arthritis on Stable Methotrexate Therapy With 104-Week Open Label Extension

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.

VX-509 is an oral, selective Janus kinase 3 (JAK3) inhibitor being developed by Vertex. In
autoimmune diseases, JAK3 is an essential component of the immune signaling cascade. This
cascade ultimately contributes to abnormal immune response that results in chronic
inflammation and, in the case of rheumatoid arthritis (RA), irreversible damage to cartilage
and bones. Selective inhibition of JAK3 offers a new disease modifying approach to the
treatment of RA, and a broad range of other autoimmune diseases.

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.
We found this trial at
32
sites
Mesquite, Texas
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Austin, TX
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Bethlehem, Pennsylvania
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Birmingham, Alabama
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Birmingham, AL
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Boca Raton, Florida
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Boca Raton, FL
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Brooklyn, New York
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Brooklyn, NY
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Buenos Aires,
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Charlotte, North Carolina
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Charlotte, NC
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Clarksburg, West Virginia
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Clarksburg, WV
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Clifton, New Jersey
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Clifton, NJ
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Daytona Beach, Florida
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Daytona Beach, FL
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Duncansville, Pennsylvania 16635
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Duncansville, PA
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Durham, North Carolina
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Durham, NC
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Freehold, New Jersey
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Freehold, NJ
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Hickory, North Carolina
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Hickory, NC
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Houston, TX
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Huntsville, Alabama
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Huntsville, AL
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Jackson, Tennessee
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Jackson, TN
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Kalamazoo, Michigan
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Kalamazoo, MI
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Las Vegas, Nevada
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Las Vegas, NV
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Long Beach, California
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Long Beach, CA
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New Port Richey, Florida
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New Port Richey, FL
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North Miami Beach, Florida
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North Miami Beach, FL
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Ocala, FL
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Oklahoma City, Oklahoma
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Oklahoma City, OK
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Omaha, Nebraska
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Omaha, NE
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San Antonio, Texas
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San Antonio, TX
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Springfield, Illinois
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Springfield, IL
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St. Louis, Missouri
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St. Louis, MO
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Tampa, FL
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Tustin, California
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Wichita, Kansas
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Wichita, KS
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