A Magnetic Resonance Imaging Study and Arthroscopic Biopsy Substudy in Subjects With Active Rheumatoid Arthritis Receiving VX-509, an Oral JAK3 Inhibitor
NCT ID: NCT01754935
Last Updated: 2015-05-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
43 participants
INTERVENTIONAL
2013-01-31
2014-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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VX-509 100 mg qd Arm
VX-509
50 mg oral tablet
VX-509 200 mg qd Arm
VX-509
50 mg oral tablet
VX-509 300 mg qd Arm
VX-509
50 mg oral tablet
Placebo Arm
VX-509 matching placebo
0 mg oral tablet
Interventions
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VX-509
50 mg oral tablet
VX-509 matching placebo
0 mg oral tablet
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Vertex Pharmaceuticals Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Bradley Bloom, MD, FACR, FAAP
Role: STUDY_CHAIR
Vertex Pharmaceuticals Incorporated
Locations
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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
Vertex Investigational Site
Heerlen, , Netherlands
Vertex Investigational Site
Utrecht, , Netherlands
Vertex Investigational Site
Johannesburg, , South Africa
Vertex Investigational Site
Pretoria, , South Africa
Vertex Investigational Site
Stellenbosch, , South Africa
Countries
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References
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Genovese MC, Yang F, Ostergaard M, Kinnman N. Efficacy of VX-509 (decernotinib) in combination with a disease-modifying antirheumatic drug in patients with rheumatoid arthritis: clinical and MRI findings. Ann Rheum Dis. 2016 Nov;75(11):1979-1983. doi: 10.1136/annrheumdis-2015-208901. Epub 2016 Apr 15.
Other Identifiers
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2012-003439-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
VX12-509-103
Identifier Type: -
Identifier Source: org_study_id
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