24-week Study With Open Label Extension of VX-509, an Oral JAK3 Inhibitor, in Subjects Taking Methotrexate
NCT ID: NCT01590459
Last Updated: 2015-11-20
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
359 participants
INTERVENTIONAL
2012-04-30
2014-07-31
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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Placebo Arm
VX-509 matching placebo
0 mg oral tablet
VX-509 100 mg qd Arm
VX-509
50 mg oral tablet
VX-509 150 mg qd Arm
VX-509
50 mg oral tablet
VX-509 100 mg bid Arm
VX-509
50 mg oral tablet
VX-509 200 mg qd Arm
VX-509
50 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
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Vertex Pharmaceuticals Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Ali Ashrafzadeh, MD, FACR
Role: STUDY_CHAIR
Quintiles, Inc.
Locations
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Vertex Investigational Site
Birmingham, Alabama, United States
Vertex Investigational Site
Huntsville, Alabama, United States
Vertex Investigational Site
Long Beach, California, United States
Vertex Investigational Site
Tustin, California, United States
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Boca Raton, Florida, United States
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Daytona Beach, Florida, United States
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New Port Richey, Florida, United States
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North Miami Beach, Florida, United States
Vertex Investigational Site
Ocala, Florida, United States
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Tampa, Florida, United States
Vertex Investigational Site
Springfield, Illinois, United States
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Wichita, Kansas, United States
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Kalamazoo, Michigan, United States
Vertex Investigational Site
St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Clifton, New Jersey, United States
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Freehold, New Jersey, United States
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Brooklyn, New York, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Hickory, North Carolina, United States
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Oklahoma City, Oklahoma, United States
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Bethlehem, Pennsylvania, United States
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Duncansville, Pennsylvania, United States
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Jackson, Tennessee, United States
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Austin, Texas, United States
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Houston, Texas, United States
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Mesquite, Texas, United States
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San Antonio, Texas, United States
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Clarksburg, West Virginia, United States
Vertex Investigational Site
Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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Santa Fe, , Argentina
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Plovdiv, , Bulgaria
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Sevlievo, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Veliko Tarnovo, , Bulgaria
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Brno, , Czechia
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Bruntál, , Czechia
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Mladá Boleslav, , Czechia
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Ostrava - Trebovice, , Czechia
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Prague, , Czechia
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Zlín, , Czechia
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Tallinn, , Estonia
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Tallinn, , Estonia
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Tallinn, , Estonia
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Tallinn, , Estonia
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Cologne, , Germany
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Leipzig, , Germany
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Würzburg, , Germany
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Zerbst, , Germany
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Baja, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Szikszó, , Hungary
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Chihuahua City, , Mexico
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Cuauhtémoc, , Mexico
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San Luis Potos, , Mexico
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San Miguel Chapultepec, , Mexico
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Bialystok, , Poland
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Elblag, , Poland
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Krakow, , Poland
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Lublin, , Poland
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Poznan, , Poland
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Poznan, , Poland
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Torun, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Brăila, , Romania
Vertex Investigational Site
Bucharest, , Romania
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Bucharest, , Romania
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Judetul Galati, , Romania
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Kemerovo, , Russia
Vertex Investigational Site
Moscow, , Russia
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Ryazan, , Russia
Vertex Investigational Site
Saint Petersburg, , Russia
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Saint Petersburg, , Russia
Vertex Investigational Site
Yaroslavl, , Russia
Vertex Investigational Site
Belgrade, , Serbia
Vertex Investigational Site
Niška Banja, , Serbia
Vertex Investigational Site
Novi Sad, , Serbia
Vertex Investigational Site
Bratislava, , Slovakia
Vertex Investigational Site
Dunajská Streda, , Slovakia
Vertex Investigational Site
Poprad, , Slovakia
Vertex Investigational Site
Rimavská Sobota, , Slovakia
Vertex Investigational Site
Donetsk, , Ukraine
Vertex Investigational Site
Kharkiv, , Ukraine
Vertex Investigational Site
Lviv, , Ukraine
Vertex Investigational Site
Odesa, , Ukraine
Vertex Investigational Site
Vinnytsia, , Ukraine
Countries
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Other Identifiers
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2011-004419-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
VX11-509-102
Identifier Type: -
Identifier Source: org_study_id