A 12-week Study of 4 Doses of VX-509 in Subjects With Active Rheumatoid Arthritis
NCT ID: NCT01052194
Last Updated: 2012-12-13
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
206 participants
INTERVENTIONAL
2010-02-28
2011-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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25 mg b.i.d. VX-509
VX-509
tablets, 25mg b.i.d. for 12 weeks
50 mg b.i.d. VX-509
VX-509
tablet, 50 mg b.i.d. for 12 weeks
100 mg b.i.d. VX-509
VX-509
tablet, 100 mg b.i.d. for 12 weeks
150 mg b.i.d. VX-509
VX-509
tablet, 150 mg b.i.d. for 12 weeks
Placebo
Placebo
tablet, placebo b.i.d. for 12 weeks
Interventions
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Placebo
tablet, placebo b.i.d. for 12 weeks
VX-509
tablets, 25mg b.i.d. for 12 weeks
VX-509
tablet, 50 mg b.i.d. for 12 weeks
VX-509
tablet, 100 mg b.i.d. for 12 weeks
VX-509
tablet, 150 mg b.i.d. for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* Subjects must have a swollen joint count of ≥6 out of 28 joints and tender joint count of ≥6 out of 28 joints. Joints that have had prior surgery are to be excluded from the joint count.
* Baseline CRP level must be 1.5 times greater than the upper limit of normal at Screening.
* Subjects must have failed at least 1 nonbiologic DMARD for any reason.
* Subjects may have previously failed no more than 1 biologic DMARD and discontinued treatment for reasons other than inadequate response. Subjects must not have been treated with Rituximab previously.
* Subjects must be willing to comply with contraception requirements.
Exclusion Criteria
* History or evidence of a clinically significant disorder other than RA (including but not limited to cardiopulmonary, oncologic, renal, metabolic, hematologic or psychiatric disorders), condition or disease 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 clinically important abnormalities in screening physical examination or in screening laboratory test results (including the presence of either hepatitis B surface antigen, hepatitis C virus antibody, or HIV types 1 -- Subjects with elevation in alanine aminotransferase or aspartate aminotransferase above the upper limit of normal.
* History of hematologic disorders including neutropenia and thrombocytopenia.
* Subjects with an acute or chronic active infection requiring systemic antimicrobial treatment, or subjects who are at high risk of developing an infection due to a compromised immune system. Antifungals for onychomycosis or low-dose antibiotics for rosacea, that are not inhibitors or inducers of CYP3A, will be allowed.
* Subjects who require concomitant use of any inhibitors or inducers of cytochrome P450 (CYP) 3A.
* Subjects who have been treated with intra-articular injections of corticosteroids within 28 days prior to Day 1.
* Subjects who have planned major surgery (e.g., joint replacement) or any procedures during the study.
* Have received any live, attenuated vaccinations within 1 month prior to study drug administration.
* History of drug or alcohol abuse or excessive alcohol as determined by the investigator, during the last 12 months before the screening visit.
* History of TB infection of any kind (pulmonary or extrapulmonary, active or latent), regardless of history of anti-TB treatment.
18 Years
75 Years
ALL
No
Sponsors
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Vertex Pharmaceuticals Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Vertex Pharmaceuticals Incorporated
Locations
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Birmingham, Alabama, United States
Huntsville, Alabama, United States
Peoria, Arizona, United States
La Mesa, California, United States
Trumbull, Connecticut, United States
Tampa, Florida, United States
Tampa, Florida, United States
Venice, Florida, United States
Decatur, Georgia, United States
Worcester, Massachusetts, United States
St Louis, Missouri, United States
Charlotte, North Carolina, United States
Oklahoma City, Oklahoma, United States
Duncansville, Pennsylvania, United States
Charleston, South Carolina, United States
Dallas, Texas, United States
Spokane, Washington, United States
Clarksburg, West Virginia, United States
Antwerp, , Belgium
Karlovac, , Croatia
Opatija, , Croatia
Zagreb, , Croatia
Erfurt, , Germany
Frankfurt, , Germany
Hamburg, , Germany
Hildesheim, , Germany
Nauheim, , Germany
Zerbst, , Germany
Balatonfüred, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Veszprém, , Hungary
Elblag, , Poland
Limanow, , Poland
Lublin, , Poland
Wroclaw, , Poland
San Juan, , Puerto Rico
Baia Mare, , Romania
Brăila, , Romania
Bucharest, , Romania
Galati, , Romania
Kemerovo, , Russia
Novosibirsk, , Russia
Ryazan, , Russia
Vladimir, , Russia
Voronezh, , Russia
Belgrade, , Serbia
Niška Banja, , Serbia
Countries
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Other Identifiers
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2009-017438-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
VX09-509-101
Identifier Type: -
Identifier Source: org_study_id