A 12-week Study of 4 Doses of VX-509 in Subjects With Active Rheumatoid Arthritis
A 12-week, Double-blind, Randomized, Parallel-group, Placebo-controlled Study of 4 Doses of VX-509 in Subjects With Active Rheumatoid Arthritis
2 other identifiers
interventional
206
10 countries
48
Brief Summary
This study is designed to evaluate safety and assess initial efficacy of VX-509, a JAK3 inhibitor, for treatment of subjects with active RA. This study will assess the clinical response of 4 doses of VX-509 compared to placebo when administered for 12 weeks to patients with active RA. The study will also evaluate the safety and tolerability of VX-509 compared to placebo when administered for 12 weeks to subjects with active RA.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 rheumatoid-arthritis
Started Feb 2010
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 18, 2010
CompletedFirst Posted
Study publicly available on registry
January 20, 2010
CompletedStudy Start
First participant enrolled
February 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedDecember 13, 2012
December 1, 2012
1.4 years
January 18, 2010
December 12, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Proportion of subjects who achieve an ACR20 response
Week 12
Change from baseline in DAS28
Week 12
Secondary Outcomes (5)
Proportion of subjects who achieve an ACR50,70 response
Week 12
Proportion of subjects who achieve moderate or good EULAR response
Week 12
Magnitude of improvement in the components of the ACR response criteria
Week 12
Pharmacokinetics of VX-509
Week 6
Pharmacodynamics (PD) of biomarker responses
Week 6
Study Arms (5)
25 mg b.i.d. VX-509
EXPERIMENTAL50 mg b.i.d. VX-509
EXPERIMENTAL100 mg b.i.d. VX-509
EXPERIMENTAL150 mg b.i.d. VX-509
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- All subjects must have been diagnosed with RA as defined by the ACR revised criteria with disease duration of at least 6 months from confirmed diagnosis
- 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.
You may not qualify if:
- Subjects with inflammatory rheumatological disorders other than RA.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (48)
Unknown Facility
Birmingham, Alabama, 35216, United States
Unknown Facility
Huntsville, Alabama, 35801, United States
Unknown Facility
Peoria, Arizona, 85381, United States
Unknown Facility
La Mesa, California, 97942, United States
Unknown Facility
Trumbull, Connecticut, 06611, United States
Unknown Facility
Tampa, Florida, 33612, United States
Unknown Facility
Tampa, Florida, 33614, United States
Unknown Facility
Venice, Florida, 34292, United States
Unknown Facility
Decatur, Georgia, 30033, United States
Unknown Facility
Worcester, Massachusetts, 01610, United States
Unknown Facility
St Louis, Missouri, 63141, United States
Unknown Facility
Charlotte, North Carolina, 28210, United States
Unknown Facility
Oklahoma City, Oklahoma, 73104, United States
Unknown Facility
Duncansville, Pennsylvania, 16635, United States
Unknown Facility
Charleston, South Carolina, 29406, United States
Unknown Facility
Dallas, Texas, 75235, United States
Unknown Facility
Spokane, Washington, 99204, United States
Unknown Facility
Clarksburg, West Virginia, 26301, United States
Unknown Facility
Antwerp, Belgium
Unknown Facility
Karlovac, Croatia
Unknown Facility
Opatija, Croatia
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Zagreb, Croatia
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Erfurt, Germany
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Frankfurt, Germany
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Hamburg, Germany
Unknown Facility
Hildesheim, Germany
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Nauheim, Germany
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Zerbst, Germany
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Balatonfüred, Hungary
Unknown Facility
Budapest, Hungary
Unknown Facility
Debrecen, Hungary
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Veszprém, Hungary
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Elblag, Poland
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Limanow, Poland
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Lublin, Poland
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Wroclaw, Poland
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San Juan, Puerto Rico
Unknown Facility
Baia Mare, Romania
Unknown Facility
Brăila, Romania
Unknown Facility
Bucharest, Romania
Unknown Facility
Galati, Romania
Unknown Facility
Kemerovo, Russia
Unknown Facility
Novosibirsk, Russia
Unknown Facility
Ryazan, Russia
Unknown Facility
Vladimir, Russia
Unknown Facility
Voronezh, Russia
Unknown Facility
Belgrade, Serbia
Unknown Facility
Niška Banja, Serbia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Vertex Pharmaceuticals Incorporated
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 18, 2010
First Posted
January 20, 2010
Study Start
February 1, 2010
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
December 13, 2012
Record last verified: 2012-12