- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01052194
A 12-week Study of 4 Doses of VX-509 in Subjects With Active Rheumatoid Arthritis
December 12, 2012 updated by: Vertex Pharmaceuticals Incorporated
A 12-week, Double-blind, Randomized, Parallel-group, Placebo-controlled Study of 4 Doses of VX-509 in Subjects With Active Rheumatoid Arthritis
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
206
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Antwerpen, Belgium
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Karlovac, Croatia
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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
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Hildesheim, Germany
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Nauheim, Germany
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Zerbst, Germany
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Balatonfured, Hungary
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Budapest, Hungary
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Debrecen, Hungary
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Veszprem, 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
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Baia Mare, Romania
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Braila, Romania
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Bucharest, Romania
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Galati, Romania
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Kemerovo, Russian Federation
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Novosibirsk, Russian Federation
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Ryazan, Russian Federation
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Vladimir, Russian Federation
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Voronezh, Russian Federation
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Belgrade, Serbia
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Niska Banja, Serbia
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Alabama
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Birmingham, Alabama, United States, 35216
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Huntsville, Alabama, United States, 35801
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Arizona
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Peoria, Arizona, United States, 85381
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California
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La Mesa, California, United States, 97942
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Connecticut
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Trumbull, Connecticut, United States, 06611
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Florida
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Tampa, Florida, United States, 33612
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Tampa, Florida, United States, 33614
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Venice, Florida, United States, 34292
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Georgia
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Decatur, Georgia, United States, 30033
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Massachusetts
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Worcester, Massachusetts, United States, 01610
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Missouri
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St. Louis, Missouri, United States, 63141
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North Carolina
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Charlotte, North Carolina, United States, 28210
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
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Pennsylvania
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Duncansville, Pennsylvania, United States, 16635
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South Carolina
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Charleston, South Carolina, United States, 29406
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Texas
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Dallas, Texas, United States, 75235
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Washington
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Spokane, Washington, United States, 99204
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West Virginia
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Clarksburg, West Virginia, United States, 26301
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo
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tablet, placebo b.i.d. for 12 weeks
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Experimental: 25 mg b.i.d. VX-509
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tablets, 25mg b.i.d. for 12 weeks
tablet, 50 mg b.i.d. for 12 weeks
tablet, 100 mg b.i.d. for 12 weeks
tablet, 150 mg b.i.d. for 12 weeks
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Experimental: 50 mg b.i.d. VX-509
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tablets, 25mg b.i.d. for 12 weeks
tablet, 50 mg b.i.d. for 12 weeks
tablet, 100 mg b.i.d. for 12 weeks
tablet, 150 mg b.i.d. for 12 weeks
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Experimental: 100 mg b.i.d. VX-509
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tablets, 25mg b.i.d. for 12 weeks
tablet, 50 mg b.i.d. for 12 weeks
tablet, 100 mg b.i.d. for 12 weeks
tablet, 150 mg b.i.d. for 12 weeks
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Experimental: 150 mg b.i.d. VX-509
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tablets, 25mg b.i.d. for 12 weeks
tablet, 50 mg b.i.d. for 12 weeks
tablet, 100 mg b.i.d. for 12 weeks
tablet, 150 mg b.i.d. for 12 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Proportion of subjects who achieve an ACR20 response
Time Frame: Week 12
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Week 12
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Change from baseline in DAS28
Time Frame: Week 12
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Week 12
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Proportion of subjects who achieve an ACR50,70 response
Time Frame: Week 12
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Week 12
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Proportion of subjects who achieve moderate or good EULAR response
Time Frame: Week 12
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Week 12
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Magnitude of improvement in the components of the ACR response criteria
Time Frame: Week 12
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Week 12
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Pharmacokinetics of VX-509
Time Frame: Week 6
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Week 6
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Pharmacodynamics (PD) of biomarker responses
Time Frame: Week 6
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Week 6
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (Actual)
July 1, 2011
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
January 18, 2010
First Submitted That Met QC Criteria
January 18, 2010
First Posted (Estimate)
January 20, 2010
Study Record Updates
Last Update Posted (Estimate)
December 13, 2012
Last Update Submitted That Met QC Criteria
December 12, 2012
Last Verified
December 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VX09-509-101
- 2009-017438-32 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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