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A 12-week Study of 4 Doses of VX-509 in Subjects With Active Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT01052194
First received: January 18, 2010
Last updated: December 12, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: Placebo
Drug: VX-509
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A 12-week, Double-blind, Randomized, Parallel-group, Placebo-controlled Study of 4 Doses of VX-509 in Subjects With Active Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Vertex Pharmaceuticals Incorporated:

Primary Outcome Measures:
  • Proportion of subjects who achieve an ACR20 response [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Change from baseline in DAS28 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects who achieve an ACR50,70 response [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Proportion of subjects who achieve moderate or good EULAR response [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Magnitude of improvement in the components of the ACR response criteria [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Pharmacokinetics of VX-509 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • Pharmacodynamics (PD) of biomarker responses [ Time Frame: Week 6 ] [ Designated as safety issue: No ]

Enrollment: 206
Study Start Date: February 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 25 mg b.i.d. VX-509 Drug: VX-509
tablets, 25mg b.i.d. for 12 weeks
Experimental: 50 mg b.i.d. VX-509 Drug: VX-509
tablet, 50 mg b.i.d. for 12 weeks
Experimental: 100 mg b.i.d. VX-509 Drug: VX-509
tablet, 100 mg b.i.d. for 12 weeks
Experimental: 150 mg b.i.d. VX-509 Drug: VX-509
tablet, 150 mg b.i.d. for 12 weeks
Placebo Comparator: Placebo Drug: Placebo
tablet, placebo b.i.d. for 12 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01052194

  Show 48 Study Locations
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
Investigators
Study Director: Medical Monitor Vertex Pharmaceuticals Incorporated
  More Information

No publications provided

Responsible Party: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT01052194     History of Changes
Other Study ID Numbers: VX09-509-101, 2009-017438-32
Study First Received: January 18, 2010
Last Updated: December 12, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Vertex Pharmaceuticals Incorporated:
Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 27, 2014