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A Magnetic Resonance Imaging Study and Arthroscopic Biopsy Substudy in Subjects With Active Rheumatoid Arthritis Receiving VX-509, an Oral JAK3 Inhibitor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01754935
Recruitment Status : Completed
First Posted : December 21, 2012
Last Update Posted : May 19, 2015
Sponsor:
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated

Study Description
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Brief Summary:
The current study is designed to evaluate the safety and efficacy, including MRI imaging, across a range of VX-509 doses in subjects with active rheumatoid arthritis (RA) who have had an inadequate response to disease-modifying antirheumatic drugs (DMARDs).

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: VX-509 Drug: VX-509 matching placebo Phase 2

Detailed Description:
VX-509 is an oral, selective Janus kinase 3 (JAK3) inhibitor being developed by Vertex. In autoimmune diseases, JAK3 is an essential component of the immune signaling cascade. This cascade ultimately contributes to abnormal immune response that results in chronic inflammation and, in the case of rheumatoid arthritis (RA), irreversible damage to cartilage and bones. Selective inhibition of JAK3 offers a new disease modifying approach to the treatment of RA, and a broad range of other autoimmune diseases.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of VX-509 Using Magnetic Resonance Imaging and Arthroscopic Biopsies in Subjects With Active Rheumatoid Arthritis on Stable Disease-Modifying Antirheumatic Drugs
Study Start Date : January 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : February 2014

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Arms and Interventions
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Arm Intervention/treatment
Experimental: VX-509 100 mg qd Arm Drug: VX-509
50 mg oral tablet
Experimental: VX-509 200 mg qd Arm Drug: VX-509
50 mg oral tablet
Experimental: VX-509 300 mg qd Arm Drug: VX-509
50 mg oral tablet
Placebo Comparator: Placebo Arm Drug: VX-509 matching placebo
0 mg oral tablet


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of subjects achieving a ≥20% improvement in disease severity according to the American College of Rheumatology criteria (ACR20), using C reactive protein (CRP) (ACR20 CRP) [ Time Frame: Week 12 ]
  2. Change from baseline in Disease Activity Score 28 using CRP (4-component) (DAS28-4[CRP]) [ Time Frame: Week 12 ]
  3. Change from baseline in OMERACT RAMRIS synovitis score in designated hand wrist [ Time Frame: Week 12 ]
  4. Change from baseline in OMERACT RAMRIS bone marrow edema (osteitis) in designated hand wrist [ Time Frame: Week 12 ]
  5. Change from baseline in OMERACT RAMRIS erosion score in designated hand wrist [ Time Frame: Week 12 ]

Secondary Outcome Measures :
  1. Proportion of subjects achieving a ACR50 CRP and ACR70 CRP responses [ Time Frame: Week 12 ]
  2. Proportion of subjects with DAS28 CRP <2.6, and those who achieve a remission, moderate response or good response according to the European League Against Rheumatism (EULAR) response criteria [ Time Frame: Week 12 ]
  3. ACR hybrid scores [ Time Frame: Week 12 ]
  4. Change from baseline in Health Assessment Questionnaire -Disability Index (HAQ-DI) [ Time Frame: Week 12 ]
  5. Change from baseline in OMERACT RAMRIS synovitis, bone marrow edema (osteitis), erosion scores [ Time Frame: Week 6 ]
  6. PK parameters of VX-509 and its metabolite in plasma (maximum observed concentration [Cmax] and area under the concentration versus time curve [AUC]) [ Time Frame: Week 12 ]
  7. Safety and tolerability as indicated by adverse events, laboratory tests, electrocardiograms (ECGs) and vital signs [ Time Frame: Week 12 ]
  8. Change from baseline in the Physical Function subscale of the 36-item Short Form (SF-36) [ Time Frame: Week 12 ]
  9. Change from baseline in the Physical Component and Mental Health Components of the SF-36 [ Time Frame: Week 12 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects 18 to 65 years of age (inclusive)
  • Diagnosis of RA
  • Swollen joint count of ≥6 out of 66 joints and tender joint count of ≥6 out of 68 joints
  • Seropositivity based on either a positive rheumatoid factor or anti cyclic citrullinated peptide antibody at screening -OR- known erosive disease based on previous X-ray report or erosions detected on screening hand and foot X-ray
  • Baseline CRP level or Westergren erythrocyte sedimentation rate ≥1.2 × upper limit of normal
  • Receiving stable therapy with 1 of the following DMARDs: methotrexate, sulfasalazine, leflunomide, anti-malarial drug, or penicillamine
  • Palpable 2+ synovitis of the wrist or ≥2 MCPs in the MRI-designated hand

Exclusion Criteria:

  • History or presence of a clinically significant medical disorder other than RA 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.
  • Inflammatory, rheumatological disorders other than RA, where arthritis may be a prominent feature
  • Planned surgery during the study
  • History of alcohol or drug 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.
  • Pregnant or nursing an infant or with a life partner who is pregnant, nursing, or planning to become pregnant
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01754935


Locations
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United States, California
Vertex Investigational Site
Stanford, California, United States
Vertex Investigational Site
Upland, California, United States
United States, Florida
Vertex Investigational Site
Fort Lauderdale, Florida, United States
Vertex Investigational Site
Venice, Florida, United States
Vertex Investigational Site
West Palm Beach, Florida, United States
United States, Georgia
Vertex Investigational Site
Canton, Georgia, United States
Vertex Investigational Site
Decatur, Georgia, United States
United States, Kansas
Vertex Investigational Site
Kansas City, Kansas, United States
United States, Kentucky
Vertex Investigational Site
Elizabethtown, Kentucky, United States
United States, Maryland
Vertex Investigational Site
Frederick, Maryland, United States
United States, Nebraska
Vertex Investigational Site
Lincoln, Nebraska, United States
United States, New York
Vertex Investigational Site
Rochester, New York, United States
United States, North Carolina
Vertex Investigational Site
Greenboro, North Carolina, United States
United States, Pennsylvania
Vertex Investigational Site
Duncansville, Pennsylvania, United States
United States, South Carolina
Vertex Investigational Site
Charleston, South Carolina, United States
United States, Tennessee
Vertex Investigational Site
Memphis, Tennessee, United States
United States, Texas
Vertex Investigational Site
Katy, Texas, United States
Vertex Investigational Site
San Antonio, Texas, United States
Vertex Investigational Site
Webster, Texas, United States
United States, Washington
Vertex Investigational Site
Seattle, Washington, United States
Vertex Investigational Site
Spokane, Washington, United States
Denmark
Vertex Investigational Site
Hillerød, Denmark
Vertex Investigational Site
Hjørring, Denmark
Estonia
Vertex Investigational Site
Tallinn, Estonia
Lithuania
Vertex Investigational Site
Vilnius, Lithuania
Netherlands
Vertex Investigational Site
Heerlen, Netherlands
Vertex Investigational Site
Utrecht, Netherlands
South Africa
Vertex Investigational Site
Johannesburg, South Africa
Vertex Investigational Site
Pretoria, South Africa
Vertex Investigational Site
Stellenbosch, South Africa
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
Investigators
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Study Chair: Bradley Bloom, MD, FACR, FAAP Vertex Pharmaceuticals Incorporated
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT01754935    
Other Study ID Numbers: VX12-509-103
2012-003439-41 ( EudraCT Number )
First Posted: December 21, 2012    Key Record Dates
Last Update Posted: May 19, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases