A Study to Assess Immune Response Following Zoster Vaccination to Subjects With Rheumatoid Arthritis Receiving Tofacitinib or Placebo With Background Methotrexate
- Registration Number
- NCT02147587
- Lead Sponsor
- Pfizer
- Brief Summary
This study will evaluate immune response following administration of zoster vaccine in subjects with rheumatoid arthritis who are receiving background methotrexate and initiate 5 mg twice daily of tofacitinib or placebo for tofacitinib 2 to 3 weeks following vaccination.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 112
- Subjects must have moderate to severe rheumatoid arthritis inadequately controlled by methotrexate as defined by the American College of Rheumatology (ACR) classification criteria for Rheumatoid arthritis, painful and swollen joint counts and C-reactive protein (CRP).
- Screening CRP >3 mg/L or CDAI score > 10 at screening or at baseline before vaccination.
- Subjects must have active disease at screening and baseline.
- Must be at least 50 years of age or older.
- History of receiving any varicella-zoster virus vaccine
- Receipt of any vaccines within 6 weeks of first dose of study treatment.
- Subjects with current infections or history of infections.
- History of recurrent (more than one episode) of herpes zoster or disseminated (a single episode) of herpes zoster or disseminated (a single episode) of herpes simplex.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo tofacitinib BID (oral) (70 subjects) Placebo Zoster vaccine will be administered to subjects on background methotrexate; treatment with placebo twice daily will begin 2 to 3 weeks following vaccination and continue for 12 weeks. Tofacitinib 5 mg BID (oral) (70 subjects) Tofacitinib Zoster vaccine will be administered to subjects on background methotrexate; treatment with 5 mg tofacitinib twice daily will begin 2 to 3 weeks following vaccination and continue for 12 weeks.
- Primary Outcome Measures
Name Time Method Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Immunoglobulin G (IgG) Levels at Week 4 Baseline (pre-vaccination; Day -14), Week 4 (6 weeks post-vaccination) VZV-specific IgG levels as measured by enzyme-linked immunosorbent assay (ELISA).
- Secondary Outcome Measures
Name Time Method Absolute Values in VZV-Specific IgG Levels at Day 1, Week 4 and Week 12 Day 1 (2 weeks post-vaccination), Week 4 (6 weeks post-vaccination), Week 12 (14 weeks post-vaccination) The absolute geometric mean titer (GMT) of VZV-specific IgG levels was calculated from logarithmically transformed assay values.
Fold Change From Baseline in VZV-Specific IgG Levels at Day 1 and Week 12 Baseline (pre-vaccination; Day -14), Day 1 (2 weeks post-vaccination), Week 12 (14 weeks post-vaccination) Percentage of Participants With >=1.5 Fold Change in VZV-Specific IgG Levels Day 1, Week 4 and Week 12 Day 1 (2 weeks post-vaccination), Week 4 (6 weeks post-vaccination), Week 12 (14 weeks post-vaccination) VZV-specific IgG levels as measured by ELISA. A ratio greater than or equal to (\>=)1.5 was defined as a responder.
Trial Locations
- Locations (36)
Rheumatology Consultants, PLLC
🇺🇸Knoxville, Tennessee, United States
Baylor Research Institute Arthritis Care and Research Center
🇺🇸Dallas, Texas, United States
Center for Arthritis and Rheumatic Diseases
🇺🇸Miami, Florida, United States
Diagnostic Rheumatology And Research, PC
🇺🇸Indianapolis, Indiana, United States
Drug Shipping Address (IRB# 14-000826) Ronald Regan
🇺🇸Los Angeles, California, United States
UCLA David Geffen School of Medicine
🇺🇸Los Angeles, California, United States
NEA Baptist Clinic
🇺🇸Jonesboro, Arkansas, United States
Pacific Arthritis Center Medical Group
🇺🇸Santa Maria, California, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Inland Rheumatology Clinical Trials, Inc.
🇺🇸Upland, California, United States
DMI Research, Inc.
🇺🇸Pinellas Park, Florida, United States
Suncoast Clinical Research, Inc.
🇺🇸New Port Richey, Florida, United States
Suncoast Medical Clinic
🇺🇸Saint Petersburg, Florida, United States
Sun Coast Medical Clinic
🇺🇸Saint Petersburg, Florida, United States
Health Point Medical Group, Inc.
🇺🇸Tampa, Florida, United States
Arthritis Treatment Center
🇺🇸Frederick, Maryland, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
PMG Research of Hickory, LLC
🇺🇸Hickory, North Carolina, United States
Buffalo Rheumatology and Medicine, PLLC
🇺🇸Orchard Park, New York, United States
Clinical Research Center of Reading LLP
🇺🇸Wyomissing, Pennsylvania, United States
Office of John P. Lavery, MD, PA
🇺🇸Allen, Texas, United States
Florida Arthritis and Osteoporosis Center
🇺🇸Port Richey, Florida, United States
Novant Health Imaging Julian Road
🇺🇸Salisbury, North Carolina, United States
East Penn Rheumatology Associates, PC
🇺🇸Bethlehem, Pennsylvania, United States
Gulf Coast Medical Center
🇺🇸Port Richey, Florida, United States
Piedmont Rheumatology, P.A
🇺🇸Hickory, North Carolina, United States
Sarasota Arthritis Research Center
🇺🇸Sarasota, Florida, United States
The Center for Rheumatology, LLP
🇺🇸Albany, New York, United States
Deerbrook Medical Associates
🇺🇸Vernon Hills, Illinois, United States
PMG Research of Salisbury, LLC
🇺🇸Salisbury, North Carolina, United States
Arthritis Clinic
🇺🇸Jackson, Tennessee, United States
West Tennessee Research Institute
🇺🇸Jackson, Tennessee, United States
Altoona Center for Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
Palmetto Clinical Trial Services, LLC
🇺🇸Greenville, South Carolina, United States
The Vancouver Clinic (Drug Shipment Only)
🇺🇸Vancouver, Washington, United States
The Vancouver Clinic, Inc, PS
🇺🇸Vancouver, Washington, United States