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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
112
5 mg twice daily of tofacitinib with background methotrexate for 12 weeks
Placebo tablets twice daily with background methotrexate for 12 weeks
Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Immunoglobulin G (IgG) Levels at Week 4
VZV-specific IgG levels as measured by enzyme-linked immunosorbent assay (ELISA).
Time frame: Baseline (pre-vaccination; Day -14), Week 4 (6 weeks post-vaccination)
Fold Change From Baseline in VZV-Specific IgG Levels at Day 1 and Week 12
Time frame: Baseline (pre-vaccination; Day -14), Day 1 (2 weeks post-vaccination), Week 12 (14 weeks post-vaccination)
Absolute Values in VZV-Specific IgG Levels at Day 1, Week 4 and Week 12
The absolute geometric mean titer (GMT) of VZV-specific IgG levels was calculated from logarithmically transformed assay values.
Time frame: Day 1 (2 weeks post-vaccination), Week 4 (6 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
VZV-specific IgG levels as measured by ELISA. A ratio greater than or equal to (\>=)1.5 was defined as a responder.
Time frame: Day 1 (2 weeks post-vaccination), Week 4 (6 weeks post-vaccination), Week 12 (14 weeks post-vaccination)
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NEA Baptist Clinic
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UCLA David Geffen School of Medicine
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Pacific Arthritis Center Medical Group
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Inland Rheumatology Clinical Trials, Inc.
Upland, California, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Center for Arthritis and Rheumatic Diseases
Miami, Florida, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, United States
DMI Research, Inc.
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Florida Arthritis and Osteoporosis Center
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...and 26 more locations