A Study to Assess Immune Response Following Zoster Vaccination to Subjects With Rheumatoid Arthritis Receiving Tofacitinib or Placebo With Background Methotrexate

Phase 2

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

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.

Exclusion Criteria

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.

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.

Locations (36): NEA Baptist Clinic
🇺🇸
Jonesboro, Arkansas, 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
Pacific Arthritis Center Medical Group
🇺🇸
Santa Maria, California, United States
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.
🇺🇸
Pinellas Park, Florida, United States
Florida Arthritis and Osteoporosis Center
🇺🇸
Port Richey, Florida, United States
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NEA Baptist Clinic
🇺🇸Jonesboro, Arkansas, United States