Phase 2
Completed N=112
A Study to Assess Immune Response Following Zoster Vaccination to Subjects With Rheumatoid Arthritis Receiving Tofacitinib or Placebo With Background Methotrexate
Source: ClinicalTrials.gov NCT02147587 ↗Enrolled (actual)
112
Serious AEs
2.7%
Results posted
Apr 2018
Primary outcomePrimary: Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Immunoglobulin G (IgG) Levels at Week 4 — 1.736; 2.105 fold rise
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Immunoglobulin G (IgG) Levels at Week 4 |
1.736; 2.105 | — |
| SECONDARY Fold Change From Baseline in VZV-Specific IgG Levels at Day 1 and Week 12 |
1.947; 2.005; 1.496; 1.636 | — |
| SECONDARY Absolute Values in VZV-Specific IgG Levels at Day 1, Week 4 and Week 12 |
361.603; 384.219; 322.486; 403.422; 278.599; 312.328 | — |
| SECONDARY Percentage of Participants With >=1.5 Fold Change in VZV-Specific IgG Levels Day 1, Week 4 and Week 12 |
47.17; 55.56; 43.40; 57.41; 43.18; 45.83 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02147587). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.