A3921237: Immune response to zoster vaccine in rheumatoid arthritis
Research type
Research Study
Full title
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 2 STUDY TO ASSESS THE IMMUNE RESPONSE FOLLOWING ADMINISTRATION OF ZOSTER VACCINE TO SUBJECTS WITH RHEUMATOID ARTHRITIS RECEIVING TOFACITINIB (CP-690,550) OR PLACEBO WITH BACKGROUND METHOTREXATE TREATMENT
IRAS ID
159957
Contact name
Thomas Sheeran
Contact email
Sponsor organisation
Pfizer Inc.
Eudract number
2014-000706-34
Research summary
Herpes zoster virus manifests itself as shingles, an acute vesicular rash, often accompanied by chronic pain. Currently, the live zoster vaccine is considered to be contraindicated in patients receiving certain immunosuppressive medications commonly used to treat rheumatoid arthritis (RA), but Advisory Committee on Immunization Practices (ACIP) and American College of Rheumatology (ACR) guidance recommends the use of the vaccine in the target population of this study.
The study has therefore been designed to evaluate the participant's immune response to, and the safety of, the zoster vaccine, following administration of the vaccine in subjects with RA who are already receiving methotrexate and will commence taking study drug or placebo at least two weeks after vaccination.
Participants will be aged 50 or over and will have moderate to severe rheumatoid arthritis inadequately controlled by methotrexate alone. Participants will visit the hospital where the research is being conducted on 6 occasions. They will have their general health monitored, blood samples taken and a chest x-ray and ECG. They will also be asked to complete health questionnaires to assess their RA and its affect on their daily lives. The study will take approximately 22 weeks from screening visit to final follow-up visit.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
14/WM/1078
Date of REC Opinion
6 Oct 2014
REC opinion
Further Information Favourable Opinion