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

Completed · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT02147587

Run by

Pfizer

People needed

112

Starts

2014-06-01

Expected to finish

2015-07-01

Last updated by the study team

2018-04-11

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Gulf Coast Medical Center — Port Richey, Florida, United States
• Sarasota Arthritis Research Center — Sarasota, Florida, United States
• Suncoast Medical Clinic — St. Petersburg, Florida, United States
• Sun Coast Medical Clinic — St. Petersburg, Florida, United States
• Health Point Medical Group, Inc. — Tampa, Florida, United States
• Deerbrook Medical Associates — Vernon Hills, Illinois, United States
• Diagnostic Rheumatology And Research, PC — Indianapolis, Indiana, United States
• Arthritis Treatment Center — Frederick, Maryland, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• The Center for Rheumatology, LLP — Albany, New York, United States
• Buffalo Rheumatology and Medicine, PLLC — Orchard Park, New York, United States
• Piedmont Rheumatology, P.A — Hickory, North Carolina, United States
• PMG Research of Hickory, LLC — Hickory, North Carolina, United States
• PMG Research of Salisbury, LLC — Salisbury, North Carolina, United States
• Novant Health Imaging Julian Road — Salisbury, North Carolina, United States

Full record on ClinicalTrials.gov

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