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NCT02147587 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess Immune Response Following Zoster Vaccination to Subjects With Rheumatoid Arthritis Receiving Tofacitinib or Placebo With Background Methotrexate
A Phase 2 study of Rheumatoid Arthritis, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 112
- Enrollment target
- 20
- Study locations
NCT02147587: Completed Phase 2 study of Rheumatoid Arthritis, sponsored by Pfizer.
NCT02147587 is a Phase 2 study of Rheumatoid Arthritis that has completed, run by Pfizer. The registered enrollment target is 112 participants, below the 4,690-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02147587, a Phase 2 study of Rheumatoid Arthritis, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 112 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
VZV-specific IgG levels as measured by enzyme-linked immunosorbent assay (ELISA).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Tofacitinib
Study Locations (20)
Florida
- Jacksonville Center for Clinical Research - Jacksonville
- Center for Arthritis and Rheumatic Diseases - Miami
- Suncoast Clinical Research, Inc. - New Port Richey
- DMI Research, Inc. - Pinellas Park
- Florida Arthritis and Osteoporosis Center - Port Richey
- Gulf Coast Medical Center - Port Richey
- Sarasota Arthritis Research Center - Sarasota
- Suncoast Medical Clinic - St. Petersburg
- Sun Coast Medical Clinic - St. Petersburg
- Health Point Medical Group, Inc. - Tampa
California
- Drug Shipping Address (IRB# 14-000826) Ronald Regan - Los Angeles
- UCLA David Geffen School of Medicine - Los Angeles
- Pacific Arthritis Center Medical Group - Santa Maria
- Inland Rheumatology Clinical Trials, Inc. - Upland
Arkansas
- NEA Baptist Clinic - Jonesboro
Illinois
- Deerbrook Medical Associates - Vernon Hills
Indiana
- Diagnostic Rheumatology And Research, PC - Indianapolis
Maryland
- Arthritis Treatment Center - Frederick
New Hampshire
- Dartmouth-Hitchcock Medical Center - Lebanon
New York
- The Center for Rheumatology, LLP - Albany
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2014-06 |
| Est. Completion | 2015-07 |
| Phase | Phase 2 |
What the finished NCT02147587 record still lists
NCT02147587 is an interventional study that assigns participants to a tested intervention. The registered 112 participants enrollment target is mid-sized for trials with a published cap, below the 4,690-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02147587 names 20 study sites across 8 states, led by Florida, California, Arkansas.
Frequently Asked Questions
What is clinical trial NCT02147587 about?
NCT02147587 is a clinical study titled "A Study to Assess Immune Response Following Zoster Vaccination to Subjects With Rheumatoid Arthritis Receiving Tofacitinib or Placebo With Background Methotrexate". 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.
What is the current status of trial NCT02147587?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 112 participants. The study started on 2014-06. Estimated completion is 2015-07.
What conditions does trial NCT02147587 study?
This clinical trial studies the following conditions: Rheumatoid Arthritis.
What interventions are being tested in trial NCT02147587?
The interventions under investigation include: Placebo (DRUG), Tofacitinib (DRUG).
Who is sponsoring clinical trial NCT02147587?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02147587 being conducted?
This trial has 20 study locations across Arkansas, California, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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