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

Part of paid clinical trials in Jonesboro, Arkansas.

Sponsor
Pfizer
Study ID
NCT02147587
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tofacitinib — DRUG
    5 mg twice daily of tofacitinib with background methotrexate for 12 weeks
  • Placebo — DRUG
    Placebo tablets twice daily with background methotrexate for 12 weeks

Study Details

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 Dates

Start date
Jun 30, 2014
Status verified
Mar 2018
Primary completion
Jun 30, 2015
Completion
Jul 31, 2015

Study Design

Enrollment
112 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tofacitinib 5 mg BID (oral) (70 subjects)
    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.
  • Placebo Comparator: Placebo tofacitinib BID (oral) (70 subjects)
    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.

Primary Outcome Measure

Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Immunoglobulin G (IgG) Levels at Week 4 [ Time Frame: Baseline (pre-vaccination; Day -14), Week 4 (6 weeks post-vaccination) ]

Locations (36)

FacilityCityStateZIPSite coordinators
NEA Baptist ClinicJonesboroArkansas72401-
Drug Shipping Address (IRB# 14-000826) Ronald ReganLos AngelesCalifornia90095-
UCLA David Geffen School of MedicineLos AngelesCalifornia90095-
Pacific Arthritis Center Medical GroupSanta MariaCalifornia93454-
Inland Rheumatology Clinical Trials, Inc.UplandCalifornia91786-
Jacksonville Center for Clinical ResearchJacksonvilleFlorida32216-
Center for Arthritis and Rheumatic DiseasesMiamiFlorida33173-
Suncoast Clinical Research, Inc.New Port RicheyFlorida34652-
DMI Research, Inc.Pinellas ParkFlorida33782-
Florida Arthritis and Osteoporosis CenterPort RicheyFlorida34668-
Gulf Coast Medical CenterPort RicheyFlorida34668-
Sarasota Arthritis Research CenterSarasotaFlorida34239-
Sun Coast Medical ClinicSt. PetersburgFlorida33710-
Suncoast Medical ClinicSt. PetersburgFlorida33705-
Health Point Medical Group, Inc.TampaFlorida33614-
Deerbrook Medical AssociatesVernon HillsIllinois60061-
Diagnostic Rheumatology And Research, PCIndianapolisIndiana46227-
Arthritis Treatment CenterFrederickMaryland21702-
Dartmouth-Hitchcock Medical CenterLebanonNew Hampshire03756-
The Center for Rheumatology, LLPAlbanyNew York12206-
Buffalo Rheumatology and Medicine, PLLCOrchard ParkNew York14127-
Piedmont Rheumatology, P.AHickoryNorth Carolina28602-
PMG Research of Hickory, LLCHickoryNorth Carolina28602-
Novant Health Imaging Julian RoadSalisburyNorth Carolina28147-
PMG Research of Salisbury, LLCSalisburyNorth Carolina28144-
East Penn Rheumatology Associates, PCBethlehemPennsylvania18015-
Altoona Center for Clinical ResearchDuncansvillePennsylvania16635-
Clinical Research Center of Reading LLPWyomissingPennsylvania19610-
Palmetto Clinical Trial Services, LLCGreenvilleSouth Carolina29601-
Arthritis ClinicJacksonTennessee38305-
West Tennessee Research InstituteJacksonTennessee38305-
Rheumatology Consultants, PLLCKnoxvilleTennessee37909-1907-
Office of John P. Lavery, MD, PAAllenTexas75013-
Baylor Research Institute Arthritis Care and Research CenterDallasTexas75231-
The Vancouver Clinic (Drug Shipment Only)VancouverWashington98664-
The Vancouver Clinic, Inc, PSVancouverWashington98664-

Find similar trials in Jonesboro, AR

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
NEA Baptist Clinic· Jonesboro, ARDrug Shipping Address (IRB# 14-000826) Ronald Regan· Los Angeles, CAUCLA David Geffen School of Medicine· Los Angeles, CAPacific Arthritis Center Medical Group· Santa Maria, CAInland Rheumatology Clinical Trials, Inc.· Upland, CAJacksonville Center for Clinical Research· Jacksonville, FL

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