A Study of the Effects of RoActemra/Actemra on Vaccination in Patients With Rheumatoid Arthritis on Background Methotrexate (VISARA)

Part of paid clinical trials in Anniston, Alabama.

Sponsor
Genentech, Inc.
Study ID
NCT01163747
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • tocilizumab — BIOLOGICAL
    Intravenous repeating dose
  • methotrexate — DRUG
    A stable dose of between 7.5 and 25 mg/week, oral or parenteral.
  • 23-Valent Pneumococcal Polysaccharide Vaccine — BIOLOGICAL
    Intramuscular or subcutaneous injection
  • Tetanus Toxoid Adsorbed Vaccine — BIOLOGICAL
    Intramuscular injection

Study Details

This randomized, parallel-group, open-label study will evaluate the effect of Actemra (tocilizumab) on vaccination in patients with active rheumatoid arthritis who have an inadequate response to methotrexate and who have had an inadequate clinical response or were intolerant to treatment with one or more anti-tumor necrosis factor (anti-TNF) therapies.

Key Dates

Start date
Sep 30, 2010
Status verified
Nov 2012
Primary completion
Dec 31, 2011
Completion
Jun 30, 2012

Study Design

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

Arms

  • Active Comparator: Methotrexate
    Participants continued to receive their standard dose of methotrexate up to Week 8. From Week 8 participants also received 8 mg/kg tocilizumab intravenously every 4 weeks until Week 20. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
  • Experimental: Tocilizumab + Methotrexate
    Participants received 8 mg/kg tocilizumab intravenously at Baseline (Day 1) and every 4 weeks up to Week 20, in addition to their standard dose of methotrexate. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.

Primary Outcome Measure

Percentage of Participants Who Responded to ≥ 6 of 12 Anti-pneumococcal Antibody Serotypes [ Time Frame: Baseline (Week 3) and Week 8 (5 weeks post-vaccination) ]

Locations (47)

FacilityCityStateZIPSite coordinators
-AnnistonAlabama36207-
-BirminghamAlabama35294-
-HuntsvilleAlabama35801-
-GlendaleArizona85304-
-MesaArizona85202-
-Paradise ValleyArizona85037-
-Paradise ValleyArizona85253-
-ScottsdaleArizona85258-
-JonesboroArkansas72401-
-FullertonCalifornia92835-
-HemetCalifornia92543-
-San LeandroCalifornia94578-
-Santa MariaCalifornia93454-
-UplandCalifornia91786-
-BridgeportConnecticut06606-
-MelbourneFlorida32901-
-South MiamiFlorida33143-
-TavaresFlorida32778-
-BoiseIdaho83702-
-Idaho FallsIdaho83404-
-MaywoodIllinois60153-
-Vernon HillsIllinois60061-
-South BendIndiana46601-
-BaltimoreMaryland21224-
-BaltimoreMaryland21286-
-Saint Clair ShoresMichigan48080-
-TupeloMississippi38801-
-Las VegasNevada89128-
-ManalapanNew Jersey07726-
-AlbanyNew York12206-
-BelmontNorth Carolina28012-
-CharlotteNorth Carolina28210-
-GreenvilleNorth Carolina27834-
-ClevelandOhio44109-
-GallipolisOhio45631-
-Middleburg HeightsOhio44130-
-Lake OswegoOregon97035-
-DuncansvillePennsylvania16635-
-PhiladelphiaPennsylvania19152-
-WexfordPennsylvania15090-
-WyomissingPennsylvania19610-
-CharlestonSouth Carolina29407-
-OrangeburgSouth Carolina29118-
-DallasTexas75246-
-MesquiteTexas75150-
-TacomaWashington98405-
-ClarksburgWest Virginia26301-

Find similar trials in Anniston, AL

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders

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