Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate and Have Had Inadequate Response to Single TNF-alpha Antagonist

Part of paid clinical trials in Anniston, Alabama.

Sponsor
AstraZeneca
Study ID
NCT01197755
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • fostamatinib — DRUG
    fostamatinib 100 mg twice daily
  • fostamatinib — DRUG
    fostamatinib 100 mg twice daily/150 mg once daily
  • placebo — DRUG
    Placebo twice daily

Study Details

The purpose of the study is to evaluate the effectiveness of two dosing regimens of fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking methotrexate and have had an inadequate response to a single TNF-alpha antagonist. The study will last for approximately six months.

Key Dates

Start date
Sep 30, 2010
Status verified
Feb 2014
Primary completion
Feb 28, 2013
Completion
Feb 28, 2013

Study Design

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

Arms

  • Experimental: Dosing Regimen A
    Oral Treatment
  • Experimental: Dosing Regimen B
    Oral Treatment
  • Placebo Comparator: Dosing Regimen C
    Oral Treatment

Primary Outcome Measure

Proportion of Patients Achieving ACR20 at Week 24, Comparison Between Fostamatinib and Placebo [ Time Frame: 24 weeks ]

Locations (67)

FacilityCityStateZIPSite coordinators
Research SiteAnnistonAlabama--
Research SiteHuntsvilleAlabama--
Research SiteTuscaloosaAlabama--
Research SiteMesaArizona--
Research SiteScottsdaleArizona--
Research SiteHot SpringsArkansas--
Research SiteGlendaleCalifornia--
Research SiteLa JollaCalifornia--
Research SiteLong BeachCalifornia--
Research SitePalo AltoCalifornia--
Research SiteSanta MariaCalifornia--
Research SiteTorranceCalifornia--
Research SiteTustinCalifornia--
Research SiteUplandCalifornia--
Research SiteColorado SpringsColorado--
Research SiteBridgeportConnecticut--
Research SiteTrumbullConnecticut--
Research SiteLewesDelaware--
Research SiteBrandonFlorida--
Research SiteJacksonvilleFlorida--
Research SiteOcalaFlorida--
Research SiteOrlandoFlorida--
Research SiteTampaFlorida--
Research SiteVeniceFlorida--
Research SiteZephyrhillsFlorida--
Research SiteAtlantaGeorgia--
Research SiteCantonGeorgia--
Research SiteIdaho FallsIdaho--
Research SiteDecaturIllinois--
Research SiteCedar RapidsIowa--
Research SiteBowling GreenKentucky--
Research SiteElizabethtownKentucky--
Research SiteCroftonMaryland--
Research SiteFall RiverMassachusetts--
Research SiteWorcesterMassachusetts--
Research SiteLansingMichigan--
Research SiteFlowoodMississippi--
Research SiteFlorissantMissouri--
Research SiteRichmond HeightsMissouri--
Research SiteLas CrucesNew Mexico--
Research SiteAlbanyNew York--
Research SiteBrooklynNew York--
Research SiteOleanNew York--
Research SiteRochesterNew York--
Research SiteRoslynNew York--
Research SiteSmithtownNew York--
Research SiteCharlotteNorth Carolina--
Research SiteDurhamNorth Carolina--
Research SiteGreensboroNorth Carolina--
Research SiteDaytonOhio--
Research SiteMayfield VillageOhio--
Research SiteLake OswegoOregon--
Research SiteDuncansvillePennsylvania--
Research SitePhiladelphiaPennsylvania--
Research SitePittsburghPennsylvania--
Research SiteWest ReadingPennsylvania--
Research SiteCharlestonSouth Carolina--
Research SiteGreenvilleSouth Carolina--
Research SiteHixsonTennessee--
Research SiteMemphisTennessee--
Research SiteNashvilleTennessee--
Research SiteAmarilloTexas--
Research SiteAustinTexas--
Research SiteDallasTexas--
Research SiteHoustonTexas--
Research SiteSan AntonioTexas--
Research SiteTacomaWashington--

Find similar trials in Anniston, AL

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Research Site· Anniston, ALResearch Site· Huntsville, ALResearch Site· Tuscaloosa, ALResearch Site· Mesa, AZResearch Site· Scottsdale, AZResearch Site· Hot Springs, AR

Related Studies