Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding.

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AstraZeneca
Study ID
NCT01197534
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

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 disease modifying anti-rheumatic drug (DMARD) but not responding. The study will last for 1 year.

Key Dates

Start date
Sep 30, 2010
Status verified
Mar 2014
Primary completion
Mar 31, 2013
Completion
Mar 31, 2013

Study Design

Enrollment
913 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 With ACR20 at Week 24, Comparison Between Fostamatinib and Placebo [ Time Frame: 24 weeks ]

Locations (57)

FacilityCityStateZIPSite coordinators
Research SiteBirminghamAlabama--
Research SiteGlendaleArizona--
Research SiteMesaArizona--
Research SitePhoenixArizona--
Research SiteScottsdaleArizona--
Research SiteTucsonArizona--
Research SiteHot SpringsArkansas--
Research SiteHuntington BeachCalifornia--
Research SiteTorranceCalifornia--
Research SiteTrumbullConnecticut--
Research SiteWashington D.C.District of Columbia--
Research SiteBoca RatonFlorida--
Research SiteBrandonFlorida--
Research SiteJacksonvilleFlorida--
Research SiteMiamiFlorida--
Research SiteOrlandoFlorida--
Research SiteTampaFlorida--
Research SiteVeniceFlorida--
Research SiteZephyrhillsFlorida--
Research SiteCantonGeorgia--
Research SiteDecaturGeorgia--
Research SiteMaconGeorgia--
Research SiteBoiseIdaho--
Research SiteSouth BendIndiana--
Research SiteElizabethtownKentucky--
Research SiteCroftonMaryland--
Research SiteCumberlandMaryland--
Research SiteHagerstownMaryland--
Research SiteKalamazooMichigan--
Research SiteFlowoodMississippi--
Research SiteSt LouisMissouri--
Research SiteKalispellMontana--
Research SiteOmahaNebraska--
Research SiteManalapanNew Jersey--
Research SiteLas CrucesNew Mexico--
Research SiteBrooklynNew York--
Research SiteRochesterNew York--
Research SiteRoslynNew York--
Research SiteSyracuseNew York--
Research SiteCharlotteNorth Carolina--
Research SiteDurhamNorth Carolina--
Research SiteDaytonOhio--
Research SiteDuncansvillePennsylvania--
Research SitePhiladelphiaPennsylvania--
Research SiteWest ReadingPennsylvania--
Research SiteGreenvilleSouth Carolina--
Research SiteOrangeburgSouth Carolina--
Research SiteMemphisTennessee--
Research SiteAmarilloTexas--
Research SiteAustinTexas--
Research SiteDallasTexas--
Research SiteHoustonTexas--
Research SiteLubbockTexas--
Research SiteMesquiteTexas--
Research SiteSan AntonioTexas--
Research SiteChesapeakeVirginia--
Research SiteTacomaWashington--

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