Open-Label, Multicenter Extension Study for Patients Completing Treatment Phase of a Rigel-Sponsored R935788 Studies

Part of paid clinical trials in La Jolla, California.

Sponsor
AstraZeneca
Study ID
NCT00805467
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

Study Details

The purpose of this new research study is to gain additional information about how safe and effective R935788 is over a longer period of time.

Key Dates

Start date
Aug 31, 2008
Status verified
May 2014
Primary completion
Aug 31, 2013
Completion
Aug 31, 2013

Study Design

Enrollment
624 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    R935788 50 mg tablet, orally, twice-a-day
  • Experimental: 2
    R935788 100 mg tablet, orally, twice-a-day
  • Experimental: 3
    R935788 100 mg tablet, orally, once-a-day
  • Experimental: 4
    R935788 150 mg tablet, orally, once-a-day

Primary Outcome Measure

Percentage of Patients Who Had at Least 1 Treatment Emergent Adverse Event in Any Category [ Time Frame: Entry in extension to end of study, up to a maximum of 5 years. (Variable by subject - median duration of 3 years) ]

Locations (35)

FacilityCityStateZIPSite coordinators
Research SiteLa JollaCalifornia--
Research SitePalm DesertCalifornia--
Research SitePalo AltoCalifornia--
Research SiteSan DiegoCalifornia--
Research SiteSanta MariaCalifornia--
Research SiteHamdenConnecticut--
Research SiteWashington D.C.District of Columbia--
Research SiteAventuraFlorida--
Research SiteBoca RatonFlorida--
Research SiteGainesvilleFlorida--
Research SiteOcalaFlorida--
Research SiteOrange ParkFlorida--
Research SiteOrlandoFlorida--
Research SiteSouth MiamiFlorida--
Research SiteVeniceFlorida--
Research SiteBoiseIdaho--
Research SiteCoeur d'AleneIdaho--
Research SiteSouth BendIndiana--
Research SiteElizabethtownKentucky--
Research SiteCumberlandMaryland--
Research SiteHagerstownMaryland--
Research SiteLansingMichigan--
Research SiteOmahaNebraska--
Research SiteRoslynNew York--
Research SiteSmithtownNew York--
Research SiteRaleighNorth Carolina--
Research SiteMayfiled VillageOhio--
Research SiteEriePennsylvania--
Research SiteWillow GrovePennsylvania--
Research SiteWyomissingPennsylvania--
Research SiteJacksonTennessee--
Research SiteAustinTexas--
Research SiteSan AntonioTexas--
Research SiteOklahoma CityWashington--
Research SiteSpokaneWashington--

Find similar trials in La Jolla, CA

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Research Site· La Jolla, CAResearch Site· Palm Desert, CAResearch Site· Palo Alto, CAResearch Site· San Diego, CAResearch Site· Santa Maria, CAResearch Site· Hamden, CT

Related Studies