Efficacy and Safety of Adalimumab in Subjects With Moderately to Severely Active Ulcerative Colitis

Part of paid clinical trials in Anaheim, California.

Sponsor
Abbott
Study ID
NCT00408629
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • adalimumab — BIOLOGICAL
    Prefilled syringe, 40 mg, 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week between Weeks 4 and 50.
  • placebo — BIOLOGICAL
    Matching Placebo for prefilled syringe, 40 mg,

Study Details

This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of the human anti-tumor necrosis factor (TNF) monoclonal antibody adalimumab (ADA) in patients with moderately to severely active ulcerative colitis (UC).

Key Dates

Start date
Nov 30, 2006
Status verified
Apr 2011
Primary completion
Mar 31, 2010
Completion
Mar 31, 2010

Study Design

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

Arms

  • Experimental: adalimumab group
  • Experimental: placebo group

Primary Outcome Measure

Proportion of Participants Who Achieved Clinical Remission Per Mayo Score at Week 8 [ Time Frame: Week 8 ]

Locations (36)

FacilityCityStateZIPSite coordinators
Site Ref # / Investigator 5394AnaheimCalifornia92801-
Site Ref # / Investigator 3753Wheat RidgeColorado80033-
Site Ref # / Investigator 3754HamdenConnecticut06518-
Site Ref # / Investigator 12903GainesvilleFlorida32607-
Site Ref # / Investigator 3747HollywoodFlorida33021-
Site Ref # / Investigator 5106JacksonvilleFlorida32256-
Site Ref # / Investigator 11601NaplesFlorida34102-
Site Ref # / Investigator 6846SarasotaFlorida34239-
Site Ref # / Investigator 3742Winter ParkFlorida32789-
Site Ref # / Investigator 3760ZephyrhillsFlorida33542-
Site Ref # / Investigator 3739AtlantaGeorgia30342-
Site Ref # / Investigator 7658MaconGeorgia31201-
Site Ref # / Investigator 5397MolineIllinois61265-
Site Ref # / Investigator 7453TopekaKansas66606-
Site Ref # / Investigator 3759AnnapolisMaryland21401-
Site Ref # / Investigator 3762AnnapolisMaryland21401-
Site Ref # / Investigator 3738LuthervilleMaryland21093-
Site Ref # / Investigator 7472TroyMichigan48098-
Site Ref # / Investigator 3744RochesterMinnesota55905-
Site Ref # / Investigator 6088St LouisMissouri63128-
Site Ref # / Investigator 3756Great NeckNew York11021-
Site Ref # / Investigator 3752CharlotteNorth Carolina28207-
Site Ref # / Investigator 3758JacksonvilleNorth Carolina28546-
Site Ref # / Investigator 3745CincinnatiOhio45219-
Site Ref # / Investigator 7709Oklahoma CityOklahoma73104-
Site Ref # / Investigator 3740TulsaOklahoma74104-
Site Ref # / Investigator 3765SayrePennsylvania18840-
Site Ref # / Investigator 3741ColumbiaSouth Carolina29204-
Site Ref # / Investigator 3737GermantownTennessee38138-
Site Ref # / Investigator 3743NashvilleTennessee37212-1610-
Site Ref # / Investigator 5107NashvilleTennessee37205-
Site Ref # / Investigator 6077NashvilleTennessee37203-
Site Ref # / Investigator 5398OgdenUtah84405-
Site Ref # / Investigator 3750SpokaneWashington99204-
Site Ref # / Investigator 8064SpokaneWashington99202-
Site Ref # / Investigator 3761West BendWisconsin53095-

Find similar trials in Anaheim, CA

By condition
Ulcerative colitis
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Site Ref # / Investigator 5394· Anaheim, CASite Ref # / Investigator 3753· Wheat Ridge, COSite Ref # / Investigator 3754· Hamden, CTSite Ref # / Investigator 12903· Gainesville, FLSite Ref # / Investigator 3747· Hollywood, FLSite Ref # / Investigator 5106· Jacksonville, FL

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