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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Abbott
Study ID
NCT00385736
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 (loading dose then every other week dosing). 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4.
  • adalimumab — BIOLOGICAL
    Prefilled syringe, 40 mg (loading dose then every other week dosing). 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
  • placebo — BIOLOGICAL
    Placebo for 40 mg syringe. Matching placebo for loading dose and every other week dosing. Subjects received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab eow thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).

Study Details

The objective of this study is to assess the efficacy and safety of adalimumab for the induction of clinical remission in subjects with moderately to severely active ulcerative colitis.

Key Dates

Start date
Nov 30, 2006
Status verified
Apr 2011
Primary completion
Apr 30, 2009
Completion
Mar 31, 2010

Study Design

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

Arms

  • Experimental: Adalimumab 80/40
  • Experimental: Adalimumab 160/80/40
  • Placebo Comparator: Placebo

Primary Outcome Measure

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

Locations (29)

FacilityCityStateZIPSite coordinators
Site Ref # / Investigator 2080BirminghamAlabama35209-
Site Ref # / Investigator 6034MobileAlabama36617-
Site Ref # / Investigator 5100FayettevilleArkansas72703-
Site Ref # / Investigator 5390OrangeCalifornia92868-
Site Ref # / Investigator 5392San DiegoCalifornia92123-
Site Ref # / Investigator 2245BridgeportConnecticut06606-
Site Ref # / Investigator 2240GainesvilleFlorida32610-
Site Ref # / Investigator 2230South MiamiFlorida33143-
Site Ref # / Investigator 2231AtlantaGeorgia30342-
Site Ref # / Investigator 5393AtlantaGeorgia30308-
Site Ref # / Investigator 2498ChicagoIllinois60637-
Site Ref # / Investigator 2078Chevy ChaseMaryland20815-
Site Ref # / Investigator 2238Silver SpringsMaryland20901-
Site Ref # / Investigator 1971BostonMassachusetts02114-
Site Ref # / Investigator 2246RochesterMinnesota55905-
Site Ref # / Investigator 2243Kansas CityMissouri64131-
Site Ref # / Investigator 2247MexicoMissouri65265-
Site Ref # / Investigator 2233LincolnNebraska68503-
Site Ref # / Investigator 2236Cedar KnollsNew Jersey07927-
Site Ref # / Investigator 2072New YorkNew York10028-
Site Ref # / Investigator 2241CharlotteNorth Carolina28211-
Site Ref # / Investigator 2232RaleighNorth Carolina27612-
Site Ref # / Investigator 11801WilmingtonNorth Carolina28403-
Site Ref # / Investigator 2074CincinnatiOhio45219-
Site Ref # / Investigator 2126ClevelandOhio44106-5066-
Site Ref # / Investigator 6090GermantownTennessee38138-
Site Ref # / Investigator 2076NashvilleTennessee37203-
Site Ref # / Investigator 2229BellevueWashington98004-
Site Ref # / Investigator 2077MilwaukeeWisconsin53215-

Find similar trials in Birmingham, AL

By condition
Ulcerative colitis
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Site Ref # / Investigator 2080· Birmingham, ALSite Ref # / Investigator 6034· Mobile, ALSite Ref # / Investigator 5100· Fayetteville, ARSite Ref # / Investigator 5390· Orange, CASite Ref # / Investigator 5392· San Diego, CASite Ref # / Investigator 2245· Bridgeport, CT

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