Effects of Adalimumab on Mucosal Healing in Subjects With Crohn's Disease Involving the Colon

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Abbott
Study ID
NCT00348283
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • adalimumab — BIOLOGICAL
    At Baseline (Week 0), subjects received an OL dose of 160 mg adalimumab SC followed by an OL dose of 80 mg adalimumab SC at Week 2 (induction dose). At Week 4, subjects were randomized to either adalimumab 40 mg SC eow or placebo SC eow. Adalimumab 40 mg eow dosing through blinded portion of study, which continued through Week 52. While all subjects began blinded study drug (placebo or adalimumab), subjects could have switched to an OL dose of adalimumab upon disease flare or non-response at or after Week 8.
  • placebo — BIOLOGICAL
    At Baseline (Week 0), subjects received an OL dose of 160 mg adalimumab SC followed by an OL dose of 80 mg adalimumab SC at Week 2 (induction dose). At Week 4, subjects were randomized to either adalimumab 40 mg SC eow or placebo SC eow. Placebo SC eow dosing through blinded portion of study, which continued through Week 52. While all subjects began blinded study drug (placebo or adalimumab), subjects could have switched to an OL dose of adalimumab upon disease flare or non-response at or after Week 8.
  • adalimumab — BIOLOGICAL
    At Baseline (Week 0), subjects received an OL dose of 160 mg adalimumab SC followed by an OL dose of 80 mg adalimumab SC at Week 2 (induction dose). At Week 4, subjects were randomized to either adalimumab 40 mg SC eow or placebo SC eow. Adalimumab or placebo SC eow dosing through blinded portion of study, which continued through Week 52. While all subjects began blinded study drug (placebo or adalimumab), subjects could have switched to an OL dose of adalimumab upon disease flare or non-response at or after Week 8. In the Open-Label arm, interventions were either adalimumab 40 mg SC eow or adalimumab 40 mg SC weekly. There was no placebo intervention post Week 52.

Study Details

The goal of this study was to test whether adalimumab can induce mucosal healing in subjects with moderate to severe ileocolonic Crohn's Disease.

Key Dates

Start date
Aug 31, 2006
Status verified
Apr 2011
Primary completion
Sep 30, 2008

Study Design

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

Arms

  • Placebo Comparator: Double Blind
    Blinded study through Week 52. Adalimumab compared to placebo during blinded portion.
  • Other: Open Label
    Note: No comparator was used in Open-Label portion of study. From Week 8, subjects could have switched to open-label (OL) adalimumab 40mg administered subcutaneously (SC) every other week (eow)or OL adalimumab 40 mg SC every week (ew) dosing to treat disease flare or non-response. At Week 52, all remaining subjects were allowed to switch to the Open-Label portion of the study.

Primary Outcome Measure

Number of Subjects Without Mucosal Ulceration at Week 12 [ Time Frame: Week 12 ]

Locations (7)

FacilityCityStateZIPSite coordinators
-AtlantaGeorgia30342-
-ChicagoIllinois60637-
-Chevy ChaseMaryland20815-
-PlymouthMinnesota55446-
-RochesterMinnesota55905-0002-
-MexicoMissouri65265-3726-
-Great NeckNew York11021-

Find similar trials in Atlanta, GA

By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease

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