A Study of Adalimumab for the Maintenance of Clinical Remission in Japanese Subjects With Crohn's Disease

Sponsor
Abbott
Study ID
NCT00445432
Phase
PHASE2/PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • adalimumab — BIOLOGICAL
    Subcutaneous injection of 40 mg adalimumab (0.8 mL/injection) every other week (eow)
  • Placebo — OTHER
    Subcutaneous injection of placebo (0.8 mL/injection) every other week (eow)

Study Details

To demonstrate the efficacy and safety of adalimumab for the maintenance of clinical remission in Japanese subjects with Crohn's disease.

Key Dates

Start date
Mar 31, 2007
Status verified
Feb 2012
Primary completion
Mar 31, 2009
Completion
Nov 30, 2010

Study Design

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

Arms

  • Experimental: DB Adalimumab 40 mg eow
    Subjects received double-blind (DB) 40 mg adalimumab subcutaneously (SC) every other week (eow) during the DB treatment period lasting 52 weeks.
  • Placebo Comparator: Placebo eow
    Subjects received placebo subcutaneously (SC) every other week (eow) during the double-blind treatment period lasting 52 weeks.
  • Experimental: OL Adalimumab 40 mg eow
    Subjects received open-label (OL) 40 mg adalimumab subcutaneously (SC) every other week (eow) during the double-blind treatment period lasting 52 weeks.

Primary Outcome Measure

Number of Participants Who Had Clinical Remission at Week 52 of Double-blind Treatment [ Time Frame: Week 52 of double-blind treatment ]

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