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

Sponsor
Abbott
Study ID
NCT00445939
Phase
PHASE2/PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • adalimumab — BIOLOGICAL
    160 mg at Week 0, 80 mg at Week 2
  • adalimumab — BIOLOGICAL
    80 mg at Week 0, 40 mg at Week 2
  • placebo — BIOLOGICAL
    Placebo at Week 0 and Week 2

Study Details

The purpose of this study is to demonstrate the efficacy and safety of adalimumab for the induction of clinical remission in Japanese subjects with Crohn's disease.

Key Dates

Start date
Feb 28, 2007
Status verified
Jun 2011
Primary completion
Dec 31, 2007

Study Design

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

Arms

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

Primary Outcome Measure

The Number of Subjects With a Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) at Week 4 [ Time Frame: 4 Weeks ]

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