Remission in Subjects With Crohn's Disease, 1 Year Phase

Conditions

• Crohn's Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Double-blind (DB) adalimumab placebo — BIOLOGICAL
  Double-blind nonactive matching subcutaneous injection
• DB adalimumab 40 mg eow — BIOLOGICAL
  Double-blind adalimumab 40 mg every other week by subcutaneous injection
• DB adalimumab 40 mg ew — BIOLOGICAL
  Double-blind adalimumab 40 mg every week by subcutaneous injection
• OL adalimumab 40 mg — BIOLOGICAL
  Open-label adalimumab every other week or every week by subcutaneous injection

Study Details

The objectives were: (1) To demonstrate the efficacy of adalimumab in the maintenance of clinical remission up to 56 weeks in participants with Crohn's disease who participated in NCT00055523; (2) To delineate the safety of adalimumab when administered to participants with Crohn's disease up to 56 weeks.

Key Dates

Start date

Aug 31, 2002

Status verified

Apr 2011

Primary completion

Jan 31, 2005

Completion

Dec 31, 2008

Study Design

Enrollment

276 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Double-blind (DB) adalimumab placebo
  Double-blind nonactive matching subcutaneous injection
• Experimental: Double-blind adalimumab 40 mg every other week (eow)
  Double-blind adalimumab 40 mg eow by subcutaneous injection
• Experimental: Double-blind adalimumab 40 mg every week (ew)
  Double-blind adalimumab 40 mg every week by subcutaneous injection
• Experimental: Open-label adalimumab 40 mg
  Open-label adalimumab 40 mg eow or ew by subcutaneous injection

Primary Outcome Measure

Number of Randomized Participants Achieving Clinical Remission at Week 56 - Non-Responder Imputation (NRI) [ Time Frame: Week 56 ]

Locations (43)

Find similar trials in Berkeley, CA

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