Remission in Subjects With Crohn's Disease, Open Label Extension

Conditions

• Crohn's Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Adalimumab 40 mg eow or ew — BIOLOGICAL
  Adalimumab 40 mg by subcutaneous injection every other week or every week

Study Details

The objectives were: (1) To demonstrate the efficacy of adalimumab in the long-term maintenance of clinical remission in participants with Crohn's disease; and (2) To delineate the long-term safety of adalimumab when administered to participants with Crohn's disease.

Key Dates

Start date

Aug 31, 2002

Status verified

Apr 2011

Primary completion

Dec 31, 2008

Completion

Dec 31, 2008

Study Design

Enrollment

177 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Adalimumab 40 mg every other week or every week

Primary Outcome Measure

Number of Participants Achieving Clinical Remission (Crohn's Disease Activity Index[CDAI] <150 Points) at Week 104 of Study M02-433 (Starting From Week 0 of NCT00055497) (Through 1 Year of Participation in NCT01070303). [ Time Frame: Week 104 ]

Locations (43)

Find similar trials in Berkeley, CA

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