Adalimumab for the treatment of fistulas in patients with Crohn's disease.

ABSTRACT:

Objective

To evaluate the efficacy of adalimumab in the healing of draining fistulas in patients with active Crohn's disease (CD).

Design

A phase III, multicentre, randomised, double-blind, placebo controlled study with an open-label extension was conducted in 92 sites.

Patients

A subgroup of adults with moderate to severely active CD (CD activity index 220-450) for >or=4 months who had draining fistulas at baseline.

Interventions

All patients received initial open-label adalimumab induction therapy (80 mg/40 mg at weeks 0/2). At week 4, all patients were randomly assigned to receive double-blind placebo or adalimumab 40 mg every other week or weekly to week 56 (irrespective of fistula status). Patients completing week 56 of therapy were then eligible to enroll

SUBMITTER: Colombel JF 

PROVIDER: S-EPMC2689393 | biostudies-literature | 2009 Jul

REPOSITORIES: biostudies-literature