Adalimumab for maintenance treatment of Crohn's disease: results of the CLASSIC II trial.

ABSTRACT:

Background

Adalimumab induced clinical remission after four weeks in patients with active Crohn's disease in the CLASSIC I trial.

Objective

To evaluate long term efficacy and safety of adalimumab maintenance therapy in Crohn's disease in a follow-on randomised controlled trial (CLASSIC II).

Methods

In the preceding CLASSIC I trial, 299 patients with moderate to severe Crohn's disease naive to tumour necrosis factor antagonists received induction therapy with adalimumab 40 mg/20 mg, 80 mg/40 mg, or 160 mg/80 mg, or placebo, at weeks 0 and 2. In all, 276 patients from CLASSIC I enrolled in CLASSIC II and received open-label adalimumab 40 mg at weeks 0 (week 4 of CLASSIC I) and 2; 55 patients in remission at both weeks 0 and 4 were re-randomised to adalimumab 40 mg every

SUBMITTER: Sandborn WJ 

PROVIDER: S-EPMC2701613 | biostudies-literature | 2007 Sep

REPOSITORIES: biostudies-literature