Adalimumab for maintenance of clinical response and remission in patients with Crohn's disease: the CHARM trial

Autor: Stephen B. Hanauer, Paul F. Pollack, Ju Li, Remo Panaccione, William J. Sandborn, Robert Enns, Paul Rutgeerts, Stefan Schreiber, Dan Byczkowski, Jean-Frederic Colombel, J. D. Kent
Rok vydání: 2006
Předmět:
Zdroj: Gastroenterology. 132(1)
ISSN: 0016-5085
Popis: Background & Aims: This study evaluated the efficacy and safety of adalimumab, a fully human, anti‐tumor necrosis factor monoclonal antibody administered subcutaneously, in the maintenance of response and remission in patients with moderate to severe Crohn’s disease (CD). Methods: Patients received open-label induction therapy with adalimumab 80 mg (week 0) followed by 40 mg (week 2). At week 4, patients were stratified by response (decrease in Crohn’s Disease Activity Index >70 points from baseline) and randomized to double-blind treatment with placebo, adalimumab 40 mg every other week (eow), or adalimumab 40 mg weekly through week 56. Coprimary end points were the percentages of randomized responders who achieved clinical remission (Crohn’s Disease Activity Index score
Databáze: OpenAIRE