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 |
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Rok vydání: | 2006 |
Předmět: |
musculoskeletal diseases
Adult Male medicine.medical_specialty Adolescent Placebo Antibodies Monoclonal Humanized Gastroenterology Management of Crohn's disease Severity of Illness Index Placebos Maintenance therapy Crohn Disease Internal medicine Adalimumab medicine Humans Certolizumab pegol skin and connective tissue diseases Aged Hepatology business.industry Remission Induction Antibodies Monoclonal Digestive System Fistula Middle Aged medicine.disease Crohn's Disease Activity Index Infliximab Surgery Treatment Outcome Delayed hypersensitivity Antirheumatic Agents Female business medicine.drug |
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 |
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