A phase II study of laquinimod in Crohn's disease
| Autor: | Jean F. Colombel, Hadas Barkay, Kurt Brown, Geert R. D'Haens, Paul Rutgeerts, William J. Sandborn, Brian G. Feagan, Asi Haviv, Anat Sakov |
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| Přispěvatelé: | AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, Gastroenterology and Hepatology |
| Jazyk: | angličtina |
| Rok vydání: | 2015 |
| Předmět: |
Adult
Male medicine.medical_specialty Adolescent Anti-Inflammatory Agents Phases of clinical research Administration Oral CROHN'S DISEASE Quinolones Placebo Gastroenterology law.invention chemistry.chemical_compound Young Adult Pharmacotherapy Randomized controlled trial Crohn Disease Double-Blind Method law Internal medicine medicine Humans IBD CLINICAL Adverse effect Aged Dose-Response Relationship Drug business.industry Inflammatory Bowel Disease CLINICAL DECISION MAKING Induction chemotherapy PHARMACOTHERAPY Induction Chemotherapy Middle Aged Surgery Clinical trial Treatment Outcome chemistry Female business Laquinimod CLINICAL TRIALS Follow-Up Studies |
| Zdroj: | Gut, 64(8), 1227-1235. BMJ Publishing Group Gut |
| ISSN: | 0017-5749 |
| DOI: | 10.1136/gutjnl-2014-307118 |
| Popis: | Objective Laquinimod is an oral therapeutic agent under investigation for the treatment of Crohn's disease (CD), Huntington's disease, lupus nephritis and multiple sclerosis. This dose escalation study evaluated the safety and efficacy of laquinimod as induction therapy in patients with active moderate–severe CD. Design Multicentre, double-blind, sequential-cohort, randomised controlled trial with laquinimod doses of 0.5, 1, 1.5 or 2 mg/day or placebo (n=45 per cohort randomised in a 2:1 ratio) for 8 weeks with 4-week follow-up. Stable concomittant therapies and prior use of anti-tumour necrosis factor agents were permitted. Comprehensive safety assessments were performed and efficacy analyses included the proportions of patients in clinical remission (CD Activity Index (CDAI) |
| Databáze: | OpenAIRE |
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