Abstract | BACKGROUND: METHODS: Seventy-nine adult patients with active CD ( Crohn's Disease Activity Index [CDAI] score > or = 150) despite ongoing infliximab treatment were randomized 2:1 to receive 3 intravenous infusions of natalizumab (300 mg; n = 52) or placebo (n = 27) every 4 weeks. Patients received infliximab (5 mg/kg) every 8 weeks for at least 10 weeks before randomization and throughout the study. The primary objective was to assess the short-term safety and tolerability of natalizumab in patients concurrently receiving infliximab. Secondary and tertiary objectives included measures of efficacy, health-related quality of life (HRQoL), and effects on inflammatory markers. A subset of patients also participated in a pharmacokinetic/pharmacodynamic (PK/PD) analysis of the effects of concurrent treatment. RESULTS: CONCLUSIONS:
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Authors | Bruce E Sands, Richard Kozarek, Jack Spainhour, Charles F Barish, Scott Becker, Lawrence Goldberg, Seymour Katz, Ronald Goldblum, Rena Harrigan, Deborah Hilton, Stephen B Hanauer |
Journal | Inflammatory bowel diseases
(Inflamm Bowel Dis)
Vol. 13
Issue 1
Pg. 2-11
(Jan 2007)
ISSN: 1078-0998 [Print] England |
PMID | 17206633
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- Antibodies, Monoclonal
- Antibodies, Monoclonal, Humanized
- Gastrointestinal Agents
- Natalizumab
- Serum Albumin
- Integrin alpha4
- C-Reactive Protein
- Infliximab
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Topics |
- Adult
- Antibodies, Monoclonal
(administration & dosage, adverse effects, pharmacokinetics)
- Antibodies, Monoclonal, Humanized
- C-Reactive Protein
(analysis)
- Crohn Disease
(blood, drug therapy)
- Double-Blind Method
- Drug Therapy, Combination
- Female
- Gastrointestinal Agents
(administration & dosage, adverse effects, pharmacokinetics)
- Humans
- Infliximab
- Integrin alpha4
(immunology)
- Male
- Natalizumab
- Quality of Life
- Serum Albumin
(analysis)
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