Abstract | BACKGROUND & AIMS: METHODS: Thirty patients with active Crohn's disease ( Crohn's Disease Activity Index [CDAI] > or =151 and < or =450) received a 3-mg/kg infusion of natalizumab (n = 18) or placebo (n = 12) by double-blind randomization. The study's primary endpoint was change in CDAI at week 2. RESULTS: At week 2, the CDAI decreased significantly from baseline after infusion of natalizumab (mean 45 points) but not placebo (mean 11 points). Seven (39%) natalizumab-treated patients achieved remission at week 2, compared with 1 (8%) treated with placebo. In contrast, 4 (33%) of the placebo-treated patients required rescue medication by week 2, compared with 2 (11%) natalizumab-treated patients. Significant increases in circulating B and T lymphocytes were detected only after natalizumab administration. The frequency of commonly reported adverse events did not differ significantly between groups. CONCLUSIONS:
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Authors | F H Gordon, C W Lai, M I Hamilton, M C Allison, E D Srivastava, M G Fouweather, S Donoghue, C Greenlees, J Subhani, P L Amlot, R E Pounder |
Journal | Gastroenterology
(Gastroenterology)
Vol. 121
Issue 2
Pg. 268-74
(Aug 2001)
ISSN: 0016-5085 [Print] United States |
PMID | 11487536
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antibodies, Monoclonal
- Antigens, CD
- Biomarkers
- Integrin alpha4
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Topics |
- Adult
- Antibodies, Monoclonal
(administration & dosage, adverse effects, pharmacokinetics)
- Antigens, CD
(immunology)
- Biomarkers
- Crohn Disease
(immunology, therapy)
- Double-Blind Method
- Female
- Humans
- Integrin alpha4
- Male
- Middle Aged
- Quality of Life
- Treatment Outcome
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