Phase I, double-blind, randomized, placebo-controlled, dose-escalation study of NI-0401 (a fully human anti-CD3 monoclonal antibody) in patients with moderate to severe active Crohn's disease

Inflammatory Bowel Diseases

Volumn 16, Issue 10, 2010, Pages 1708-1716

  Van Der Woude, C Janneke ^a   Stokkers, Pieter ^b   Van Bodegraven, Ad A ^c   Van Assche, Gert ^d   Hebzda, Zbigniew ^e   Paradowski, Leszek ^f   D'Haens, Geert ^d   Ghosh, Subrata ^g   Feagan, Brian ^h   Rutgeerts, Paul ^d   Dijkstra, Gerard ⁱ   De Jong, Dirk J ^j   Oldenburg, Bas ^k   Farhan, Mahdi ^l   Richard, Tristan ^l   Dean, Yann ^l   Hommes, Daniel W ^m  

^a ERASMUS MEDICAL CENTER   (Netherlands)

^b ACADEMIC MEDICAL CENTER   (Netherlands)

^c VU UNIVERSITY MEDICAL CENTER   (Netherlands)

^d UZ Gasthuisberg Leuven ^*  (Belgium)

^e Military Clinical Hospital Krakow   (Poland)

^f Clinic of Gastroenterology and Hepatology Wroclaw   (Poland)

^g IMPERIAL COLLEGE LONDON   (United Kingdom)

^h ROBARTS RESEARCH INSTITUTE   (Canada)

ⁱ UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

^j RADBOUD UNIVERSITY MEDICAL CENTER   (Netherlands)

^k UNIVERSITY MEDICAL CENTER UTRECHT   (Netherlands)

^l NOVIMMUNE SA   (Switzerland)

^m LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

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Author keywords

Anti CD3; Biologic therapies; Crohn's disease; NI 0401; Phase I clinical trial

Indexed keywords

C REACTIVE PROTEIN; CORTICOSTEROID; IBUPROFEN; MESALAZINE; METHOTREXATE; MONOCLONAL ANTIBODY CD3; NI 0401; PARACETAMOL; TUMOR NECROSIS FACTOR ANTIBODY; UNCLASSIFIED DRUG;

ABDOMINAL PAIN; ADULT; AGED; ANOREXIA; ARTICLE; CHILL; CLINICAL ARTICLE; CLINICAL TRIAL; COLON CARCINOGENESIS; COLON FISTULA; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROHN DISEASE; CYTOKINE RELEASE SYNDROME; DIARRHEA; DISEASE SEVERITY; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG ERUPTION; DRUG SAFETY; FEMALE; FEVER; HEADACHE; HUMAN; HYPOTENSION; IMMUNOGENICITY; INTESTINE OBSTRUCTION; MALE; MULTICENTER STUDY; MYALGIA; NAUSEA; OUTCOME ASSESSMENT; PERIANAL ABSCESS; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REMISSION; TONSILLITIS; VOMITING;

ADOLESCENT; ADULT; AGED; ANTIBODIES, MONOCLONAL; CROHN DISEASE; DISEASE PROGRESSION; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FEMALE; FOLLOW-UP STUDIES; HUMANS; MALE; MIDDLE AGED; PROSPECTIVE STUDIES; RECEPTOR-CD3 COMPLEX, ANTIGEN, T-CELL; REMISSION INDUCTION; TREATMENT OUTCOME; YOUNG ADULT;

EID: 78649270953     PISSN: 10780998     EISSN: 15364844     Source Type: Journal    
DOI: 10.1002/ibd.21252     Document Type: Article

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