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A Study to Assess Efficacy, Safety and Tolerability of the Anti-IL-13 Monoclonal Antibody QAX576 in the Treatment of Perinanal Fistulas in Patients Suffering From Crohn's Disease

This study has been completed.
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Gerhard Rogler, University of Zurich Identifier:
First received: March 14, 2011
Last updated: May 27, 2015
Last verified: May 2015

Test safety and efficacy and of a novel IL-13 AB in the treatment of perianal fistulas

  • Trial with medicinal product

Condition Intervention Phase
Crohn's Disease
Drug: QAX567
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • complete closure of fistula

Enrollment: 3
Study Start Date: January 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion criteria: - diagnosis of Crohn's disease > 6 month with fistula - at least 1 ineffective fistula treatment in the past

Exclusion criteria: - TNF a antibody treatment failed in the past

- planned surgery

  Contacts and Locations
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Please refer to this study by its identifier: NCT01316601

Zurich, Switzerland
Sponsors and Collaborators
Gerhard Rogler
Novartis Pharmaceuticals
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
  More Information

Responsible Party: Gerhard Rogler, Prof.Dr.Dr. Gerhard Rogler, University of Zurich Identifier: NCT01316601     History of Changes
Other Study ID Numbers: Novartis CQAX576 
Study First Received: March 14, 2011
Last Updated: May 27, 2015
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases processed this record on October 21, 2016