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.
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Gerhard Rogler, University of Zurich
ClinicalTrials.gov Identifier:
NCT01316601
First received: March 14, 2011
Last updated: May 27, 2015
Last verified: May 2015
  Purpose

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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01316601

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

Responsible Party: Gerhard Rogler, Prof.Dr.Dr. Gerhard Rogler, University of Zurich
ClinicalTrials.gov 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
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on May 26, 2016