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A Phase II Efficacy Study in Fistulizing Crohn's Disease Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01355614
First received: May 16, 2011
Last updated: April 8, 2013
Last verified: April 2013
History of Changes
  Purpose

This study will assess the safety and efficacy of QAX576 if patients with fistulizing Crohn's disease.


Condition Intervention Phase
Crohn's Disease
 Drug: QAX576
Drug: Infliximab
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Double-blind, Active Controlled Study to Assess Efficacy, Safety and Tolerability of the Anti-IL13 Monoclonal Antibody QAX576 in the Treatment of Perianal Fistulas in Patients Suffering From Crohn's Disease

Resource links provided by NLM:

Drug Information available for: Infliximab
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Assessment of efficacy of QAX576 to induce complete closure for at least 4 weeks of all perianal fistulas in patients suffering from Crohn's disease by: clinical observation and cutaneous photodocumentation [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of safety and tolerability of QAX576 in patients suffering from Crohn's disease as measured by lab assessments, ECG, physical exam etc [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 19
Study Start Date: June 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: QAX576 Drug: QAX576
Infliximab Drug: Infliximab

  Eligibility

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

Inclusion Criteria:

  • At least one draining enterocutaneous perianal fistula
  • Diagnosis of Crohn's disease (CD) must have been established for at least 6 months
  • At least one ineffective fistula treatment (but no previously failed anti-TNFα (tumour necrosis factor) antibody treatment)
  • Patients should not suffer from any other health problems that may jeopardize their participation in the study.

Exclusion Criteria:

  • Current or recent (within 30 days of enrollment, or 5 half-lives of the compound, whichever is longer) use of anti-TNFα antibody treatment
  • Active Crohn's disease
  • Recent or pending abdominal or ano-rectal surgery, particularly presence of stricture, or abscess, or retention for which surgery might be indicated
  • Previously failed anti-TNFα antibody treatment
  • Intercurrent bacterial or viral (intestinal) infection (serologically or microbiologically confirmed)

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01355614

Locations
Germany
Novartis Investigative Site
Berlin, Germany, 13353
Novartis Investigative Site
Berlin, Germany, 12200
Novartis Investigative Site
Jena, Germany, 07740
Novartis Investigative Site
Kiel, Germany, 24105
Novartis Investigative Site
Muenchen, Germany, 93053
Switzerland
Novartis Investigative Site
Zuerich, Switzerland, 8091
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01355614     History of Changes
Other Study ID Numbers: CQAX576A2209, 2010-019973-13
Study First Received: May 16, 2011
Last Updated: April 8, 2013
Health Authority: Switzerland: Swissmedic
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Crohn's Disease
Fistula

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Infliximab
 Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Antirheumatic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 16, 2013