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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01355614
Recruitment Status : Completed
First Posted : May 18, 2011
Last Update Posted : February 23, 2017
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

May 16, 2011
May 18, 2011
February 23, 2017
June 2011
March 2013   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01355614 on Archive Site
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 ]
Same as current
Not Provided
Not Provided
A Phase II Efficacy Study in Fistulizing Crohn's Disease Patients
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
This study will assess the safety and efficacy of QAX576 if patients with fistulizing Crohn's disease.
Not Provided
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Crohn's Disease
  • Drug: QAX576
  • Drug: Infliximab
  • Experimental: QAX576
    Intervention: Drug: QAX576
  • Infliximab
    Intervention: Drug: Infliximab
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
March 2013
March 2013   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Germany,   Switzerland
2010-019973-13 ( EudraCT Number )
Not Provided
Not Provided
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP