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: February 6, 2014
Last verified: February 2014

May 16, 2011
February 6, 2014
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01355614 on ClinicalTrials.gov 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 ] [ Designated as safety issue: Yes ]
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
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Switzerland
 
NCT01355614
CQAX576A2209, 2010-019973-13
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
February 2014

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