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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01355614
First Posted: May 18, 2011
Last Update Posted: February 23, 2017
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.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  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 (Participant, 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:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

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 ]

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 ]

Enrollment: 10
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01355614


Locations
Germany
Novartis Investigative Site
Berlin, Germany, 12203
Novartis Investigative Site
Berlin, Germany, 13353
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

Additional Information:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01355614     History of Changes
Other Study ID Numbers: CQAX576A2209
2010-019973-13 ( EudraCT Number )
First Submitted: May 16, 2011
First Posted: May 18, 2011
Last Update Posted: February 23, 2017
Last Verified: February 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Crohn's Disease
Fistula

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents