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
2 other identifiers
interventional
10
2 countries
6
Brief Summary
This study will assess the safety and efficacy of QAX576 if patients with fistulizing Crohn's disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2011
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2011
CompletedFirst Posted
Study publicly available on registry
May 18, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedFebruary 23, 2017
February 1, 2017
1.8 years
May 16, 2011
February 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
52 weeks
Secondary Outcomes (1)
Assessment of safety and tolerability of QAX576 in patients suffering from Crohn's disease as measured by lab assessments, ECG, physical exam etc
52 weeks
Study Arms (2)
QAX576
EXPERIMENTALInfliximab
OTHERInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Novartis Investigative Site
Berlin, Germany, 12203, Germany
Novartis Investigative Site
Kiel, Germany, 24105, Germany
Novartis Investigative Site
München, Germany, 93053, Germany
Novartis Investigative Site
Berlin, 13353, Germany
Novartis Investigative Site
Jena, 07740, Germany
Novartis Investigative Site
Zurich, 8091, Switzerland
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2011
First Posted
May 18, 2011
Study Start
June 1, 2011
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
February 23, 2017
Record last verified: 2017-02