A Phase II Efficacy Study in Fistulizing Crohn's Disease Patients
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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
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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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 ]
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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