A Phase II Efficacy Study in Fistulizing Crohn's Disease Patients
- Registration Number
- NCT01355614
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This study will assess the safety and efficacy of QAX576 if patients with fistulizing Crohn's disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description QAX576 QAX576 - Infliximab Infliximab -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Novartis Investigative Site
🇨🇭Zuerich, Switzerland