Crohn's Disease
Conditions
Keywords
Crohn's Disease, Fistula
Brief summary
This study will assess the safety and efficacy of QAX576 if patients with fistulizing Crohn's disease.
Interventions
DRUGQAX576
DRUGInfliximab
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Germany, Switzerland
Outcome results
None listed