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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT01355614
Date of registration: 16/05/2011
Prospective Registration: Yes
Primary sponsor: Novartis Pharmaceuticals
Public title: A Phase II Efficacy Study in Fistulizing Crohn's Disease Patients
Scientific 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
Date of first enrolment: June 2011
Target sample size: 10
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01355614
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).  
Phase:  Phase 2
Countries of recruitment
Germany Switzerland
Contacts
Name:     Novartis Pharmaceuticals
Address: 
Telephone:
Email:
Affiliation:  Novartis Pharmaceuticals
Key inclusion & exclusion 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-TNFa (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-TNFa 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-TNFa antibody treatment

- Intercurrent bacterial or viral (intestinal) infection (serologically or
microbiologically confirmed)

Other protocol-defined inclusion/exclusion criteria may apply



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Crohn's Disease
Intervention(s)
Drug: Infliximab
Drug: QAX576
Primary Outcome(s)
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(s)
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]
Secondary ID(s)
2010-019973-13
CQAX576A2209
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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