A Phase II Efficacy Study in Fistulizing Crohn's Disease Patients

Novartis

Status and phase: Completed; Phase 2

Conditions: Crohn's Disease

Treatments: Drug: Infliximab; Drug: QAX576

Study type: Interventional

Funder types: Industry

Identifiers

NCT01355614

CQAX576A2209

2010-019973-13 (EudraCT Number)

Details and patient eligibility

About

This study will assess the safety and efficacy of QAX576 if patients with fistulizing Crohn's disease.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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10 participants in 2 patient groups

QAX576

Experimental group

Treatment:

Drug: QAX576

Infliximab

Other group

Treatment:

Drug: Infliximab