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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2013-03-31

Brief Summary

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

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Detailed Description

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Conditions

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Crohn's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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QAX576

Group Type EXPERIMENTAL

QAX576

Intervention Type DRUG

Infliximab

Group Type OTHER

Infliximab

Intervention Type DRUG

Interventions

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QAX576

Intervention Type DRUG

Infliximab

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No