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Completed

NCT Number: NCT01355614

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

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

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Fistula Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

QAX576

Drug

Infliximab

Drug

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 18, 2011
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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