Status:

COMPLETED

A Humanized Anti-Interferon-γ Monoclonal Antibody (HuZAF) for Moderate to Severe Crohn's Disease

Lead Sponsor:

Facet Biotech

Conditions:

Crohn's Disease

Colitis

Eligibility:

All Genders

18-70 years

Phase:

PHASE2

Brief Summary

The purpose of the HARMONY study is to assess the safety and efficacy of an investigational drug called HuZAF, in patients with moderate to severe Crohn's disease (CD). HuZAF is a humanized anti-Inter...

Detailed Description

Participants will be randomized, assigned by chance, to one of five treatment groups consisting of: four groups differing in the amount of study drug given and one placebo group. The initial dose of s...

Eligibility Criteria

Inclusion

  • Patients 18-70 years old
  • Patients with moderate to severe Crohn's disease
  • Patients who have had Crohn's disease for at least 6 months
  • Patients who have previously been treated for Crohn's disease

Exclusion

    Key Trial Info

    Start Date :

    March 1 2002

    Trial Type :

    INTERVENTIONAL

    End Date :

    April 1 2004

    Estimated Enrollment :

    175 Patients enrolled

    Trial Details

    Trial ID

    NCT00072943

    Start Date

    March 1 2002

    End Date

    April 1 2004

    Last Update

    March 13 2012

    Active Locations (19)

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    Page 1 of 5 (19 locations)

    1

    Advanced Clinical Research Institute

    Anaheim, California, United States, 92801

    2

    Doctor's Office

    Orange, California, United States, 92868

    3

    Gainesville VA Medical Center

    Gainesville, Florida, United States, 32608

    4

    Waterside Clinical Research Services, Inc.

    West Palm Beach, Florida, United States, 33407