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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Facet Biotech
ClinicalTrials.gov Identifier:
NCT00072943
First received: November 12, 2003
Last updated: March 9, 2012
Last verified: March 2012
  Purpose

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-Interferon-gamma (anti-IFN-γ) monoclonal antibody, which binds and blocks IFN-γ, a protein in the immune system that is involved in inflammation. Antibodies are proteins normally produced by our immune system to help fight off foreign substances. Scientists have been able to make therapeutic humanized monoclonal antibodies, similar to the antibodies in our bodies, to target diseases.


Condition Intervention Phase
Crohn's Disease
Colitis
Intestinal Disease
Gastrointestinal Disease
Digestive System Disease
Drug: anti-Interferon-gamma monoclonal antibody
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase II, Double-Blind, Placebo-Controlled Study to Determine the Safety and Efficacy of a Humanized Anti-Interferon-γ Monoclonal Antibody (HuZAF) Administered to Patients With Moderate to Severe Crohn's Disease

Resource links provided by NLM:


Further study details as provided by Facet Biotech:

Estimated Enrollment: 175
Study Start Date: March 2002
Study Completion Date: April 2004
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
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 study drug will be given intravenously, injected into a vein in the arm. Four weeks later, three subsequent doses of study drug will be given subcutaneously, through the skin, every four weeks for three doses. Patients will be followed for approximately six months after receiving their final dose.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00072943

  Hide Study Locations
Locations
United States, California
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
Doctor's Office
Orange, California, United States, 92868
United States, Florida
Gainesville VA Medical Center
Gainesville, Florida, United States, 32608
Waterside Clinical Research Services, Inc.
West Palm Beach, Florida, United States, 33407
United States, Georgia
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States, 30342
United States, Illinois
Doctor's Office
Chicago, Illinois, United States, 60637-1426
United States, Kentucky
University of Kentucky Medical Center, Division of Digestive Disease & Nutrition
Lexington, Kentucky, United States, 40536
United States, Massachusetts
Massachusetts General Hospital, Gastrointestinal Unit
Boston, Massachusetts, United States, 02114
United States, Nebraska
Gastroenterology Specialities P.C.
Lincoln, Nebraska, United States, 68503
United States, North Carolina
Carolina Digestion Health Associates
Charlottesville, North Carolina, United States, 28211
United States, Ohio
Consultants for Clinical Research
Cincinnati, Ohio, United States, 45219
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
University Pittsburgh Medical Center, Division of Gastroenterology, Hepatology and Nutrition, Inflammatory Bowel Disease Center
Pittsburgh, Pennsylvania, United States, 15261
United States, Texas
Houston Medical Research Associates
Houston, Texas, United States, 77090
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Canada, British Columbia
Vancouver General Hospital, Dept. of Medicine
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Manitoba
Health Science Centre
Winnipeg, Manitoba, Canada, R3A 1R9
Canada, Nova Scotia
Queen Elizabeth II Health Science Center, McKenzie Building, Pathology
Halifax,, Nova Scotia, Canada, B3H 1V8
Canada, Ontario
London Health Science Center, University Campus
London,, Ontario, Canada, N6A 5A5
Sponsors and Collaborators
Facet Biotech
  More Information

Additional Information:
No publications provided

Responsible Party: Facet Biotech
ClinicalTrials.gov Identifier: NCT00072943     History of Changes
Other Study ID Numbers: 707
Study First Received: November 12, 2003
Last Updated: March 9, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Facet Biotech:
Crohn's Disease
Colitis
Monoclonal antibody therapy
anti-interferon gamma

Additional relevant MeSH terms:
Colitis
Crohn Disease
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Colonic Diseases
Gastroenteritis
Inflammatory Bowel Diseases
Antibodies
Antibodies, Monoclonal
Immunoglobulins
Interferon-gamma
Interferons
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014