NCT00072943

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-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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2002

Geographic Reach
2 countries

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 12, 2003

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 17, 2003

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
Last Updated

March 13, 2012

Status Verified

March 1, 2012

Enrollment Period

2.1 years

First QC Date

November 12, 2003

Last Update Submit

March 9, 2012

Conditions

Crohn's DiseaseColitisIntestinal DiseaseGastrointestinal DiseaseDigestive System Disease

Keywords

Crohn's DiseaseColitisMonoclonal antibody therapyanti-interferon gamma

Interventions

anti-Interferon-gamma monoclonal antibodyDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (19)

Advanced Clinical Research Institute

Anaheim, California, 92801, United States

Location

Doctor's Office

Orange, California, 92868, United States

Location

Gainesville VA Medical Center

Gainesville, Florida, 32608, United States

Location

Waterside Clinical Research Services, Inc.

West Palm Beach, Florida, 33407, United States

Location

Atlanta Gastroenterology Associates

Atlanta, Georgia, 30342, United States

Location

Doctor's Office

Chicago, Illinois, 60637-1426, United States

Location

University of Kentucky Medical Center, Division of Digestive Disease & Nutrition

Lexington, Kentucky, 40536, United States

Location

Massachusetts General Hospital, Gastrointestinal Unit

Boston, Massachusetts, 02114, United States

Location

Gastroenterology Specialities P.C.

Lincoln, Nebraska, 68503, United States

Location

Carolina Digestion Health Associates

Charlottesville, North Carolina, 28211, United States

Location

Consultants for Clinical Research

Cincinnati, Ohio, 45219, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

University Pittsburgh Medical Center, Division of Gastroenterology, Hepatology and Nutrition, Inflammatory Bowel Disease Center

Pittsburgh, Pennsylvania, 15261, United States

Location

Houston Medical Research Associates

Houston, Texas, 77090, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Vancouver General Hospital, Dept. of Medicine

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Health Science Centre

Winnipeg, Manitoba, R3A 1R9, Canada

Location

Queen Elizabeth II Health Science Center, McKenzie Building, Pathology

Halifax, Nova Scotia, B3H 1V8, Canada

Location

London Health Science Center, University Campus

London, Ontario, N6A 5A5, Canada

Location

Related Links

MeSH Terms

Conditions

Crohn DiseaseColitisIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisColonic Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2003

First Posted

November 17, 2003

Study Start

March 1, 2002

Primary Completion

April 1, 2004

Study Completion

April 1, 2004

Last Updated

March 13, 2012

Record last verified: 2012-03

Locations

CA(4)US(15)