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

Tracking Information
First Received Date ^ICMJE	November 12, 2003
Last Updated Date	August 2, 2008
Start Date ^ICMJE	March 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00072943 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Humanized Anti-Interferon-γ Monoclonal Antibody (HuZAF) for Moderate to Severe Crohn's Disease
Official Title ^ICMJE	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
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.
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.
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Allocation: Randomized Control: Placebo Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Crohn's Disease Colitis Intestinal Disease Gastrointestinal Disease Digestive System Disease
Intervention ^ICMJE	Drug: anti-Interferon-gamma monoclonal antibody
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	175
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Canada

Administrative Information
NCT ID ^ICMJE	NCT00072943
Responsible Party
Study ID Numbers ^ICMJE	707
Study Sponsor ^ICMJE	PDL BioPharma, Inc.
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Facet Biotech
Verification Date	August 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP