Safety, Tolerability, and Pharmacokinetics of CAT-192 (Human Anti-TGF-Beta1 Monoclonal Antibody) in Patients With Early Stage Diffuse Systemic Sclerosis

This study has been completed.

First Received: August 12, 2002 Last Updated: June 19, 2008 History of Changes

Sponsor:	Genzyme
Collaborator:	Cambridge Antibody Technology
Information provided by:	Genzyme
ClinicalTrials.gov Identifier:	NCT00043706

Purpose

Systemic Sclerosis (also known as Scleroderma) is a chronic, autoimmune disease of the connective tissue generally classified as one of the rheumatic diseases. Systemic Sclerosis causes fibrosis (scar tissue) to be formed in the skin and internal organs. The fibrosis eventually causes the involved skin to harden, limiting mobility, and can also damage other organs. Excess Transforming Growth Factor Beta-1 (TGF-beta1) activity may result in the abnormal fibrosis characteristic of Systemic Sclerosis. An antibody against TGF-beta1 may modify pathologic processes characterized by inappropriate fibrosis. Genzyme Corporation is currently investigating a human monoclonal antibody (CAT-192) that neutralizes active TGF-beta1. This study is being conducted in the U.S. and Europe to evaluate the safety, tolerability, and pharmacokinetics of repeated treatments with CAT-192 in patients with early stage diffuse Systemic Sclerosis.

Condition	Intervention	Phase
Systemic Sclerosis Scleroderma	Drug: Human Anti-Transforming Growth Factor Beta-1 Monoclonal Antibody	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Phase 1/2 Double Blind, Placebo Controlled, Randomized, Dose Ranging, Repeat Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of CAT-192 Human Anti-TGF-Beta1 Monoclonal Antibody in Patients With Early Stage Diffuse Systemic Sclerosis

Resource links provided by NLM:

MedlinePlus related topics: Scleroderma

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of diffuse systemic sclerosis
Duration of disease 18 months or less
Modified Rodnan Skin Score in a range as identified by the study protocol
Evidence of worsening disease activity
Ability to attend follow-up assessments for a minimum of 9 months
Agree to delay elective surgery during the trial and up to 9 months after final infusion
Agree to delay reproduction during the trial and up to 9 months after final infusion

Exclusion Criteria:

Women who are pregnant or lactating
Clinical evidence of other definable connective tissue or autoimmune disease
Severe kidney, heart, lung, or gastrointestinal disease
Treatment with protocol-specified immunosuppressants within 4 weeks of starting the clinical study
Treatment with systemic corticosteroids in a dose greater than 10 mg/day of prednisone or equivalent (inhaled steroids at standard doses are allowed)
Current treatment by photopheresis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00043706

Locations

United States, California
UCLA—Department of Medicine, Division of Rheumatology
Los Angeles, California, United States, 90095
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
United States, New Jersey
UMDNJ Scleroderma Program
New Brunswick, New Jersey, United States, 08903
United States, Texas
University of Texas - Houston Medical School
Houston, Texas, United States, 77030

Sponsors and Collaborators

Genzyme

Cambridge Antibody Technology

More Information

No publications provided

Study ID Numbers:	ATGFB1-001-01
Study First Received:	August 12, 2002
Last Updated:	June 19, 2008
ClinicalTrials.gov Identifier:	NCT00043706 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Skin Diseases
Immunologic Factors
Mitosis Modulators
Physiological Effects of Drugs
Sclerosis
Pharmacologic Actions
Antibodies, Monoclonal

Antibodies
Pathologic Processes
Connective Tissue Diseases
Scleroderma, Diffuse
Mitogens
Scleroderma, Systemic
Immunoglobulins

ClinicalTrials.gov processed this record on November 27, 2009