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.
Sponsor:
Collaborator:
Cambridge Antibody Technology
Information provided by:
Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT00043706
First received: August 12, 2002
Last updated: June 19, 2008
Last verified: July 2004
  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 1
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: 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:


Further study details as provided by Genzyme, a Sanofi Company:

  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
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: 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, a Sanofi Company
Cambridge Antibody Technology
  More Information

No publications provided

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

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Sclerosis
Pathologic Processes
Connective Tissue Diseases
Skin Diseases
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Mitogens
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 16, 2014