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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:
ClinicalTrials.gov Identifier:
NCT00043706
First Posted: August 14, 2002
Last Update Posted: March 5, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Cambridge Antibody Technology
Information provided by:
Sanofi
August 12, 2002
August 14, 2002
March 5, 2015
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Complete list of historical versions of study NCT00043706 on ClinicalTrials.gov Archive Site
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Safety, Tolerability, and Pharmacokinetics of CAT-192 (Human Anti-TGF-Beta1 Monoclonal Antibody) in Patients With Early Stage Diffuse Systemic Sclerosis
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
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.
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Interventional
Phase 1
Phase 2
Primary Purpose: Treatment
  • Systemic Sclerosis
  • Scleroderma
Drug: Human Anti-Transforming Growth Factor Beta-1 Monoclonal Antibody
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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September 2003
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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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00043706
ATGFB1-001-01
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Genzyme, a Sanofi Company
Cambridge Antibody Technology
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Sanofi
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP