NCT00043706

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

4 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

First Submitted

Initial submission to the registry

August 12, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 14, 2002

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2003

Completed
Last Updated

March 5, 2015

Status Verified

March 1, 2015

First QC Date

August 12, 2002

Last Update Submit

March 4, 2015

Conditions

Systemic SclerosisScleroderma

Interventions

Human Anti-Transforming Growth Factor Beta-1 Monoclonal AntibodyDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

UCLA-Department of Medicine, Division of Rheumatology

Los Angeles, California, 90095, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

UMDNJ Scleroderma Program

New Brunswick, New Jersey, 08903, United States

Location

University of Texas - Houston Medical School

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Scleroderma, SystemicScleroderma, Diffuse

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 12, 2002

First Posted

August 14, 2002

Study Completion

September 1, 2003

Last Updated

March 5, 2015

Record last verified: 2015-03

Locations

US(4)