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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00043706
Other study ID # ATGFB1-001-01
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received August 12, 2002
Last updated March 4, 2015
Est. completion date September 2003

Study information

Verified date March 2015
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date September 2003
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Primary Purpose: Treatment


Intervention

Drug:
Human Anti-Transforming Growth Factor Beta-1 Monoclonal Antibody


Locations

Country Name City State
United States Boston Medical Center Boston Massachusetts
United States University of Texas - Houston Medical School Houston Texas
United States UCLA—Department of Medicine, Division of Rheumatology Los Angeles California
United States UMDNJ Scleroderma Program New Brunswick New Jersey

Sponsors (2)

Lead Sponsor Collaborator
Genzyme, a Sanofi Company Cambridge Antibody Technology

Country where clinical trial is conducted

United States, 

See also
  Status Clinical Trial Phase
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Completed NCT04300426 - Safety and Efficacy of Anaerobic Cultivated Human Intestinal Microbiome Transplantation in Systemic Sclerosis (ReSScue) Phase 2
Recruiting NCT06058091 - RY_SW01 Cell Injection Therapy in Systemic Sclerosis Phase 1/Phase 2
Recruiting NCT04356755 - Subcutaneous Injections of ASC to Heal Digital Ulcers in Patients With Scleroderma. Phase 2
Suspended NCT06210945 - Study to Evaluate the Safety, Tolerability, and Activity of CM-101 in Patients With Systemic Sclerosis Phase 2
Not yet recruiting NCT05947682 - Manufacturing of Allogeneic Adipose Tissue-derived Mesenchymal Stromal Cells for Treatment of Severe Systemic Sclerosis N/A
Not yet recruiting NCT04303208 - Sirtuin 3 and Sirtuin 7 in Systemic Sclerosis N/A
Not yet recruiting NCT05177380 - Efficacy of a Personalized Rehabilitation Program of Facial Involvement in Systemic Sclerosis N/A
Recruiting NCT02551042 - CSL Behring Sclero XIII Phase 2
Terminated NCT02243111 - Detecting Pulmonary Arterial Hypertension (PAH) in Patients With Systemic Sclerosis (SSc) by Ultrasound N/A
Terminated NCT02246348 - Evaluating Lung Doppler Signals in Patients With Systemic Sclerosis (SSc) N/A
Completed NCT01933334 - Safety and Tolerability of Pirfenidone in Patients With Systemic Sclerosis−Related Interstitial Lung Disease (SSc-ILD) (LOTUSS) Phase 2
Completed NCT01468792 - Hemodynamic Changes in Connective Tissue Disease N/A
Terminated NCT00848107 - Open-Label Study of Oral Treprostinil in Digital Ulcers Phase 2
Completed NCT00984932 - Effect of Rosuvastatin on Systemic Sclerosis-related Pulmonary Hypertension Phase 3
Completed NCT00074568 - Scleroderma Registry
Not yet recruiting NCT06412614 - Evaluation of Patients With Systemic Sclerosis Without Specific or Associated Autoantibodies
Terminated NCT00622687 - Effect of Different Iloprost Doses on Symptoms in Systemic Sclerosis Phase 2
Recruiting NCT04464434 - Upfront Autologous HSCT Versus Immunosuppression in Early Diffuse Cutaneous Systemic Sclerosis Phase 4
Recruiting NCT04246528 - SPIN Self-Management Feasibility Trial With Progression to Full-scale Trial (SPIN-SELF) N/A