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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 Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Safety, Tolerability, and Pharmacokinetics of CAT-192 (Human Anti-TGF-Beta1 Monoclonal Antibody) in Patients with Early Stage Diffuse Systemic Sclerosis conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Safety, Tolerability, and Pharmacokinetics of CAT-192 (Human Anti-TGF-Beta1 Monoclonal Antibody) in Patients with Early Stage Diffuse Systemic Sclerosis Clinical research trials and Safety, Tolerability, and Pharmacokinetics of CAT-192 (Human Anti-TGF-Beta1 Monoclonal Antibody) in Patients with Early Stage Diffuse Systemic Sclerosis healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Safety, Tolerability, and Pharmacokinetics of CAT-192 (Human Anti-TGF-Beta1 Monoclonal Antibody) in Patients with Early Stage Diffuse Systemic Sclerosis. Safety, Tolerability, and Pharmacokinetics of CAT-192 (Human Anti-TGF-Beta1 Monoclonal Antibody) in Patients with Early Stage Diffuse Systemic Sclerosis Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Safety, Tolerability, and Pharmacokinetics of CAT-192 (Human Anti-TGF-Beta1 Monoclonal Antibody) in Patients with Early Stage Diffuse Systemic Sclerosis clinical trial. Test subjects typically receive the most effective healthcare possible for their Safety, Tolerability, and Pharmacokinetics of CAT-192 (Human Anti-TGF-Beta1 Monoclonal Antibody) in Patients with Early Stage Diffuse Systemic Sclerosis condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Safety, Tolerability, and Pharmacokinetics of CAT-192 (Human Anti-TGF-Beta1 Monoclonal Antibody) in Patients with Early Stage Diffuse Systemic Sclerosis  Safety, Tolerability, and Pharmacokinetics of CAT-192 (Human Anti-TGF-Beta1 Monoclonal Antibody) in Patients with Early Stage Diffuse Systemic Sclerosis
Safety, Tolerability, and Pharmacokinetics of CAT-192 (Human Anti-TGF-Beta1 Monoclonal Antibody) in Patients with Early Stage Diffuse Systemic Sclerosis
For Condition: Systemic Sclerosis,Scleroderma
Status: No longer recruiting
Sponsor(s): Genzyme , Cambridge Antibody Technology
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Boston Medical Center
Boston, Massachusetts, 02118
United States
UMDNJ Scleroderma Program
New Brunswick, New Jersey, 08903
United States
University of Texas - Houston Medical School
Houston, Texas, 77030
United States
UCLA—Department of Medicine, Division of Rheumatology
Los Angeles, California, 90095
United States
Additional Information:
Study ID Numbers: ATGFB1-001-01;
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00043706
Other Systemic Sclerosis Studies:
1. Psychological Treatments for Scleroderma
2. Study of Families with Twins or Siblings Discordant for Rheumatic Disorders
3. Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Scleroderma Patients
4. Safety, Tolerability, and Pharmacokinetics of CAT-192 (Human Anti-TGF-Beta1 Monoclonal Antibody) in Patients with Early Stage Diffuse Systemic Sclerosis
5. Oral Type I Collagen for Relieving Scleroderma
Related Studies:
Other Systemic Sclerosis Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Safety, Tolerability, and Pharmacokinetics of CAT-192 (Human Anti-TGF-Beta1 Monoclonal Antibody) in Patients with Early Stage Diffuse Systemic Sclerosis
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