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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 Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. 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 site dedicated 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 throughout 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 potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, 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 volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid 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. Participants typically obtain the most effective healthcare available for their Safety, Tolerability, and Pharmacokinetics of CAT-192 (Human Anti-TGF-Beta1 Monoclonal Antibody) in Patients with Early Stage Diffuse Systemic Sclerosis condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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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 Scleroderma Studies:
1. Psychological Treatments for Scleroderma
2. Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Iloprost for Raynaud's Phenomenon Secondary to Systemic Sclerosis
3. Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Scleroderma Patients
4. Phase II Study of Recombinant Relaxin for Progressive Systemic Sclerosis
5. Stem Cell Transplant to Treat Patients with Systemic Sclerosis
Related Studies:
Other Scleroderma Clinical Trials
Other New Jersey Clinical Trials
Other New Brunswick 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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