Safety, Tolerability, and Pharmacokinetics of CAT-192 (Human Anti-TGF-Beta1 Monoclonal Antibody) in Patients With Early Stage Diffuse Systemic Sclerosis - Tabular View

Tracking Information
First Received Date ^ICMJE	August 12, 2002
Last Updated Date	June 19, 2008
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00043706 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Safety, Tolerability, and Pharmacokinetics of CAT-192 (Human Anti-TGF-Beta1 Monoclonal Antibody) in Patients With Early Stage Diffuse Systemic Sclerosis
Official Title ^ICMJE	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
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.
Detailed Description
Study Phase	Phase I, Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment
Condition ^ICMJE	Systemic Sclerosis Scleroderma
Intervention ^ICMJE	Drug: Human Anti-Transforming Growth Factor Beta-1 Monoclonal Antibody
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00043706
Responsible Party
Study ID Numbers ^ICMJE	ATGFB1-001-01
Study Sponsor ^ICMJE	Genzyme
Collaborators ^ICMJE	Cambridge Antibody Technology
Investigators ^ICMJE
Information Provided By	Genzyme
Verification Date	July 2004
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP