Status:
TERMINATED
Thalidomide for Decreasing Collagen Biosynthesis in People With Progressive Systemic Sclerosis
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Scleroderma, Systemic
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
Progressive systemic sclerosis (SSc) is an immune-based disease that causes abnormal connective tissue growth of the skin and internal organs. At this point, there are no effective therapies for treat...
Detailed Description
Progressive systemic sclerosis (SSc), also known as scleroderma, is a disease of the body's connective tissue. It is characterized by fibrosis of the skin, or formation of scar-like tissue, resulting ...
Eligibility Criteria
Inclusion
- Diagnosis of scleroderma
- Agrees to use an effective form of contraception for 1 month prior to study entry, throughout the study, and for 60 days after completing the study
- Positive serum anti-nuclear antibody titer
Exclusion
- Systemic sclerosis-like illnesses associated with environmental, ingested, or injected agents or with other connective tissue diseases
- Significant existing damage to any of the following internal organs:
- Kidneys, defined as a serum creatinine level greater than 2 mg/dl or renal crisis
- Lungs, defined as needing supplemental oxygen
- Heart, defined as left ventricular ejection fraction less than or equal to 40%
- Gut, defined as pseudo-obstruction or malabsorption requiring total parental nutrition
- Concurrent interventional therapy that might independently influence the outcome of this trial (e.g., D-penicillamine, cyclosporine, interferon-γ, methotrexate, or photophorosis)
- Clinically significant and inadequately medically treated concurrent endocrine, blood, liver, lung, or kidney diseases
- Pregnant
- Recent drug or alcohol abuse
- Documented noncompliance
- Significant psychiatric history
- Therapy with another investigational drug within 4 weeks prior to study entry
- Screening laboratory results exceeding the following limits: hemoglobin level less than 7 gm/dl; white blood cell level less than 3,000/nl; platelet count less than 50/nl; alanine aminotransferase (ALT) level greater than 65 U/L; creatinine level greater than 2 mg/dl
Key Trial Info
Start Date :
August 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00418132
Start Date
August 1 2000
End Date
October 1 2007
Last Update
March 11 2016
Active Locations (1)
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1
New York University School of Medicine General Clinical Research Center, Bellevue Hospital
New York, New York, United States, 10016