Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004563
Status:
COMPLETED
Last Update Posted:
2015-03-27
First Post:
2000-02-09
Brief Title:
Scleroderma Lung Disease
Sponsor:
The University of Texas Health Science Center Houston
Organization:
The University of Texas Health Science Center Houston
Study Overview
Official Title:
Cyclophosphamide Versus Placebo in Scleroderma Lung Study
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SLS
Brief Summary:
To evaluate the efficacy and safety of cyclophosphamide versus placebo for the prevention and progression of symptomatic pulmonary disease in patients with systemic sclerosis
Detailed Description:
BACKGROUND
Systemic sclerosis is a connective tissue disease of unknown etiology characterized by microvascular injury and excessive fibrosis of the skin and viscera In the United States 5000 to 10000 new cases are diagnosed annually Approximately 80 percent of these persons will eventually develop some degree of lung involvement and restrictive lung disease interstitial fibrosis is now the leading cause of morbidity and mortality in systemic sclerosis An inflammatory alveolitis is thought to be the precursor of interstitial pulmonary fibrosis in systemic sclerosis An effective treatment for SSc interstitial lung disease has yet to be identified Cyclophosphamide CYC is already being widely used by rheumatologists desperate to do something to halt rapidly declining lung function in SSC patients Thus the time is ripe to perform a placebo-controlled trial of CYC in this disease
Pulmonary scleroderma strikes all races and is most prevalent among women during their child-bearing child-rearing and working years A positive outcome from this trial demonstrating that oral cyclophosphamide has a beneficial effect on pulmonary fibrosis would be of great importance by offering a scientific basis for treatment Similarly a negative result demonstrating no benefit from cyclophosphamide therapy would also be important in avoiding hazardous and expensive therapy that is now being used widely
DESIGN NARRATIVE
Multicenter placebo-controlled randomized double-blind Subjects are recruited at 12 clinical centers and randomized to 2 mgkgday of cyclophosphamide or placebo Follow-up visits for pulmonary assessments occur every three months for two years after treatment If patients fail the cyclophosphamide treatment they will be offered azathioprine for the remainder of the 24 month trial The primary endpoint of the study is change in forced vital capacity at the end of 12 months of treatment Secondary endpoints include quality of life activity and dyspnea indices and carbon monoxide diffusing capacity Recruitment ends in December 2003
Systemic sclerosis is a connective tissue disease of unknown etiology characterized by microvascular injury and excessive fibrosis of the skin and viscera In the United States 5000 to 10000 new cases are diagnosed annually Approximately 80 percent of these persons will eventually develop some degree of lung involvement and restrictive lung disease interstitial fibrosis is now the leading cause of morbidity and mortality in systemic sclerosis An inflammatory alveolitis is thought to be the precursor of interstitial pulmonary fibrosis in systemic sclerosis An effective treatment for SSc interstitial lung disease has yet to be identified Cyclophosphamide CYC is already being widely used by rheumatologists desperate to do something to halt rapidly declining lung function in SSC patients Thus the time is ripe to perform a placebo-controlled trial of CYC in this disease
Pulmonary scleroderma strikes all races and is most prevalent among women during their child-bearing child-rearing and working years A positive outcome from this trial demonstrating that oral cyclophosphamide has a beneficial effect on pulmonary fibrosis would be of great importance by offering a scientific basis for treatment Similarly a negative result demonstrating no benefit from cyclophosphamide therapy would also be important in avoiding hazardous and expensive therapy that is now being used widely
DESIGN NARRATIVE
Multicenter placebo-controlled randomized double-blind Subjects are recruited at 12 clinical centers and randomized to 2 mgkgday of cyclophosphamide or placebo Follow-up visits for pulmonary assessments occur every three months for two years after treatment If patients fail the cyclophosphamide treatment they will be offered azathioprine for the remainder of the 24 month trial The primary endpoint of the study is change in forced vital capacity at the end of 12 months of treatment Secondary endpoints include quality of life activity and dyspnea indices and carbon monoxide diffusing capacity Recruitment ends in December 2003
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01HL060839 | NIH | None | httpsreporternihgovquickSearchU01HL060839 |