Morbidity and Mortality Follow Up for the Scleroderma Lung Study
The primary intent of this study is to add to the body of knowledge on scleroderma patients with interstitial lung disease. While lung disease is recognized as the leading cause of death amongst patients with scleroderma, there is not a large body of literature describing the long-term morbidity and mortality rate of these scleroderma patients. For this reason, the investigators are following participants of the Scleroderma Lung Study (NCT00004563) after their participation in that study was concluded. In addition, the investigators will assess if the subjects who received one year of oral cyclophosphamide in the Scleroderma Lung Study experienced progression of their scleroderma-related lung disease following the end of the study.
|Study Design:||Observational Model: Cohort|
|Official Title:||Morbidity and Mortality Follow Up of Participants of the Scleroderma Lung Study 1|
- Time to death or first organ failure [ Time Frame: 9-12 years ] [ Designated as safety issue: No ]
|Study Start Date:||July 2012|
|Study Completion Date:||August 2013|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Patients who received cyclophosphamide
Patients who received cyclophosphamide on the Scleroderma Lung Study
|Other: Followup survey|
Patients who received placebo
Patients who received placebo on the Scleroderma Lung Study
|Other: Followup survey|
Retrospective and prospective data will be collected about patients who participated in the Scleroderma Lung Study (SLS). An attempt will be made to include all of the participants of the Scleroderma Lung Study, who were reported as alive at the end of that study.
A total of 158 subjects (79 per treatment arm) were randomized on the original Scleroderma Lung Study. Of those, 109 subjects completed the study. A single telephone interview with the participants to assess the occurrence of severe events and a review of the participant's medical records may be conducted. The outcome information will be combined with information collected about all participants in the SLS study. The data being collected includes information on mortality, development of cancers, development of organ failure, and performance status.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01762449
|Study Chair:||Keith Sullivan, MD||Duke University|
|Study Chair:||Daniel Furst, MD||University of California, Los Angeles|
|Principal Investigator:||Donald Tashkin, MD||University of California, Los Angeles|