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Morbidity and Mortality Follow Up for the Scleroderma Lung Study

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ClinicalTrials.gov Identifier: NCT01762449
Recruitment Status : Completed
First Posted : January 7, 2013
Last Update Posted : January 23, 2014
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief Summary:
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.

Condition or disease Intervention/treatment
Scleroderma Other: Followup survey

Detailed Description:

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.


Study Type : Observational
Actual Enrollment : 158 participants
Observational Model: Cohort
Official Title: Morbidity and Mortality Follow Up of Participants of the Scleroderma Lung Study 1
Study Start Date : July 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : August 2013


Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. Time to death or first organ failure [ Time Frame: 9-12 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who participated in the Scleroderma Lung Study
Criteria

Inclusion Criteria:

  • Participation in the Scleroderma Lung Study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01762449


Sponsors and Collaborators
Duke University
Investigators
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

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01762449     History of Changes
Other Study ID Numbers: Pro00026357
First Posted: January 7, 2013    Key Record Dates
Last Update Posted: January 23, 2014
Last Verified: January 2014

Keywords provided by Duke University:
Scleroderma
interstitial lung disease

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Scleroderma, Localized
Connective Tissue Diseases
Skin Diseases
Cyclophosphamide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists