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Morbidity and Mortality Follow Up for the Scleroderma Lung Study

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01762449
First received: January 4, 2013
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention
Scleroderma
 Other: Followup survey

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Morbidity and Mortality Follow Up of Participants of the Scleroderma Lung Study 1

Resource links provided by NLM:

MedlinePlus related topics: Scleroderma
U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Time to death or first organ failure [ Time Frame: 9-12 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 158
Study Start Date: July 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01762449     History of Changes
Other Study ID Numbers: Pro00026357
Study First Received: January 4, 2013
Last Updated: May 7, 2013
Health Authority: United States: Institutional Review Board

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
 Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists

ClinicalTrials.gov processed this record on May 23, 2013