NCT01762449

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 7, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

January 23, 2014

Status Verified

January 1, 2014

Enrollment Period

11 months

First QC Date

January 4, 2013

Last Update Submit

January 22, 2014

Conditions

Scleroderma

Keywords

Sclerodermainterstitial lung disease

Outcome Measures

Primary Outcomes (1)

  • Time to death or first organ failure

    9-12 years

Study Arms (2)

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

Interventions

Followup surveyOTHER
Patients who received cyclophosphamidePatients who received placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who participated in the Scleroderma Lung Study

You may qualify if:

  • Participation in the Scleroderma Lung Study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Scleroderma, DiffuseLung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Scleroderma, SystemicConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin DiseasesLung DiseasesRespiratory Tract Diseases

Study Officials

  • Keith Sullivan, MD

    Duke University

    STUDY CHAIR

  • Daniel Furst, MD

    University of California, Los Angeles

    STUDY CHAIR

  • Donald Tashkin, MD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2013

First Posted

January 7, 2013

Study Start

July 1, 2012

Primary Completion

June 1, 2013

Study Completion

August 1, 2013

Last Updated

January 23, 2014

Record last verified: 2014-01