Systemic Sclerosis Clinical and Biomarker Study (NCT02531009) | Clinical Trial Compass
WithdrawnNot Applicable
Systemic Sclerosis Clinical and Biomarker Study
0Started 2015-12
Plain-language summary
The primary objective of the study is to assess the change in systemic sclerosis (SSc)-associated gastrointestinal (GI) tract symptoms over a 1-year period in participants with SSc.
Who can participate
Age range18 Years
SexALL
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Key Inclusion Criteria:
Healthy volunteers
* Must be in good health as determined by the Investigator, based on medical history, physical examination, and vital signs.
Participants with diffuse cutaneous systemic sclerosis (dcSSc):
* Must fulfill the 2013 classification criteria for SSc of the American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR).
* Absence of the anti-centromere autoantibody.
Participants with limited cutaneous systemic sclerosis (lcSSc):
* Must fulfill the 2013 classification criteria for SSc of the ACR and EULAR.
* Subjects with lcSSc must have disease duration of less than 5 years.
Key Exclusion Criteria:
* History of any clinically significant medical condition that can interfere with the conduct of the study, or that in the opinion of the Investigator, would compromise data interpretation.
* An active severe infection as determined by the Investigator.
* Female subjects who are pregnant or currently breastfeeding.
* A known history of malignancy.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
What they're measuring
1
Change in University of California at Los Angeles Scleroderma Clinical Trial Consortium GI Tract (UCLA-SCTC GIT) instrument score in participants with SSc