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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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