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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.
No study treatment will be administered. Study participants will continue to be treated by their respective physicians according to standard clinical practice. Data on concomitant therapy and procedures, administered as part of standard of care, will be collected at baseline and at each study visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy | Approximately 10 healthy adults will be enrolled into this study | ||
| SSc | Participants with dcSSc and lcSSc |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in University of California at Los Angeles Scleroderma Clinical Trial Consortium GI Tract (UCLA-SCTC GIT) instrument score in participants with SSc | This participant-reported assessment is a 34-item instrument designed to measure GI tract involvement in participants with SSc. The UCLA SCTC GIT 2.0 has 7 multi-item scales: Reflux, Distension/Bloating, Diarrhea, Fecal Soilage, Constipation, Emotional Well-being, and Social Functioning and a total GIT score. All scales are scored from 0 [better health-related quality of life (HRQOL)] to 3 (worse HRQOL) except the diarrhea and constipation scales (ranges 0-2 and 0-2.5, respectively). The Total GIT Score, is developed by averaging 6 of 7 scales (excluding constipation) with lower scores indicating better HRQOL. | Baseline to Month 12 |
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Key Inclusion Criteria:
Healthy volunteers
Participants with diffuse cutaneous systemic sclerosis (dcSSc):
Participants with limited cutaneous systemic sclerosis (lcSSc):
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
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Study participants will be recruited at participating locations in a standard clinical practice setting.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
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| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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RNA (ribonucleic acid) will be extracted for gene expression from the skin biopsies, skin tape, and blood.