Systemic Sclerosis Clinical and Biomarker Study

Withdrawn

• Conditions: Healthy; Systemic Sclerosis

• Registration Number: NCT02531009
• Lead Sponsor: Biogen

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2015-08-20
• Study First Submitted QC: 2015-08-20
• Study First Posted: 2015-08-21
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-30
• Last Update Posted: 2015-11-01
• Study Start: 2015-12
• Primary Completion: 2017-03
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in University of California at Los Angeles Scleroderma Clinical Trial Consortium GI Tract (UCLA-SCTC GIT) instrument score in participants with SSc	Baseline to Month 12	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.