Clinical Trial: Systemic Sclerosis Clinical and Biomarker Study

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Observational

Official Title: A Multicenter, Prospective, Longitudinal Study to Evaluate Gastrointestinal Function and Clinical and Molecular Biomarkers in Subjects With Early and Late Diffuse Cutaneous Systemic Sclerosis,

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 Summary: 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.
Sponsor: Biogen

Current Primary Outcome: Change in University of California at Los Angeles Scleroderma Clinical Trial Consortium GI Tract (UCLA-SCTC GIT) instrument score in participants with SSc [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Biogen

Dates:
Date Received: August 20, 2015
Date Started: December 2015
Date Completion: March 2017
Last Updated: October 30, 2015
Last Verified: October 2015