NCT02531009

Systemic Sclerosis Clinical and Biomarker Study

A Multicenter, Prospective, Longitudinal Study to Evaluate Gastrointestinal Function and Clinical and Molecular Biomarkers in Subjects With Early and Late Diffuse Cutaneous Systemic Sclerosis, Limited Cutaneous Systemic Sclerosis, and Healthy Volunteers

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy
• Systemic Sclerosis

Timeline

• Start date: 2015-12-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2015-08-21
• Last updated: 2015-11-02