Systemic Sclerosis Clinical and Biomarker Study

Healthy Clinical Trial

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, Limited Cutaneous Systemic Sclerosis, and Healthy Volunteers

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02531009
• Other study ID #: 995SS001
• Status: Withdrawn
• Phase: N/A
• First received: August 20, 2015
• Last updated: October 30, 2015
• Start date: December 2015
• Est. completion date: March 2017

Study information

• Verified date: October 2015
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Healthy
• Scleroderma, Diffuse
• Scleroderma, Limited
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No