Systemic Sclerosis Clinical and Biomarker Study

NCT02531009 | Withdrawn

• 1 other identifier: 995SS001
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy; Systemic Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Healthy

Approximately 10 healthy adults will be enrolled into this study

SSc

Participants with dcSSc and lcSSc

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study participants will be recruited at participating locations in a standard clinical practice setting.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Biospecimen

Retention: SAMPLES WITH DNA

RNA (ribonucleic acid) will be extracted for gene expression from the skin biopsies, skin tape, and blood.

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2015
• First Posted: August 21, 2015
• Study Start: December 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: November 2, 2015

Record last verified: 2015-10