Systemic Sclerosis Clinical and Biomarker Study

Biogen

Status

Withdrawn

Conditions

Healthy

Systemic Sclerosis

Study type

Observational

Funder types

Industry

Identifiers

NCT02531009

995SS001

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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