Trial Condition(s):

Systemic Sclerosis

Exploration of a composite clinical endpoint in patients with early diffuse cutaneous systemic sclerosis in the Prospective Registry of Early Systemic Sclerosis (PRESS)

Bayer Identifier:

20238

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

Study Completed

Trial Purpose

The current study aims to explore the application of a composite clinical endpoint to define disease progression in a population of patients with early diffuse cutaneous systemic sclerosis (dcSSc), based on worsening of skin fibrosis, decline of lung function and SSc-related internal organ involvement (IOI) and to describe what proportion of patients meet the progression criteria within one year of entering the PRESS registry.

Inclusion Criteria
- diagnosis of dcSSc fulfilling American College of Rheumatology (ACR) 2013 criteria 
- a maximum of two years since first non-Raynaud’s symptoms 
- valid measurements of at least one of the three progression criteria at baseline and at least one follow-up, with a time interval of 12±3 months after the baseline visit
Exclusion Criteria
- No individuals under the age of 18 will be included in the study

Trial Summary

Enrollment Goal
130
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
Unspecified
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many locations, United States

Status
Completed
 

Trial Design