Trial Condition(s):

Systemic Sclerosis

Time to event analysis of components of a composite clinical endpoint for diffuse systemic sclerosis in the prospective registry of early systemic sclerosis (PRESS) cohort

Bayer Identifier:

20556

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

Study Completed

Trial Purpose

The current study aims to inform the development of a clinical study program for potential soluble guanylate cyclase (sGC) in systemic sclerosis (SSc), by conducting a time to event analysis of disease progression in the prospective registry of early systemic sclerosis (PRESS) database.

Inclusion Criteria
- Diagnosis of diffuse systemic sclerosis (dcSSc) fulfilling the 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
239
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