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
EU CT Number:
Not Available
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 visitExclusion Criteria
- No individuals under the age of 18 will be included in the study
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many locations, United States | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
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
Trial Type:
Observational
Intervention Type:
Other
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Cumulative event rate for a number of single and composite disease progression criteria derived from the composite clinical endpointBased on the proposed composite clinical endpoint, a number of single and composite disease progression criteria will be assessed. The disease progression criteria are defined as change from baseline to any follow-up assessment based on the following variables: • mRSS increase from baseline by ≥ 4 units or ≥20% or • Absolute decline in FVC% predicted from baseline by ≥10% or • IOI, defined as o LVEF ≤ 45% or o Renal crisis or o Pulmonary Hypertension (PH)Timeframe: At 12 ± 3 months
Secondary Outcome
- Mortality for progressors vs non-progressors, as defined using the composite clinical endpointThe PRESS cohort will be stratified into progressors and non-progressors using a composite clinical endpoint assessed at 12+/- 3 months, based on: • mRSS increase from baseline by ≥ 4 units or ≥20% or • Absolute decline in FVC% predicted from baseline by ≥10% or • IOI, defined as o LVEF ≤ 45% or o Renal crisis or o PHTimeframe: At 12 ± 3 months
Additional Information
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