check_circleStudy Completed

Systemic sclerosis

Bayer Identifier:

20556

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

EU CT Number:

Not Available
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 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.

Key Participants Requirements

Sex

N/A

Age

18 Years
  • - 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


  • - No individuals under the age of 18 will be included in the study

Trial summary

Enrollment Goal
239
Trial Dates
October 2018 - December 2018
Phase
N/A
Could I Receive a placebo
No
Products
Unspecified
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
United States

Primary Outcome

  • Cumulative event rate for a number of single and composite disease progression criteria derived from the composite clinical endpoint
    Based 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)
    date_rangeTime Frame:
    At 12 ± 3 months

Secondary Outcome

  • Mortality for progressors vs non-progressors, as defined using the composite clinical endpoint
    The 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 PH
    date_rangeTime Frame:
    At 12 ± 3 months

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
N/A

Additional Information

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