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
EU CT Number:
Not Available
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
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
Exploration of a composite clinical endpoint in patients with early diffuse cutaneous systemic sclerosis in the Prospective Registry of Early Systemic Sclerosis (PRESS)
Trial Type:
Observational
Intervention Type:
Other
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Disease progressionDisease progression criteria were defined as change from baseline to follow-up assessment at 12±3 months based on the following variables: • Modified Rodnan skin score mRSS progression (mRSS increase by ≥4 units or ≥20%) • Forced vital capacity (FVC) progression (FVC% predicted absolute decline ≥10%) • IOI: internal organ involvement • Pulmonary Hypertension (PH) on echo • mRSS or FVC progression • mRSS progression or IOI • FVC progression or IOI • Composite clinical endpoint (mRSS or FVC progression or IOI) • Composite clinical endpoint including PH on echoTimeframe: At 12 ± 3 months
Secondary Outcome
- Additional disease progression criteriaThe secondary variables utilized alternative cut-offs for the variables listed above, to define disease progression, previously applied in the literature. These five criteria were also defined as change from baseline to follow-up assessment at 12±3 months based on the following variables: • mRSS >5 units or ≥25% • FVC% predicted relative decline ≥15% • mRSS >5 units or ≥25% or IOI • mRSS >5 units or ≥ 25% or FVC%predicted absolute decline ≥10% • mRSS >5 units or ≥25% or FVC%predicted relative decline ≥15%Timeframe: At 12 ± 3 months
Additional Information
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