check_circleStudy Completed

Systemic Sclerosis

Bayer Identifier:

20238

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

EU CT Number:

Not Available
Exploration of a composite clinical endpoint in patients with early diffuse cutaneous systemic sclerosis in the Prospective Registry of Early Systemic Sclerosis (PRESS)

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.

Key Participants Requirements

Sex

All

Age

18 Years
  • - 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


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

Trial summary

Enrollment Goal
130
Trial Dates
September 2018 - September 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

  • Disease progression
    Disease 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 echo
    date_rangeTime Frame:
    At 12 ± 3 months

Secondary Outcome

  • Additional disease progression criteria
    The 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%
    date_rangeTime Frame:
    At 12 ± 3 months

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
N/A

Additional Information

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