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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02062125
Other study ID # Pro2012001886
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 31, 2012
Est. completion date March 15, 2024

Study information

Verified date March 2024
Source Rutgers, The State University of New Jersey
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

This is a 10 year study of scleroderma patients with calcinosis 1) to better understand how common and if there are any risk factors for having calcinosis 2) to identify common complications associated with scleroderma-related calcinosis. .


Description:

This is a prospective study of scleroderma- spectrum patients focused on soft tissue calcinosis in order 1) to better understand the risk factors (including clinical/laboratory characteristics, and serology) of calcinosis in the scleroderma-spectrum disorders (limited or diffuse systemic sclerosis with or without overlap of inflammatory arthritis and/or myositis). 2) view common complications associated with calcinosis. Better understanding of scleroderma calcinosis would lead to other studies that eventually will define better treatment options for this incurable and often disabling complication.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date March 15, 2024
Est. primary completion date March 15, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - Adult scleroderma subjects with and without calcinosis Exclusion Criteria: - Subjects unwilling to participate

Study Design


Locations

Country Name City State
United States RWJ Medical School New Brunswick New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary risk factors and outcomes in scleroderma calcinosis This is an observational study of scleroderma calcinosis to assess possible risk factors (including serologic studies and disease types) as well as common complications that occur in those with scleroderma calcinosis during this time period. We will assess for increased burden of calcinosis with associated musculoskeletal complications from calcinosis over 10 years.
No additional intervention will be delivered, other than standard of care for this complication.
10 years
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