Clinical Trial: Calcinosis in a Single-Center Scleroderma Population
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]
Official Title: A Prospective, Observational Study of Calcinosis in a Single-Center Population With Scleroderma-Spectrum Disorders
Brief 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.
Detailed Summary:
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.
Sponsor: Rutgers, The State University of New Jersey
Current Primary Outcome: risk factors and outcomes in scleroderma calcinosis [ Time Frame: 10 years ]
This is an observational study of scleroderma calcinosis over 3 years duration, to assess possible risk factors (including serologic studies and disease types) as well as common complications that occur in those with scleroderma calcinosis in this time period.
No additional intervention will be delivered, other than standard of care for this complication.
Original Primary Outcome: risk factors and outcomes in scleroderma calcinosis [ Time Frame: 3 years ]
This is an observational study of scleroderma calcinosis over 3 years duration, to assess possible risk factors (including serologic studies and disease types) as well as common complications that occur in those with scleroderma calcinosis in this time period.
No additional intervention will be delivered, other than standard of care for this complication.
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Rutgers, The State University of New Jersey
Dates:
Date Received: February 7, 2014
Date Started: October 2012
Date Completion: December 2030
Last Updated: November 17, 2016
Last Verified: November 2016
