Calcinosis in a Single-Center Scleroderma Population (SSc-calcinosis)
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|ClinicalTrials.gov Identifier: NCT02062125|
Recruitment Status : Active, not recruiting
First Posted : February 13, 2014
Last Update Posted : April 29, 2019
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.
|Condition or disease|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||300 participants|
|Target Follow-Up Duration:||10 Years|
|Official Title:||A Prospective, Observational Study of Calcinosis in a Single-Center Population With Scleroderma-Spectrum Disorders|
|Actual Study Start Date :||October 2012|
|Estimated Primary Completion Date :||October 2022|
|Estimated Study Completion Date :||December 2030|
- risk factors and outcomes in scleroderma calcinosis [ Time Frame: 10 years ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02062125
|United States, New Jersey|
|RWJ Medical School|
|New Brunswick, New Jersey, United States, 08903|