Calcinosis in a Single-Center Scleroderma Population

Scleroderma Clinical Trial

— SSc-calcinosis  

Official title:

A Prospective, Observational Study of Calcinosis in a Single-Center Population With Scleroderma-Spectrum Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02062125
• Other study ID #: Pro2012001886
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Calcinosis
• Scleroderma
• Scleroderma, Diffuse
• Scleroderma, Localized
• Scleroderma, Systemic

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