Calcinosis in a Single-Center Scleroderma Population

Completed

• Conditions: Calcinosis; Scleroderma

• Registration Number: NCT02062125
• Lead Sponsor: Rutgers, The State University of New Jersey

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.

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Detailed 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.

Study Timeline

• Study Start: 2012-10-31
• Study First Submitted: 2014-02-07
• Study First Submitted QC: 2014-02-10
• Study First Posted: 2014-02-13
• Status Verified: 2024-03
• Primary Completion: 2024-03-15
• Study Completion: 2024-03-15
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• Adult scleroderma subjects with and without calcinosis

Exclusion Criteria

• Subjects unwilling to participate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
risk factors and outcomes in scleroderma calcinosis	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.

Trial Locations

Locations (1)

RWJ Medical School; 🇺🇸 New Brunswick, New Jersey, United States