Calcinosis in a Single-Center Scleroderma Population

NCT ID: NCT02062125

Last Updated: 2024-03-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 66 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2024-03-15

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 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.

Conditions

Scleroderma; Calcinosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Adult scleroderma subjects with and without calcinosis

Exclusion Criteria

• Subjects unwilling to participate

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Vivien Hsu, M.D.

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

RWJ Medical School

New Brunswick, New Jersey, United States

Countries

United States

Other Identifiers

Pro2012001886

Identifier Type: -

Identifier Source: org_study_id