Calcinosis in a Single-Center Scleroderma Population (SSc-calcinosis)

March 20, 2024 updated by: Vivien Hsu, M.D., Rutgers, The State University of New Jersey

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

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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Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

66

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • RWJ Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adult scleroderma subjects with and without calcinosis will be enrolled

Description

Inclusion Criteria:

  • Adult scleroderma subjects with and without calcinosis

Exclusion Criteria:

  • Subjects unwilling to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rutgers, The State University of New Jersey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2012

Primary Completion (Actual)

March 15, 2024

Study Completion (Actual)

March 15, 2024

Study Registration Dates

First Submitted

February 7, 2014

First Submitted That Met QC Criteria

February 10, 2014

First Posted (Estimated)

February 13, 2014

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro2012001886

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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