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SSc-calcinosis: Calcinosis in a Single-Center Scleroderma Population

Sponsor
Rutgers, The State University of New Jersey (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02062125
Collaborator
(none)
300
Enrollment
1
Location
218
Anticipated Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

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

  1. to identify common complications associated with scleroderma-related calcinosis.

.

Condition or Disease Intervention/Treatment Phase

    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).

    1. 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 Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Prospective, Observational Study of Calcinosis in a Single-Center Population With Scleroderma-Spectrum Disorders
    Actual Study Start Date :
    Oct 31, 2012
    Anticipated Primary Completion Date :
    Oct 31, 2022
    Anticipated Study Completion Date :
    Dec 31, 2030

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Adult scleroderma subjects with and without calcinosis
    Exclusion Criteria:
    • Subjects unwilling to participate

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 RWJ Medical School New Brunswick New Jersey United States 08903

    Sponsors and Collaborators

    • Rutgers, The State University of New Jersey

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vivien Hsu, M.D., Professor of Medicine, Rutgers, The State University of New Jersey
    ClinicalTrials.gov Identifier:
    NCT02062125
    Other Study ID Numbers:
    • Pro2012001886
    First Posted:
    Feb 13, 2014
    Last Update Posted:
    Apr 28, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Vivien Hsu, M.D., Professor of Medicine, Rutgers, The State University of New Jersey
    scleroderma
    calcinosis
    Additional relevant MeSH terms:
    Scleroderma, Systemic
    Scleroderma, Diffuse
    Scleroderma, Localized
    Calcinosis

    Study Results

    No Results Posted as of Apr 28, 2022