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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Rutgers, The State University of New Jersey
Sponsor:
Information provided by (Responsible Party):
Vivien Hsu, M.D., Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT02062125
First received: February 7, 2014
Last updated: August 1, 2014
Last verified: August 2014
  Purpose

This is a 3 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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Condition
Scleroderma
Calcinosis

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: A Prospective, Observational Study of Calcinosis in a Single-Center Population With Scleroderma-Spectrum Disorders

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • risk factors and outcomes in scleroderma calcinosis [ Time Frame: 3 years ] [ Designated as safety issue: No ]

    This is an observational study of scleroderma calcinosis over 3 years duration, to assess possible risk factors (including serologic studies and disease types) as well as common complications that occur in those with scleroderma calcinosis in this time period.

    No additional intervention will be delivered, other than standard of care for this complication.



Estimated Enrollment: 300
Study Start Date: October 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Adult scleroderma subjects with and without calcinosis will be enrolled

Criteria

Inclusion Criteria:

  • Adult scleroderma subjects with and without calcinosis

Exclusion Criteria:

  • Subjects unwilling to participate
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02062125

Contacts
Contact: Vivien Hsu, MD 732-418-8484 hsuvm@rwjms.rutgers.edu

Locations
United States, New Jersey
RWJ Medical School Recruiting
New Brunswick, New Jersey, United States, 08903
Sponsors and Collaborators
Rutgers, The State University of New Jersey
  More Information

No publications provided

Responsible Party: Vivien Hsu, M.D., Associate Professor of Medicine, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT02062125     History of Changes
Other Study ID Numbers: Pro2012001886
Study First Received: February 7, 2014
Last Updated: August 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Rutgers, The State University of New Jersey:
scleroderma
calcinosis

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Scleroderma, Localized
Calcinosis
Connective Tissue Diseases
Skin Diseases
Calcium Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 18, 2014