NCT02062125

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. .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 31, 2012

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 13, 2014

Completed
10.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2024

Completed
Last Updated

March 21, 2024

Status Verified

March 1, 2024

Enrollment Period

11.4 years

First QC Date

February 7, 2014

Last Update Submit

March 20, 2024

Conditions

SclerodermaCalcinosis

Keywords

sclerodermacalcinosis

Outcome Measures

Primary Outcomes (1)

  • risk factors and outcomes in scleroderma calcinosis

    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

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult scleroderma subjects with and without calcinosis will be enrolled

You may qualify if:

  • Adult scleroderma subjects with and without calcinosis

You may not qualify if:

  • Subjects unwilling to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RWJ Medical School

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Conditions

Scleroderma, DiffuseCalcinosis

Condition Hierarchy (Ancestors)

Scleroderma, SystemicConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin DiseasesCalcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

February 7, 2014

First Posted

February 13, 2014

Study Start

October 31, 2012

Primary Completion

March 15, 2024

Study Completion

March 15, 2024

Last Updated

March 21, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)