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CompletedNCT02062125SSc-calcinosisUpdated Mar 21, 2024

Calcinosis in a Single-Center Scleroderma Population

An observational study in Scleroderma and Calcinosis, sponsored by Rutgers, The State University of New Jersey. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-03-21.

Sponsored by Rutgers, The State University of New Jersey · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
66
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

.

Read the 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.

02

Conditions studied

  • Scleroderma
  • Calcinosis

Keywords

  • scleroderma
  • calcinosis
03

In context

Scleroderma, Diffuse

310 studies on the registry are indexed under Scleroderma, Diffuse; 76 are open to participants now.

This study's enrollment of 66 is below the median of 113 across 68 observational studies indexed under Scleroderma, Diffuse.

Browse Scleroderma, Diffuse studies →

Lead sponsor

Rutgers, The State University of New Jersey is the lead sponsor of 506 studies on the registry; 131 are open to participants now.

Of its 39 completed or terminated interventional studies of FDA-regulated products, 31 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Adult scleroderma subjects with and without calcinosis will be enrolled

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult scleroderma subjects with and without calcinosis

Exclusion criteria

Exclusion Criteria:

  • Subjects unwilling to participate
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
66 participants (actual)
Target follow-up
10 Years
Patient registry
Yes
06

What researchers measure

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.

    Time frame: 10 years

07

Study locations

1 site
  • RWJ Medical School
    New Brunswick, New Jersey 08903, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2012 to primary completion in Mar 2024, 136 months.

Of 32 observational studies under Scleroderma, Diffuse, half reached primary completion within 80 months of starting (the median), counting those still running; a quarter within 44. This study's 136 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 7, 2014
First posted
Feb 13, 2014
StartActual
Oct 31, 2012
Primary completionActual
Mar 15, 2024
CompletionActual
Mar 15, 2024
Last update
Mar 21, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02062125
Responsible party
Vivien Hsu, M.D. (Professor of Medicine, Rutgers, The State University of New Jersey) — Principal investigator
First posted
Feb 13, 2014
Start date
Oct 31, 2012
Primary completion
Mar 15, 2024
Completion
Mar 15, 2024
Last update
Mar 21, 2024

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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