Calcinosis Study | National Institute of Environmental Health Sciences
Source: https://www.niehs.nih.gov/research/atniehs/labs/crb/studies/closed-studies/calcinosis
Archived: 2026-04-23 17:18
Calcinosis Study | National Institute of Environmental Health Sciences
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Calcinosis Study
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Closed for Recruitment
Study Background
This study is no longer accepting participants.
To find studies that are currently recruiting, please visit the
Join an
NIEHS Study
website
For More Information
ClinicalTrials.gov
NIH Clinical Studies
This study is aiming to find out more about calcinosis, the development of calcium deposits in various parts of the body, in people with dermatomyositis (DM) and juvenile dermatomyositis (JDM). Calcinosis can be painful and cause disabilities and other problems, so scientists want to find treatments for it. This study is examining the safety and efficacy of a medication to treat calcinosis, called sodium thiosulfate.
Eligibility Criteria
Participants aged 7 older
Meets Bohan and Peter criteria, as modified by the International Myositis Assessment and Clinical Studies Group (IMACS), for probable or definite DM or JDM
Has extensive calcinosis, defined as calcinosis involving at least 2 extremities or the torso
Has moderate to severe calcinosis, defined as having a calcinosis activity visual analogue scale score of greater than or equal to 3.5 cm out of 10 cm
Is willing and able to comply with the requirements of the protocol and to undergo all testing
Can have IV access established to receive study infusions
Myositis disease activity is stable
Medications for myositis are stable for at least 6 weeks prior to study entry
Men and women of reproductive potential must agree to use a reliable form of birth control during the 62-week duration of the study
Subjects or their legal guardian must sign a written informed consent
Stable myositis disease activity will be defined by physician global and patient/parent global VAS that are < 4 cm, as well as creatine kinase (CK), lactate dehydrogenase (LDH), aldolase, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) that are less than or equal to 2X upper limit of normal (ULN).
If a patient has a medication for myositis changed in this window for reasons besides their myositis activity and has returned to their baseline medication use prior to enrollment they will still be eligible.
Principal Investigator
Adam I. Schiffenbauer, M.D.
Deputy Head and Associate Research Physician
Tel 301-451-6270
[email protected]
Lead Associate Investigator
Lisa G. Rider, M.D.
Head and Senior Clinician
Tel 301-451-6272
[email protected]
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Last Reviewed: December 30, 2025
Skip Navigation
Calcinosis Study
Close the left navigation
Add
Closed for Recruitment
Study Background
This study is no longer accepting participants.
To find studies that are currently recruiting, please visit the
Join an
NIEHS Study
website
For More Information
ClinicalTrials.gov
NIH Clinical Studies
This study is aiming to find out more about calcinosis, the development of calcium deposits in various parts of the body, in people with dermatomyositis (DM) and juvenile dermatomyositis (JDM). Calcinosis can be painful and cause disabilities and other problems, so scientists want to find treatments for it. This study is examining the safety and efficacy of a medication to treat calcinosis, called sodium thiosulfate.
Eligibility Criteria
Participants aged 7 older
Meets Bohan and Peter criteria, as modified by the International Myositis Assessment and Clinical Studies Group (IMACS), for probable or definite DM or JDM
Has extensive calcinosis, defined as calcinosis involving at least 2 extremities or the torso
Has moderate to severe calcinosis, defined as having a calcinosis activity visual analogue scale score of greater than or equal to 3.5 cm out of 10 cm
Is willing and able to comply with the requirements of the protocol and to undergo all testing
Can have IV access established to receive study infusions
Myositis disease activity is stable
Medications for myositis are stable for at least 6 weeks prior to study entry
Men and women of reproductive potential must agree to use a reliable form of birth control during the 62-week duration of the study
Subjects or their legal guardian must sign a written informed consent
Stable myositis disease activity will be defined by physician global and patient/parent global VAS that are < 4 cm, as well as creatine kinase (CK), lactate dehydrogenase (LDH), aldolase, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) that are less than or equal to 2X upper limit of normal (ULN).
If a patient has a medication for myositis changed in this window for reasons besides their myositis activity and has returned to their baseline medication use prior to enrollment they will still be eligible.
Principal Investigator
Adam I. Schiffenbauer, M.D.
Deputy Head and Associate Research Physician
Tel 301-451-6270
[email protected]
Lead Associate Investigator
Lisa G. Rider, M.D.
Head and Senior Clinician
Tel 301-451-6272
[email protected]
Back
to Top
Last Reviewed: December 30, 2025