Skip Navigation
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Your Environment. Your Health.

Calcinosis Study

Closed for Recruitment

Study Background

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
Adam I. Schiffenbauer, M.D.
Deputy Head and Associate Research Physician
Tel 301-451-6270
adam.schiffenbauer@nih.gov
10 Center Dr
NIHBC 10 - CLINICAL CENTER - MAGNUSON
Bethesda, MD 20892-1627

Lead Associate Investigator

Lisa Rider, M.D.
Lisa Rider, M.D.
Head and Senior Clinician
Tel 301-451-6272
riderl@mail.nih.gov
10 Center Dr
NIHBC 10 - CRC - HATFIELD
Bethesda, MD 20892-1301
Back
to Top