Sodium Thiosulfate for Treatment of Calcinosis Associated With Juvenile and Adult Dermatomyositis (NCT03267277) | Clinical Trial Compass
CompletedPhase 2/3
Sodium Thiosulfate for Treatment of Calcinosis Associated With Juvenile and Adult Dermatomyositis
United States15 participantsStarted 2017-10-05
Plain-language summary
Background:
Dermatomyositis (DM) and juvenile dermatomyositis (JDM) cause inflammation in the muscles. People with DM and JDM can develop calcium deposits in places they should not, known as calcinosis. Calcinosis can be painful and cause disabilities and other problems. Researchers want to learn more about calcinosis to find treatments for it.
Objective:
To test if sodium thiosulfate (STS) can treat people with DM with calcinosis.
Eligibility:
People ages 7 and older who have moderate or severe calcinosis. They must have stable DM and calcium deposits in the torso or at least 2 limbs.
Design:
Participants will be screened with:
* Medical history
* Physical exam
* Muscle strength and function tests
* Blood and urine tests
Participants will have several visits:
* 7-day pre-treatment visit about 10 weeks before starting STS
* Treatment visits over 10 weeks. They will get STS 3 times a week through IV infusion. They may be hospitalized the whole time. If they tolerate the drug, they may be discharged at certain times. During these times, they will return for the infusions.
* 3- to 5-day post-treatment visits 24 weeks and 62 weeks after starting STS.
Visits may include repeats of screening tests and:
* Questionnaires
* Scans: They lie in a machine that takes pictures of the body. They may be injected with a radioactive agent.
* Durometry: A small instrument applies pressure on the skin or exposed calcinosis.
* Measurements of blood flow in the arms and fingernail blood vessels
* Photographs of the skin
* Kidney ultrasound
* Tests of kidney function
* Calcinosis aspiration: A needle placed into areas of calcinosis removes liquid.
Who can participate
Age range7 Years
SexALL
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Inclusion criteria
✓. At least 7 years of age
✓. 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\*\*
Exclusion criteria
✕. Is pregnant or breastfeeding
What they're measuring
1
Change in Calcinosis Activity Visual Analogue Scale Score
Timeframe: Week 10 minus week 0 (on therapy) and week 0 minus week -10 (baseline)
Trial details
NCT IDNCT03267277
SponsorNational Institute of Environmental Health Sciences (NIEHS)
. Has known allergies to sodium thiosulfate, any of its components, or dextrose
✕. Has severe myositis disease activity as defined by patient/parent or physician global activity visual analogue scale score \>4 cm out of 10 cm
✕. Has had an escalation of immunosuppressive therapy in the 2 months prior to enrollment for the purpose of treating active myositis disease activity, including the addition of a new agent to treat the patients underlying disease or an increase in dose of an existing medication used to treat the patient's disease (other than an adjustment for weight or body surface area in children)
✕. Has a malignancy or had a malignancy within 5 years of diagnosis of their DM (except for benign skin lesions or basal cell carcinoma)
✕. Known or suspected history of alcohol or drug abuse in the 6 months prior to study enrollment
✕. Has systemic lupus erythematosus, scleroderma, or a condition other than DM that is associated with calcinosis as a complication
✕. Has had a change in medications used specifically for calcinosis in the 2 months prior to enrollment, including but not limited to alendronate, etidronate, pamidronate, probenecid, colchicine, diltiazem, thalidomide, and aluminum hydroxide