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Sodium Thiosulfate for Dermatomyositis
Study Summary
This trial is testing whether sodium thiosulfate can treat people with dermatomyositis who have calcinosis.
- Dermatomyositis
- Inflammatory Myopathies
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2023 Phase 2 & 3 trial • 15 Patients • NCT03267277Trial Design
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- You have widespread calcinosis, which means it affects at least two limbs or the torso.Your myositis disease is not changing or getting worse.You have severe myositis, based on your or your parent's/physician's assessment of the disease activity.You have increased your medication for myositis within the last 2 months.You have changed your calcinosis medications in the past 2 months. This includes drugs like alendronate, etidronate, pamidronate, probenecid, colchicine, diltiazem, thalidomide, and aluminum hydroxide.You have taken probenecid, diltiazem, aluminum hydroxide, or hydrochlorothiazide in the 2 months before joining the study.You have severe heart, kidney, or liver problems, or a history of certain heart rhythm issues, kidney stones, or specific electrolyte imbalances.You have very weak bones or have had a bone break in the past year.You have trouble swallowing and need to eat using methods other than your mouth.You need extra oxygen to help you breathe.You have had more than three episodes of a skin infection called cellulitis that required strong antibiotics in the past year, or had cellulitis within one month before the study.You have taken or are currently taking sodium thiosulfate in any form.You are taking more than 1mg of prednisone per kilogram of body weight each day, or an equivalent amount of another oral corticosteroid.You weigh less than 26 kilograms.You are on a different schedule for taking steroids or IVIG than every 1, 2, or 5 weeks.You have a long-term infection like hepatitis, HIV, HTLV 1, or HTLV 2 that could make it hard to check for muscle disease.You have experienced a serious diabetes-related problem in the year before joining the study.Your hemoglobin level is too low, which may not be safe for you to take part in the study.You have been diagnosed with dermatomyositis or juvenile dermatomyositis following specific medical criteria.You have had cancer within the past 5 years, except for non-threatening skin growths or basal cell carcinoma.You have certain autoimmune diseases or conditions that cause calcinosis.You are taking any medications that might change how sodium thiosulfate works in your body.You have had problems with alcohol or drug abuse in the last 6 months before joining the study.You have widespread calcinosis affecting at least two limbs or the torso.You have a moderate to severe level of calcinosis, with a score of 3.5 or higher on a pain scale.Your myositis condition is not changing or getting worse.Your myositis disease is stable if your doctor and you rate it as less than 4 out of 10, and certain blood tests are within a specific range.If you changed your myositis medication for reasons other than your myositis symptoms, but then went back to your original medication before joining the study, you can still participate.
- Group 1: Treatment
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many volunteers are currently testing this treatment?
"That is correct, the online information indicates that this trial is still looking for patients. The posting went up on October 5th, 2017 and was updated November 1st, 2022. They require 250 individuals total from 1 location."
Are volunteers being accepted for this experiment currently?
"The trial is currently looking for candidates, with the most recent update being on 11/1/2022. The study is looking to recruit 250 patients from 1 site."
Would someone below the age of 55 be able to join this research project?
"Eligibility for this particular clinical trial is determined by age, with patients falling between the age of 7 to 99 being able to enroll. There are 17 other clinical trials specifically for individuals under 18 and 95 for senior citizens."
Do I fit the prerequisites to be a part of this clinical trial?
"This trial is looking for 250 people with dermatomyositis, aged 7 to 99. To be eligible, participants must also have extensive calcinosis (involving at least 2 extremities or the torso), 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), and be willing and able to comply with the requirements of the protocol and undergo all testing. IV access must also be established in order to receive study infusions."
Is Sodium Thiosulfate a new medication for testing?
"At this moment, there are 17 live studies investigating Sodium Thiosulfate. Out of these, 3 are in Phase 3. The research is being conducted in many places, with the greatest density being in Auburn, New South Wales. However, there are a total of 65 trial locations."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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