Study of Sodium Thiosulfate Injections for Patients with Ectopic Calcifications or Ossifications from Dermatomyositis, Systemic Sclerosis, or iPPSD2

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for certain types of abnormal tissue growths in the body. These growths are known as ectopic calcifications and ectopic ossifications. The trial is specifically looking at these conditions when they occur due to three diseases: dermatomyositis, systemic sclerosis, and a rare condition called iPPSD2. The treatment being tested is a solution called sodium thiosulfate, which is given as an injection under the skin.

The purpose of the study is to see how effective sodium thiosulfate is in reducing these abnormal growths over a period of six months. Participants will first go through a six-month observation period, followed by six months of receiving the treatment. During this time, the size of the growths will be monitored using imaging techniques, and any changes in pain or quality of life will also be assessed.

This study aims to provide valuable information on whether sodium thiosulfate can help manage these conditions and improve the lives of those affected by them. Participants will be closely monitored for any side effects or changes in their condition throughout the study period.

1 initial assessment

The trial begins with an initial assessment to confirm eligibility. This includes a review of medical history and current health status.

Eligibility is based on the presence of ectopic calcification or ossification due to specific conditions such as dermatomyositis, systemic sclerosis, or iPPSD2.

2 run-in period

A run-in period of 6 months is conducted before the main treatment phase. During this time, no active treatment is administered.

This period is used to establish baseline measurements of the calcifications or ossifications using CT scans.

3 treatment phase

The treatment phase lasts for 6 months, during which a 10% solution of sodium thiosulfate is injected subcutaneously.

The injections are administered locally to the affected areas to evaluate their effect on the calcifications or ossifications.

4 monitoring and evaluation

Throughout the treatment phase, regular monitoring is conducted to assess the volume of calcifications or ossifications using CT scans.

Additional evaluations include monitoring for any adverse events, changes in bone density, and pain levels associated with the treatment.

5 final assessment

At the end of the treatment phase, a final assessment is conducted to measure the percentage change in the volume of calcifications or ossifications.

The final assessment also includes evaluations of pain and quality of life to determine the overall impact of the treatment.

Who Can Join the Study?

The patient must have ectopic calcification (abnormal calcium deposits in the body) due to dermatomyositis (a condition causing skin and muscle inflammation) or systemic sclerosis (a disease causing hardening of the skin and connective tissues) and be 18 years or older.
Alternatively, the patient can have ectopic ossification (abnormal bone formation) due to iPPSD2 (a specific genetic condition) and be between 2 and 30 years old.
The need for STS infusion (a treatment involving a specific solution) must be confirmed by a group of medical experts, based on the significant health impact of the calcification or ossification.
The patient should not have any planned surgery for the calcifications or ossifications in the next 12 months.
Women who can have children must use highly effective birth control methods, such as hormonal contraception, an intrauterine device, or other reliable methods, during the study and for one month after the last injection. Men with partners who can have children should use condoms during the study and for 91 days after the last injection.
The patient or their parents must sign a form agreeing to participate in the study.
The patient must be part of or have benefits from the social security system.

Who Cannot Join the Study?

Patients who have a different condition than those specified, such as ectopic ossification or ectopic calcification due to other causes.
Patients who are not within the specified age range for the study.
Patients who are not able to give informed consent or understand the study requirements.
Patients who are pregnant or breastfeeding.
Patients who have a history of allergic reactions to the treatment being tested.
Patients who are currently participating in another clinical trial.
Patients with severe health conditions that could interfere with the study.
Patients who have had recent surgery or are planning to have surgery during the study period.
Patients who are unable to comply with the study procedures and visits.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire Rouen	Rouen	France
Centre Hospitalier Universitaire De Rennes	Rennes	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Clpids Hbbgscdqvto El Ulhrjofxbjuoj Dy Llsjqfc	Limoges	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	05.06.2020

Trial locations

Investigated drugs:

Sodium Thiosulfate Pentahydrate

Sodium Thiosulfate: This medication is used in the trial to treat abnormal calcium deposits in the body, known as calcifications, and unwanted bone growths, known as ossifications. It is administered through subcutaneous injections, which means it is injected under the skin. The study aims to see how effective this treatment is over a period of six months for conditions like dermatomyositis, systemic sclerosis, and iPPSD2.

Investigated diseases:

Dermatomyositis – Dermatomyositis is an inflammatory disease characterized by muscle weakness and a distinctive skin rash. The condition often begins with a violet or dusky red rash, typically on the face, eyelids, knuckles, elbows, knees, chest, and back. Muscle weakness usually affects the muscles closest to the trunk, such as those in the hips, thighs, shoulders, and neck. Over time, the weakness can make it difficult to climb stairs, lift objects, or even rise from a seated position. The disease can also cause joint pain, fatigue, and difficulty swallowing. In some cases, calcifications can form in the skin and muscles, leading to further complications.

Systemic Sclerosis – Systemic sclerosis, also known as scleroderma, is a chronic connective tissue disease characterized by changes in the skin, blood vessels, muscles, and internal organs. The disease often begins with skin thickening and hardening, particularly on the hands and face. Over time, it can lead to restricted movement and joint pain. Systemic sclerosis can also affect internal organs, such as the lungs, heart, and kidneys, leading to a range of symptoms depending on the organs involved. The condition may cause calcifications in the skin and other tissues, contributing to stiffness and discomfort. The progression and severity of symptoms can vary widely among individuals.

iPPSD2 – iPPSD2, or idiopathic progressive pseudorheumatoid dysplasia type 2, is a rare genetic disorder that affects bone and joint development. It is characterized by progressive joint stiffness, pain, and swelling, often beginning in childhood. The condition can lead to a decrease in joint mobility and may cause deformities over time. Ectopic ossification, or abnormal bone formation in soft tissues, is a common feature of iPPSD2. This can result in additional stiffness and discomfort, impacting daily activities. The progression of symptoms can vary, with some individuals experiencing more severe effects than others.

Trial ID:

2024-511620-13-00

Protocol code:

I17004

NCT ID:

NCT03582800

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Sodium Thiosulfate Injections for Patients with Ectopic Calcifications or Ossifications from Dermatomyositis, Systemic Sclerosis, or iPPSD2

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?