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New treatment option for Systemic Sclerosis
Official title Subcutaneous Injection of Sodium Thiosulfate for Ectopic Calcifications or Ossifications. A Pilot Study
ClinicalTrials.gov ID: NCT03582800
What this study is testing
What is STS?
STS is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for systemic sclerosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Ectopic soft tissue calcifications or ossifications can complicate the course of numerous diseases; most of them are rare or very rare. Even if the clinical, radiological and pathological presentation of ectopic calcifications and ossifications are different, the same hypotheses are discussed considering their hypothetical pathophysiology.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 and older
You may be able to join if
- Patient presenting with:
- ectopic ossification secondary to iPPSD2 or
- ectopic calcification secondary to dermatomyositis or
- ectopic calcification secondary to systemic sclerosis
- Patient aged 2 years or over
You likely can't join if
- Allergy to STS or one of the excipients used
- Contraindication to local injection of STS
- Anticoagulant therapy
- Pregnant, parturient or breastfeeding woman
- Patient deprived of freedom by a court judgment or an administrative decision
- Patient undergoing psychiatric care under coercion
See the full eligibility criteria
- Patient presenting with:
- ectopic ossification secondary to iPPSD2 or
- ectopic calcification secondary to dermatomyositis or
- ectopic calcification secondary to systemic sclerosis
- Patient aged 2 years or over
- Indication of STS infusion validated by a multidisciplinary committee, based on the significant morbidity and/or functional impact of the targeted calcification/ossification
- Patient with no planned surgery of the calcifications/ossifications for the twelve coming months
- Women of childbearing potential on highly effective contraception (such as hormonal contraception, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner or sexual...
- Men with women of childbearing potential partners should use condoms during the whole treatment period and until 91 days after the last injection.
- Informed consent signed by the patient / parents
- Patient affiliated to the social security system
- Allergy to STS or one of the excipients used
- Contraindication to local injection of STS
- Anticoagulant therapy
- Pregnant, parturient or breastfeeding woman
- Patient deprived of freedom by a court judgment or an administrative decision
- Patient undergoing psychiatric care under coercion
- Legally protected adult patients (guardianship / curatorship)
- Patient unable to give consent
- Patient placed under judicial protection
The study team makes the final eligibility decision.
Where it's taking place
- Bordeaux, France
- Bron, France
- Le Kremlin-Bicêtre, France
- Limoges, France
- Paris, France
- Rouen, France
- Toulouse, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 months and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bordeaux, France; Bron, France; Le Kremlin-Bicêtre, France; Limoges, France; Paris, France; Rouen, France and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.