2023-510255-34-00
Not yet recruiting
Phase 4
A prospective, multi-centre, open-label, investigator-initiated randomised controlled study investigating calcinosis cutis in patients with systemic sclerosis undergoing treatment with sodium thiosulfate assessed by novel biomarkers and diagnostic imaging
Aarhus Universitetshospital2 sites in 1 country75 target enrollmentStarted: May 22, 2024Last updated:
Overview
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Aarhus Universitetshospital
- Enrollment
- 75
- Locations
- 2
- Primary Endpoint
- Complete remission of CC from week 0 to week 28 [ Time Frame: Week 1, week 5, week 17, week 21, week 28 ] defined as removal of total calcinosis volume in scans and/or clinical complete clearance
Overview
Brief Summary
This is a prospective, multi-centre, investigator-initiated randomized controlled study, with the overall objective of evaluating the efficacy and safety of intralesional sodium thiosulfate (STS) treatment in patients with calcinosis cutis (CC). The primary aim is to assess remission (complete/partial) in CC lesions during treatment with STS.
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •SSc fulfilling ACA/EULAR 2013 criteria as well as patients with positive U1RNP and mixed connective tissue disease with overlap syndrome to SSc
- •Provides signed, written informed consent
- •Above 18 and under 90 years of age at baseline
- •Legally competent, able to give verbal, written and informed consent
- •Communicate in Danish verbally as well as in writing
- •Subject in good general health and willing to participate
- •Is willing and able to comply with the requirements of the protocol and to undergo all testing
- •Medications for SSc are stable for at least 6 weeks prior to study entry
- •If subjects received STS treatment on the selected lesion before, a washout period of 3 months must be complete upon study entry
Exclusion Criteria
- •Individuals with other skin diseases in the skin area of interest
- •Individuals with CC of other causality
- •Individuals whose CC lesion is not accessible for imaging e.g., inside the ear, inside nostrils.
- •Breastfeeding
- •Women of child-bearing potential not using a contraceptive agent at the time of inclusion
- •Known hypersensitivity to STS
Outcomes
Primary Outcomes
Complete remission of CC from week 0 to week 28 [ Time Frame: Week 1, week 5, week 17, week 21, week 28 ] defined as removal of total calcinosis volume in scans and/or clinical complete clearance
Complete remission of CC from week 0 to week 28 [ Time Frame: Week 1, week 5, week 17, week 21, week 28 ] defined as removal of total calcinosis volume in scans and/or clinical complete clearance
Partial remission of CC from week 0 to week 28 [ Time Frame: Week 1, week 5, week 17, week 21, week 28 ] defined as partial removal of calcinosis volume in scans and/or clinical improvement in PtGA score
Partial remission of CC from week 0 to week 28 [ Time Frame: Week 1, week 5, week 17, week 21, week 28 ] defined as partial removal of calcinosis volume in scans and/or clinical improvement in PtGA score
Secondary Outcomes
- Assessment of treatment efficacy of intralesional STS [ Time Frame: Week 1, week 5, week 17, week 21, week 28 ]
- Change in CC lesion severity patient- and physician global score, PtGA and PhGA (1-10) [ Time Frame: Week 1, week 5, week 17, week 21, week 28 ]
- Change in CC lesion seen on imaging (RCM, DECT, and CBCT): size, density, remission (complete/partial) [ Time Frame: Week 1, week 28 ]
- Comparison of imaging modalities to assess change in CC (RCM, DECT, and CBCT) [ Time Frame: Week 1, week 28 ]
- Validation of/comparison to the Radiological scoring system for CC [ Time Frame: Week 1, week 28 ] The Radiological scoring system for CC is a newer scoring system to assess severity of CC affecting the hands in patients with SSc developed by the Scleroderma Clinical Trials Consortium. Currently, no standardised outcomes for CC exist. This novel radiographic scoring system accounts for the area coverage, density, and anatomic location of CC affecting the hands in patients with SSc
- Clinical assessment: ulcer size, inflammatory surroundings and clinical photos [ Time Frame: Week 1, week 5, week 17, week 21, week 28 ]
- Changes in biomarkers, measured by blood and skin analyses (e.g., to evaluate changes due to therapy, or differences between responders and non-responders to therapy) [ Time Frame: Week 1, week 5, week 17, week 28 ]
- Incidence and severity of adverse events, including laboratory abnormalities, over time [ Time Frame: Week 1, week 5, week 17, week 21, week 28 ]
- QoL outcome: Short-form 36, (SF-36) and Health Assessment Questionnaire Disability Index (HAQ-DI) [ Time Frame: Week 1, week 5, week 17, week 28 ]
- Change in total calcinosis volume and demonstration of PET/MRI imaging of CC lesions [ Time Frame: Week 28 ]
Investigators
Anne Braae Olesen
Scientific
Aarhus Universitetshospital
Study Sites (2)
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