Rheopheresis for Raynaud's and Digital Ulcers in Systemic Sclerosis

Study Overview
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Brief Summary
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In this feasibility study, we aim to explore therapeutic Rheopheresis (RheoP) as a novel treatment option for SSc-associated Raynaud's phenomenon and/or digital ulcers and compare it to the standard of care treatment (intravenous iloprost. RheoP has been used for RP/DU with some success in observational studies, nevertheless, the optimal treatment modality, duration, or frequency of RheoP (and PEX in general) in SSc has not been established as of yet.

Official Title
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A Randomized Controlled Prospective Single-center Feasibility Study of Rheopheresis for Raynaud's Syndrome and Digital Ulcers in Systemic Sclerosis

Conditions
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Systemic Sclerosis, Raynaud Phenomenon, Digital Ulcer, Scleroderma

Intervention / Treatment
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* Procedure: Rheopheresis treatment
* Drug: Intravenous Infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients fulfilling ACR/EULAR classification criteria for SSc Presence of RP with or without DU Failure of at least one standard of care treatment (CCB or iloprost) for at least three months RCS > 4 Possibility to obtain venous access (either through a peripherally or centrally inserted catheter) Exclusion Criteria: Significant anemia (<8 g/dL) Clinically relevant hemorrhagic diathesis or coagulopathy Diabetes mellitus Serious acute or chronic kidney (eGFR<30 ml/min/1.73m2) or liver failure Hypotension with systolic blood pressure <100 mmHg Chronic viral infections (HIV, Hepatitis B, C) Epilepsia, psychosis, dementia, or other relevant neurologic condition precluding the conduct of plasmapheresis Malignant disease or any other condition with life expectancy <12 months Known history of alcohol or drug abuse Long-term serious tobacco abuse with documented severe vascular disease (Fontaine >III). Severe hyperlipoproteinemia, defined as a significant elevation of Lp(a) or LDL cholesterol despite standard doses of medical therapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>2 Rheopheresis treatments per week x 2, followed by 8 weeks without treatment, 8 overall treatments | Procedure: Rheopheresis treatment<br>* After obtaining venous access, anticoagulated blood is pumped through a plasmafilter. The plasma is then run through the Rheofilter and large plasma proteins are removed. Finally, cells are reinfused, and blood is returned to the patient.<br>|
| Experimental: Arm 2<br>2 Rheopheresis treatments in week 1, followed by 1 treatment every 2 weeks, 8 overall treatments | Procedure: Rheopheresis treatment<br>* After obtaining venous access, anticoagulated blood is pumped through a plasmafilter. The plasma is then run through the Rheofilter and large plasma proteins are removed. Finally, cells are reinfused, and blood is returned to the patient.<br>|
| Active Comparator: Control Group<br>Standard of care treatment with intravenous iloprost | Drug: Intravenous Infusion<br>* Standard of care treatment consists of intravenous iloprost infusions at a dose of 0.5-2 ng/kg/min administered over at least 6 hours as per local standard<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Raynaud Condition Score (RCS) | changes of the Raynaud Condition after treatment, higher RCS denotes worse clinical findings | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of new digital ulcers | To assess the number of new digital ulcers with treatment | 24 weeks | 
| Time to healing of existing digital ulcers | Time to healing of existing digital ulcers | 24 weeks | 
| Scleroderma Health Assessment Questionnaire | Changes in the SHAQ with treatment; higher scores mean better functional status | 24 weeks | 
| Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score | changes in the FACIT-Fatigue score with treatment; higher scores indicate a better clinical status | 24 weeks | 
| Quick DASH | changes in the Quick DASH with treatment; lower scores mean better functional status | 24 weeks | 
| Nailfold video capillaroscopy changes | changes in in NVC assessments with treatment | 24 weeks | 
| Whole blood viscosity | changes in Whole blood viscosity with treatment | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheopheresis, Raynaud Phenomenon, Systemic Sclerosis, Digital Ulcers, Therapeutic plasma exchange