Rheopheresis for Raynaud's and Digital Ulcers in Systemic Sclerosis (RHEACT)

Peter Korsten

Status: Enrolling

Conditions: Scleroderma; Systemic Sclerosis; Raynaud Phenomenon; Digital Ulcer

Treatments: Procedure: Rheopheresis treatment; Drug: Intravenous Infusion

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05204784

36/7/21

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult patients fulfilling ACR/EULAR classification criteria for SSc
2. Presence of RP with or without DU
3. Failure of at least one standard of care treatment (CCB or iloprost) for at least three months
4. RCS > 4
5. Possibility to obtain venous access (either through a peripherally or centrally inserted catheter)

Exclusion criteria

1. Significant anemia (<8 g/dL)
2. Clinically relevant hemorrhagic diathesis or coagulopathy
3. Diabetes mellitus
4. Serious acute or chronic kidney (eGFR<30 ml/min/1.73m2) or liver failure
5. Hypotension with systolic blood pressure <100 mmHg
6. Chronic viral infections (HIV, Hepatitis B, C)
7. Epilepsia, psychosis, dementia, or other relevant neurologic condition precluding the conduct of plasmapheresis
8. Malignant disease or any other condition with life expectancy <12 months
9. Known history of alcohol or drug abuse
10. Long-term serious tobacco abuse with documented severe vascular disease (Fontaine >III).
11. Severe hyperlipoproteinemia, defined as a significant elevation of Lp(a) or LDL cholesterol despite standard doses of medical therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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30 participants in 3 patient groups

Arm 1

Experimental group

Description:

2 Rheopheresis treatments per week x 2, followed by 8 weeks without treatment, 8 overall treatments

Treatment:

Procedure: Rheopheresis treatment

Arm 2

Experimental group

Description:

2 Rheopheresis treatments in week 1, followed by 1 treatment every 2 weeks, 8 overall treatments

Treatment:

Procedure: Rheopheresis treatment

Control Group

Active Comparator group

Description:

Standard of care treatment with intravenous iloprost

Treatment:

Drug: Intravenous Infusion