Rheopheresis for Raynaud's and Digital Ulcers in Systemic Sclerosis

Not Applicable

• Conditions: Raynaud Phenomenon; Digital Ulcer; Scleroderma; Systemic Sclerosis
• Interventions: Procedure: Rheopheresis treatment; Drug: Intravenous Infusion

• Registration Number: NCT05204784
• Lead Sponsor: Peter Korsten

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-29
• Study First Submitted QC: 2022-01-10
• Study First Posted: 2022-01-24
• Study Start: 2022-02-28
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-18
• Last Update Posted: 2022-03-23
• Primary Completion: 2023-12
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Arm 2	Rheopheresis treatment	2 Rheopheresis treatments in week 1, followed by 1 treatment every 2 weeks, 8 overall treatments
Arm 1	Rheopheresis treatment	2 Rheopheresis treatments per week x 2, followed by 8 weeks without treatment, 8 overall treatments
Control Group	Intravenous Infusion	Standard of care treatment with intravenous iloprost

Primary Outcome Measures

Name	Time	Method
Raynaud Condition Score (RCS)	24 weeks	changes of the Raynaud Condition after treatment, higher RCS denotes worse clinical findings

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Medical Center Göttingen; 🇩🇪 Göttingen, Lower Saxony, Germany