Clinical trial NCT05204784: Rheopheresis for Raynaud's and Digital Ulcers in Systemic Sclerosis
Official title: A Randomized Controlled Prospective Single-center Feasibility Study of Rheopheresis for Raynaud's Syndrome and Digital Ulcers in Systemic Sclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Systemic Sclerosis
Raynaud Phenomenon
Digital Ulcer
Scleroderma
Keywords: Rheopheresis
Raynaud Phenomenon
Systemic Sclerosis
Digital Ulcers
Therapeutic plasma exchange
Lead sponsor: University of Göttingen
Sponsor class: OTHER
Collaborators: name: DiaMed GmbH
First posted: 2022-01-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Raynaud Condition Score (RCS)
timeFrame: 24 weeks
Secondary outcomes:
measure: Development of new digital ulcers
timeFrame: 24 weeks
measure: Time to healing of existing digital ulcers
timeFrame: 24 weeks
measure: Scleroderma Health Assessment Questionnaire
timeFrame: 24 weeks
measure: Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score
timeFrame: 24 weeks
measure: Quick DASH
timeFrame: 24 weeks
measure: Nailfold video capillaroscopy changes
timeFrame: 24 weeks
measure: Whole blood viscosity
timeFrame: 24 weeks
Other outcomes:
measure: Exploratory objectives
timeFrame: 24 weeks
Locations:
city: Göttingen
country: Germany
facility: University Medical Center Göttingen
state: Lower Saxony
Study officials:
affiliation: University Medical Center Göttingen
name: Peter Korsten, Dr. med.
role: PRINCIPAL_INVESTIGATOR
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