Back to resultsRheopheresis for Raynaud's and Digital Ulcers in Systemic Sclerosis (RHEACT)
Primary Purpose
Systemic Sclerosis, Raynaud Phenomenon, Digital Ulcer
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Rheopheresis treatment
Intravenous Infusion
Sponsored by
About this trial
This is an interventional treatment trial for Systemic Sclerosis focused on measuring Rheopheresis, Raynaud Phenomenon, Systemic Sclerosis, Digital Ulcers, Therapeutic plasma exchange
Eligibility Criteria
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
Sites / Locations
- University Medical Center GöttingenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Arm 1
Arm 2
Control Group
Arm Description
2 Rheopheresis treatments per week x 2, followed by 8 weeks without treatment, 8 overall treatments
2 Rheopheresis treatments in week 1, followed by 1 treatment every 2 weeks, 8 overall treatments
Standard of care treatment with intravenous iloprost
Outcomes
Primary Outcome Measures
Raynaud Condition Score (RCS)
changes of the Raynaud Condition after treatment, higher RCS denotes worse clinical findings
Secondary Outcome Measures
Development of new digital ulcers
To assess the number of new digital ulcers with treatment
Time to healing of existing digital ulcers
Time to healing of existing digital ulcers
Scleroderma Health Assessment Questionnaire
Changes in the SHAQ with treatment; higher scores mean better functional status
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score
changes in the FACIT-Fatigue score with treatment; higher scores indicate a better clinical status
Quick DASH
changes in the Quick DASH with treatment; lower scores mean better functional status
Nailfold video capillaroscopy changes
changes in in NVC assessments with treatment
Whole blood viscosity
changes in Whole blood viscosity with treatment
Full Information
NCT ID
NCT05204784
First Posted
November 29, 2021
Last Updated
March 18, 2022
Sponsor
Peter Korsten
Collaborators
DiaMed GmbH
1. Study Identification
Unique Protocol Identification Number
NCT05204784
Brief Title
Rheopheresis for Raynaud's and Digital Ulcers in Systemic Sclerosis
Acronym
RHEACT
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
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Peter Korsten
Collaborators
DiaMed GmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Sclerosis, Raynaud Phenomenon, Digital Ulcer, Scleroderma
Keywords
Rheopheresis, Raynaud Phenomenon, Systemic Sclerosis, Digital Ulcers, Therapeutic plasma exchange
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
2 Rheopheresis treatments per week x 2, followed by 8 weeks without treatment, 8 overall treatments
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
2 Rheopheresis treatments in week 1, followed by 1 treatment every 2 weeks, 8 overall treatments
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Standard of care treatment with intravenous iloprost
Intervention Type
Procedure
Intervention Name(s)
Rheopheresis treatment
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Intravenous Infusion
Intervention Description
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
Primary Outcome Measure Information:
Title
Raynaud Condition Score (RCS)
Description
changes of the Raynaud Condition after treatment, higher RCS denotes worse clinical findings
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Development of new digital ulcers
Description
To assess the number of new digital ulcers with treatment
Time Frame
24 weeks
Title
Time to healing of existing digital ulcers
Description
Time to healing of existing digital ulcers
Time Frame
24 weeks
Title
Scleroderma Health Assessment Questionnaire
Description
Changes in the SHAQ with treatment; higher scores mean better functional status
Time Frame
24 weeks
Title
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score
Description
changes in the FACIT-Fatigue score with treatment; higher scores indicate a better clinical status
Time Frame
24 weeks
Title
Quick DASH
Description
changes in the Quick DASH with treatment; lower scores mean better functional status
Time Frame
24 weeks
Title
Nailfold video capillaroscopy changes
Description
changes in in NVC assessments with treatment
Time Frame
24 weeks
Title
Whole blood viscosity
Description
changes in Whole blood viscosity with treatment
Time Frame
24 weeks
Other Pre-specified Outcome Measures:
Title
Exploratory objectives
Description
changes in miRNA
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Korsten, Dr. med.
Phone
+49-551-39-60400
Email
peter.korsten@med.uni-goettingen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Korsten, Dr. med.
Organizational Affiliation
University Medical Center Göttingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Göttingen
City
Göttingen
State/Province
Lower Saxony
ZIP/Postal Code
37075
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PETER KORSTEN
Phone
+49-551-39-60400
Email
peter.korsten@med.uni-goettingen.de
12. IPD Sharing Statement
Plan to Share IPD
No
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Rheopheresis for Raynaud's and Digital Ulcers in Systemic Sclerosis
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