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

March 18, 2022 updated by: Peter Korsten

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm 1
2 Rheopheresis treatments per week x 2, followed by 8 weeks without treatment, 8 overall treatments
Procedure: Rheopheresis treatment
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.
EXPERIMENTAL: Arm 2
2 Rheopheresis treatments in week 1, followed by 1 treatment every 2 weeks, 8 overall treatments
Procedure: Rheopheresis treatment
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.
ACTIVE_COMPARATOR: Control Group
Standard of care treatment with intravenous iloprost
Drug: Intravenous Infusion
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

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory objectives
Time Frame: 24 weeks
changes in miRNA
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peter Korsten

Collaborators

DiaMed GmbH

Investigators

  • Principal Investigator: Peter Korsten, Dr. med., University Medical Center Göttingen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 28, 2022

Primary Completion (ANTICIPATED)

December 1, 2023

Study Completion (ANTICIPATED)

June 1, 2024

Study Registration Dates

First Submitted

November 29, 2021

First Submitted That Met QC Criteria

January 10, 2022

First Posted (ACTUAL)

January 24, 2022

Study Record Updates

Last Update Posted (ACTUAL)

March 23, 2022

Last Update Submitted That Met QC Criteria

March 18, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 36/7/21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Systemic Sclerosis

Clinical Trials on Rheopheresis treatment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe