Systemic SclerosisRHEACTNCT05204784
Rheopheresis for Raynaud's and Digital Ulcers in Systemic Sclerosis
A study testing Rheopheresis treatment and Intravenous Infusion in people with Systemic Sclerosis and Raynaud Phenomenon, run by Peter Korsten at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis, Raynaud Phenomenon, Digital Ulcer
- What is being tested?
- Rheopheresis treatment and Intravenous Infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 28 Feb 2022to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Medical Center Göttingen
Göttingen, Lower Saxony, 37075
PETER KORSTEN, +49-551-39-60400, peter.korsten@med.uni-goettingen.de
About this study
Official title: 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.
- Conditions
- Systemic Sclerosis, Raynaud Phenomenon, Digital Ulcer, Scleroderma
- Being tested
- Rheopheresis treatment, Intravenous Infusion
- Keywords
- Rheopheresis, Raynaud Phenomenon, Systemic Sclerosis, Digital Ulcers, Therapeutic plasma exchange
- Medical subject headings
- Scleroderma, Systemic, Raynaud Disease, digital ulcers, Scleroderma, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rheopheresis treatmentProcedure or surgery
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.
Intravenous InfusionDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | 2 Rheopheresis treatments per week x 2, followed by 8 weeks without treatment, 8 overall treatments Receives: Procedure: Rheopheresis treatment |
| Arm 2 | Experimental | 2 Rheopheresis treatments in week 1, followed by 1 treatment every 2 weeks, 8 overall treatments Receives: Procedure: Rheopheresis treatment |
| Control Group | Active comparator | Standard of care treatment with intravenous iloprost Receives: Drug: Intravenous Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Raynaud Condition Score (RCS)
changes of the Raynaud Condition after treatment, higher RCS denotes worse clinical findings
Measured: 24 weeks
Secondary outcomes (7)
Development of new digital ulcers
To assess the number of new digital ulcers with treatment
Measured: 24 weeks
Time to healing of existing digital ulcers
Time to healing of existing digital ulcers
Measured: 24 weeks
Scleroderma Health Assessment Questionnaire
Changes in the SHAQ with treatment; higher scores mean better functional status
Measured: 24 weeks
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score
changes in the FACIT-Fatigue score with treatment; higher scores indicate a better clinical status
Measured: 24 weeks
Quick DASH
changes in the Quick DASH with treatment; lower scores mean better functional status
Measured: 24 weeks
Nailfold video capillaroscopy changes
changes in in NVC assessments with treatment
Measured: 24 weeks
Whole blood viscosity
changes in Whole blood viscosity with treatment
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start28 Feb 2022
- Primary completionDec 2023 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peter Korsten
- Sponsor type
- University, hospital or other
- Collaborators
- DiaMed GmbH
- Responsible party
- Sponsor-investigator, Peter Korsten, University of Göttingen
- Investigators
- Peter Korsten, Dr. med., Principal investigator, University Medical Center Göttingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05204784
- Sponsor's protocol ID
- 36/7/21
- Acronym
- RHEACT
- Status last verified
- Mar 2022
- First submitted
- 29 Nov 2021
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wigley FM. Clinical practice. Raynaud's Phenomenon. N Engl J Med. 2002 Sep 26;347(13):1001-8. doi: 10.1056/NEJMcp013013. No abstract available.
PubMed 12324557Gabrielli A, Avvedimento EV, Krieg T. Scleroderma. N Engl J Med. 2009 May 7;360(19):1989-2003. doi: 10.1056/NEJMra0806188. No abstract available.
PubMed 19420368Allanore Y, Simms R, Distler O, Trojanowska M, Pope J, Denton CP, Varga J. Systemic sclerosis. Nat Rev Dis Primers. 2015 Apr 23;1:15002. doi: 10.1038/nrdp.2015.2.
PubMed 27189141Abraham S, Steen V. Optimal management of digital ulcers in systemic sclerosis. Ther Clin Risk Manag. 2015 Jun 15;11:939-47. doi: 10.2147/TCRM.S82561. eCollection 2015.
PubMed 26109864Herrick AL. Management of Raynaud's phenomenon and digital ischemia. Curr Rheumatol Rep. 2013 Jan;15(1):303. doi: 10.1007/s11926-012-0303-1.
PubMed 23292819Matucci-Cerinic M, Denton CP, Furst DE, Mayes MD, Hsu VM, Carpentier P, Wigley FM, Black CM, Fessler BJ, Merkel PA, Pope JE, Sweiss NJ, Doyle MK, Hellmich B, Medsger TA Jr, Morganti A, Kramer F, Korn JH, Seibold JR. Bosentan treatment of digital ulcers related to systemic sclerosis: results from the RAPIDS-2 randomised, double-blind, placebo-controlled trial. Ann Rheum Dis. 2011 Jan;70(1):32-8. doi: 10.1136/ard.2010.130658. Epub 2010 Aug 30.
PubMed 20805294Korsten P, Niewold TB, Zeisberg M, Utset TO, Cho D, Zachary LS, Sweiss NJ, Volkov S. Increased Whole Blood Viscosity Is Associated with the Presence of Digital Ulcers in Systemic Sclerosis: Results from a Cross-Sectional Pilot Study. Autoimmune Dis. 2017;2017:3529214. doi: 10.1155/2017/3529214. Epub 2017 Nov 29.
PubMed 29318042Koss MJ, Kurz P, Tsobanelis T, Lehmacher W, Fassbender C, Klingel R, Koch FH. Prospective, randomized, controlled clinical study evaluating the efficacy of Rheopheresis for dry age-related macular degeneration. Dry AMD treatment with Rheopheresis Trial-ART. Graefes Arch Clin Exp Ophthalmol. 2009 Oct;247(10):1297-306. doi: 10.1007/s00417-009-1113-7. Epub 2009 Jul 23.
PubMed 19629514Kostal M, Drsata J, Blaha M, Lanska M, Chrobok V. Rheopheresis in treatment of idiopathic sensorineural sudden hearing loss. J Otolaryngol Head Neck Surg. 2017 Jun 29;46(1):50. doi: 10.1186/s40463-017-0228-9.
PubMed 28662721Klingel R, Erdtracht B, Gauss V, Piazolo A, Mausfeld-Lafdhiya P, Diehm C. Rheopheresis in patients with critical limb ischemia--results of an open label prospective pilot trial. Ther Apher Dial. 2005 Dec;9(6):473-81. doi: 10.1111/j.1744-9987.2005.00276.x.
PubMed 16354279Klingel R, Mumme C, Fassbender T, Himmelsbach F, Altes U, Lotz J, Pohlmann T, Beyer J, Kustner E. Rheopheresis in patients with ischemic diabetic foot syndrome: results of an open label prospective pilot trial. Ther Apher Dial. 2003 Aug;7(4):444-55. doi: 10.1046/j.1526-0968.2003.00082.x.
PubMed 12887730Harris ES, Meiselman HJ, Moriarty PM, Metzger A, Malkovsky M. Therapeutic plasma exchange for the treatment of systemic sclerosis: A comprehensive review and analysis. J Scleroderma Relat Disord. 2018 Jun;3(2):132-152. doi: 10.1177/2397198318758606. Epub 2018 Mar 9.
PubMed 35382237Schwartz J, Padmanabhan A, Aqui N, Balogun RA, Connelly-Smith L, Delaney M, Dunbar NM, Witt V, Wu Y, Shaz BH. Guidelines on the Use of Therapeutic Apheresis in Clinical Practice-Evidence-Based Approach from the Writing Committee of the American Society for Apheresis: The Seventh Special Issue. J Clin Apher. 2016 Jun;31(3):149-62. doi: 10.1002/jca.21470.
PubMed 27322218Khanna D, Lovell DJ, Giannini E, Clements PJ, Merkel PA, Seibold JR, Matucci-Cerinic M, Denton CP, Mayes MD, Steen VD, Varga J, Furst DE; Scleroderma Clinical Trials Consortium co-authors. Development of a provisional core set of response measures for clinical trials of systemic sclerosis. Ann Rheum Dis. 2008 May;67(5):703-9. doi: 10.1136/ard.2007.078923. Epub 2007 Sep 24.
PubMed 17893248Cutolo M, Smith V, Furst DE, Khanna D, Herrick AL. Points to consider-Raynaud's phenomenon in systemic sclerosis. Rheumatology (Oxford). 2017 Sep 1;56(suppl_5):v45-v48. doi: 10.1093/rheumatology/kex199.
PubMed 28992170
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Prospective Single-center Feasibility Study of Rheopheresis for Raynaud's Syndrome and Digital Ulcers in Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT05204784
- Acronym / sponsor ID
- RHEACT / 36/7/21
- Conditions
- Systemic Sclerosis, Raynaud Phenomenon, Digital Ulcer, Scleroderma
- Keywords
- Rheopheresis, Raynaud Phenomenon, Systemic Sclerosis, Digital Ulcers, Therapeutic plasma exchange
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peter KorstenUniversity, hospital or other
- Collaborators
- DiaMed GmbH
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 24 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Procedure: Rheopheresis treatment2 Rheopheresis treatments per week x 2, followed by 8 weeks without treatment, 8 overall treatments |
| Arm 2 | Experimental | Procedure: Rheopheresis treatment2 Rheopheresis treatments in week 1, followed by 1 treatment every 2 weeks, 8 overall treatments |
| Control Group | Active comparator | Drug: Intravenous InfusionStandard of care treatment with intravenous iloprost |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rheopheresis treatmentAfter 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. | Procedure or surgery | Arm 1, Arm 2 |
| Intravenous InfusionStandard 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 | Drug | Control Group |
Primary outcome
Raynaud Condition Score (RCS)
Time frame: 24 weeks
changes of the Raynaud Condition after treatment, higher RCS denotes worse clinical findings
7 secondary outcomes
Development of new digital ulcers
Time frame: 24 weeks
Time to healing of existing digital ulcers
Time frame: 24 weeks
Scleroderma Health Assessment Questionnaire
Time frame: 24 weeks
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score
Time frame: 24 weeks
Quick DASH
Time frame: 24 weeks
Nailfold video capillaroscopy changes
Time frame: 24 weeks
Whole blood viscosity
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
- Background: PubMed 12324557Wigley FM. Clinical practice. Raynaud's Phenomenon. N Engl J Med. 2002 Sep 26;347(13):1001-8. doi: 10.1056/NEJMcp013013. No abstract available.
- Background: PubMed 19420368Gabrielli A, Avvedimento EV, Krieg T. Scleroderma. N Engl J Med. 2009 May 7;360(19):1989-2003. doi: 10.1056/NEJMra0806188. No abstract available.
- Background: PubMed 27189141Allanore Y, Simms R, Distler O, Trojanowska M, Pope J, Denton CP, Varga J. Systemic sclerosis. Nat Rev Dis Primers. 2015 Apr 23;1:15002. doi: 10.1038/nrdp.2015.2.
- Background: PubMed 26109864Abraham S, Steen V. Optimal management of digital ulcers in systemic sclerosis. Ther Clin Risk Manag. 2015 Jun 15;11:939-47. doi: 10.2147/TCRM.S82561. eCollection 2015.
- Background: PubMed 23292819Herrick AL. Management of Raynaud's phenomenon and digital ischemia. Curr Rheumatol Rep. 2013 Jan;15(1):303. doi: 10.1007/s11926-012-0303-1.
- Background: PubMed 20805294Matucci-Cerinic M, Denton CP, Furst DE, Mayes MD, Hsu VM, Carpentier P, Wigley FM, Black CM, Fessler BJ, Merkel PA, Pope JE, Sweiss NJ, Doyle MK, Hellmich B, Medsger TA Jr, Morganti A, Kramer F, Korn JH, Seibold JR. Bosentan treatment of digital ulcers related to systemic sclerosis: results from the RAPIDS-2 randomised, double-blind, placebo-controlled trial. Ann Rheum Dis. 2011 Jan;70(1):32-8. doi: 10.1136/ard.2010.130658. Epub 2010 Aug 30.
- Background: PubMed 29318042Korsten P, Niewold TB, Zeisberg M, Utset TO, Cho D, Zachary LS, Sweiss NJ, Volkov S. Increased Whole Blood Viscosity Is Associated with the Presence of Digital Ulcers in Systemic Sclerosis: Results from a Cross-Sectional Pilot Study. Autoimmune Dis. 2017;2017:3529214. doi: 10.1155/2017/3529214. Epub 2017 Nov 29.
- Background: PubMed 19629514Koss MJ, Kurz P, Tsobanelis T, Lehmacher W, Fassbender C, Klingel R, Koch FH. Prospective, randomized, controlled clinical study evaluating the efficacy of Rheopheresis for dry age-related macular degeneration. Dry AMD treatment with Rheopheresis Trial-ART. Graefes Arch Clin Exp Ophthalmol. 2009 Oct;247(10):1297-306. doi: 10.1007/s00417-009-1113-7. Epub 2009 Jul 23.
- Background: PubMed 28662721Kostal M, Drsata J, Blaha M, Lanska M, Chrobok V. Rheopheresis in treatment of idiopathic sensorineural sudden hearing loss. J Otolaryngol Head Neck Surg. 2017 Jun 29;46(1):50. doi: 10.1186/s40463-017-0228-9.
- Background: PubMed 16354279Klingel R, Erdtracht B, Gauss V, Piazolo A, Mausfeld-Lafdhiya P, Diehm C. Rheopheresis in patients with critical limb ischemia--results of an open label prospective pilot trial. Ther Apher Dial. 2005 Dec;9(6):473-81. doi: 10.1111/j.1744-9987.2005.00276.x.
- Background: PubMed 12887730Klingel R, Mumme C, Fassbender T, Himmelsbach F, Altes U, Lotz J, Pohlmann T, Beyer J, Kustner E. Rheopheresis in patients with ischemic diabetic foot syndrome: results of an open label prospective pilot trial. Ther Apher Dial. 2003 Aug;7(4):444-55. doi: 10.1046/j.1526-0968.2003.00082.x.
- Background: PubMed 35382237Harris ES, Meiselman HJ, Moriarty PM, Metzger A, Malkovsky M. Therapeutic plasma exchange for the treatment of systemic sclerosis: A comprehensive review and analysis. J Scleroderma Relat Disord. 2018 Jun;3(2):132-152. doi: 10.1177/2397198318758606. Epub 2018 Mar 9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Korsten, Dr. med. principal investigator
University Medical Center Göttingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rheopheresis treatment and Intravenous Infusion in people with Systemic Sclerosis and Raynaud Phenomenon, run by Peter Korsten at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Korsten, Dr. med. (+49-551-39-60400, peter.korsten@med.uni-goettingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Raynaud Condition Score (RCS) (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05204784, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2022.