Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| DiaMed GmbH | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | 2 Rheopheresis treatments per week x 2, followed by 8 weeks without treatment, 8 overall treatments |
|
| Arm 2 | Experimental | 2 Rheopheresis treatments in week 1, followed by 1 treatment every 2 weeks, 8 overall treatments |
|
| Control Group | Active Comparator | Standard of care treatment with intravenous iloprost |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rheopheresis treatment | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Raynaud Condition Score (RCS) | changes of the Raynaud Condition after treatment, higher RCS denotes worse clinical findings | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Development of new digital ulcers | To assess the number of new digital ulcers with treatment | 24 weeks |
| Time to healing of existing digital ulcers | Time to healing of existing digital ulcers |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory objectives | changes in miRNA | 24 weeks |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peter Korsten, Dr. med. | Contact | +49-551-39-60400 | peter.korsten@med.uni-goettingen.de |
| Name | Affiliation | Role |
|---|---|---|
| Peter Korsten, Dr. med. | University Medical Center Göttingen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Göttingen | Recruiting | Göttingen | Lower Saxony | 37075 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12324557 | Background | 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. | |
| 19420368 | Background | Gabrielli A, Avvedimento EV, Krieg T. Scleroderma. N Engl J Med. 2009 May 7;360(19):1989-2003. doi: 10.1056/NEJMra0806188. No abstract available. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| D011928 | Raynaud Disease |
| C000721267 | digital ulcers |
| D045743 | Scleroderma, Diffuse |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D000090122 | Livedoid Vasculopathy |
Not provided
Not provided
| ID | Term |
|---|---|
| D007262 | Infusions, Intravenous |
| ID | Term |
|---|---|
| D061605 | Administration, Intravenous |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Intravenous Infusion | Drug | 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 |
|
| 24 weeks |
| Scleroderma Health Assessment Questionnaire | Changes in the SHAQ with treatment; higher scores mean better functional status | 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 | 24 weeks |
| Quick DASH | changes in the Quick DASH with treatment; lower scores mean better functional status | 24 weeks |
| Nailfold video capillaroscopy changes | changes in in NVC assessments with treatment | 24 weeks |
| Whole blood viscosity | changes in Whole blood viscosity with treatment | 24 weeks |
| 27189141 | Background | Allanore 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. |
| 26109864 | Background | Abraham 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. |
| 23292819 | Background | Herrick AL. Management of Raynaud's phenomenon and digital ischemia. Curr Rheumatol Rep. 2013 Jan;15(1):303. doi: 10.1007/s11926-012-0303-1. |
| 20805294 | Background | Matucci-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. |
| 29318042 | Background | Korsten 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. |
| 19629514 | Background | Koss 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. |
| 28662721 | Background | Kostal 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. |
| 16354279 | Background | Klingel 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. |
| 12887730 | Background | Klingel 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. |
| 35382237 | Background | Harris 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. |
| 27322218 | Background | Schwartz 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. |
| 17893248 | Background | Khanna 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. |
| 28992170 | Background | Cutolo 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. |
| 7506013 | Background | Wigley FM, Wise RA, Seibold JR, McCloskey DA, Kujala G, Medsger TA Jr, Steen VD, Varga J, Jimenez S, Mayes M, Clements PJ, Weiner SR, Porter J, Ellman M, Wise C, Kaufman LD, Williams J, Dole W. Intravenous iloprost infusion in patients with Raynaud phenomenon secondary to systemic sclerosis. A multicenter, placebo-controlled, double-blind study. Ann Intern Med. 1994 Feb 1;120(3):199-206. doi: 10.7326/0003-4819-120-3-199402010-00004. |
| 24092682 | Background | van den Hoogen F, Khanna D, Fransen J, Johnson SR, Baron M, Tyndall A, Matucci-Cerinic M, Naden RP, Medsger TA Jr, Carreira PE, Riemekasten G, Clements PJ, Denton CP, Distler O, Allanore Y, Furst DE, Gabrielli A, Mayes MD, van Laar JM, Seibold JR, Czirjak L, Steen VD, Inanc M, Kowal-Bielecka O, Muller-Ladner U, Valentini G, Veale DJ, Vonk MC, Walker UA, Chung L, Collier DH, Ellen Csuka M, Fessler BJ, Guiducci S, Herrick A, Hsu VM, Jimenez S, Kahaleh B, Merkel PA, Sierakowski S, Silver RM, Simms RW, Varga J, Pope JE. 2013 classification criteria for systemic sclerosis: an American college of rheumatology/European league against rheumatism collaborative initiative. Ann Rheum Dis. 2013 Nov;72(11):1747-55. doi: 10.1136/annrheumdis-2013-204424. |
| 12355489 | Background | Merkel PA, Herlyn K, Martin RW, Anderson JJ, Mayes MD, Bell P, Korn JH, Simms RW, Csuka ME, Medsger TA Jr, Rothfield NF, Ellman MH, Collier DH, Weinstein A, Furst DE, Jimenez SA, White B, Seibold JR, Wigley FM; Scleroderma Clinical Trials Consortium. Measuring disease activity and functional status in patients with scleroderma and Raynaud's phenomenon. Arthritis Rheum. 2002 Sep;46(9):2410-20. doi: 10.1002/art.10486. |
| 35492333 | Derived | Rademacher JG, Tampe B, Borisch A, Buschfort RM, von Figura A, Asendorf T, Korsten P. Study Protocol: A Randomized Controlled Prospective Single-Center Feasibility Study of Rheopheresis for Raynaud's Syndrome and Digital Ulcers in Systemic Sclerosis (RHEACT Study). Front Med (Lausanne). 2022 Apr 14;9:871744. doi: 10.3389/fmed.2022.871744. eCollection 2022. |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D017445 | Skin Diseases, Vascular |
| D007263 |
| Infusions, Parenteral |