Immunoadsorption vs. Plasmapheresis in the Escalation Therapy of Relapse in Multiple Sclerosis
1 other identifier
interventional
61
1 country
1
Brief Summary
This observational study investigates the efficacy and safety of immunoadsorption versus plasmapheresis in 60 patients with relapse in Multiple Sclerosis and Clinically isolated syndrome who do not fully recover after a high doses of intravenous corticosteroids.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable multiple-sclerosis
Started Feb 2016
Typical duration for not_applicable multiple-sclerosis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 22, 2016
CompletedFirst Posted
Study publicly available on registry
February 2, 2016
CompletedStudy Start
First participant enrolled
February 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 3, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 25, 2019
CompletedSeptember 11, 2019
September 1, 2019
2.9 years
January 22, 2016
September 10, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Multiple Sclerosis Functional Composite (MSFC)
4 weeks
Secondary Outcomes (11)
Expanded Disability Status Scale (EDSS)
2 and 4 weeks
EuroQol (EQ5D-5L)
2 and 4 weeks
Response Rate
4 weeks
Vision
4 weeks
Visually Evoked Potentials (VEP; P100 latency)
4 weeks
- +6 more secondary outcomes
Study Arms (2)
Immunoadsorption
EXPERIMENTALImmunoadsorption on 5 consecutive days with protein A columns and 2,5-fold patient's plasma volume
Plasmapheresis
ACTIVE COMPARATORPlasmapheresis on 5 consecutive days with 2l plasma exchange
Interventions
Eligibility Criteria
You may qualify if:
- relapse of Multiple Sclerosis or Clinically Isolated Syndrome (without complete remission after high dose steroid therapy)
- informed consent
- age ≥ 12 years old
You may not qualify if:
- clinical or laboratory signs of infection
- intake of Angiotensin Converting Enzyme Inhibitor within 1 week prior to first treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Neurology, University of Ulm
Ulm, Baden-Wurttemberg, 89081, Germany
Related Publications (2)
Vardakas I, Dorst J, Huss A, Mayer B, Fangerau T, Taranu D, Tumani H, Senel M. Serum neurofilament light chain and glial fibrillary acidic protein for predicting response to apheresis in steroid-refractory multiple sclerosis relapses. Eur J Neurol. 2024 Aug;31(8):e16323. doi: 10.1111/ene.16323. Epub 2024 May 3.
PMID: 38700322DERIVEDDorst J, Fangerau T, Taranu D, Eichele P, Dreyhaupt J, Michels S, Schuster J, Ludolph AC, Senel M, Tumani H. Safety and efficacy of immunoadsorption versus plasma exchange in steroid-refractory relapse of multiple sclerosis and clinically isolated syndrome: A randomised, parallel-group, controlled trial. EClinicalMedicine. 2019 Nov 14;16:98-106. doi: 10.1016/j.eclinm.2019.10.017. eCollection 2019 Nov.
PMID: 31832624DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Prof. Dr.
Study Record Dates
First Submitted
January 22, 2016
First Posted
February 2, 2016
Study Start
February 26, 2016
Primary Completion
January 3, 2019
Study Completion
January 25, 2019
Last Updated
September 11, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share