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Immunoadsorption vs. Plasmapheresis in the Escalation Therapy of Relapse in Multiple Sclerosis

Primary Purpose

Multiple Sclerosis, Clinically Isolated Syndrome

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Immunoadsorption
Plasmapheresis
Sponsored by
Albert Christian Ludolph, Prof.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Immunoadsorption, Plasmapheresis

Eligibility Criteria

12 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • relapse of Multiple Sclerosis or Clinically Isolated Syndrome (without complete remission after high dose steroid therapy)
  • informed consent
  • age ≥ 12 years old

Exclusion Criteria:

  • clinical or laboratory signs of infection
  • intake of Angiotensin Converting Enzyme Inhibitor within 1 week prior to first treatment

Sites / Locations

  • Department of Neurology, University of Ulm

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Immunoadsorption

Plasmapheresis

Arm Description

Immunoadsorption on 5 consecutive days with protein A columns and 2,5-fold patient's plasma volume

Plasmapheresis on 5 consecutive days with 2l plasma exchange

Outcomes

Primary Outcome Measures

Multiple Sclerosis Functional Composite (MSFC)

Secondary Outcome Measures

Expanded Disability Status Scale (EDSS)
EuroQol (EQ5D-5L)
Response Rate
defined as share of patients who show an improvement of least 10% in MSFC (see Outcome 1) compared to baseline value
Vision
defined as percentage of normal vision as measured by visual test according to EDSS standardized testing (see outcome 2)
Visually Evoked Potentials (VEP; P100 latency)
Somatosensory Evoked Potentials (SEP; Medianus and Tibialis; N20-, P40-latency)
Thickness of Retinal Nerve Fiber Layer (RNFL) in Optical Coherence Tomography (OCT)
Verbaler Lern- und Merkfähigkeitstest (VLMT) score
MSFC
Thickness of Ganglion Cell Layer (GCL) in OCT
Symbol Digit Modalities Test (SDMT) score

Full Information

First Posted
January 22, 2016
Last Updated
September 10, 2019
Sponsor
Albert Christian Ludolph, Prof.
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1. Study Identification

Unique Protocol Identification Number
NCT02671682
Brief Title
Immunoadsorption vs. Plasmapheresis in the Escalation Therapy of Relapse in Multiple Sclerosis
Official Title
Immunoadsorption vs. Plasmapheresis in the Escalation Therapy of Relapse in Multiple Sclerosis and Clinically Isolated Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
February 26, 2016 (Actual)
Primary Completion Date
January 3, 2019 (Actual)
Study Completion Date
January 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Albert Christian Ludolph, Prof.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Clinically Isolated Syndrome
Keywords
Immunoadsorption, Plasmapheresis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immunoadsorption
Arm Type
Experimental
Arm Description
Immunoadsorption on 5 consecutive days with protein A columns and 2,5-fold patient's plasma volume
Arm Title
Plasmapheresis
Arm Type
Active Comparator
Arm Description
Plasmapheresis on 5 consecutive days with 2l plasma exchange
Intervention Type
Procedure
Intervention Name(s)
Immunoadsorption
Intervention Type
Procedure
Intervention Name(s)
Plasmapheresis
Primary Outcome Measure Information:
Title
Multiple Sclerosis Functional Composite (MSFC)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Expanded Disability Status Scale (EDSS)
Time Frame
2 and 4 weeks
Title
EuroQol (EQ5D-5L)
Time Frame
2 and 4 weeks
Title
Response Rate
Description
defined as share of patients who show an improvement of least 10% in MSFC (see Outcome 1) compared to baseline value
Time Frame
4 weeks
Title
Vision
Description
defined as percentage of normal vision as measured by visual test according to EDSS standardized testing (see outcome 2)
Time Frame
4 weeks
Title
Visually Evoked Potentials (VEP; P100 latency)
Time Frame
4 weeks
Title
Somatosensory Evoked Potentials (SEP; Medianus and Tibialis; N20-, P40-latency)
Time Frame
4 weeks
Title
Thickness of Retinal Nerve Fiber Layer (RNFL) in Optical Coherence Tomography (OCT)
Time Frame
4 weeks
Title
Verbaler Lern- und Merkfähigkeitstest (VLMT) score
Time Frame
4 weeks
Title
MSFC
Time Frame
2 weeks
Title
Thickness of Ganglion Cell Layer (GCL) in OCT
Time Frame
4 weeks
Title
Symbol Digit Modalities Test (SDMT) score
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: relapse of Multiple Sclerosis or Clinically Isolated Syndrome (without complete remission after high dose steroid therapy) informed consent age ≥ 12 years old Exclusion Criteria: clinical or laboratory signs of infection intake of Angiotensin Converting Enzyme Inhibitor within 1 week prior to first treatment
Facility Information:
Facility Name
Department of Neurology, University of Ulm
City
Ulm
State/Province
Baden-Württemberg
ZIP/Postal Code
89081
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31832624
Citation
Dorst 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.
Results Reference
derived

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Immunoadsorption vs. Plasmapheresis in the Escalation Therapy of Relapse in Multiple Sclerosis

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