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

September 10, 2019 updated by: Albert Christian Ludolph, Prof.

Immunoadsorption vs. Plasmapheresis in the Escalation Therapy of Relapse in Multiple Sclerosis and Clinically Isolated Syndrome

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

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 Locations

  • Germany
    • Baden-Württemberg
      • Ulm, Baden-Württemberg, Germany, 89081
        • Department of Neurology, University of Ulm

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

12 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immunoadsorption
Immunoadsorption on 5 consecutive days with protein A columns and 2,5-fold patient's plasma volume
Procedure: Immunoadsorption
Active Comparator: Plasmapheresis
Plasmapheresis on 5 consecutive days with 2l plasma exchange
Procedure: Plasmapheresis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Multiple Sclerosis Functional Composite (MSFC)
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Expanded Disability Status Scale (EDSS)
Time Frame: 2 and 4 weeks
2 and 4 weeks
EuroQol (EQ5D-5L)
Time Frame: 2 and 4 weeks
2 and 4 weeks
Response Rate
Time Frame: 4 weeks
defined as share of patients who show an improvement of least 10% in MSFC (see Outcome 1) compared to baseline value
4 weeks
Vision
Time Frame: 4 weeks
defined as percentage of normal vision as measured by visual test according to EDSS standardized testing (see outcome 2)
4 weeks
Visually Evoked Potentials (VEP; P100 latency)
Time Frame: 4 weeks
4 weeks
Somatosensory Evoked Potentials (SEP; Medianus and Tibialis; N20-, P40-latency)
Time Frame: 4 weeks
4 weeks
Thickness of Retinal Nerve Fiber Layer (RNFL) in Optical Coherence Tomography (OCT)
Time Frame: 4 weeks
4 weeks
Verbaler Lern- und Merkfähigkeitstest (VLMT) score
Time Frame: 4 weeks
4 weeks
MSFC
Time Frame: 2 weeks
2 weeks
Thickness of Ganglion Cell Layer (GCL) in OCT
Time Frame: 4 weeks
4 weeks
Symbol Digit Modalities Test (SDMT) score
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

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

Sponsor

Albert Christian Ludolph, Prof.

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 26, 2016

Primary Completion (Actual)

January 3, 2019

Study Completion (Actual)

January 25, 2019

Study Registration Dates

First Submitted

January 22, 2016

First Submitted That Met QC Criteria

January 29, 2016

First Posted (Estimate)

February 2, 2016

Study Record Updates

Last Update Posted (Actual)

September 11, 2019

Last Update Submitted That Met QC Criteria

September 10, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IAPEMS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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.

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