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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-26

Study Completion Date

2019-01-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Multiple Sclerosis Clinically Isolated Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Immunoadsorption

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

Group Type EXPERIMENTAL

Immunoadsorption

Intervention Type PROCEDURE

Plasmapheresis

Plasmapheresis on 5 consecutive days with 2l plasma exchange

Group Type ACTIVE_COMPARATOR

Plasmapheresis

Intervention Type PROCEDURE

Interventions

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Immunoadsorption

Intervention Type PROCEDURE

Plasmapheresis

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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