IA or PE - What is the Best Treatment Option of Steroid Refractory Neurological Autoimmune Diseases

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

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-01

Study Completion Date

2019-12-01

Brief Summary

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In this prospective controlled monocentric observational study, we assessed safety and efficacy of therapy with IA or PE in patients with neurological autoimmune diseases. In the subgroup analysis of MS patients also the EDSS was evaluated. In addition, we investigated possible pathomechanisms, such as cytokine alterations under therapy.

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Detailed Description

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Plasma exchange (PE) and immunoadsorption (IA) are first- or second line treatment options in patients with neurological autoimmune disease, including multiple sclerosis, neuromyelitis optica, chronic inflammatory demyelinating polyneuropathy, acute inflammatory demyelinating polyradiculoneuropathy (Guillain-Barré-Syndrom) or autoimmune encephalitis. This prospective controlled monocentric observational study of patients treated with either tryptophan IA or PE in cases of autoimmune neurological therapy refractory disease was performed between 2016 and 2019. The main outcome parameter for efficiency was clinical improvement after completion of treatment with PE/IA. Symptoms were assessed before the first and after the last IA/PE. In total, all patients receive 5 treatments. As patients with various neurological autoimmune diseases were included in the study, the overall treatment response was categorized descriptively as improvement or no improvement of symptoms.

Conditions

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Neurological Autoimmune Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

prospective controlled monocentric observational study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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plasma exchange

patients were treated with plasma exchange

Group Type EXPERIMENTAL

Apheresis therapy by Octo Nova Technology (DIAMED, Cologne, Germany)

Intervention Type OTHER

One group was treated with IA and the single use tryptophan adsorber, the other group was treated with PE and the Plasmaflow (see above). In total, all patients receive 5 treatments.

immunadsorption

patients were treated with immunadsorption

Group Type EXPERIMENTAL

Apheresis therapy by Octo Nova Technology (DIAMED, Cologne, Germany)

Intervention Type OTHER

One group was treated with IA and the single use tryptophan adsorber, the other group was treated with PE and the Plasmaflow (see above). In total, all patients receive 5 treatments.

Interventions

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Apheresis therapy by Octo Nova Technology (DIAMED, Cologne, Germany)

One group was treated with IA and the single use tryptophan adsorber, the other group was treated with PE and the Plasmaflow (see above). In total, all patients receive 5 treatments.

Intervention Type OTHER

Other Intervention Names

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IA treatment: using single-use tryptophane adsorber TR 350 in combination with the OP-0,5W plasma separator (Asahi Kasei Medical, Tokyo, Japan) and the tubing system PA-420 PE treatment: using Plasmaflow OP 0,5W (L) and the tubing system AV-120 and FS-250

Eligibility Criteria

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Inclusion Criteria

* autoimmune neurological therapy refractory disease

Exclusion Criteria

* Intake of Angiotensin-converting-enzyme inhibitors (ACE inhibitors) because of allergic reactions by using tryptophan adsorber
* contraindication for any anticoagulation
* contraindication for treatment with citrate dextrose anticoagulation

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No