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

Not Applicable

Completed

• Conditions: Neurological Autoimmune Diseases
• Interventions: Other: Apheresis therapy by Octo Nova Technology (DIAMED, Cologne, Germany)

• Registration Number: NCT04687332
• Lead Sponsor: University Medical Center Mainz

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2016-06-01
• Primary Completion: 2019-09-15
• Study Completion: 2019-12-01
• Study First Submitted: 2020-12-05
• Study First Submitted QC: 2020-12-22
• Study First Posted: 2020-12-29
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-14
• Last Update Posted: 2021-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
plasma exchange	Apheresis therapy by Octo Nova Technology (DIAMED, Cologne, Germany)	patients were treated with plasma exchange
immunadsorption	Apheresis therapy by Octo Nova Technology (DIAMED, Cologne, Germany)	patients were treated with immunadsorption

Primary Outcome Measures

Name	Time	Method
Change in the "Expanded Disability Status Scale" (EDSS)	After 7 days. EDSS were assessed at baseline before the first intervention (day 1) and immediately after the last intervention (day 7).	In the subgroup of MS patients, disability was evaluated by EDSS. The Expanded Disability Status Scale is a scale system for the systematic recording (assessment) of disability in neurological patients suffering from multiple sclerosis. The scale is used to classify the severity of disability by symptoms, ranging from 0 (no symptoms) to a maximum of grade 10 (death from MS).
Change in descriptive characterization of Symptoms	After 7 days. Symptoms were assessed at baseline before the first intervention (day 1) and immediately after the last intervention (day 7).]	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.

Secondary Outcome Measures

Name	Time	Method
Change in concentration of human cytokines	After 7 days. Cytokines were measured before and after the first intervention (day 1) and immediately before and after the last intervention (day 7).	Measurement of IL-12, IL-17, IL-18, CSF-1, IL-34, IL-6, TNF-alpha and IL-28.
Change in concentration of Immunglobulins	After 7 days. Immunglobulins were measured before and after the first intervention (day 1) and immediately before after the last intervention (day 7).	Measurement of IgE, IgM, IgG levels and IgG subclasses.

Trial Locations

Locations (1)

UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz I. Medizinische Klinik und Poliklinik; 🇩🇪 Mainz, Rheinland-Pfalz, Germany