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

NCT04687332 | Completed

• 1 other identifier: IA vs PE
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurological Autoimmune Diseases

Keywords

Plasma exchange (PE); immunoadsorption (IA); multiple sclerosis; neuromyelitis optica,; chronic inflammatory demyelinating polyneuropathy; acute inflammatory demyelinating polyradiculoneuropathy; autoimmune encephalitis

Outcome Measures

Primary Outcomes (2)

• Change in descriptive characterization of Symptoms

  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.

  After 7 days. Symptoms were assessed at baseline before the first intervention (day 1) and immediately after the last intervention (day 7).]

• Change in the "Expanded Disability Status Scale" (EDSS)

  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).

  After 7 days. EDSS were assessed at baseline before the first intervention (day 1) and immediately after the last intervention (day 7).

Secondary Outcomes (2)

• 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).

• 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).

Study Arms (2)

plasma exchange

EXPERIMENTAL

patients were treated with plasma exchange

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

immunadsorption

EXPERIMENTAL

patients were treated with immunadsorption

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

Interventions

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

Also known as: 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

immunadsorption; plasma exchange

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• autoimmune neurological therapy refractory disease

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Mainz: lead

Study Sites (1)

UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz I. Medizinische Klinik und Poliklinik

Mainz, Rhineland-Palatinate, 55130, Germany

Location

MeSH Terms

Conditions

Multiple Sclerosis; Neuromyelitis Optica; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; Guillain-Barre Syndrome; Autoimmune Diseases of the Nervous System

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Myelitis, Transverse; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Eye Diseases; Polyradiculoneuropathy; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Post-Infectious Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Nephrology and Dialysis

Model Details: prospective controlled monocentric observational study

Study Record Dates

• First Submitted: December 5, 2020
• First Posted: December 29, 2020
• Study Start: June 1, 2016
• Primary Completion: September 15, 2019
• Study Completion: December 1, 2019
• Last Updated: February 17, 2021

Record last verified: 2021-02

Locations

DE (1)