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NCT Number: NCT04687332

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

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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Key information

Conditions

Neurological Autoimmune Diseases Autoimmune Diseases Autoimmune Diseases of the Nervous System Chronic Disease Cranial Nerve Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Eye Diseases Guillain-Barre Syndrome Immune System Diseases Multiple Sclerosis Myelitis, Transverse Nervous System Diseases Neuromuscular Diseases Neuromyelitis Optica Optic Nerve Diseases Optic Neuritis Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Polyneuropathies Polyradiculoneuropathy Polyradiculoneuropathy, Chronic Inflammatory Demyelinating Post-Infectious Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Mainz, Rhineland-Palatinate, 55130, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: 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

Primary outcomes

  1. Change in descriptive characterization of Symptoms

    Time frame: 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.

  2. Change in the "Expanded Disability Status Scale" (EDSS)

    Time frame: 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).

Secondary outcomes

  1. Change in concentration of Immunglobulins

    Time frame: 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.

  2. Change in concentration of human cytokines

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Medical Center Mainz

Other

Registry information

Official study title

Immunoadsorption or Plasma Exchange - What is the Best Treatment Option of Steroid Refractory Neurological Autoimmune Diseases

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Dec 29, 2020
Registry last updated
Feb 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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