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

Primary Purpose

Neurological Autoimmune Diseases

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Apheresis therapy by Octo Nova Technology (DIAMED, Cologne, Germany)
Sponsored by
University Medical Center Mainz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neurological Autoimmune Diseases focused on measuring Plasma exchange (PE), immunoadsorption (IA), multiple sclerosis, neuromyelitis optica,, chronic inflammatory demyelinating polyneuropathy, acute inflammatory demyelinating polyradiculoneuropathy, autoimmune encephalitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

plasma exchange

immunadsorption

Arm Description

patients were treated with plasma exchange

patients were treated with immunadsorption

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

Change in concentration of Immunglobulins
Measurement of IgE, IgM, IgG levels and IgG subclasses.
Change in concentration of human cytokines
Measurement of IL-12, IL-17, IL-18, CSF-1, IL-34, IL-6, TNF-alpha and IL-28.

Full Information

First Posted
December 5, 2020
Last Updated
February 14, 2021
Sponsor
University Medical Center Mainz
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1. Study Identification

Unique Protocol Identification Number
NCT04687332
Brief Title
IA or PE - What is the Best Treatment Option of Steroid Refractory Neurological Autoimmune Diseases
Official Title
Immunoadsorption or Plasma Exchange - What is the Best Treatment Option of Steroid Refractory Neurological Autoimmune Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2016 (Actual)
Primary Completion Date
September 15, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Mainz

4. Oversight

Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurological Autoimmune Diseases
Keywords
Plasma exchange (PE), immunoadsorption (IA), multiple sclerosis, neuromyelitis optica,, chronic inflammatory demyelinating polyneuropathy, acute inflammatory demyelinating polyradiculoneuropathy, autoimmune encephalitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective controlled monocentric observational study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
plasma exchange
Arm Type
Experimental
Arm Description
patients were treated with plasma exchange
Arm Title
immunadsorption
Arm Type
Experimental
Arm Description
patients were treated with immunadsorption
Intervention Type
Other
Intervention Name(s)
Apheresis therapy by Octo Nova Technology (DIAMED, Cologne, Germany)
Other Intervention Name(s)
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
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in descriptive characterization of Symptoms
Description
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.
Time Frame
After 7 days. Symptoms were assessed at baseline before the first intervention (day 1) and immediately after the last intervention (day 7).]
Title
Change in the "Expanded Disability Status Scale" (EDSS)
Description
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).
Time Frame
After 7 days. EDSS were assessed at baseline before the first intervention (day 1) and immediately after the last intervention (day 7).
Secondary Outcome Measure Information:
Title
Change in concentration of Immunglobulins
Description
Measurement of IgE, IgM, IgG levels and IgG subclasses.
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).
Title
Change in concentration of human cytokines
Description
Measurement of IL-12, IL-17, IL-18, CSF-1, IL-34, IL-6, TNF-alpha and IL-28.
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz I. Medizinische Klinik und Poliklinik
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55130
Country
Germany

12. IPD Sharing Statement

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

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