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

Neurological Autoimmune Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04687332
• Other study ID #: IA vs PE
• Status: Completed
• Phase: N/A
• Start date: June 1, 2016
• Est. completion date: December 1, 2019

Study information

• Verified date: February 2021
• Source: University Medical Center Mainz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 1, 2019
• Est. primary completion date: September 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Diseases
• Neurological Autoimmune Diseases

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Germany	UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz I. Medizinische Klinik und Poliklinik	Mainz	Rheinland-Pfalz

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Mainz

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).]
Primary	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	Change in concentration of Immunglobulins	Measurement of IgE, IgM, IgG levels and IgG subclasses.	After 7 days. Immunglobulins were measured before and after the first intervention (day 1) and immediately before after the last intervention (day 7).
Secondary	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.	After 7 days. Cytokines were measured before and after the first intervention (day 1) and immediately before and after the last intervention (day 7).