Clinical trial NCT04687332: 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
Overall status: COMPLETED
Phase: NA
Conditions: Neurological Autoimmune Diseases
Keywords: Plasma exchange (PE)
immunoadsorption (IA)
multiple sclerosis
neuromyelitis optica,
chronic inflammatory demyelinating polyneuropathy
acute inflammatory demyelinating polyradiculoneuropathy
autoimmune encephalitis
Lead sponsor: University Medical Center Mainz
Sponsor class: OTHER
First posted: 2020-12-29
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective controlled monocentric observational study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in descriptive characterization of Symptoms
timeFrame: After 7 days. Symptoms were assessed at baseline before the first intervention (day 1) and immediately after the last intervention (day 7).]
measure: Change in the "Expanded Disability Status Scale" (EDSS)
timeFrame: After 7 days. EDSS were assessed at baseline before the first intervention (day 1) and immediately after the last intervention (day 7).
Secondary outcomes:
measure: Change in concentration of Immunglobulins
timeFrame: After 7 days. Immunglobulins were measured before and after the first intervention (day 1) and immediately before after the last intervention (day 7).
measure: Change in concentration of human cytokines
timeFrame: After 7 days. Cytokines were measured before and after the first intervention (day 1) and immediately before and after the last intervention (day 7).
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz I. Medizinische Klinik und Poliklinik
state: Rheinland-Pfalz
Study officials:
References: