Neurological Autoimmune DiseasesNCT04687332
IA or PE - What is the Best Treatment Option of Steroid Refractory Neurological Autoimmune Diseases
A study testing Apheresis therapy by Octo Nova Technology (DIAMED, Cologne, Germany) in people with Neurological Autoimmune Diseases, run by University Medical Center Mainz at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neurological Autoimmune Diseases
- What is being tested?
- Apheresis therapy by Octo Nova Technology (DIAMED, Cologne, Germany)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2016to 1 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- autoimmune neurological therapy refractory disease
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz I. Medizinische Klinik und Poliklinik
Mainz, Rhineland-Palatinate, 55130
About this study
Official title: Immunoadsorption or Plasma Exchange - 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.
Read the 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.
- Conditions
- Neurological Autoimmune Diseases
- Being tested
- Apheresis therapy by Octo Nova Technology (DIAMED, Cologne, Germany)
- Keywords
- Plasma exchange (PE), immunoadsorption (IA), multiple sclerosis, neuromyelitis optica,, chronic inflammatory demyelinating polyneuropathy, acute inflammatory demyelinating polyradiculoneuropathy, autoimmune encephalitis
- Medical subject headings
- Multiple Sclerosis, Neuromyelitis Optica, Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, Guillain-Barre Syndrome, Autoimmune Diseases of the Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apheresis therapy by Octo Nova Technology (DIAMED, Cologne, Germany)Other
Also called 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
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.
| Study group | Role | What they receive |
|---|---|---|
| plasma exchange | Experimental | patients were treated with plasma exchange Receives: Other: Apheresis therapy by Octo Nova Technology (DIAMED, Cologne, Germany) |
| immunadsorption | Experimental | patients were treated with immunadsorption Receives: Other: Apheresis therapy by Octo Nova Technology (DIAMED, Cologne, Germany) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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
Measurement of IgE, IgM, IgG levels and IgG subclasses.
Measured: 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
Measurement of IL-12, IL-17, IL-18, CSF-1, IL-34, IL-6, TNF-alpha and IL-28.
Measured: After 7 days. Cytokines were measured before and after the first intervention (day 1) and immediately before and after the last intervention (day 7).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start1 Jun 2016
- Primary completion15 Sep 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurological Autoimmune DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- prospective controlled monocentric observational study
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Julia Weinmann-Menke, University Medical Center Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04687332
- Sponsor's protocol ID
- IA vs PE
- Status last verified
- Feb 2021
- First submitted
- 5 Dec 2020
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunoadsorption or Plasma Exchange - What is the Best Treatment Option of Steroid Refractory Neurological Autoimmune Diseases
- ClinicalTrials.gov ID
- NCT04687332
- Acronym / sponsor ID
- IA vs PE
- Conditions
- Neurological Autoimmune Diseases
- Keywords
- Plasma exchange (PE), immunoadsorption (IA), multiple sclerosis, neuromyelitis optica,, chronic inflammatory demyelinating polyneuropathy, acute inflammatory demyelinating polyradiculoneuropathy, autoimmune encephalitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University Medical Center MainzUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 15 Sep 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 29 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective controlled monocentric observational study
| Arm | Type | Receives |
|---|---|---|
| plasma exchange | Experimental | Other: Apheresis therapy by Octo Nova Technology (DIAMED, Cologne, Germany)patients were treated with plasma exchange |
| immunadsorption | Experimental | Other: Apheresis therapy by Octo Nova Technology (DIAMED, Cologne, Germany)patients were treated with immunadsorption |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- autoimmune neurological therapy refractory disease
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apheresis therapy by Octo Nova Technology (DIAMED, Cologne, Germany)Also: 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-250One 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 | immunadsorption, plasma exchange |
Primary outcome
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.
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).
2 secondary outcomes
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apheresis therapy by Octo Nova Technology (DIAMED, Cologne, Germany) in people with Neurological Autoimmune Diseases, run by University Medical Center Mainz at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).]). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2021.