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

CompletedNot a drug-phase studyMS (type not specified)NCT04687332

What it found

No results found

We found no results in the registry or in papers.

This trial finished 7 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Apheresis therapy by Octo Nova Technology (DIAMED, Cologne, Germany)

What it measured

Main measures

  • Change in descriptive characterization of Symptoms

    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)

    After 7 days. EDSS were assessed at baseline before the first intervention (day 1) and immediately after the last intervention (day 7).

    Disability progression

Other measures (2)

  • Change in concentration of Immunglobulins

    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

    After 7 days. Cytokines were measured before and after the first intervention (day 1) and immediately before and after the last intervention (day 7).

    Blood or spinal fluid markersImmune response

Who could take part

MS (type not specified) · 18 to 80

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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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History

    1. Started

      Jun 2016

    2. Main results due

      Sept 2019

    3. Finished

      Dec 2019

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