Immunoadsorption Therapy in Managing NMDAR Antibodies Encephalitis
Prospective Assessment of Efficacy of Immunoadsorption Therapy in Managing Childhood NMDA-Receptor (NMDAR) Antibodies Encephalitis
Assistance Publique - Hôpitaux de Paris
20 participants
Jun 23, 2021
INTERVENTIONAL
Conditions
Summary
The purpose of the study is to assess the efficacy of immunoadsorption therapy (IA) on improving the neurological status of severe pediatric anti-NMDAR encephalitis patients.
Eligibility
Inclusion Criteria5
- Age: 0-18 years inclusive
- Autoimmune encephalitis with positive anti-NMDAR antibodies in CSF (definite anti-NMDAR encephalitis according to Graus's criteria (Graus et al., 2016).
- PCPCS and mRS at 4 or over at the inclusion after first line therapy (steroids and/or IgIV) when Rituximab therapy is warranted
- Parents or legal guardians signed the Informed consent form
- Social insurance affiliation
Exclusion Criteria11
- Autoimmune encephalitis without NMDAR antibodies
- PCPCS and mRS scores under 4 after first-line therapy
- Contraindication to perform central vascular access
- Pregnancy, breastfeeding or absence of effective contraception (including abstinence) in a pubertal patient.
- Contraindication to perform IA therapy :
- Clinical conditions that prohibit transitory volume changes
- Indications that prohibit anticoagulation using Heparin and/or ACD-A solutions
- History of hypercoagulability
- Generalized viral, bacterial and/or mycotic infections
- Severe immune deficiencies (e.g. AIDS)
- Suspected allergies against sheep antibodies or agarose
Interventions
10 IA sessions performed in 28 days maximum, using TherasorbTM adsorbers which contain sheep derived polyvalent antihuman-immunoglobulin coupled to SepharoseTM CL-4B.
Concomitantly, Rituximab will be given each week for 4 weeks (one injection by week +/- 3 days): * at least 1 day before each IA session * the last injection will occur after the last session IA (minimum one day after)
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03274375