immunomodulatory treatment by rituximab: 1g for adults or 375 mg/m2 for children, renewed at 14 days (+/- 3 days)
Study summary
This is an open phase III randomized clinical trial studying the superiority of management by immunomodulator treatment of psychiatric disorders (psychosis and bipolar disorders) for patients previously identified as carriers of autoimmunity such as as the presence of a pathogenic anti-glutamatergic NMDA receptor antibody (NMDAr-Ac).
Eligibility
Sex
ALL
Min age
6 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* For Adult: First acute or relapse of psychotic disorders defined by the BPRS-E scale with or without standard pharmacological treatment.
* For Children: Child over 6 years old with a first acute or relapse of psychotic disorders defined by the Kiddie sads-PL scale with or without standard pharmacological treatment.
* Biological diagnosis of pathogenic CNS autoantibodies in the blood.
* MDC scale score \>3 is required for inclusion in step 2.
* Normal ECG in case of previous heart disease.
* Informed consent of the patient or his legal representatives.
* Effective contraception for women of childbearing potential during the study and for at least 12 months after the last rituximab administration.
Exclusion Criteria:
* Developmental disorder related to a genetic disease.
* Co-existing disorder of severe neurological disease.
* Chronic psychotic disorders receiving ongoing neuroleptic treatment with efficacy.
* Hypersensitivity to the active substance (rituximab) or to murine proteins, or to any of the other excipients
* Blood platelets \< 75x109/L
* Neutrophils \< 1.5x109/L
* Neoplastic pathology,
* Hepatitis B or HIV infection,
* Contraindication to immunosuppressant treatment (active severe infection, severely immunocompromised state).
* Severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease
* Pregnant or breastfeeding women
* Currently receiving an investigational drug or received an investigational drug or device within 30 days (or 5 half-lives for drugs, whichever is longer) prior to screening.
* Previous treatment with rituximab in the past 12 months.
* Patients with a history of recurring or chronic infections or with underlying conditions which may further predispose them to serious infection (e.g. hypogammaglobulinemia).
* Recent vaccination with live viral vaccine (within 3 months).
* Any other medical illness or disability that, in the opinion of the investigator, would compromise effective trial participation.
Primary outcome measure(s)
Adult patients : the remission of psychiatric symptoms at 3 months — 3 months after randomization The primary endpoint outcome is the remission of psychiatric symptoms at 3 months, defined as:
\- For adult patients: 20% decrease from baseline of Brief psychiatric rating scale-Extended (BPRS-E scale).
Minor patients : the remission of psychiatric symptoms at 3 months — 3 months after randomization The primary endpoint outcome is the remission of psychiatric symptoms at 3 months, defined as:
\- For patients \<18years or adults patients included at adolescent age at 2nd step inclusion visit: clinically significant difference ≤3 from baseline of CBCL/6-18 (Child Behavior Checklist) scale.
Trial sites (9)
Facility
City
Region
Status
Centre Hospitalier Charles Perrens
Bordeaux
France
CHU de Bordeaux
Bordeaux
France
Centre hospitalier le Vinatier
Bron
France
CHU de Clermond Ferrand
Clermont-Ferrand
France
APHP Louis Mourier
Colombes
France
APHP Henri Mondor
Créteil
France
APHP Kremlin Bicetre
Le Kremlin-Bicêtre
France
CHU de Montpellier
Montpellier
France
CHU de Strasbourg
Strasbourg
France
More University Hospital, Bordeaux trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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