Long-term outcomes and safety of repeated rituximab treatment in psychotic disorders – RITS-LONG

Prior treatment

• Malignancy, currently or within three years prior to inclusion.
• Treatments with monoclonal antibodies (other than rituximab), other immunomodulation treatments, or cytostatics within one year prior to inclusion.

Other illness

• Any other physical condition that, in the judgement of the investigator, would make the subject unsuitable for participation in the trial.
• Clinically relevant ongoing infection.
• Chronic infections.
• Positive screening test for hepatitis B, C, HIV, or tuberculosis at Baseline in RCT-Rits.
• Severe heart disease.

Other

• Pregnancy or breastfeeding.
• Hypogammaglobulinemia or neutropenia.
• Weight below 40 kg.
• Unable to make an informed decision to consent.

• Have participated in the RCT-Rits trial.
• Signed informed consent.
• Duration of illness exceeding 2 years.
• Meets DSM-5 diagnostic criteria for schizophrenia or schizoaffective disorder at Baseline in RCT-Rits.
• Women (WOCBP) must be willing to use contraceptives or abstain for the duration of the study until one year after last rituximab treatment.
• Subjects should be assessed by the investigator to be clear and oriented when giving informed consent.