2026-525324-26-00RecruitingPhase 2
Long-term outcomes and safety of repeated rituximab treatment in psychotic disorders – RITS-LONG
Region Oerebro Laen4 sites in 1 country122 target enrollmentStarted: October 1, 2026Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 122
- Locations
- 4
- Primary Endpoint
- The proportion of participants rated as more than minimally improved (CGI-I ≤ 2.5), assessed 4 months (±1 month) after two infusions of rituximab in the RITS-LONG trial. Improvement is evaluated relative to baseline symptom severity and functional status recorded in the RITS-LONG study.The results are compared to the historical placebo response estimated from the preceding RCT-Rits trial and presented separately by initial treatment group in the RCT-Rits (placebo or rituximab)
Study Overview
Brief Summary
To investigate the long-term outcomes and safety from repeated adjuvant treatment with the immunomodulatory drug rituximab in patients with schizophrenia or schizoaffective disorder.
Eligibility Criteria
- Ages
- 18 years to 64 years (18-64 Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •Pregnancy or breastfeeding.
- •Malignancy, currently or within three years prior to inclusion.
- •Hypogammaglobulinemia or neutropenia.
- •Any other physical condition that, in the judgement of the investigator, would make the subject unsuitable for participation in the trial.
- •Weight below 40 kg.
- •Clinically relevant ongoing infection.
- •Chronic infections.
- •Positive screening test for hepatitis B, C, HIV, or tuberculosis at Baseline in RCT-Rits.
- •Severe heart disease.
- •Unable to make an informed decision to consent.
- •Treatments with monoclonal antibodies (other than rituximab), other immunomodulation treatments, or cytostatics within one year prior to inclusion.
Outcomes
Primary Outcomes
The proportion of participants rated as more than minimally improved (CGI-I ≤ 2.5), assessed 4 months (±1 month) after two infusions of rituximab in the RITS-LONG trial. Improvement is evaluated relative to baseline symptom severity and functional status recorded in the RITS-LONG study.The results are compared to the historical placebo response estimated from the preceding RCT-Rits trial and presented separately by initial treatment group in the RCT-Rits (placebo or rituximab)
The proportion of participants rated as more than minimally improved (CGI-I ≤ 2.5), assessed 4 months (±1 month) after two infusions of rituximab in the RITS-LONG trial. Improvement is evaluated relative to baseline symptom severity and functional status recorded in the RITS-LONG study.The results are compared to the historical placebo response estimated from the preceding RCT-Rits trial and presented separately by initial treatment group in the RCT-Rits (placebo or rituximab)
Secondary Outcomes
- Self-rated health (VAS-Health): Patient’s self-rated general well-being using the Visual Analogue Scale (VAS-Health).
- Clinical improvement (CGI-I): Proportion of participants rated as more than minimally improved according to Clinical Global Impression – Improvement, CGI-I (Guy, 1976) score of ≤ 2.5 at Time point 1 and Time point 2.
- Severity of illness (CGI-S): Clinician-rated Clinical Global Impression – Severity (CGI-S) score
- Personal and Social Performance Scale (PSP): Clinician-rated assessment of overall functioning and disability (PSP score)
- Self-Assessment of Negative Symptoms (SNS) and Level 1 Cross-cutting symptom measure of global symptom severity (CCSM): Patient-reported negative symptom severity (SNS total score) and comorbid psychiatric symptoms (CCSM)
- Informant-rated improvement (I-CGI-I): Informant’s (e.g. significant other or close relative) rating of patient improvement using the Informant-CGI-I at Time point 1 and Time point 2, compared with placebo in RCT-Rits. CGI-I was not originally developed for informant assessment but used as such in the RCT-Rits trial.
- Positive and Negative Syndrome Scale (PANSS): A semi structured clinical interview for assessing symptoms and severity of psychotic disorders (Kay et al. 1987). PANSS will be assessed at Time point 1 and Time point 2.
- Biomarkers: Changes in relevant peripheral biomarkers.
- Patient and significant-other satisfaction and experience: Quantitative and qualitative assessments of satisfaction and experiences related to rituximab treatment, collected at Time point 1.
Investigators
Axel Nordenskjöld
Scientific
Region Oerebro Laen
Study Sites (4)
Loading locations...
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