Long-term outcomes and safety of repeated rituximab treatment in psychotic disorders – RITS-LONG
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 122
- 试验地点
- 4
- 主要终点
- 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)
研究概览
简要总结
To investigate the long-term outcomes and safety from repeated adjuvant treatment with the immunomodulatory drug rituximab in patients with schizophrenia or schizoaffective disorder.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
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)
次要结局
- 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.
研究者
Axel Nordenskjöld
Scientific
Region Oerebro Laen