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Not yet taking people in SwedenPhase 2

Long-term effects and safety of repeated rituximab in psychotic disorders

Tests repeated rituximab treatment in adults with schizophrenia or schizoaffective disorder.

Key facts

Who runs it
Region Oerebro Laen
Where
Helsingborg, Karlstad, Orebro, and Umea, SwedenSee the 4 sites
Registry title
Long-term outcomes and safety of repeated rituximab treatment in psychotic disorders – RITS-LONG
Status
Not yet recruiting
Phase
Phase 2
People taking part
122 people, planned
Started
1 Oct 2026
Expected to end
31 Dec 2031
Type of study
Interventional
Record updated
5 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with schizophrenia or schizoaffective disorder who took part in the earlier RCT-Rits trial. It studies long-term results and safety of repeated rituximab treatment.

Age
18 to 64 years
Sex
All sexes can join.
Disease stage
Schizophrenia or schizoaffective disorder (DSM-5) at the start of RCT-Rits, with illness lasting more than 2 years.
Earlier treatment
Must have taken part in the RCT-Rits trial. Must not have had monoclonal antibodies other than rituximab, other immune-changing treatments, or cytostatics in the year before joining.
Biomarker or test result
Screening tests for hepatitis B, C, HIV and tuberculosis at the start of RCT-Rits must be negative.

Main reasons for not taking part

  • Pregnancy or breastfeeding
  • Cancer now or within the last 3 years
  • Low immunoglobulin levels (hypogammaglobulinemia) or low neutrophil count (neutropenia)
  • Weight below 40 kg (88 lb)
  • Ongoing or chronic infection, or severe heart disease

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • 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

Who cannot take part

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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 64 years old?

Where in Sweden

  • Region Skane Helsingborg HospitalHelsingborg, SwedenNot yet recruiting
  • Region VaermlandKarlstad, SwedenNot yet recruiting
  • Region Oerebro LaenOrebro, SwedenNot yet recruiting
  • Region VaesterbottenUmea, SwedenNot yet recruiting

About the trial

What the trial wants to find out

To investigate the long-term outcomes and safety from repeated adjuvant treatment with the immunomodulatory drug rituximab in patients with schizophrenia or schizoaffective disorder.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
Long-term outcomes and safety of repeated rituximab treatment in psychotic disorders – RITS-LONG
Plain-language title
Long-term effects and safety of repeated rituximab in psychotic disordersGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 11 November 2026.
Fit questions
Built from 2026-525324-26-00, who can take part
Record updated
5 June 2026