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    Summary
    EudraCT Number:2018-004618-17
    Sponsor's Protocol Code Number:RITS-PS-2019
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-12-18
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSweden - MPA
    A.2EudraCT number2018-004618-17
    A.3Full title of the trial
    Rituximab - Immunotherapy for Schizophrenia spectrum disorder in adults. An open pilot study.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immunological treatment for Schizophrenia
    Immunologisk behandling av schizofreni
    A.4.1Sponsor's protocol code numberRITS-PS-2019
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorRegion Örebro län
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportRegion Örebro län
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRegion Örebro län
    B.5.2Functional name of contact pointPsykiatriska kliniken USÖ
    B.5.3 Address:
    B.5.3.1Street AddressUniversitetssjukhuset Örebro
    B.5.3.2Town/ cityÖrebro
    B.5.3.3Post code70185
    B.5.3.4CountrySweden
    B.5.4Telephone number+46701655102
    B.5.6E-mailsusanne.bejerot@regionorebrolan.se
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name MabThera
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMabThera
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRITUXIMAB
    D.3.9.1CAS number 174722-31-7
    D.3.9.4EV Substance CodeSUB12570MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment-resistant patients with schizophrenia spectrum disorder (SSD)
    E.1.1.1Medical condition in easily understood language
    Treatment-resistant patients with schizophrenia spectrum disorder (SSD)
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate whether severely ill, treatment resistant, psychiatric patients with schizophrenia spectrum disorder (SSD) are significantly improved after treatment with the immunomodulatory drug rituximab (anti-CD20 antibodies) compared to baseline.
    E.2.2Secondary objectives of the trial
    - To examine whether baseline levels of inflammatory markers predict treatment response.
    - To examine whether changes in inflammatory markers and B-cell depletion correlate with treatment response.
    - To examine metabolic mediators prior and after treatment and if they correlate with treatment response.
    - To examine whether there is a change in gut permeability after treatment.
    - To examine whether there is a change in cognition after treatment.
    - To investigate if there is a change in brain activity after treatment.
    - To investigate the patients’ experiences of the novel treatment with a qualitative content analysis.
    - To assess safety and tolerability of rituximab during treatment for SSD
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Age: 18 to 40 years
    2) Duration of psychiatric illness: exceeding 2 years
    3) Rated “Markedly ill”, “Severely ill” or ”Among the most extremely ill patients” on the Clinical Global Impression – Severity scale (CGI-S)
    4) Global Assessment of Functioning below 50
    5) Current diagnosis according to Diagnostic and Statistical Manual for Mental Disorders, 5th edition (DSM-5) of SSD (schizophrenia spectrum disorder)
    6) Treatment resistance, i.e. failing to remit despite adequate treatments
    7) If female and with any risk for pregnancy: willing to use contraceptives.
    8) If antipsychotic treatment is prescribed the plasma concentrations of the drug must be tested and shown to be within the therapeutic interval.
    9) Subjects should be judged by the investigator to be lucid and oriented to person, place, time, and situation when giving the informed consent.
    10) Immunoglobulin levels within the normal range
    E.4Principal exclusion criteria
    1) on-going immunomodulatory treatment
    2) pregnancy or breast-feeding
    3) weight below 40 kg
    4) clinically relevant on-going infection
    5) chronic infections
    6) positive screening test for hepatitis B, C, HIV, or tuberculosis
    7) any change of psychotropic medication within the previous 4 weeks
    8) much or very much improved already at baseline according to CGI-I, I i.e. scores of 1 or 2 by the clinician
    9) severe heart failure (NYHA grade IV) or other severe heart disease or history of cardiac arrhythmia or myocardial infarction
    10) unable to make an informed decision to consent to the trial
    11) in compulsory treatment
    12) treatment with clozapine within the last 2 months
    13) Previous treatments with immunosuppressive agents
    14) Malignancy currently or within 2 years prior to inclusion

    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure is change in symptoms measured as change in PANSS score.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 20, 40 and 52
    E.5.2Secondary end point(s)
    • Global improvement at week 20, according to a balanced assessment (mean value of three independent assessors: 1) The treating clinician, 2) The patient’s self-assessment and 3) A next-of-kin) using the Clinical Global Impression-Improvement (CGI-I) scale (range 1-7; 1 representing “Very much improved”).
    • Change in Personal and Social Performance Scale (PCP) measuring overall disability
    • Change from baseline up to week 20 of illness severity (CGI-S) assessed by the clinician
    • Difference from baseline up to week 20 in inflammatory markers in blood (gene expression and proteins) in relationship to clinical response (CGI-I)
    • Proportion of responders to treatment, i.e. rated as much or very much improved since baseline according to CGI-I assessed by three different informants: 1) The treating clinician, 2) The patient’s self-assessment and 3) A next of kin. If the mean value of these three is below 2.5 then the patient will be regarded as a responder (representing much or very much improved since baseline).
    • Safety and tolerability of rituximab during treatment for SSD measured with the questionnaire Any Adverse Reactions (AAR).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 20, 40 and 52
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 12
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Standard of care
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-02-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-24
    P. End of Trial
    P.End of Trial StatusOngoing
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