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    Summary
    EudraCT Number:2018-002641-11
    Sponsor's Protocol Code Number:PRIDE
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-07-26
    Trial results View 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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2018-002641-11
    A.3Full title of the trial
    The BRIDGE-PMR study: B-cell depletion with Rituximab for Dose reduction of Glucocorticoids: Efficacy in PolyMyalgia Rheumatica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study on the efficacy of rituximab in patients with polymyalgia rheumatica
    Onderzoek naar de effectiviteit van rituximab bij patiënten met polymyalgia rheumatica
    A.3.2Name or abbreviated title of the trial where available
    BRIDGE-PMR
    A.4.1Sponsor's protocol code numberPRIDE
    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 SponsorSint Maartenskliniek
    B.1.3.4CountryNetherlands
    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 supportSint Maartenskliniek
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSint Maartenskliniek
    B.5.2Functional name of contact pointPrincipal investigator
    B.5.3 Address:
    B.5.3.1Street Addresshengstdal 3
    B.5.3.2Town/ cityubbergen
    B.5.3.3Post code6574 NA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+310243659985
    B.5.6E-maila.vandermaas@maartenskliniek.nl
    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 rixathon
    D.2.1.1.2Name of the Marketing Authorisation holdersandoz
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 namerixathon
    D.3.2Product code L01X C02
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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
    polymyalgia rheumatica
    E.1.1.1Medical condition in easily understood language
    polymyalgia rheumatica
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    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
    Determining the GC-sparing effect of RTX by assessing the proportion of PMR patients with GC-free remission and GC cumulative dose after 20 weeks
    E.2.2Secondary objectives of the trial
    Assessing the effect of 1* 1000 mg RTX on disease activity in PMR patients by determining the change of ESR and CRP, PMR-AS, inner core domain set as proposed by the OMERACT, SF-36, EQ5D-5L, HAQ-DI from baseline to 20 weeks;
    Assessing biomarkers such as B-cells, BAFF, IL-6, T-cells and anti-ferritin antibodies and RTX antibodies;
    Determining the frequency and types of GC-related adverse events during the study by using the GTI
    Determining the frequency and types of GC- and RTX-related adverse events during the study
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ·PMR according to the ACR/EULAR 2012 PMR core classification criteria
    ·Signed written informed consent
    E.4Principal exclusion criteria
    ·Not being able to speak, read or write Dutch
    ·PMR diagnosed >4 weeks before inclusion in the study
    ·Exposure to GC or other immunosuppressant treatments in the past 3 months
    ·Known concomitant GCA or other rheumatic diseases such as RA, spondylarthropathies, connective tissue diseases, drug-induced myopathies, active and untreated thyroid disorders, Parkinson disorder or fibromyalgia
    ·Previous hypersensitivity for prednisone, RTX or murine peptides
    ·Contra-indications to RTX such as active current infection, including hepatitis B or tuberculosis infection, state of severe immunodeficiency, severe heart failure (NYHA-class IV)
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of PMR patients in GC-free remission.
    E.5.1.1Timepoint(s) of evaluation of this end point
    20 weeks
    E.5.2Secondary end point(s)
    -GC cumulative dose
    -The change of ESR and CRP, PMR-AS, inner core domain set as proposed by the OMERACT, SF-36, EQ5D-5L, HAQ-DI from baseline to 20 weeks;
    -Assessing biomarkers such as B-cells, BAFF, IL-6, T-cells and anti-ferritin antibodies and RTX antibodies;
    -The frequency and types of GC-related adverse events during the study measured using the GTI;
    -The frequency and types of GC- and RTX-related adverse events during the study.
    E.5.2.1Timepoint(s) of evaluation of this end point
    20 weeks
    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 Yes
    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 Yes
    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
    Last visit of the last subject undergoing the trial
    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 months
    E.8.9.1In the Member State concerned days
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state40
    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)
    none
    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 Decision2018-07-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-11-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-08-19
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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