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    Summary
    EudraCT Number:2020-005096-12
    Sponsor's Protocol Code Number:OPRERA
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-04-09
    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 number2020-005096-12
    A.3Full title of the trial
    Utvärdering av två kortison behandlingsstrategier hos patienter med nydiagnostiserad, tidigare obehandlad reumatoid artrit: en randomiserad, öppen, non-inferiority klinisk studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Utvärdering av två kortison behandlingsstrategier hos patienter med nydiagnostiserad, tidigare obehandlad ledgångsreumatism: en randomiserad, öppen, non-inferiority klinisk studie
    A.4.1Sponsor's protocol code numberOPRERA
    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 SponsorKarolinska Universitetssjukhuset
    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 supportNanna Svartz forskningsstipendium
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportKarolinska Institutet
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportVetenskapsrådet (sökt)
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKarolinska Universitetssjukhuset
    B.5.2Functional name of contact pointKoordinerande prövare
    B.5.3 Address:
    B.5.3.1Street AddressME Gastro, Hud, Reuma. Tema Inflammation och åldrande
    B.5.3.2Town/ cityStockholm
    B.5.3.3Post code141 86
    B.5.3.4CountrySweden
    B.5.4Telephone number+4676211 90 18
    B.5.6E-mailaikaterini.chatzidionysiou@ki.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 Prednisolon Pfizer
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer AB
    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 namePrednisolon Pfizer
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPREDNISOLONE
    D.3.9.4EV Substance CodeSUB10018MIG
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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
    Rheumatoid arthritis
    E.1.1.1Medical condition in easily understood language
    Ledgångsreumatism
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level PT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Är en snabb nedtrappning av lågdos Prednisolon icke inferior till en långsammare nedtrappning av samma startdos Prednisolon vid nydebuterad RA?
    E.2.2Secondary objectives of the trial
    Secondary objectives 1-6:
    Är en snabb nedtrappning av lågdos Prednisolon icke inferior till en långsammare nedtrappning av samma startdos Prednisolon för att:
    - förebygga strukturella förändringar enligt radiografisk progression?
    - förbättra smärta enligt VAS smärta?
    - förbättra funktionsförmåga enligt HAQ?
    - förbättra livskvalitet enligt EQ5D?
    - förbättra trötthet enligt VAS trötthet
    - förbättra allmänhälsa enligt VAS allmänhälsa

    Secondary objective nr 7:
    Är en snabb nedtrappning av lågdos Prednisolon förknippad med en bättre säkerhetsprofil jämfört med en långsammare nedtrappning av samma startdos Prednisolon?

    Secondary objective nr 8:
    Är en snabb nedtrappning av lågdos Prednisolon förknippad med ökad användning av bDMARDs jämfört med en långsammare nedtrappning av samma startdos Prednisolon vid månad 12 och 24?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signerat samtycke
    2. Diagnos RA enligt 2010 klassifikationskriterier
    3. Ålder ≥18år
    4. Behandlingsnaiva RA patienter
    5. Patienter som har indikation för behandling med prednisolon enligt de behandlingsriktlinjer och utan kontraindikationer för kortisonbehandling i de doser som vi använder för denna indikation
    E.4Principal exclusion criteria
    1. Aktuell behandling med kortison per os* (*Patienter som har nyligen fått kortison behandling för RA, upp till 2 veckor innan, dos 10mg/d, kan bli aktuella för studien)
    2. Okontrollerad diabetes mellitus, definierat som HbA1c > 52 mmol/mol
    3. Okontrollerad svår hypertoni, vilket definieras som systoliskt blodtryck ≥180 mmHg och/eller diastoliskt blodtryck ≥110 mmHg
    4. Okontrollerad glaukom, definierat som glaukom (enligt ögonläkarens bedömning) som inte är kirurgiskt åtgärdad eller under medicinsk behandling
    5. Gravida eller ammande kvinnor
    6. Patienter som har mycket låg sjukdomsaktivitet (DAS28<2.6) och behandlande reumatolog anser kortison bridging therapy som onödig)
    7. Ovilja av patienten att få kortisonbehandling
    E.5 End points
    E.5.1Primary end point(s)
    Klinisk effektivitet definierat som time-averaged DAS28 vid månad 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Månad 12
    E.5.2Secondary end point(s)
    1. Andel patienter med radiografisk progression av artritförändringar vid månad 12 och 24 jämfört med baseline. Radiografisk progression baseras på radiologens bedömning, och det inkluderar nytillkomna usurer och/eller periartikulär osteoporos och/eller ledbroskreduktion.
    2. Förbättring av smärta baserad påVAS smärta (0-10cm) vid månad 6, 12 och 24.
    3. Förbättring av funktionsförmåga baserad på HAQ vid månad 6, 12 och 24.
    4. Förbättring av livskvalitet baserad på EQ5D vid månad 6, 12 och 24.
    5. Förbättring av trötthet baserad på VAS trötthet (0-10cm) vid månad 6, 12 och 24.
    6. Förbättring av allmänhälsa enligt VAS allmänhälsa (0-10cm) vid månad 6, 12 och 24.
    7. Säkerhet (AEs och SAEs) under studiens duration (2 år).
    8. Andel patienter som behövde intensifiering av behandling med tillägg av en bDMARD på grund av ineffektivitet vid månad 12 och månad 24
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Vid månad 12 och 24 jämfört med baseline.
    2. Vid månad 6, 12 och 24.
    3. Vid månad 6, 12 och 24.
    4. Vid månad 6, 12 och 24.
    5. Vid månad 6, 12 och 24.
    6. Vid månad 6, 12 och 24.
    7. Under studiens duration (2 år).
    8. Vid månad 12 och 24.
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Studie med två olika nedtrappningsregimer av Prednisolon.
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    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 years4
    E.8.9.1In the Member State concerned months6
    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) No
    F.1.2.1Number of subjects for this age range: 83
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 83
    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 state166
    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)
    Patienterna följs upp enligt klinisk rutin.
    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 Decision2021-05-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-05
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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