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    Summary
    EudraCT Number:2015-002729-21
    Sponsor's Protocol Code Number:VUMC-ARC-GLORIA
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-04-27
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2015-002729-21
    A.3Full title of the trial
    The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study Comparing the cost-effectiveness and safety of additional low-dose glucocorticoid in treatment strategies for elderly patients with rheumatoid arthritis
    Estudo de uso de baixa dose de glucocorticoides na Artrite Reumatoide comparando a
    relação custo-eficácia e segurança da utilização de baixa dose adicional de
    glucocorticoides como estratégia de tratamento de doentes idosos com artrite reumatoide.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to compare the cost effectiveness and safety of low dose glucocorticoids in elderly patients with rheumatoid arthritis
    Um estudo para comparar a relação custo-eficácia e segurança da utilização de baixa dose de glucocorticoides em pacientes idosos com artrite reumatoide
    A.3.2Name or abbreviated title of the trial where available
    Gloria
    A.4.1Sponsor's protocol code numberVUMC-ARC-GLORIA
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02585258
    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 SponsorVU University Medical Center
    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 support European Committee: Horizon 2020
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVU medical Center
    B.5.2Functional name of contact pointProject Coordinator
    B.5.3 Address:
    B.5.3.1Street AddressDe Boelelaan 1118
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1081 HZ
    B.5.3.4CountryNetherlands
    B.5.6E-mailleonie@middelinc.com
    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 prednisolone Labesfal
    D.2.1.1.2Name of the Marketing Authorisation holderLabesfal-Laboratórios Almiro, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationPortugal
    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 nameprednisolone
    D.3.4Pharmaceutical form Capsule
    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.3.9.1CAS number 50-24-8
    D.3.9.3Other descriptive namePREDNISOLONE
    D.3.9.4EV Substance CodeSUB10018MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Rheumatoid artritis
    Artrite reumatoide
    E.1.1.1Medical condition in easily understood language
    Rheumatoid artritis
    Artrite reumatoide
    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 20.0
    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
    a)To assess the effectiveness, safety and cost-effectiveness of 2 years of low-dose GC therapy (5 mg/day) compared to placebo as co-treatment for elderly RA patients in a pragmatic randomized trial
    b)Study medication adherence through a medication packaging solution, and test the effectiveness of smart device technology to improve adherence
    a) Avaliar a eficácia, a segurança e o custo-efetividade do tratamento de uma baixa dose de GC (5 mg/dia) em comparação com placebo administrada por dois anos como co-tratamento para doentes idosos com AR (= 65 anos) num ensaio randomizado pragmático; b) Avaliar a adesão à medicação do estudo através do controlo do frasco da medicação, e testar a eficácia do uso de tecnologias inteligentes para melhorar a adesão.
    E.2.2Secondary objectives of the trial
    not applicable
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    test the effectiveness of smart device technology to improve adherence
    Testar a eficacia do uso de um dispositivo inteligente para melhorar a adesão
    E.3Principal inclusion criteria
    RA according to the 1987 or 2010 classification criteria of the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) (Aletaha D 2010);

    Inadequate disease control, as evidenced by a 28-joint disease activity score (DAS28) of ≥ 2.60.
    For eligibility, the DAS28 can be calculated with ESR or CRP, and also recalculated from the DAS of 44 joints. A DAS28 may be calculated with clinical and lab assessments obtained no more than 4 weeks before the baseline visit.

    age ≥ 65 years.
    AR de acordo com os critérios de classificação de 1987 e 2010 do American College of Rheumatology (ACR) e da European League Against Rheumatism (EULAR) (Aletaha D 2010);
    controlo inadequado da doença, tal como demonstrado pelo disease activity score de 28 articulações calculada com a taxa de sedimentação de eritrócitos (DAS28) ≥2.60;

    Para elegibilidade, o DAS28 pode ser calculado com ESR ou CRP, e também recalculado a partir do DAS de 44 articulações. Um DAS28 pode ser calculado com avaliações clínicas e de laboratório obtidas não mais de 4 semanas antes da visita de base
    Idade ≥ 65 anos.
    E.4Principal exclusion criteria
    Change, stop or start of antirheumatic treatment in the last month prior to eligibility assessment, including methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, azathioprine, intramuscular and oral gold, cyclosporine, biologic agents including anti-TNF, anakinra, abatacept, rituximab, tocilizumab (temporary exclusion);
    Treatment with systemic GC: oral or parenteral GC with a cumulative prednisolone equivalent dose of 200 mg or higher in the last 3 months;
    Treatment with any GC (oral, intra-articular, intravenous or intramuscular) in the last 30 days (temporary exclusion);
    Exposure to investigational therapy in the last three months;
    Current participation in another clinical trial;
    Major surgery, donation or loss of approximately 500 ml blood within 4 weeks prior to the screening visit (temporary exclusion)
    Absolute contraindication to low-dose prednisolone, as determined by the treating physician, such as: uncontrolled chronic infections, diabetes mellitus, hypertension, osteoporosis. When these conditions are under control (e.g. with antiosteoporosis drugs, antihypertensive drugs) these patients can enter;
    Absolute contraindication to Calcium and/or Vitamin D supplement as determined by the treating physician, such as: hyperparathyroidism (when insufficiently treated);
    Uncontrolled comorbid conditions, short life span, etc. as determined by the treating physician.
    Absolute indication to start with oral or intravenous GC, according to the treating physician;
    Inability to comply with medical instructions or inability to assess major outcomes at 6-monthly visits, in the assessment of the treating physician.
    A alteração, r e t i r a d a ou i nt r odução de tratamento antirreumático no ultimo mês, anterior à avaliação de elegibilidade, incluindo metotrexato, sulfassalazina, hidroxicloroquina, leflunomida, azatioprina, ouro intramuscular e oral, ciclosporina, agentes biológicos, incluindo anti-TNF,
    anakinra, abatacept, rituximabe, tocilizumab (exclusão temporária);
    • Tratamento com GC sistémicos: GC oral ou parenteral com uma dose equivalente de prednisolona de 200 mg, ou mais, nos passados 3 meses;
    • Tratamento com qualquer GC (oral, intra-articular, intravenoso ou intramuscular) nos últimos 30 dias (exclusão temporária);

    • Exposição a terapêutica experimental nos últimos três meses;

    • Atual participação em outro ensaio clínico;

    • Grande cirurgia, doação ou perda de aproximadamente de 500 ml de sangue nas 4 semanas anteriores à visita de screening (exclusão temporária)
    • Contraindicações absolutas para baixas-doses de prednisolona determinadas pelo médico assistente, tais como: infeções crónicas não controladas, diabetes mellitus, hipertensão, osteoporose. Quando estas condições estão sob controlo, (ex. com fármacos contra a osteoporose, fármacos anti- hipertensivos)
    estes doentes podem ser incluídos;

    • Contraindicação absoluta à suplementação c o m cálcio e/ou vitamina D determinada pel o médico assistente, tal como: hiperparatiroidismo (quando não adequadamente tratado);


    • Comorbilidades não controladas, baixa esperança de vida, etc. tal como determinado pelo médico assistente.

    • Indicação absoluta para iniciar GC por via oral ou intravenosa, de acordo com o médico assistente;

    • Incapacidade em obedecer às instruções médicas ou incapacidade de avaliar os resultados major na consulta do mês 6, na avaliação do médico assistente.


    E.5 End points
    E.5.1Primary end point(s)
    Signs and symptoms: the time-averaged mean value of the DAS28.
    To measure safety, the primary endpoint is the total number of patients experiencing at least one serious adverse event, or one clinical event related to the disease or its therapy.
    Other major outcomes are cost-effectiveness, cost-utility, and medication adherence.
    Sinais e simtomas: a diminuição média ao longo do tempo (estimado a partir de modelos lineares mistos) do DAS28
    Para avaliar a segurança o objetivo primário é o número total de doentes que tiveram pelo menos um efeito/reação adversa grave, ou um evento clínico relacionado com a doença ou o seu tratamento.
    Outros resultados importantes serão a custo-efetividade, custo-utilidade, e adesão à medicação.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, 3, 6, 12, 18 and 24 months
    Inicio, 3, 6, 12, 18 e 24 meses
    E.5.2Secondary end point(s)
    Damage progression: 2-year change in total Sharp/van der Heijde damage score of hands and forefeet radiographs.
    WHO-ILAR core set of RA outcome measures, including pain, patient and physician global assessment, physical disability, joint counts (swollen joints and tender joints), acute phase reactants (C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR)), and radiographs of hands and forefeet at 0 and 2 years
    Severity and duration of morning stiffness
    Fatigue
    SF36 - The Short Form 36-item Health Survey, a questionnaire about QoL
    RA Impact of Disease (RAID) tool – The RAID is a validated questionnaire assessing the seven most important domains of impact of RA on the patients
    Health Assessment Questionnaire (HAQ)
    Cost questionnaire, including; Activity limitation (part of cost questionnaire); Work disability (for those holding a paid job, part of cost questionnaire)
    Utility/Quality-adjusted life years (QALY): Euro-QoL in 5 dimensions (EQ-5D)
    • Evolução das lesões: alterações verificadas ao longo de 2 anos na pontuação total de lesões constatadas nas radiografias às mãos e antepés segundo a escala de Sharp/van der Heidje.
    • conjunto de parâmetros utilizados pela OMS/ILAR para medir os resultados da AR, incluindo dor, avaliação global pelo médico e doente, incapacidade física, contagens de articulações (articulações inchadas e articulações dolorosas), proteínas de fase aguda (proteína C-reativa (CRP) e velocidade
    de hemossedimentação (VHS)) e radiografias das mãos e antepés nos anos 0 e 2
    • Gravidade e duração da rigidez matinal
    • Cansaço
    • SF36 - Breve questionário sobre o estado de saúde, com 36 itens, para medir a qualidade de vida.

    • Instrumento de avaliação do impacto da AR (AIAR) - A AIAR é um questionário validado que avalia os sete mais importantes domínios do impacto da AR nos doentes
    • Questionário de Avaliação de Saúde (Health Assessment Questionnaire, HAQ)
    • questionário de custos, incluindo
    o Limitação da atividade (parte do questionário de custos)
    o Incapacidade para o trabalho (para aqueles que têm o emprego remunerado, parte do questionário de custos)
    • Anos de vida ajustados pela qualidade/utilidade (QALY): Euro-QoL em 5 dimensões (EQ-5D)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, 3, 6, 9, 12, 15, 18, 21 and 24 months
    Inicio, 3, 6, 9, 12, 15, 18, 21 e 24 meses
    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 Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    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 years5
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    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.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 800
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 800
    F.4.2.2In the whole clinical trial 800
    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)
    After month 24 the study medication will slowly tapered in linear fashion to zero in 3 months by inserting increasing numbers of non-treatment days. During this period the treating physician can start normal treatment.
    Após 24 mesesa a medicação do estudo será lentamente reduzida de forma linear até zero em 3 meses através da inserção de um número crescente de dias sem tratamento. Durante este período, o médico pode iniciar o tratamento normal.
    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 Decision2016-05-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-01-29
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