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    EudraCT Number:2019-001773-90
    Sponsor's Protocol Code Number:MiCROBPsA
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-17
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2019-001773-90
    A.3Full title of the trial
    Metagenomic analysis of the gut microbiota in patients with psoriatic arthritis upon treatment with the jak-stat inhibitor tofacitinib: correlations with immunological, clinical and imaging markers
    Analisi metagenomica del microbiota intestinale in pazienti affetti da Artrite Psoriasica in trattamento con Tofacitinib e correlazioni con markers immunologici, clinici ed ecografici
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Analysis of Gut bacteria in patients with psoriatic arthritis upon treatment with tofacitinib correlations with serologic, clinical and ultrasound markers of disease activity
    Analisi della flora batterica intestinale in pazienti affetti da Artrite Psoriasica in trattamento con tofacitinib e correlazione con indici sierologici, clinici ed ecografici dell'attività di malattia
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberMiCROBPsA
    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.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 supportPFIZER Srl
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAzienda Ospedaliera Sant'Andrea
    B.5.2Functional name of contact pointUOC Medicina Interna
    B.5.3 Address:
    B.5.3.1Street Addressvia di Grottarossa 1035
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00189
    B.5.4Telephone number0633776043
    B.5.5Fax number0633775531
    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. name XELJANZ -
    D. of the Marketing Authorisation holderPFIZER EUROPE MA EEIG
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameTofacitinib
    D.3.2Product code [N.A]
    D.3.4Pharmaceutical form Film-coated 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.3.9.1CAS number 477600-75-2
    D.3.9.2Current sponsor codeTofacitinib
    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. cell therapy medicinal product Information not present in EudraCT
    D. therapy medical product Information not present in EudraCT
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Psoriatic Arthritis
    Artrite Psoriasica
    E.1.1.1Medical condition in easily understood language
    Psoriatic arthritis
    Artrite psoriasica
    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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10037160
    E.1.2Term Psoriatic arthritis
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Aim of this prospective study is to analyse the variety and composition of the gut microbiota in PsA patients before and upon treatment with the jak-stat inhibitor tofacitinib throughout a 1-year follow-up.
    Scopo dello studio è analizzare la varietà e composizione del microbiota intestinale in pazienti affetti da artrite psoriasica in terapia con l'inibitore jak-stat tofacitinib durante un follow-up di 1 anno.
    E.2.2Secondary objectives of the trial
    Correlations between the gut microbiota composition and validated immunological/clinical and US parameters of disease activity will also be evaluated aiming at identifying possible predictors markers of tofacitinib effectiveness.
    Verranno valutate eventuali correlazioni tra la composizione del microbiota intestinale e validati indici di attività di malattia sierologici, clinici ed ecografici al fine di identificare potenziali predittori di efficacia terapeutica.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female, 18 to 65 years of age, inclusive
    - PsA diagnosis according to the CASPAR criteria, moderate to severe activity (more than 4 swollen joints and/or DAPSA = 15 and/or ASDASpcr = 1.3 and/or BASDAI =4),
    - able to understand the study procedures and sign the informed consent.
    - Current therapy with methotrexate at standard dosage.
    - Inadequate responder, as for EULAR response criteria, to at least six months methotrexate therapy at standard dosage
    - Maschi o femmine di età compresa tra i 18 e 65 anni
    - diagnosi di artrite psoriasica secondo i criteri CASPAR, con attività di malattia moderato/severa (> 4 articolazioni tumefatte, e/o DAPSA = 15 e/o ASDASpcr = 1.3 e/o BASDAI =4),
    - capaci di comprendere le procedure dello studio e firmare il consenso informato
    - concomitante terapia con methotrexate a dosaggio standard
    - inadeguata risposta secondo i criteri EULAR ad almeno 6 mesi di terapia con methotrexate a dosaggio standard
    E.4Principal exclusion criteria
    - Any sort of contraindications to tofacitinib at the time of enrolment as for local label (SmPc), hypersensitivity to the active substance or to any of the excipients, active tuberculosis, serious infections such as sepsis or opportunistic infections, severe hepatic impairment, pregnancy and lactation, malignancies, known risk factors for VTE, any uncontrolled clinically significant laboratory abnormality, experiencing intolerance to MTX
    - Qualsiasi controindicazione all'utilizzo del tofacitinib al momento dell'arruolamento come per RCP, ipersensibilità al principio attivo o qualsiasi eccipiente, tubercolosi attiva o altre infezioni in atto come sepsi o infezioni opportunistiche, disfunzione epatica severa, gravidanza e allattamento, neoplasie, fattori di rischio tromboembolico, qualsiasi significativa alterazione dei parametri di laboratorio, intolleranza al MTX
    E.5 End points
    E.5.1Primary end point(s)
    The mean change from baseline in microbial diversity and the mean microbial variations at each taxonomic level at T2 and T4
    Modificazioni medie dal basale nella varietà del microbiota intestinale e la composizione ad ogni livello tassonomico al T2 e T4
    E.5.1.1Timepoint(s) of evaluation of this end point
    At six and twelve months from baseline visit (T2 and T4)
    Sei e 12 mesi dalla visita basale (T2 e T4)
    E.5.2Secondary end point(s)
    Correlations between gut micro-organisms variations at each taxonomic level, and disease activity changes from baseline at T2 and T4 in particular:
    DAPSA, BASDAI, ASDAS at the clinical examination, power-doppler signal, synovial hypertrophy and tendon thickness at the ultrasonography
    Correlazioni tra le modificazioni nella composizione del microbiota intestinale ad ogni livello tassonomico e le modificazioni dell'attività di malattia al T2 e T4, in particolare:
    DAPSA, BASDAI, ASDAS valutate clinicamente, segnale power doppler, sinovite proliferativa, spessore tendineo all'inserzione, all'ecografia
    E.5.2.1Timepoint(s) of evaluation of this end point
    At six and twelve months from baseline visit (T2 and T4)
    Sei e 12 mesi dalla visita basale (T2 e T4)
    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 No
    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. 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 No
    E.8.1.2Open No
    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 Yes
    E. trial design description
    Non è presente un braccio di controllo nel disegno dello studio in quanto la valutazione viene effet
    There are no comparator and control arm because the same patients will be evaluated before and durin
    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 trial1
    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.8.4.1Number of sites anticipated in Member State concerned1
    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 Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial 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: 20
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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)
    Patients will be treated as for GCP
    I pazienti saranno trattati come da norme di GCP
    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 Decision2020-03-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-21
    P. End of Trial
    P.End of Trial StatusOngoing
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