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    Summary
    EudraCT Number:2020-003006-31
    Sponsor's Protocol Code Number:ASPIRE
    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:2021-08-02
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-003006-31
    A.3Full title of the trial
    Predictive value of colonic mucosal and synovial tissues profiles for response to JAKs inhibitor in patients affected by ulcerative colitis and concomitant peripheral arthritis
    Valore predittivo del profilo tissutale della mucosa colica e del tessuto sinoviale per la risposta alla terapia con i JAKs inibitori nei pazienti affetti da concomitante rettocolite ulcerosa ed artrite periferica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Predictive value of colonic mucosal and synovial tissues profiles for response to JAKs inhibitor in patients affected by ulcerative colitis and concomitant peripheral arthritis
    Valore predittivo del profilo tissutale della mucosa colica e del tessuto sinoviale per la risposta alla terapia con i JAKs inibitori nei pazienti affetti da concomitante rettocolite ulcerosa ed artrite periferica
    A.3.2Name or abbreviated title of the trial where available
    ASPIRE
    ASPIRE
    A.4.1Sponsor's protocol code numberASPIRE
    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 SponsorFONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
    B.1.3.4CountryItaly
    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
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFONDAZIONE POLICLINICO UNIVERSITARIO A. GEMELLI IRCCS
    B.5.2Functional name of contact pointDOREZIONE SCIENTIFICA
    B.5.3 Address:
    B.5.3.1Street AddressLARGO A. GEMELLI 8
    B.5.3.2Town/ cityROMA
    B.5.3.3Post code00168
    B.5.3.4CountryItaly
    B.5.4Telephone number0630155701
    B.5.5Fax number0630155701
    B.5.6E-mailDIREZIONE.SCIENTIFICA@POLICLINICOGEMELLI.IT
    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.2.5The 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 nameTOFACINITIB
    D.3.2Product code [TOFACINITIB]
    D.3.4Pharmaceutical form Gastro-resistant 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 INNTOFACINITIB
    D.3.9.1CAS number 477600-75-2
    D.3.9.2Current sponsor codeTOFACINITIB
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee 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
    Ulcerative colitis and concomitant peripheral arthritis
    Rettocolite Ulcerosa ed artrite periferica concomitante
    E.1.1.1Medical condition in easily understood language
    Ulcerative colitis and concomitant peripheral arthritis
    Rettocolite Ulcerosa ed artrite periferica concomitante
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10045282
    E.1.2Term UC
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Description of baseline and post treatment CM and ST specific profile in terms of CD68+, CD21+, CD20+, CD3+ and CD117+ and JAK/STAT activation pathway of UC patients with concomitant peripheral arthritis possibly associated with JAK inhibitor response.
    Secondary objectives
    Nei pazienti affetti da Rettocolite Ulcerosa ed artrite periferica concomitante, candidati a trattamento con tofacitinib in accordo a RCP:

    - l’obiettivo primario è la descrizione del profilo della mucosa colica e del tessuto sinoviale in termini di espressione di cellule CD68+, CD21+, CD20+, CD3+ e CD117+ e di attivazione del pathway JAK/STAT al basale e dopo trattamento con tofacitinib;
    E.2.2Secondary objectives of the trial
    Obtain the gene signature of synovial tissue and colonic mucosa of UC patients with peripheral joint involvement and a list of deregulated gene of synovial tissue and colonic mucosa paired samples.
    L’obiettivo secondario dello studio è caratterizzare il profilo genetico, identificando i geni deregolati, a livello della mucosa colica e del tessuto sinoviale.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male and female patients, 18-70 years old
    • A moderately-to-severely active UC and a concomitant active peripheral arthritis.
    • Indication in clinical practice to start therapy with tofacitinib
    • Fertile female who accepts to not get pregnant during the study (see Appendix 1)
    • Uomini e donne, età compresa tra i 18-70 anni
    • Colite ulcerosa con attività moderata-severa ed artrite periferica concomitante attiva
    • Indicazione, come da pratica clinica, ad iniziare terapia con tofacitinib
    • Donne in età fertile che accettano di non intraprendere una gravidanza nel periodo di studio (Vedi App. 1del protocollo)
    E.4Principal exclusion criteria
    -Patients not able to provide a written informed consent
    -Any contraindication to tofacitinib, according to RCP:
    - hypersensitivity to the active substance or to any of the excipients;
    - active tuberculosis, serious infections, opportunistic infections, sepsis;
    -pregnancy and breastfeeding;
    -severe hepatic impairment (Child Pugh C);
    -Haemoglobin < 9 g/dl;
    -absolute lymphocyte count <750 cells/mm3 and absolute neutrophil count < 1000/mm3;
    -Concomitant therapy with biological therapies, such as anti TNF-alpha, IL-1R or IL-6R antagonists, anti-CD20 monoclonal antibodies, IL-17 antagonists, IL12-23 antagonists, anti-integrins, or other immunosuppressants such as thiopurines (azatioprina or 6-mercaptopurine), cyclosporine and tacrolimus, according to RCP.
    -Pazienti non in grado di esprimere il consenso informato
    -Una delle controindicazioni a tofacitinib, in accordo alla RCP:
    - ipersensibilità al principio attivo o ad uno dei suoi eccipienti;
    -tubercolosi attiva, infezioni gravem infezioni opportunistiche e sepsi;
    -gravidanza ed allattamento;
    -compromissione epatica grave (Child Pugh C)
    -Anemia con emoglobina < 9 g/dl;
    -Conta linfocitaria assoluta <750 cells/mm3 e conta neutrofilica assoluta < 1000/mm3;
    -Terapia biologiche concomitanti, quali anti TNF-alpha, IL-1R e IL-6R antagonisti, anticorpi monoclonali anti-CD20, IL-17 antagonisti, IL12-23 antagonisti, anti-integrine o altri immunosoppressori quali tiopurine (azatioprina o 6-mercaptopurina), ciclosporina e tacrolimus, in accordo alla RCP
    E.5 End points
    E.5.1Primary end point(s)
    -Primary endpoint: to indentify mucosal and synovial biomarkers predicting response to tofacinitib in patients affected by UC and concomitant peripheral arthrits at 12 months;
    Response to tofacitinib therapy will be measured in terms of:
    -clinical remission of UC, defined as =2 points and no individual subscore >1 point of PMS; 7
    -clinical remission defined as DAS44 < 1.6 and/or Boolean defined remission (ACR EULAR Classification criteria)10-11
    L’endpoint primario dello studio è identificare bio-marcatori di derivazione tissutale colica e sinoviale di risposta al trattamento con tofacitinib nei pazienti affetti da rettocolite ulcerosa e artrite periferica concomitante a 12 mesi;
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 months
    24 mesi
    E.5.2Secondary end point(s)
    -Secondary endpoint: to characterize the gene signature of synovial tissue and colonic mucosa of UC patients with concomitant peripheral arthrits.
    L’endpoint secondario dello studio è caratterizzare il profilo genetico a livello della mucosa colica e del tessuto sinoviale nei pazienti affetti da rettocolite ulcerosa e artrite periferica concomitante.
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 months
    24 mesi
    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 No
    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) 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 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) Yes
    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
    LVLS
    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
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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: 27
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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)
    NA
    NA
    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 Decision2021-02-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-23
    P. End of Trial
    P.End of Trial StatusOngoing
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