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    Summary
    EudraCT Number:2020-002695-12
    Sponsor's Protocol Code Number:NL71383.018.20
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-09-02
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2020-002695-12
    A.3Full title of the trial
    Tofacitinib in the treatment of chronic, recurrent and/or antibiotic refractory pouchitis: a multi-omics approach
    Tofacitinib voor de behandeling van chronische, recidiverende, en/of antibiotica refractaire pouchitis: een multi-omics benadering
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of refractory pouchitis with tofacitinib
    Behandeling van hardnekkige pouchitis met tofacitinib
    A.3.2Name or abbreviated title of the trial where available
    TOFA-Pouchitis
    TOFA-Pouchitis
    A.4.1Sponsor's protocol code numberNL71383.018.20
    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 SponsorAmsterdam UMC, location AMC
    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 supportPfizer
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmsterdam UMC, location AMC
    B.5.2Functional name of contact pointPhD candidate
    B.5.3 Address:
    B.5.3.1Street AddressMeibergdreef 9
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1105AZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number310205661260
    B.5.6E-maild.c.dejong@amsterdamumc.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 Xeljanz 5mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    Chronic, recurrent and/or antibiotic refractory pouchitis in patients with ulcerative colitis
    Chronische, recidiverende en/of antibiotica refractaire pouchitis in patiënten met colitis ulcerosa
    E.1.1.1Medical condition in easily understood language
    Pouchitis in patient with ulcerative colitis
    Pouchitis in patiënten met colitis ulcerosa
    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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    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
    To assess efficacy and safety of tofacitinib in the treatment of chronic, recurrent and/or antibiotic refractory pouchitis.
    Om de werkzaamheid en veiligheid van tofacitinib te beoordelen bij de behandeling van chronische, recidiverende en / of antibioticum-refractaire pouchitis.
    E.2.2Secondary objectives of the trial
    histologic disease activity, immune cell infiltration, gene expression of inflammatory cytokines and changes in the microbiome.
    histologische ziekteactiviteit, immuuncelinfiltratie, genexpressie van inflammatoire cytokines en veranderingen in het microbioom.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject has a history of ileal pouch anal anastomosis (IPAA) for UC, all stages completed at least 6 months prior to day one of the start of the study.
    2. Subject has chronic, recurrent and/or antibiotic refractory pouchitis, defined as a PDAI ≥ 7 , with either - ≥ 2 recurrent pouchitis episodes within 1 year prior to screening, necessitating treatment with antibiotics or other prescription, or; - Requiring maintenance antibiotic therapy for ≥ 4 weeks to maintain clinical remission and a history of at least two attempts in the last 24 months to stop this therapy, resulting in a relapse of the pouchitis episodes.
    1. Proefpersoon heeft een ileale pouch-anale anastomose (IPAA) voor colitis ulcerosa, alle stadia voltooid ten minste 6 maanden voor dag 1 van de start van de studie.
    2. Proefpersoon heeft chronische, recidiverende en/of antibiotica refractaire pouchitis, gedefinieerd als een PDAI ≥ 7, met of - ≥ 2 recidiverende pouchitis episodes binnen 1 jaar voor start screening, waardoor behandeling met antibiotica of andere middelen nodig is, of; - Continu gebruik van antibiotica onderhoudstherapie gedurende ≥ 4 weken om klinisch in remissie te blijven, en daarbij ten minste 2 pogingen in de laatste 24 maanden om de therapie te staken, wat heeft geresulteerd in een recidief van de pouchitis klachten.
    E.4Principal exclusion criteria
    1. Pouchitis due to surgery related conditions (such as an abscess, fistula, or sinus of the pouch).
    2. Absence of a previous pelvic MRI to assess secondary causes of pouchitis.
    3. Irritable pouch syndrome (symptoms without evidence of pouchitis on endoscopy and histology).
    4. Mechanical complications of the pouch (e.g. pouch stricture or pouch fistula).
    5. Diverting ileostomy.
    6. Positive stool sample for C. difficile, enteric pathogens, pathogenic ova or parasites at screening.
    7. Active herpes zoster infection or history of disseminated zoster infection.
    8. Evidence of an active infection during screening, or known history of chronic HBV, HCV, HIV infection, or if subject is immunodeficient.
    9. Active or latent infection with Mycobacterium tuberculosis (TB), regardless of treatment history.
    1. Pouchitis t.g.v. operatie gerelateerde aandoeningen (zoals abces, fistel, sinus van de pouch)
    2. Geen eerdere MRI van de pouch om secundaire oorzaken van pouchitis aan te tonen.
    3. Prikkelbare pouch syndroom (symptomen suggestief voor pouchitis, zonder tekenen van inflammatie bij endoscopie en histologie).
    4. Mechanische complicaties van de pouch (strictuur of fistel).
    5. Eindstandig ileostoma.
    6. Ontlasting positief voor C. difficile, enterische pathogenen, ova of parasieten bij screening.
    7. Actieve herpes zoster infectie of voorgeschiedenis met een gedissemineerde zoster infectie.
    8. Aanwijzingen van een actieve infectie tijdens screening, of bekende voorgeschiedenis met HBV, HCV, HIV, of immunodeficientie.
    9. Actieve of latente infectie met Mycobacterium tuberculosis (TB), onafhankelijk van eerdere behandelingen.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects with chronic, recurrent and/or antibiotic refractory pouchitis achieving clinical relevant remission after 8 weeks of treatment with tofacitinib. Clinical relevant remission is defined as a PDAI score < 7 and a reduction of the overall score by ≥ 3 points from baseline.
    Proportie proefpersonen met chronische, recidiverende en / of antibioticum-refractaire pouchitis die klinisch relevante remissie bereiken na 8 weken behandeling met tofacitinib. Klinisch relevante remissie wordt gedefinieerd als een PDAI-score <7 en een verlaging van de algehele score met ≥ 3 punten ten opzichte van baseline.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 8 of treatment
    Week 8 van behandeling
    E.5.2Secondary end point(s)
    • Proportion of subjects achieving mPDAI < 5 and a reduction of the overall score by ≥ 2 points from baseline to week 8 and week 12.
    • Proportion of subjects achieving a partial response after 8 weeks, defined as a reduction in PDAI ≥ 2 points from baseline.
    • Proportion of subjects in sustained antibiotic-free remission and no need for rescue therapy until week 12.
    • Change in total PDAI.
    • Change in the endoscopic subscore of the PDAI at week 8, compared to baseline.
    • Change in histologic subscore of the PDAI at week 8, compared to baseline.
    • Time to clinical relevant remission.
    • Time to relapse.
    • Total number of patients in deep remission, defined as a PDAI of 0 at week 8.
    • Proportion of subjects not requiring further antibiotic treatment at week 8 and week 12.
    • Change in total scores of Inflammatory Bowel Disease Questionnaire (IBDQ) at week 8, compared to baseline.
    • Change in Cleveland Global Quality of Life (CGQL) at week 8, compared to baseline.
    • Change in SF-36 from baseline to week 8.
    • Incidence and severity of adverse events up to 84 days after initiating treatment.
    • Proportie proefpersonen dat een mPDAI <5 bereikt en een verlaging van de totale score met ≥ 2 punten ten opzichte van baseline tot week 8 en week 12.
    • Proportie proefpersonen dat na 8 weken een gedeeltelijke respons bereikt, gedefinieerd als een verlaging van PDAI ≥ 2 punten ten opzichte van baseline.
    • Proportie proefpersonen met aanhoudende antibioticavrije remissie, en die tot 12 weken geen andere behandeling nodig hebben.
    • Verandering in totale PDAI.
    • Verandering in de endoscopische subscore van de PDAI in week 8, vergeleken met baseline.
    • Verandering in histologische subscore van de PDAI in week 8, vergeleken met baseline.
    • Tijd tot klinisch relevante remissie.
    • Tijd tot recidief van pouchitis.
    • Totaal aantal patiënten in diepe remissie, gedefinieerd als een PDAI van 0 in week 8.
    • Proportie proefpersonen dat in week 8 en week 12 geen verdere antibioticabehandeling nodig heeft.
    • Verandering in totale scores van de Inflammatory Bowel Disease Questionnaire (IBDQ) in week 8, vergeleken met baseline.
    • Verandering in Cleveland Global Quality of Life (CGQL) in week 8, vergeleken met baseline.
    • Verandering in SF-36 van baseline tot week 8.
    • Incidentie en ernst van bijwerkingen tot 84 dagen na aanvang van de behandeling.
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 12
    week 12
    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 Yes
    E.6.13.1Other scope of the trial description
    Changes in histologic inflammation
    Veranderingen in histologische inflammatie
    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 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 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: 11
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 1
    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 state12
    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 so far
    Geen tot nu toe
    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 Decision2020-09-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-14
    P. End of Trial
    P.End of Trial StatusOngoing
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