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    The EU Clinical Trials Register currently displays   43850   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    EudraCT Number:2020-003420-16
    Sponsor's Protocol Code Number:SPRINT
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-23
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2020-003420-16
    A.3Full title of the trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study comparing two different therapeutic approaches in the treatment of moderate to severe ulcerative colitis.
    Comparación prospectiva de dos estrategias de tratamiento para la colitis ulcerosa de inicio temprano: top-down frente a step-up
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberSPRINT
    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 SponsorInstituto Clinico Humanitas
    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 supportAmgen
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationB-COM
    B.5.2Functional name of contact pointcontact@bcom.eu
    B.5.3 Address:
    B.5.3.1Street Address152 rue du Béliot
    B.5.3.2Town/ cityDax
    B.5.3.3Post code40990
    B.5.4Telephone number+33680476085
    B.5.5Fax number+33567699289
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Amgevita
    D. of the Marketing Authorisation holderAmgen Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNADALIMUMAB
    D.3.9.1CAS number 331731-18-1
    D.3.9.2Current sponsor codeEMEA/H/C/004212
    D.3.9.3Other descriptive nameAmgevita
    D.3.9.4EV Substance CodeSUB20016
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 Yes
    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
    Moderate to severe ulcerative colitis
    Colitis ulcerosa de moderada a severa
    E.1.1.1Medical condition in easily understood language
    Ulcerative colitis in a moderate or severe form
    Colitis ulcerosa en forma moderada o severa.
    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
    The primary objective is to assess the efficacy of a top-down approach in achieving histological improvement at week 52, without colectomy and without UC-related hospitalization versus a standard step-up approach.
    El objetivo primario es evaluar la eficacia de la aproximación top-down en la consecución de la mejoría histológica a la semana 52, sin colectomía y sin hospitalización relacionada con la colitis ulcerosa versus la aproximación estándar step-up.
    E.2.2Secondary objectives of the trial
    Secondary objectives will be:
    - to compare the efficacy of the top-down approach to
    induce histological remission and histological healing in the
    short-term (week 16) vs. the standard step-up approach
    - to compare the efficacy of the top-down approach to
    induce clinical remission (combined clinical and endoscopic
    improvement=sub-score of 0 or 1) in the short- and long-term
    (week 16 and week 52) vs. the standard step-up approach
    - to compare the efficacy of the top-down approach to
    induce short- and long-term mucosal healing (endoscopic and
    histologic improvement) vs. the standard step-up approach
    - to compare the safety of the top-down approach through
    week 52 vs. the standard step-up approach
    - to compare the quality of life of patients treated with the
    top-down approach through week 52 vs. the standard step-up
    - To compare the need for colectomies and UC-related
    hospitalizations in patients treated with the top-down approach
    vs. the step-up approach.
    Objetivos secundarios
    -Comparar la eficacia de la aproximación top-down para inducir remisión y curación histológica en la aproximación a corto plazo (semana 16), vs aproximación step-up estándar.
    -Comparar la eficacia de la aproximación top-dowm para inducción de remisión clínica (mejoría clínica y endoscópica=sub puntuación 0 ó 1) en las aproximaciones a corto y a largo plazo (semanas 16 y 52) vs.aproximación estándar step-up.
    -Comparar la eficacia de la aproximación top-down para la inducción a corto y a largo plazo de la curación mucosa (mejoría endoscópica e histológica) vs. aproximación estándar step-up.
    -Comparar la seguridad de la aproximación top-down en semana 52 vs. aproximación step-up.
    -Comparar la calidad de vida de los pacientes tratados mediante aproximación top-down a semana 52 vs. la aproximación step-up.
    -Comparar la necesidad de colostomías y hospitalizaciones relacionadas con la colitis ulcerosa tratada con aproximación top-down vs. aproximación top-down.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adult patients (age ≥ 18 years and < 75 years)
    - Established diagnosis of UC (confirmed clinically, endoscopically and histologically)
    since at least 3 months
    - Disease duration no longer than 24 months before the screening visit
    - Ongoing oral 5-ASA treatment ≥1.6g/day
    - Having objective signs of moderate-to-severe UC activity, defined by a total Mayo
    score of 6 to 12.
    - Proctitis, left-sided or extensive UC
    - Ability to perform study requirements
    - Ability to give informed consent according to ICH/ GCP, and national/local
    -Pacientes adultos (edad entre 18 y 75 años).
    -Diagnóstico confirmado de colitis ulcerosa (confirmado clínicamente, endoscópicamente e histológicamente) desde al menos 3 meses.
    -Duración de la enfermedad no superior a 24 meses anteriores a la visita de selección.
    -Tratamiento oral 5-ASA en curso superior o igual a 1.6g/día.
    -Presentar signos objetivos de actividad de colitis ulcerosa moderada a severa definida por una puntuación Mayo de entre 6 y 12.
    - Proctitis, de lado izquierdo o CU extensiva
    - Capacidad de seguir los requerimientos del estudio.
    - Capacidad de otorgar consentimiento informado de acuerdo con la ICH/ GCP, y la regulaciones nacionales
    E.4Principal exclusion criteria
    - Have received any kind of treatment approved for UC (thiopurine, biologics, tofacitinib) apart from 5-ASA compounds, sulphasalazine or EcN during their UC history or currently receiving local or systemic steroids (past steroids treatments are accepted)
    - Have concomitant history of segmental colitis associated to diverticula
    - Have active infections during the screening phase (patients can be rescreened after the
    infection is resolved
    - Have a diagnosis of Crohn’s disease
    - Have any contra-indication to study drugs or procedures
    - Are pregnant or in active breastfeeding at the time of inclusion.
    - Have planned intestinal surgery at time of randomization
    - Any contra-indication to anti-TNF therapy
    -Haber recibido algún tipo de tratamiento approbado para la colitis ulcerosa( tiopurina, biológico, tofacitinib) aparte de componetes 5_ASA, sulfasalacina o EcN durante su historia de colitis ulcerosa o estar recibiendo actualmente esteriodes locales o sistémicos (los tratamientos con esteriodes anteriores están aceptados).
    -Presentar historia de colitis segmental asociada a los divertículos concomitantemente.
    -Presentar infeccioens activas durante la fase de selección (los pacientes pueden ser re-seleccionados posteriormente a la resolución de la infección).
    -Presentar un diagnóstico de enfermedad de Crohn.
    -Presentar alguna contraindicación al farmaco en estudio o a los procedimientos del estudio.
    -Embarazo o lactancia en el periodo de selección.
    -Encontrase en espera de cirugía intestinal en el momento de la randomización.
    -Alguna contra-indicación frente a la terapia anti TNF.
    E.5 End points
    E.5.1Primary end point(s)
    Histological improvement (defined as a Nancy index ≤ 1) at week 52, without colectomy and without UC-related hospitalization.
    Mejoría histológica (definida como un índice de Nancy menor o igual a 1) ala semana 52, sin colectomía y sin hospitalización relacionada con la colitis ulcerosa.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 52
    Semana 52
    E.5.2Secondary end point(s)
    - Histological remission (Nancy Index =0) at week 16
    - Histological remission (Nancy Index =0) at week 52
    - Histological healing (defined as a Nancy score ≤ 1) at week 16
    - Clinical remission (PRO2 remission + endoscopic remission) at week 52
    - Clinical remission (PRO2+endoscopic remission) at week 16
    - Symptomatic remission (PRO2 remission) at week 16
    - Symptomatic remission (PRO2 remission) at week 52
    - Endoscopic improvement at week 16
    Endoscopic improvement at week 52
    - Endoscopic remission at week 16
    - Endoscopic remission at week 52
    - Mucosal healing (endoscopic and histologic improvement) at week 16
    - Mucosal healing (endoscopic and histologic improvement) at week 52
    - Changes in fecal calprotectin levels from baseline
    - Need for corticosteroids at weeks 16 and 52
    - To evaluate and compare the safety of the two strategies in terms of adverse events,
    serious adverse events, and adverse events leading to discontinuation
    - quality of life (measured by the S-IBDQ and SF-36) at weeks 16 and 52
    - Rates of colectomies at weeks 16, 52, and 104 (or end of study)
    - UC-related hospitalizations at weeks 16, 52, and 104 (or end of study)
    -Remisión histológica (Índice de Nancy=0) a la semana 16.
    -Remisión histológica (Indice de Nancy=0) a la semana 52.
    -Remisión histológica (definida como puntuación de Nancy menor o igual a 1) a la semana 16
    -Remisión clínica (remisión PRO2 +remisión endoscópica) a la semana 52.
    -Remisión clínica (remisión PRO2+remisión endoscópica) a la semana 16.
    -Remisión sintomática (remisión PRO2) a la semana 16.
    -Remisión sintomática (remisión PRO2) a la semana 52.
    - Mejoría endoscópica a la semana 16
    - Mejoría endoscópica a la semana 52
    -Remisión endoscópica ala semana 16
    -Remisión endoscópica a la semana 52
    -Curación mucosa (mejoría endoscópica e histológica) a la semana 16
    -Curación mucosa (mejoría endoscópica e histológica) a la semana 52
    -Cambios en los niveles de calprotectina fecal desde la visita basal
    -Necesidad de corticosteroides a las semanas 16 y 52.
    -Comparación y evaluación de la seguridad de las dos estrategias en términos de acontecimientos adversos, acontecimientos adversos graves, y acontecimientos adversos que conduzcan a la retirada del estudio.
    -Calidad de vida (medica con los cuestionarios S-IBDQ y SF-36) a las semanas 16 y 52.
    -Rangos de colostomías a las semanas 16, 52 y 104 (final del estudio).
    -Hospitalización relacionada con la colitis ulcerosa a las semanas 16, 52 y 104 (final dele estudio).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weekd 16 and/or week 52, depending on the endpoints
    Semanas 16 y /o semana 52 dependiendo de los hitos.
    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 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 Yes
    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 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 Yes
    E. description
    Two different therapeutic approaches are compared: step-up and top-down
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA75
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United Kingdom
    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 years3
    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 years3
    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: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 320
    F.4.2.2In the whole clinical trial 350
    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)
    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 Decision2021-08-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-27
    P. End of Trial
    P.End of Trial StatusOngoing
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