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    Summary
    EudraCT Number:2006-002670-22
    Sponsor's Protocol Code Number:P04807
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-10-04
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2006-002670-22
    A.3Full title of the trial
    Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1) Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-Up of Efficacy and Safety (Part 2)
    Confronto tra l`efficacia e la sicurezza dell`Infliximab come monoterapia o in combinazione con azatioprina, verso azatioprina in monoterapia nella colite ulcerosa da moderata a severa (Parte 1). Confronto del trattamento di mantenimento verso il trattamento intermittente con Infliximab nel mantenimento della remissione: un follow-up di efficacia e di tollerabilita` (Parte 2).
    A.4.1Sponsor's protocol code numberP04807
    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 SponsorSCHERING-PLOUGH
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Remicade
    D.2.1.1.2Name of the Marketing Authorisation holderCentocor
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNInfliximab
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number100
    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.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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    D.IMP: 2
    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.2.1.1.1Trade name imuran
    D.2.1.1.2Name of the Marketing Authorisation holderThe Wellcome Foundation
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 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 INNazathioprine
    D.3.9.2Current sponsor codeSCH 900050
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number50
    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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    moderately to severely active Ulcerative Colitis
    Colite Ulcerosa in fase attiva di grado da moderato a grave
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10009900
    E.1.2Term Colitis ulcerative
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the proportion of patients achieving remission at week 16 between Infliximab and Infliximab/Azathioprine treatment to Azathioprine monotherapy in moderately to severely active UC. Clinical remission will be defined by a total Mayo score of 2 points or lower with no individual subscore exceeding 1 point.(Phase 1) To determine whether remission in UC is better maintained by maintenance (every 8 weeks; q8w) or intermittent (upon relapse) infliximab treatment.(Phase 2)
    o Mettere a confronto la percentuale di pazienti che hanno ottenuto la remissione alla settimana 16 tra i pazienti che hanno ricevuto il trattamento con Infliximab e Infliximab/Azatioprina rispetto ai pazienti che hanno ricevuto trattamento con Azatioprina in monoterapia nella CU attiva in forma da moderata a grave. La remissione clinica sara' definita da un punteggio Mayo totale di 2 punti o inferiore e nessun punteggio individuale superiore a 1 punto. (Fase 1) Stabilire se la remissione della CU e' mantenuta dal trattamento continuo (ogni 8 settimane) o intermittente con Infliximab. (Fase 2)
    E.2.2Secondary objectives of the trial
    To compare the proportion of patients achieving remission at week 16 on combination therapy of Infliximab monotherapy to Azathioprine monotherapy in moderately to severely active UC. • To assess mucosal healing at week 16.(Phase 1) o To assess the long-term safety of continuous versus intermittent therapy with 5 mg/kg infliximab in a moderate to severe UC population. • To assess mucosal healing at week 90. • To determine the number of colectomies in non-responders and Azathioprine treated patients to patients on continuous Infliximab treatment. • To determine antibody formation to Infliximab in patients on Infliximab monotherapy to Infliximab/Azathioprine combo-therapy on intermittent or continuous Infliximab treatment.(Phase 2)
    Mettere a confronto la percentuale di pazienti che hanno ottenuto la remissione alla settimana 16 in trattamento con Infliximab in monoterapia rispetto ad Azatioprina in monoterapia nella CU attiva in forma da moderata a grave.Accertare la sicurezza a lungo termine della terapia continua rispetto alla terapia intermittente con 5mg/kg di Infliximab in una popolazione affetta da CU da moderata a grave o Accertare la guarigione delle mucose alla settimana 90 o Determinare il numero di colectomie nei pazienti non-responder e nei pazienti trattati con Azatioprina rispetto ai pazienti in trattamento continuo con Infliximab (Fase 2)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    adult patients > 21 years old with moderately to severely active UC with a Mayo score of 6 to 12 points inclusive • endoscopic evidence of disease • are on a stable dose of not more than 30 mg per day corticosteroid for at least 3 months • are naïve to Infliximab • patients who are either naïve to Azathioprine or did not receive Azathioprine or other immunomodulators for at least 3 months before entering the study • patients who did not have AEs and did not show intolerance to Azathioprine or 6-MP
    • Pazienti adulti maggiori di 21 anni con CU attiva da moderata a grave con un punteggio Mayo tra 6 e 12 punti compresi • Evidenza endoscopica della malattia • Dosaggio stabile di non piu` di 30 mg al giorno di corticosteroidi per almeno 3 mesi • Non hanno mai assunto Infliximab • Pazienti che non hanno mai assunto Azatioprina o non hanno ricevuto Azatioprina o altri immunomodulatori per almeno 3 mesi prima dell'ingresso nello studio • Pazienti che non presentano EA e non evidenziano intolleranza ad Azatioprina o 6 MP
    E.4Principal exclusion criteria
    Investigator judgment that the subject is likely to require colectomy within 12 weeks of Baseline OR b. Subject symptom complex at Screening or Baseline visits, as follows: diarrhea with &#8805;6 bowel movements/day with macroscopic blood in stool; persistent fever (&#8805;37.5°C) for at least 3 days prior to baseline; 4) tachycardia (>100 beats/minute); 5) anemia (8.5 g/dL). 2. Require, or required within the 2 months prior to baseline, surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or intra-abdominal or pancreatic abscess requiring surgical drainage or other conditions possibly confounding the evaluation of disease activity; 3. Have severe, fixed symptomatic stenosis of the large or small intestine; 4. Have current evidence of colonic obstruction or history within the 6 months prior to baseline, confirmed with objective radiographic or endoscopic evidence of a stricture with resulting obstruction (dilation of the colon proximal to the stricture on barium radiograph or an inability to traverse the stricture at endoscopy); 5. Have a history of colonic mucosal dysplasia; 6. Presence on screening endoscopy of adenomatous colonic polyps, if not removed prior to study entry, or history of adenomatous colonic polyps that were not removed; 7. Presence of a stoma; 8. Have a history of extensive colonic resection that would prevent adequate evaluation of clinical disease activity (eg, less than 30 cm of colon remaining); 9. Have a positive stool culture for enteric pathogens, pathogenic ova or parasites within 4 months prior to Baseline unless subject has received treatment and had a negative stool examination 1 week or longer after the end of treatment; 10. Have a concomitant diagnosis of congestive heart failure (CHF), including medically controlled asymptomatic subjects; 11. Have had serious infections (eg, active hepatitis, pneumonia, or pyelonephritis) within 2 months of screening. Less serious infections (such as acute upper respiratory tract infection [colds] or a simple urinary tract infection) need not be considered as an exclusion at the discretion of the investigator; 12. Have or have had an opportunistic infection (eg, herpes zoster [shingles], cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months prior to Screening; 13. Have a known infection with human immunodeficiency virus (HIV) and/or hepatitis B or hepatitis C; 14. Have a history of a known allergy to murine proteins or allergy/sensitivity to study drug or its excipients; 15. Have current signs and symptoms of systemic lupus erythematosus, or severe, progressive, or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic, or cerebral diseases; 16. Have a known history of demyelinating disease suggestive of multiple sclerosis or optic neuritis; 17. Presence of a transplanted organ (with the exception of a corneal transplant >3 months prior to screening); 18. Have a history of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (eg, nodes in the posterior triangle of the neck, infra-clavicular, epitrochlear, or periaortic areas), or splenomegaly; 19. Have any current known malignancy or malignancy within 5 years prior to screening (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence); 20. Have poor tolerability of venipuncture or lack of adequate venous access for required blood sampling and infusion of study drug during the study period; 21. Have had a known substance abuse
    1.Soggetti che hanno severa ed estesa colite evidenziata da: a.A giudizio dello sperimentatore il soggetto dovra' verosimilmente sottoporsi a colectomia entro 12 mesi dal Basale o b.Soggetti con sintomi complessi alla visita di Screening o Basale, come: diarrea con &#8805;6 movimenti intestinali/giorno con sangue macroscopico nelle feci; febbre persistente (&#8805; 37,5°C) per almento 3 giorni prima del basale 4 tachicardia (&gt;100 battiti/minuto) 5) anemia (8.5 g/dl) 2.Richiedono od hanno richiesto nei 2 mesi precedenti il basale, chirurgia per sanguinamento gastrointestinale attivo, peritonite, ostruzione intestinale o ascesso intra-addominale o pancreatico che richiede drenaggio chirurgico o altre condizioni che possono confundere la valutazione dell'attivita' della patologia; 3.Hanno stenosi severe, costanti e sintomatiche del largo o piccolo intestino; 4.Hanno evidenza di ostruzione del colon o storia, entro i 6 mesi prima del basale, confermata con evidenza radiografica o endoscopica di stenosi con risultante ostruzione (dilatazione del colon prossimale alla struttura sulla radiografia con bario o un'inabilita' ad attraversare la struttura all'endoscopia); 5.Hanno storia di displasia mucosale del colon; 6.Presenza all'endoscopia di screening di polipi adenomatosi del colon, se non rimossi prima di entrare nello studio, o storia di polipi adenomatosi del colon che non erano stati rimossi; 7.Presenza di uno stoma; 8.Hanno una storia di estesa resezione del colon che potrebbe ostacolare adeguate valutazioni dell'attivita' clinica della patologia (per es.rimangono meno di 30 cm di colon); 9.Hanno una cultura delle feci positiva per patogeni enterici, uova patogeniche o parassiti entro 4 mesi prima del basale almeno che il soggetto abbia ricevuto trattamento e abbia un esame delle feci negativo 1 settimana o piu' dopo la fine del trattamento. 10.Hanno concomitante diagnosi di scompenso cardiaco, inclusi pazienti asintomatici, controllati tramite trattamento; 11.Hanno avuto infezioni serie (per es.epatiti attive, pneumonia) nei 2 mesi precedenti lo screening.Infezioni meno serie (come infezioni acute del tratto respiratorio superiore o semplici infezioni del tratto urinario) sono da non considerare come un criterio di esclusione a discrezione dello sperimentatore. 12.Hanno od hanno avuto un'infezione opportunistica (per es.Herpes zoster, citomegalovirus, Pneumocystis carinii, aspergillosi, istoplasmosi o micobatteri piuttosto che TB) entro i 6 mesi precedenti lo screening; 13.Hanno infezione HIV e/o epatite B o C nota; 14.Hanno una storia nota di allergia alle proteine murine o allergia/sensibilita' al farmaco in studio o ai suoi eccipienti. 15.Hanno segni e sintomi correnti di lupus eritematoso sistemico, o patologie severe, in progressione o incontrollate a livello renale, epatico, ematologico, endocrino, polmonare, cardiaco, neurologico o cerebrale; 16.Hanno storia nota di patologia demielinativa indicativa di sclerosi multipla o neurite ottica; 17.Presenza di organo trapiantato (con eccezione del trapianto di cornee&gt; 3 mesi prima dello screening); 18.Hanno una storia di palotogia linfoproliferativa incluso il linfoma, o segni e sintomi suggestivi di possibile patologia linfoproliferativa (per es.noduli nel triangolo posteriore del collo, infra-clavicolari o dell'area periaortica) o splenomegalia; 19.Hanno una patologia maligna nota o l'hanno avuta nei 5 anni precedenti lo screening (eccetto per carcinoma squamoso o basale della pelle che e' stato trattato, senza evidenza di recidiva); 20.Hanno poca tolleranza alle punture o mancanza di un adeguato accesso venoso per i prelievi rechiesti e per le infusioni di farmaco durante il periodo di studio; 21.Hanno fatto abuso di sostanze o sono stati dipendenti (farmaci o alcool) nei 3 anni precedenti lo Screening; 22.Richiedono uso cronico e frequente di agenti antimotilita'
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients in remission at week 16 on Infliximab and Infliximab/Azathioprine treatment compared to Azathioprine treatment. Average remission rate over duration of treatment in patients on q8w Infliximab therapy compared to intermittent therapy.(Phase 2)
    Percentuale di pazienti in remissione alla settimana 16 in trattamento con Infliximab e Infliximab/Azatioprina rispetto ai pazienti in trattamento con Azatioprina (Fase 1) Percentuale di remissione media nell'arco della durata del trattamento nei pazienti in trattamento con Infliximab ogni 8 settimane rispetto ai pazienti in terapia intermittente (Fase 2)
    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 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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned11
    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 Information not present in EudraCT
    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 years0
    E.8.9.1In the Member State concerned months34
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months34
    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.1.1Number of subjects for this age range: 0
    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.1.3Elderly (>=65 years) Yes
    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 Yes
    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 state36
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 480
    F.4.2.2In the whole clinical trial 600
    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 Decision2007-11-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-07-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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