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    EudraCT Number:2010-022759-42
    Sponsor's Protocol Code Number:CNTO1275CRD3002
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-01-23
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2010-022759-42
    A.3Full title of the trial
    A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallelgroup, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn's Disease
    Studio multicentrico di fase 3, randomizzato, in doppio cieco, controllato verso placebo, a gruppi paralleli sulla sicurezza e sull'efficacia della terapia di induzione con ustekinumab in soggetti con malattia di Crohn allo stato attivo da moderata a grave
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients with Moderately to Severely Active Crohn's Disease
    Studio per valutare la sicurezza e l'efficacia alla terapia di induzione con ustekinumab in soggetti con malattia di Crohn allo stato attivo da moderata a grave
    A.3.2Name or abbreviated title of the trial where available
    UNITI 2
    A.4.1Sponsor's protocol code numberCNTO1275CRD3002
    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 sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCentocor R&D
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportJanssen-Cilag S.p.A.
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International NV
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 CM
    B.5.4Telephone number+31 071 524 2166
    B.5.5Fax number+31 071 524 2110
    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 No
    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 nameUstekinumab
    D.3.2Product code CNTO1275
    D.3.4Pharmaceutical form Solution for injection
    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 INNUSTEKINUMAB
    D.3.9.1CAS number 815610-63-0
    D.3.9.2Current sponsor codeCNTO1275
    D.3.9.4EV Substance CodeSUB27761
    D.3.10 Strength
    D.3.10.1Concentration unit mg/l milligram(s)/litre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number4.5 to 5.5
    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 Yes
    D. medicinal product typeAnticorpo Monoclonale
    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 placeboSolution for injection
    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 Crohn's disease
    Malattia di Crohn attiva da moderata a grave
    E.1.1.1Medical condition in easily understood language
    Digestive System and Oral Physiological Phenome
    Sistema digestivo e fenomeno fisiologico orale
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    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
    The primary objectives are: - To evaluate the efficacy of IV induction regimens of Ustekinumab in inducing clinical response in subjects with moderately to severely active Crohn's disease. - To evaluate the safety of IV induction regimens of Ustekinumab in subjects with moderately to severely active Crohn's disease.
    Gli obiettivi primari sono i seguenti: • valutare l’efficacia dei regimi di induzione con ustekinumab per via endovenosa (EV) nella determinazione della risposta clinica in soggetti con malattia di Crohn attiva da moderata a grave; • valutare la sicurezza dei regimi di induzione con ustekinumab per via EV in soggetti con malattia di Crohn attiva da moderata a grave.
    E.2.2Secondary objectives of the trial
    The secondary objectives are: - To evaluate the efficacy of IV induction regimens of Ustekinumab in inducing clinical remission. - To evaluate the efficacy of IV induction regimens of Ustekinumab in improving disease-specific health-related quality of life. - To evaluate the pharmacokinetics and pharmacodynamics of Ustekinumab therapy, including changes in C-reactive protein (CRP), fecal calprotectin, fecal lactoferrin, and other pharmacodynamic biomarkers. - To provide, along with induction study CNTO1275CRD3001, the target study population to be evaluated in the maintenance study CNTO1275CRD3003.
    Gli obiettivi secondari sono i seguenti: • valutare l’efficacia dei regimi di induzione con ustekinumab per via EV nell’indurre la remissione clinica; • valutare l’efficacia dei regimi di induzione con ustekinumab per via EV nel migliorare la qualita' di vita correlata alla salute in pazienti con malattia di Crohn; • valutare la farmacocinetica e la farmacodinamica di ustekinumab, incluse le variazioni nei livelli di proteina C reattiva (PCR), calprotectina fecale, lattoferrina fecale e altri biomarcatori farmacodinamici; • individuare, insieme con lo studio di induzione CNTO1275CRD3001, la popolazione di studio target da valutare nello studio di mantenimento CNTO1275CRD3003.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Be a man or woman ≥ 18 years of age. 2. Have Crohn`s disease or fistulizing Crohn`s disease of at least 3 months` duration, with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy. 3. Have active Crohn`s disease, defined as:a. A baseline CDAI score of ≥ 220 and ≤ 450, AND b. At least one of the following: 1)An abnormal CRP (> 0.3 mg/dL or > 3.0 mg/L ) at screening; OR 2) Calprotectin > 250 mg/kg at screening; OR 3) Endoscopy with evidence of active Crohn`s disease during the current disease flare. The endoscopy must have occurred within 3 months prior to baseline. 4. Meet the following requirements for prior or current medications for Crohn`s disease: a. Has failed conventional therapy: 1) Is currently receiving corticosteroids and/or immunomodulators at adequate therapeutic doses; OR 2) Has a history of failure to respond to or tolerate an adequate course of corticosteroids and/or immunomodulators; OR 3) Is corticosteroid dependent or has had a history of corticosteroid dependency; AND b. Has not previously demonstrated inadequate response or intolerance to 1 or more TNF antagonist therapies. 5. Adhere to the following requirements for concomitant medication for the treatment of Crohn`s disease. The following medications are permitted provided doses meeting the requirements below are stable for or have been discontinued at least 3 weeks prior to baseline (Week 0), unless otherwise specified. a. Oral 5-ASA compounds. b. Oral corticosteroids at a prednisone-equivalent dose of ≤ 40 mg/day or ≤ 9 mg/day of budesonide. c. Antibiotics being used as a primary treatment of Crohn`s disease. d. Subjects receiving conventional immunomodulators must have been taking them for ≥ 12 weeks, and on a stable dose for a least 4 weeks prior to baseline. 6. Have screening laboratory test results within the parameters mentioned in the protocol: 7. Are considered eligible according to the TB screening criteria mentioned in the protocol: 8. If a woman, before entry she must be: a. Postmenopausal, defined as 1) > 45 years of age with amenorrhea for at least 18 months, OR 2) > 45 years of age with amenorrhea for at least 6 months and a serum follicle stimulating hormone (FSH) level > 40 IU/mL OR b. Menstrual 1) Surgically sterile, or 2) If heterosexually active, practicing a highly effective method of birth control, including hormonal prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method, or male partner sterilization, consistent with local regulations regarding use of birth control methods for subjects participating in clinical trials, for the duration of their participation in the study and for 20 weeks after receiving study agent, or 3) Not heterosexually active. 9. If a woman of childbearing potential, she must have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test at screening; and a negative urine pregnancy test at Week 0. 10. If a man and heterosexually active with a woman of childbearing potential,and not surgically sterile, he must agree to use a double barrier method of birth control and to not donate sperm during the study and for 20 weeks after receiving study agent. 11. Be willing and able to adhere to the prohibitions and restrictions specified in this protocol. 12. Sign an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study, and intend to participate in the maintenance study if eligible.
    1. Soggetti di entrambi i sessi di eta' &gt;= 18 anni. 2. Malattia di Crohn o malattia di Crohn fistolizzante da almeno 3 mesi, con colite, ileite o ileocolite, confermata da precedenti esami radiografici, istologici e/o endoscopici. 3. Malattia di Crohn in fase attiva, definita come: a. un punteggio CDAI basale &gt;= 220 e &lt;= 450; E b. almeno uno dei seguenti parametri: 1) un livello anomalo di PCR (&gt;0.3 mg/dL o&gt; 3.0 mg/L) allo screening; OPPURE 2) calprotectina &gt; 250 mg/kg allo screening; OPPURE 3) evidenza endoscopica di malattia di Crohn attiva durante l’esacerbazione corrente. L’endoscopia deve essere stata effettuata nei 3 mesi precedenti il basale. 4. Il soggetto soddisfa i seguenti requisiti relativi alla terapia farmacologica precedente o corrente per la malattia di Crohn: a. non ha risposto alla terapia convenzionale: 1) e' attualmente in terapia con corticosteroidi e/o immunomodulatori a dosi terapeutiche adeguate; OPPURE 2) non ha precedentemente risposto o non ha tollerato un ciclo adeguato di terapia con corticosteroidi e/o immunomodulatori; OPPURE 3) e' dipendente dai corticosteroidi o presenta una storia di dipendenza da corticosteroidi; E b. non ha precedentemente dimostrato risposta inadeguata o intolleranza a 1 o piu' terapie con antagonisti del TNF. 5. Il soggetto soddisfa i requisiti seguenti relativi alla terapia farmacologica concomitante per il trattamento della malattia di Crohn. Sono consentiti i farmaci seguenti a condizione che le dosi rispondano ai requisiti indicati di seguito e, per almeno 3 settimane prima del basale (Settimana 0), salvo diversamente specificato, siano stabili o ne sia stata interrotta l’assunzione. a. Composti di 5-ASA per via orale. b. Corticosteroidi per via orale a una dose equivalente a &lt;= 40 mg/die di prednisone o &lt;= 9 mg/die di budesonide. c. Antibiotici assunti come trattamento primario della malattia di Crohn. d. I soggetti che ricevono immunomodulatori convenzionali devono averli assunti per &gt;= 12 settimane e a una dose stabile per almeno 4 settimane precedenti il basale. 6. I risultati degli esami di laboratorio allo screening rientrano nei parametri indicati nel protocollo. 7. I soggetti sono considerati idonei in base ai criteri di screening per la TB indicati nel protocollo. 8. Prima dell’ingresso nello studio i soggetti di sesso femminile devono essere: a. in post-menopausa, definita come: 1) eta' &gt; 45 anni con amenorrea da almeno 18 mesi; OPPURE 2) eta' &gt; 45 anni con amenorrea da almeno 6 mesi e una concentrazione sierica di ormone follicolo-stimolante (FSH) &gt; 40 IU/mL; OPPURE b. se in eta' fertile 1) chirurgicamente sterili; oppure 2) se eterosessualmente attive, devono utilizzare un metodo di contraccezione altamente efficace, inclusi contraccettivi ormonali per via orale soggetti a prescrizione, iniezioni anticoncezionali, cerotto anticoncezionale, dispositivo intrauterino, metodo di doppia barriera o sterilizzazione del partner, in conformita' con le normative locali sull’uso dei metodi di contraccezione per i soggetti partecipanti a sperimentazioni cliniche, per la durata della loro partecipazione allo studio e per 20 settimane dopo l’assunzione del farmaco in studio; oppure 3) non essere eterosessualmente attive. 9. Le donne in eta' fertile devono risultare negative a un test di gravidanza su siero per la gonadotropina corionica umana (β-hCG) effettuato allo screening nonche' a un test di gravidanza su urine effettuato alla Settimana 0. 10. I soggetti di sesso maschile eterosessualmente attivi, e nonchirurgicamentesterili con partner in eta' fertile devono acconsentire a utilizzare un metodo contraccettivo di doppia barriera e a non donare sperma durante lo studio e per 20 settimane dopo l’assunzione del farmaco in studio. 11. I soggetti devono essere disposti e in grado di sottostare ai divieti e alle restriz. specificati nel prot..
    E.4Principal exclusion criteria
    1. Has complications of Crohn`s disease such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation that might be anticipated to require surgery, could preclude the use of the CDAI to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with ustekinumab. 2. Currently has or is suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks prior to baseline, or 8 weeks prior to baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery. Subjects with active fistulas may be included if there is no anticipation of a need for surgery and there are currently no abscesses identified. 3. Has had any kind of bowel resection within 6 months or any other intra-abdominal surgery within 3 months prior to baseline. 4. Has a draining stoma or ostomy. 5. Has received any of the prescribed medications or therapies within the specified period (mentioned in the protocol). 6. Have a stool culture or other examination positive for an enteric pathogen, including Clostridium difficile toxin, in the last 4 months unless a repeat examination is negative and there are no signs of ongoing infection with that pathogen. 7. Has previously received a biologic agent targeting IL-12 or IL-23, including but not limited to ustekinumab (CNTO 1275) or briakinumab (ABT-874). 8. Has received a Bacille Calmette-Gue'rin (BCG) vaccination within 12 months or any other live bacterial or live viral vaccination within 12 weeks of baseline. 9. Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, chronic renal infection, chronic chest infection, recurrent urinary tract infection, or open, draining, or infected skin wounds or ulcers.10. Has current signs or symptoms of infection. Established nonserious infections need not be considered exclusionary at the discretion of the investigator. 11. Has a history of serious infection, including any infection requiring hospitalization or IV antibiotics, for 8 weeks prior to baseline. 12. Has evidence of a herpes zoster infection ≤ 8 weeks prior to baseline. 13. Has a history of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, prior to screening. Refer to inclusion criteria for information regarding eligibility with a history of latent TB. 14. Has evidence of current active infection, including but not limited to TB (exceptions see protocol). 15. Has or ever has had a nontuberculous mycobacterial infection or serious opportunistic infection. 16. Is known to be infected with HIV, hepatitis B, or hepatitis C. 17. Has severe, progressive, or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof. 18. Has a transplanted organ. 19. Has a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly. 20. Has any known malignancy or has a history of malignancy. 21. Has previously undergone allergy immunotherapy for prevention of anaphylactic reactions. 22. Is unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to veins. 23. Is known to have had a substance abuse problem within the previous 12 months prior to baseline. 24. Has known allergies, hypersensitivity, or intolerance to ustekinumab or its excipients. 25. Are currently or intending to participate in any other study using an investigational agent or procedure during participation in this study. 26. Is a woman who is pregnant, or breast-feeding, or planning to become
    1. Complicanze della malattia di Crohn come stenosi sintomatiche, sindrome dell’intestino corto o qualsiasi altra manifestazione per la quale si possa prevedere la necessita' di un intervento chirurgico, che potrebbe precludere l’utilizzo del punteggio CDAI per la valutazione della risposta alla terapia o che potrebbe compromettere la capacita' di valutare l’effetto del trattamento con ustekinumab. 2. Ascesso in corso o sospetto. Gli ascessi cutanei e perianali di recente insorgenza non costituiscono motivo di esclusione qualora sottoposti a drenaggio e adeguatamente trattati almeno 3 settimane prima del basale, o 8 settimane per gli ascessi intra-addominali, a condizione che non si preveda la necessita' di un ulteriore intervento chirurgico. I soggetti con fistole attive possono essere inclusi qualora non si preveda la necessita' di un intervento e non siano stati individuati ascessi in corso. 3. Qualsiasi resezione intestinale effettuata negli ultimi 6 mesi o altri eventuali interventi intra-addominali nei 3 mesi precedenti il basale. 4. Stomia drenante. 5. Assunzione di eventuali farmaci o terapie farmacologiche dietro prescrizione nel periodo specificato (indicato nel protocollo). 6. Risultato positivo per un agente patogeno enterico, inclusa la tossina Clostridium (C) difficile, a una coltura delle feci o ad altro esame effettuato negli ultimi 4 mesi, salvo l’esame ripetuto risulti negativo e non siano presenti segni di infezione in corso con tale agente patogeno. 7. Precedente assunzione di un agente biologico diretto contro l’IL-12 o l’IL-23 inclusi, a titolo esemplificativo, ustekinumab (CNTO 1275) o briakinumab (ABT-874). 8. Inoculazione di un vaccino con il bacillo Calmette-Gue'rin (BCG) o di altri eventuali vaccini vivi batterici o virali rispettivamente nei 12 mesi e nelle 12 settimane precedenti il basale. 9. Malattia infettiva cronica o ricorrente precedente o in corso, incluse, a titolo esemplificativo, infezione renale cronica, infezione toracica cronica, infezione ricorrente del tratto urinario o ferite o ulcere cutanee aperte, drenanti o infette. 10. Segni o sintomi correnti di infezione. Le infezioni non gravi accertate possono non costituire motivo di esclusione a discrezione dello sperimentatore. 11. Storia di infezione grave, inclusa qualsiasi infezione che richieda l’ospedalizzazione o la somministrazione di antibiotici per via EV, nelle 8 settimane precedenti il basale. 12. Evidenza di infezione da herpes zoster &lt;= 8 settimane prima del basale. 13. Storia di infezione granulomatosa latente o attiva, incluse istoplasmosi o coccidioidomicosi, precedente allo screening. Si faccia riferimento ai criteri di inclusione per informazioni sull’idoneita' dei soggetti con una storia di TB latente. 14. Evidenza di infezione attiva in corso inclusa, a titolo esemplificativo, la TB (per le eccezioni vedere il protocollo). 15. Eventuale infezione micobatterica non tubercolare o infezione opportunistica grave precedente o in corso. 16. Infezione nota da virus dell’HIV, dell’epatite B o dell’epatite C. 17. Presenza o segni e sintomi di malattia renale, epatica, ematologica, endocrina, polmonare, cardiaca, neurologica, cerebrale o psichiatrica grave, progressiva o non controllata. 18. Storia di trapianto d’organo. 19. Storia nota di malattia linfoproliferativa, tra cui il linfoma, o segni e sintomi indicativi di una possibile malattia linfoproliferativa come la linfoadenopatia e/o la splenomegalia. 20. Eventuali neoplasie note o storia di neoplasia. 21. Precedente terapia antiallergica per la prevenzione di reazioni anafilattiche. 22. Incapacita' o mancata disponibilita' a sottoporsi a piu' venipunture per scarsa tollerabilita' o difficile accesso venoso. 23. Problema noto di abuso di sostanze nei 12 mesi precedenti il basale. 24. Allergie, ipersensibilita' o intolleranza note a ustekinumab o ai suoi eccipienti. 25. ...segue.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is clinical response at Week 6, defined as a reduction from baseline in the CDAI score of ≥ 100 points. Subjects with a baseline CDAI score of ≥ 220 to ≤ 248 points are considered to be in clinical response if a CDAI score of < 150 is attained.
    L’endpoint primario e' la risposta clinica alla Settimana 6, definita come riduzione del punteggio CDAI >=100 punti rispetto al basale. I soggetti con punteggio CDAI basale >=220 e <=248 punti sono considerati in risposta clinica se raggiungono un punteggio CDAI <150.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At week 6
    Alla settimana 6
    E.5.2Secondary end point(s)
    The major secondary endpoints, in order of importance, are: 1. Clinical remission at Week 8, defined as a CDAI score of < 150 points. 2. Clinical response at Week 8. 3. 70-point response at Week 6, defined as a reduction from baseline in the CDAI score of ≥ 70 points. 4. 70-point response at Week 3.
    Gli endpoint secondari maggiori in ordine di importanza sono: 1. remissione clinica alla Settimana 8, definita come punteggio CDAI < 150 punti;2. risposta clinica alla Settimana 8; 3. risposta di 70 punti alla Settimana 6, definita come riduzione del punteggio CDAI rispetto al basale >=70 punti;4. risposta di 70 punti alla Settimana 3.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At week 3, 6 and 8
    Alla settimana 3, 6 e 8
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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) 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 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 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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
    Korea, Republic of
    New Zealand
    Russian Federation
    South Africa
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    Subjects entering maintenance study CNTO1275CRD3003 will be considered to have completed induction study CNTO1275CRD3002 if they've completed the Week 8 visit. Subjects not entering maintenance study CNTO1275CRD3003 will be considered to have completed induction study CNTO1275CRD3002 if they've completed the safety follow up visit approximately 20 weeks after study agent administration at Week 0.
    Per i soggetti inclusi nello studio di mantenimento CNTO1275CRD3003 lo studio di induzione CNTO1275CRD3002 sarà considerato completato qualora si siano sottoposti alla visita della Settimana 8.Per i soggetti non inclusi nello studio di manteniment
    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.1.1Number 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.1.2.1Number of subjects for this age range: 575
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 188
    F.4.2.2In the whole clinical trial 600
    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)
    Subjects may be eligible to participate in an additional trial (CNTO1275CRD3003) where they may have an opportunity to receive study agent in a blinded fashion.
    I pazienti saranno eliggibili a partecipare ad un ulteriore studio (CNTO1275CRD3003)laddove possano avere la possibilità di ricevere il farmaco in studio in cieco.
    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 Decision2011-08-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-10-25
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