Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   42316   clinical trials with a EudraCT protocol, of which   6969   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).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2010-022758-18
    Sponsor's Protocol Code Number:CNTO1275CRD3001
    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:2012-06-22
    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 number2010-022758-18
    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 Who Have Failed or Are Intolerant to TNF Antagonist Therapy
    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 attiva da moderata a grave, risultati non responsivi o intolleranti a una terapia a base di antagonisti del TNF
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients with Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy
    Studio per valutare la sicurezza e l'efficacia di Ustekinumab in pazienti con malattia di Crohn attiva da moderata a grave che hanno fallito o sono intolleranti alla terapia a base di antagonisti del fattore di necrosi tumorale (TNF)
    A.3.2Name or abbreviated title of the trial where available
    UNITI 1
    A.4.1Sponsor's protocol code numberCNTO1275CRD3001
    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 SponsorJANSSEN-CILAG INTERNATIONAL N.V.
    B.1.3.4CountryBelgium
    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 INTERNATIONAL S.p.A.
    B.4.2CountryItaly
    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.5.3.4CountryNetherlands
    B.5.4Telephone number+31 071 524 2166
    B.5.5Fax number+31 071 524 2110
    B.5.6E-mailClinicalTrialsEU@its.jnj.com
    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/ml milligram(s)/millilitre
    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.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 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.3.11.13.1Other 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 Phenomena
    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 who have failed or are intolerant to one or more tumor necrosis factor (TNF) antagonist therapies. - To evaluate the safety of IV induction regimens of Ustekinumab in subjects with moderately to severely active Crohn's disease who have failed or are intolerant to one or more TNF antagonist therapies.
    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, risultati non responsivi o intolleranti ad una o più terapie a base di antagonisti del fattore di necrosi tumorale (TNF); • valutare la sicurezza dei regimi di induzione con ustekinumab per via EV in soggetti con malattia di Crohn attiva da moderata a grave, risultati non responsivi o intolleranti ad una o più terapie a base di antagonisti del TNF.
    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 CNTO1275CRD3002, the target study population to be evaluated in the maintenance study CNTO1275CRD3003.
    Gli obiettivi secondari sono i seguenti:• valutare l’efficacia dei regimi 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 qualità 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 CNTO1275CRD3002, 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 baseline CDAI score of ≥ 220 and ≤ 450. 4. Have received infliximab, adalimumab, or certolizumab pegol at a dose approved for the treatment of Crohn's disease and a. Did not respond initially; OR b. Responded initially but then lost response with continued therapy; OR c. Were intolerant to the medication. 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 following TB screening criteria: a. Have no history of latent or active TB prior to screening. Exceptions are made for subjects currently receiving treatment for latent TB, if there is no evidence of active TB, or who have a history of latent TB and documentation of having completed adequate treatment for latent TB within 3 years prior to the first administration of study agent. It is the responsibility of the investigator to verify the adequacy of previous TB treatment and provide appropriate documentation. b. Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination. c. Have had no recent close contact with a person with active TB or, if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB prior to or simultaneously with the first administration of study agent. d. Within 2 months prior to the first administration of study agent, either have negative QuantiFERON-TB Gold test, or have a newly identified positive QuantiFERON-TB Gold test in which active TB has been ruled out, and for which appropriate treatment for latent TB has been initiated either prior to or simultaneously with the first administration of study agent. A negative tuberculin skin test is additionally required if the QuantiFERON-TB gold test is not approved/registered in that country. The QuantiFERON-TB Gold In-Tube test is not required at screening for subjects with a history of latent TB and appropriate treatment as described in 7a. e. Have a chest radiograph, taken within 3 months prior to the first administration of study agent and read by a qualified radiologist, with no evidence of current active TB or old inactive TB. 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 c
    1. Soggetti di entrambi i sessi di età &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 un punteggio CDAI basale &gt;= 220 e &lt;= 450. 4. Precedente terapia con infliximab, adalimumab o certolizumab pegol a una dose approvata per il trattamento della malattia di Crohn e a. assenza di risposta fin da subito; OPPURE b. nonostante una risposta iniziale, resistenza al farmaco alla continuazione della terapia; OPPURE c. intolleranza al farmaco. 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. Soggetti considerati idonei in base ai seguenti criteri di screening per la TB: a. non presentano storia di TB attiva o latente precedente allo screening. Fanno eccezione i soggetti in trattamento corrente per la TB latente, qualora non vi siano evidenze di TB attiva, o che presentano una storia di TB latente e che abbiano completato, e lo possano documentare, un trattamento adeguato per la TB latente nei 3 anni precedenti la prima somministrazione del farmaco in studio. Lo sperimentatore è tenuto a verificare l’adeguatezza del precedente trattamento antitubercolare e a fornire la documentazione opportuna; b. non presentano segni o sintomi indicativi di TB attiva all’anamnesi e/o all’esame obiettivo; c. non sono stati recentemente a stretto contatto con una persona affetta da TB attiva oppure, qualora lo siano stati, saranno indirizzati a un medico specialista in TB per sottoporsi a valutazione aggiuntiva e, se necessario, riceveranno un trattamento adeguato per la TB latente prima o in concomitanza con la prima somministrazione del farmaco in studio; d. nei 2 mesi precedenti la prima somministrazione del farmaco in studio, presentano risultato negativo al test QuantiFERON-TB Gold oppure risultano positivi per la prima volta al test QuantiFERON-TB Gold che abbia escluso la TB attiva e abbiano iniziato un trattamento adeguato per la TB latente prima o in concomitanza con la prima somministrazione del farmaco in studio. I soggetti devono inoltre presentare un risultato negativo al test cutaneo tubercolinico qualora il test QuantiFERON-TB Gold non sia approvato/registrato nel paese di riferimento.Il test QuantiFERON-TB Gold In-Tube non è necessario allo screening per i soggetti che presentano una storia di TB latente trattata adeguatamente come descritto al punto 7a;e. presentano una radiografia toracica, effettuata nei 3 mesi precedenti la prima somministrazione del farmaco in studio e repertata da un radiologo qualificato, che non evidenzi TB attiva in corso o precedente TB inattiva. 8. Prima dell’ingresso nello studio i soggetti di sesso femminile devono essere:a. in post-menopausa, definita come:1) età &gt; 45 anni con amenorrea da almeno 18 mesi;OPPURE 2) età &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 età fertile 1)...segue
    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-Guérin (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 p
    1. Complicanze della malattia di Crohn come stenosi sintomatiche, sindrome dell’intestino corto o qualsiasi altra manifestazione per la quale si possa prevedere la necessità di un intervento chirurgico, che potrebbe precludere l’utilizzo del punteggio CDAI per la valutazione della risposta alla terapia o che potrebbe compromettere la capacità 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 necessità di un ulteriore intervento chirurgico. I soggetti con fistole attive possono essere inclusi qualora non si preveda la necessità 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-Guérin (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’idoneità 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. Incapacità o mancata disponibilità a sottoporsi a più venipunture per scarsa tollerabilità o difficile accesso venoso. 23. Problema noto di abuso di sostanze nei 12 mesi precedenti il basale. 24. Allergie, ipersensibilità 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 è la risposta clinica alla Settimana 6, definita come riduzione del punteggio CDAI >=a 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.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 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA77
    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
    Australia
    Brazil
    Canada
    Iceland
    Israel
    Japan
    Korea, Republic of
    New Zealand
    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 CNTO1275CRD3001 if they've completed the Week 8 visit. Subjects not entering maintenance study CNTO1275CRD3003 will be considered to have completed induction study CNTO1275CRD3001 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 CNTO1275CRD3001 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: 625
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 257
    F.4.2.2In the whole clinical trial 675
    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 soggetti potranno essere eliggibili a partecipare ad un ulteriore studio (CNTO1275CRD3003) dove potranno avere l'opportunità di ricevere il farmaco 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 trial2013-07-16
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2022 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA