E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Ulcerative Colitis and Crohn¿s Disease |
Colite ulcerosa e morbo di Crohn |
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E.1.1.1 | Medical condition in easily understood language |
Ulcerative colitis is an inflammatory disease of the large bowel. Crohn¿s disease is an inflammatory disease of the gastrointestinal tract. |
La colite ulcerosa ¿ una malattia infiammatoria dell'intestino crasso. Il morbo di Crohn ¿ una malattia infiammatoria del tratto gastrointestinale. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10013099 |
E.1.2 | Term | Disease Crohns |
E.1.2 | System Organ Class | 100000004856 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045365 |
E.1.2 | Term | Ulcerative colitis |
E.1.2 | System Organ Class | 100000004856 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To monitor ongoing safety in subjects with ulcerative colitis and Crohn¿s disease and to provide access to vedolizumab for qualifying subjects who, in the opinion of the investigator, continue to derive benefit from vedolizumab and for whom continued treatment with vedolizumab is desired because there is no other comparable product available or the subject may be expected to develop worsening of disease if they were to modify treatment |
Monitorare costantemente la sicurezza in soggetti affetti da colite ulcerosa e morbo di Crohn e fornire accesso a vedolizumab per i soggetti idonei che, secondo il giudizio dello sperimentatore, continuano a trarre beneficio da vedolizumab e per i quali la prosecuzione del trattamento con vedolizumab ¿ auspicabile perch¿ non ¿ disponibile un altro prodotto paragonabile oppure perch¿ si pu¿ prevedere che i soggetti vadano incontro ad un aggravamento della malattia nel caso in cui il trattamento venga modificato. |
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E.2.2 | Secondary objectives of the trial |
Not applicable |
Non Applicabile |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Any subject who meets the inclusion criteria for the qualifying vedolizumab clinical studies and meets any of the following criteria will qualify for entry into the study:
1. Received vedolizumab (excluding comparator or placebo subjects) during participation in a qualifying vedolizumab study.
2. In the opinion of the investigator, the subject is continuing to derive benefit from vedolizumab and continued treatment with vedolizumab is desired because there is no other comparable product available or the subject may be expected to develop worsening of disease if they were to modify treatment.
3. A male subject who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 18 weeks after last dose.
4. A female subject of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study and for 18 weeks after last dose. |
I soggetti che soddisfano i criteri di inclusione per gli studi clinici di qualificazione con vedolizumab e soddisfano uno qualsiasi dei seguenti criteri si qualificano per l'ingresso nello studio:
1.Assunzione di vedolizumab (esclusi i soggetti trattati con comparatore o placebo) durante la partecipazione a uno studio di qualificazione con vedolizumab.
2.Secondo il giudizio dello sperimentatore, il soggetto continua a trarre beneficio da vedolizumab e la prosecuzione del trattamento con vedolizumab è auspicabile perché non è disponibile un altro prodotto paragonabile oppure perché si può prevedere che il soggetto vada incontro a un aggravamento della malattia nel caso in cui il trattamento venga modificato.
3.I soggetti di sesso maschile non sterilizzati e sessualmente attivi con partner di sesso femminile in età fertile acconsentono a utilizzare un metodo contraccettivo adeguato dalla firma del consenso informato per tutta la durata dello studio e per 18 settimane dopo l'ultima dose.
4.I soggetti di sesso femminile in età fertile e sessualmente attivi con partner di sesso maschile non sterilizzati acconsentono all'uso regolare di un metodo contraccettivo adeguato dalla firma del consenso informato per tutta la durata dello studio e per 18 settimane dopo l'ultima dose.
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E.4 | Principal exclusion criteria |
Any subject who meets any of the exclusion following criteria will not qualify for entry into the study:
1. For the subject’s particular clinical scenario, vedolizumab is currently available to the subject through commercial channels, including reimbursement.
2. Subject has any clinical condition or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements or poses a risk to the subject being in the study.
3. If female, the subject is pregnant or lactating or intending to become pregnant before, during, or within 18 weeks after participating in this study; or intending to donate ova during such time period.
4. If male, the subject intends to donate sperm during the course of this study or for 18 weeks thereafter.
5. Subject has received a live vaccine in the last 18 weeks or is in need of a live vaccine during the study or up to 18 weeks after the last study dose. |
I soggetti che soddisfano uno qualsiasi dei seguenti criteri di esclusione non si qualificano per l'ingresso nello studio:
1.Per il quadro clinico specifico del soggetto, vedolizumab è attualmente disponibile per il soggetto attraverso i canali commerciali, compreso il rimborso.
2.Il soggetto presenta una qualsiasi condizione clinica o ha assunto una precedente terapia che, a giudizio dello Sperimentatore, renderebbe il soggetto inadatto allo studio o incapace di rispettare i requisiti di dosaggio o pone un rischio per il soggetto che partecipa allo studio.
3.Se femmina, il soggetto è in stato di gravidanza o in allattamento, o prevede di intraprendere una gravidanza prima, durante o entro 18 settimane dalla partecipazione a questo studio; oppure intende donare ovuli durante tale periodo di tempo.
4.Se maschio, il soggetto intende donare sperma nel corso di questo studio o successivamente per 18 settimane.
5.Il soggetto ha ricevuto un vaccino vivo nelle ultime 18 settimane o necessita di un vaccino vivo durante lo studio o fino a 18 settimane dopo l'ultima dose dello studio.
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E.5 End points |
E.5.1 | Primary end point(s) |
* Number and percentage of subjects with adverse events (AEs) and serious AEs (SAEs)
* Number and percentage of subjects with adverse events of special interest (AESIs) |
* Numero e percentuale di soggetti che manifestano eventi avversi (AE) e AE seri (SAE)
* Numero e percentuale di soggetti che manifestano eventi avversi di particolare interesse (AESI)
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Not applicable |
Non applicabile |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Not applicable |
Non applicabile |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Continue to provide access to vedolizumab
for qualifying subjects (extended access program) |
Continuare a fornire accesso a vedolizumab per i soggetti idonei (programma di accesso allargato) |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 81 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
India |
Korea, Democratic People's Republic of |
Korea, Republic of |
Malaysia |
New Zealand |
Russian Federation |
Serbia |
Singapore |
South Africa |
Taiwan |
Turkey |
Ukraine |
Austria |
Belgium |
Bulgaria |
Estonia |
Hungary |
Iceland |
Italy |
Latvia |
Poland |
Romania |
Slovakia |
Czechia |
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E.8.7 | Trial 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
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Subjects will remain in the study until vedolizumab is available to the subject through commercial channels, including reimbursement, for the subject¿s clinical scenario or until subject withdrawal, whichever is sooner. Subjects will return 18 weeks after their final study infusion for a safety follow-up visit regardless of whether they remain on vedolizumab after the study (ie, they left the study due the availability of vedolizumab or they withdrew from the study for other reasons). |
I sogg resteranno nello studio fino a quando vedo sar disp attraverso i canali commerciali, compreso il rimborso, x il quadro clinico del sogg o fino al ritiro del sogg, a seconda dell'evento ke si verificher prima. I sogg torneranno 18 sett dp l'inf finale dello studio x sottoporsi a 1 visita d f-up d sicurezza a prescindere dal fatto ke dp lo studio proseguano o - la terapia cn vedo (hanno lasciato lo studio a seguito della disponibilit di vedo o si sono ritirati dallo studio x altre ragioni) |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |