E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Rheumatoid arthritis Chronic Plaque Psoriasis |
Artrite Reumatoide Psoriasi Cronica a Placche |
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E.1.1.1 | Medical condition in easily understood language |
Rheumatoid arthritis Chronic Plaque Psoriasis |
Artrite Reumatoide Psoriasi Cronica a Placche |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
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 | 10042952 |
E.1.2 | Term | Systemic rheumatoid arthritis |
E.1.2 | System Organ Class | 100000004859 |
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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 | 10071117 |
E.1.2 | Term | Plaque psoriasis |
E.1.2 | System Organ Class | 100000004858 |
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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 evaluate the longer-term safety and durability of response of subjects who completed 48 weeks of evaluations in the confirmatory safety and efficacy studies, CHS 0214-02 or CHS 0214-04, evaluating CHS 0214 in rheumatoid arthritis (RA) and plaque psoriasis (PsO), respectively. |
Valutare la sicurezza a lungo termine e la durata della risposta nei soggetti che hanno completato 48 settimane di valutazioni nell’ambito degli studi confermativi di sicurezza ed efficacia, CHS-0214-02 o CHS-0214-04, finalizzati alla valutazione di CHS-0214 rispettivamente nell’artrite reumatoide (rheumatoid arthritis, RA) e nella psoriasi a placche (plaque psoriasis, PsO). |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Have completed 48 weeks of evaluations in CHS 0214-02 and, at Week 48, had at least an ACR20, or completed 48 weeks of evaluations in CHS 0214-04 and, at Week 48, had at least a PASI-50; 2. Women who either: a) Are of childbearing potential with a negative urine pregnancy test at Week 0 Day 0 (considered to correspond to the Week 48 Visit of the preceding study) who agree to use 1 or more approved methods of birth control (hormonal contraception, intrauterine device, diaphragm plus spermicide, condom plus spermicide, or abstinence from heterosexual intercourse—abstinence from heterosexual intercourse will be acceptable only if it is the preferred and usual lifestyle of the subject regardless of study participation; abstinence should be practiced for the duration of the study (study duration includes the Early Termination (ET)/ Follow-up Visit) after taking the last dose of study drug; or b) Have been postmenopausal for at least 2 years (with amenorrhea for at least 1 year) or have had a hysterectomy, bilateral salpingo oophorectomy, or tubal ligation prior to signing the informed consent; and 3. Able and willing to give written informed consent prior to performance of any study related procedures. |
1. Aver completato 48 settimane di valutazioni nell’ambito dello studio CHS-0214-02, presentando almeno una risposta ACR20 alla Settimana 48, oppure aver completato 48 settimane di valutazioni nell’ambito dello studio CHS-0214-04, presentando almeno una risposta PASI-50 alla Settimana 48. 2. Per le donne: a) se in età fertile, presentare un test di gravidanza sulle urine negativo alla Settimana 0 Giorno 0 (momento che si considera corrispondere alla visita della Settimana 48 dello studio precedente) e accettare di utilizzare 1 o più metodi contraccettivi approvati (contraccezione ormonale, dispositivo intrauterino, diaframma più spermicida, preservativo più spermicida o astinenza dai rapporti eterosessuali -l’astinenza dai rapporti eterosessuali sarà considerata accettabile solo se rientra nello stile di vita preferito e abituale del soggetto, indipendentemente dalla partecipazione allo studio; l’astinenza deve essere praticata per la durata dello studio, ove la durata dello studio include la visita di interruzione anticipata (Early Termination, ET)/di follow-up dopo l’assunzione dell’ultima dose del farmaco in studio; o b) essere in post-menopausa da almeno 2 anni (con amenorrea da almeno 1 anno) o essere state sottoposte a isterectomia, salpingo-ooforectomia bilaterale o legatura della tube prima della firma del consenso informato; e 3. essere in grado e disponibili a fornire il proprio consenso informato scritto prima dell’esecuzione di qualsiasi procedura correlata allo studio. |
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E.4 | Principal exclusion criteria |
1. Men whose partners may become pregnant (do not agree to use contraception or who are not postmenopausal) or who may breastfeed during the study (Japan only specific exclusion). |
1. Soggetti di sesso maschile le cui partner potrebbero restare incinte (non accettano di utilizzare metodi contraccettivi o non sono in post-menopausa) o allattare durante lo studio (criterio di esclusione specifico solo per il Giappone). |
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E.5 End points |
E.5.1 | Primary end point(s) |
SAFETY: Safety will be assessed by: • Assessment of treatment-emergent AEs; • Determination of subject withdrawal information; • Assessment of injection site reactions; • Assessment of changes in safety laboratory parameters, including hematology, clinical chemistry, and pregnancy tests; • Assessment of changes in vital signs, physical examination, and electrocardiogram findings; • Monitoring for tuberculosis (TB) with regular QuantiFERON®-TB Gold test (every 12 months or more frequently for regions with high incidences of TB or to evaluate signs and symptoms that might be due to TB); and • Assessment of immunogenicity (anti-CHS 0214 antibodies)
EFFICACY: Durability of response will be measured as follows: • For subjects with RA, maintenance of an ACR20 response or greater • For subjects with PsO, maintenance of PASI-50 response or greater |
SICUREZZA:La sicurezza verrà valutata mediante: •ď€ valutazione degli AE che emergono dal trattamento; •determinazione delle informazioni relative al ritiro dei soggetti; •ď€ valutazione delle reazioni nel sito di iniezione; •valutazione delle variazioni nei parametri di laboratorio di sicurezza, inclusi esami ematologici e di chimica clinica e test di gravidanza; •valutazione delle variazioni nei segni vitali, nell’esame obiettivo e nei riscontri elettrocardiografici; •monitoraggio per la tubercolosi (TB) con test QuantiFERON®-TB Gold eseguito su base regolare (ogni 12 mesi o più frequentemente per le regioni ad alta incidenza di TB o per valutare segni e sintomi che potrebbero essere causati dalla TB); e •valutazione dell’immunogenicità (anticorpi anti-CHS-0214)
EFFICACIA: La durata della risposta sarà misurata come segue: •per i soggetti con RA, mantenimento di una risposta ACR20 o superiore •Per i soggetti con PsO, mantenimento di una risposta PASI-50 o superiore
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
SAFETY: At 1 month and 3 months following enrollment and every 3 months thereafter
EFFICACY: At each visit |
SICUREZZA: a 1 mese e 3 mesi dopo l’arruolamento e successivamente ogni 3 mesi
EFFICACIA: ad ogni visita |
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E.5.2 | Secondary end point(s) |
Retained Samples: Serum samples will be collected at each visit and retained for potential analysis of serum concentration of CHS 0214, anti-drug antibodies, or other tests as necessary to evaluate AEs, loss of response, or compliance. Serum samples will not be used to assess population pharmacokinetics (PK), biomarkers, or genetics. Samples will be stored at Medpace Reference Laboratory, LLC (MRL) and may be transferred to Charles River Laboratories or other reference laboratory for analysis at the request of the Sponsor |
Conservazione dei campioni: Campioni di siero verranno raccolti ad ogni visita e conservati per l’eventuale analisi della concentrazione sierica di CHS-0214, degli anticorpi anti-farmaco o per altri test, secondo quanto necessario per valutare AE, perdita della risposta o compliance. I campioni di siero non saranno utilizzati per valutare la farmacocinetica (Pharmacokinetics, PK) della popolazione, i biomarcatori o la genetica. I campioni saranno conservati presso Medpace Reference Laboratory, LLC (MRL) e potranno essere trasferiti su richiesta dello Sponsor ai laboratori Charles River Laboratories o ad altro laboratorio di riferimento per l’analisi. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Up to 2 years after completion of the study (data base lock). |
Fino a 2 anni dopo il completamento dello studio (chiusura della banca dati). |
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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 | Yes |
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 | No |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 15 |
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 |
Australia |
Canada |
France |
Germany |
Israel |
Italy |
Japan |
South Africa |
Spain |
United Kingdom |
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E.8.7 | Trial 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
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 11 |
E.8.9.2 | In all countries concerned by the trial days | 1 |