E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Active Psoriatic Arthritis |
Artrite Psoriasica Attiva |
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E.1.1.1 | Medical condition in easily understood language |
Psoriatic Arthritis |
Artrite Psoriasica |
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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 | 21.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10037160 |
E.1.2 | Term | Psoriatic arthritis |
E.1.2 | System Organ Class | 100000004859 |
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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 examine the efficacy of baricitinib 4 mg, once daily, versus placebo on signs and symptoms of arthritis as measured by ACR20 response at Week 16 |
Valutare l’efficacia di baricitinib 4 mg, una volta al giorno, rispetto al placebo su segni e sintomi del’artrite misurata mediante la risposta ad ACR20 alla settimana 16 |
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E.2.2 | Secondary objectives of the trial |
See correlated end point: 1. To compare baricitinib 4 mg, once daily, to placebo in the overall study population
2. To compare baricitinib 2 mg, once daily, to placebo in the overall study population.
3. To compare baricitinib 4 mg, once daily, to placebo in the subgroup of biologic naïve patients.
4. To compare baricitinib 4 mg, once daily, to placebo in the overall study population.
5. To compare baricitinib 4 mg, once daily, to placebo in the overall study population
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Vedere end point correlati: 1. Confrontare baricitinib 4 mg, una volta al giorno verso placebo nella popolazione globale dello studio
2. Confrontare baricitinib 2 mg, una volta al giorno verso placebo nella popolazione globale dello studio
3. Confrontare baricitinib 4 mg, una volta al giorno verso placebo nel sottogruppo dei pazienti naïve a trattamenti con farmaci biologici
4. Confrontare baricitinib 4 mg, una volta al giorno verso placebo nella popolazione globale dello studio
5. Confrontare baricitinib 4 mg, una volta al giorno verso placebo nella popolazione globale dello studio
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• At least 18 years in age. • Male or Female. • Presents with established diagnosis of active psoriatic arthritis (PsA) for at least 6 months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria. • Active PsA defined as the presence of at least 3 tender and at least 3 swollen joints. • Have active plaque psoriatic skin lesion. • Have at least 1 joint erosion on hand or foot x-rays as determined by the central reader OR have a hsCRP =6 milligrams per litre (0.6 mg/dL) at screening. • Participants who have active PsA despite current or prior nonsteroidal anti-inflammatory drug (NSAIDs) or conventional disease-modifying antirheumatic drugs (cDMARDs) or biologic disease-modifying antirheumatic drugs (bDMARDs). • Men must agree to use a reliable method of birth control or remain abstinent during the study and for at least 4 weeks after stopping treatment. • Women must agree to use reliable birth control or remain abstinent during the study and for at least 4 weeks after stopping treatment.
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• Almeno 18 anni di età • Maschio o Femmina • Con una diagnosi di artrite psoriasica (PsA) attiva da almeno 6 mesi e che attualmente rientra nei criteri Classification for Psoriatic Arthritis (CASPAR) • Con PsA attiva definita dalla presenza di almeno 3 articolazioni gonfie e 3 articolazioni doloranti • Con una lesione della pelle causata da placca psoriasica attiva • Con almeno una erosione di articolazione ad una mano o ad un piede visibile agli x-ray come determinato dal central reader oppure con hsCRP = 6 mg per litro (0.6 mg/dL) allo screening • Pazienti che hanno PsA attiva nonostante l’attuale o precedente uso di farmaci antiinfiammatori non steroidei (NSAIDs) o i convenzionali farmaci antireumatici (cDMARDs) o farmaci antireumatici biologici (bDMARDs) • Gli uomini devono essere d’accordo ad utilizzare un metodo contraccettivo affidabile oppure astenersi dai rapporti durante lo studio e per almeno 4 settimane dopo la fine del trattamento • Le donne devono essere d’accordo ad utilizzare un metodo contraccettivo affidabile oppure astenersi dai rapporti durante lo studio e per almeno 4 settimane dopo la fine del trattamento
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E.4 | Principal exclusion criteria |
• Have autoimmune or inflammatory conditions other than PsA that might confound the evaluation of the benefit of baricitinib therapy. • Received any Janus kinase (JAK) inhibitors (including, but not limited to, tofacitinib or baricitinib) previously or concurrently. • Serious disorder or illness other than psoriatic arthritis. • Clinically serious infection or received intravenous antibiotics for an infection, within the past 4 weeks of randomization • Pregnant or breast feeding, females of child-bearing potential not using highly effective contraception. |
• Essere affetti da patologie autoimmuni o infiammatorie oltre alla PsA che potrebbero confondere la valutazione del beneficio della terapia con baricitinib. • Aver ricevuto contestualmente o precedentemente un trattamento a base di inibitori delle Janus chinasi (JAK) (inclusi, ma non solo, tofacitinib o baricitinib). • Essere affetti da patologie gravi oltre l’artrite psoriasica • Essere affetti da infezioni clinicamente gravi o aver ricevuto antibiotici per via intravenosa a causa di un infezione nelle precedenti 4 settimane dalla randomizzazione • Donne in stato interessante o in allattamento o donne che potenzialmente potrebbero essere in allattamento non usando adeguati metodi contraccettivi
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of Participants Achieving American College of Rheumatology (ACR20) Response. |
Percentuale di pazienti che hanno raggiunto gli obbiettivi dell’ American College of Rheumatology (ACR20) |
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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) |
Change from Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Scores; Proportion of Participants Achieving ACR20 Response and change from baseline in HAQ-DI; Proportion of Participants Achieving ACR20 Response and change from baseline in HAQ-DI; Change from Baseline in Modified Total Sharp Score (mTSS); Proportion of Participants Achieving PASI75 Response in the Participants with Baseline Psoriatic Lesion Involving =3% Body Surface Area (BSA) AND Proportion of Patients Achieving MDAPASI AND Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index in the Participants with Enthesitis at Baseline AND Change from Baseline in the Leeds Dactylitis Index - Basic (LDI-B) in the Participants with Dactylitis at Baseline |
Modifiche rispetto al basale nel risultati del Questionario Health Assessment Disability Index (HAQ-DI); Percentuale di pazienti che hanno raggiunto gli obbiettivi del ACR20 e le modifiche rispetto al basale nel questionario HAQ-DI; Percentuale di pazienti che hanno raggiunto gli obbiettivi del ACR20 e le modifiche rispetto al basale nel questionario HAQ-DI; Cambiamenti rispetto al basale nei risultati del Modified Total Sharp Score (mTSS); Percentuale di pazienti che hanno raggiunto gli obbiettivi PASI75 in pazienti con lesione psoriasica che coinvolge più del 3% della superficie del corpo (body surface area, BSA) e percentuale dei pazienti che raggiungono gli obiettivi MDAPASI e cambiamenti dal baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index in pazienti con entesite al baseline e modifiche ripetto al basale nel Leeds Dactylitis Index- Basic (LDI-B) nei pazienti con Dactylitis al baseline. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Week 16; Week 16; Week 24; Week 16; Week 16 |
Settimana 16; Settimana 16; Settimana 24; Settimana 16; Settimana 16 |
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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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Yes |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 42 |
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 |
China |
India |
Japan |
Mexico |
Russian Federation |
Taiwan |
United States |
Germany |
Hungary |
Italy |
Poland |
Romania |
Spain |
Czechia |
Argentina |
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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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 1 |
E.8.9.2 | In all countries concerned by the trial days | 0 |