E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderately to Severely Active Psoriatic Arthritis |
Artrite Psoriasica in Fase Attiva Severa e Moderata |
|
E.1.1.1 | Medical condition in easily understood language |
Psoriatic Arthritis |
Artrite Psoriasica |
|
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 |
|
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 |
1. To compare the efficacy of ABT-494 15 mg QD and 30 mg QD versus placebo for the treatment of signs and symptoms of subjects with moderately to severely active PsA who have an inadequate response to bDMARDs (Bio-IR). 2. To compare the safety and tolerability of ABT-494 15 mg QD and 30 mg QD versus placebo in subjects with moderately to severely active PsA who have an inadequate response to bDMARDs. |
1. Confrontare l¿efficacia di ABT-494 15 mg una volta al giorno (QD) e 30 mg QD rispetto a placebo per il trattamento dei segni e sintomi in soggetti affetti da PsA in fase attiva di grado da moderato a grave e con risposta inadeguata ai bDMARD (Bio-IR). 2. Confrontare la sicurezza e la tollerabilit¿ di ABT-494 15 mg QD e 30 mg QD rispetto a placebo in soggetti con PsA in fase attiva di grado da moderato a grave che hanno avuto una risposta inadeguata ai bDMARD. |
|
E.2.2 | Secondary objectives of the trial |
To evaluate the long-term safety, tolerability and efficacy of ABT-494 15 mg QD and 30 mg QD in subjects with PsA who have completed Period 1. |
Valutare nel lungo termine la sicurezza, la tollerabilit¿ e l¿efficacia di ABT-494 15 mg QD e 30 mg QD in soggetti con PsA che abbiano completato il Periodo 1. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female, at least 18 years of age 2. Diagnosed with psoriatic arthritis with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR) 3. Subject has active disease at Baseline defined as = 3 tender joints (based on 68 joint counts) and = 3 swollen joints (based on 66 joint counts) at Screening and Baseline Visits. 4. Diagnosis of active plaque psoriasis or documented history of plaque psoriasis. 5. Subject has had an inadequate response or an intolerance to treatment with at least 1 bDMARD. |
1. Soggetti adulti di ambo i sessi, di età = 18 anni allo Screening. 2. Diagnosi clinica di PsA, con esordio dei sintomi almeno 6 mesi prima della Visita di Screening e conformità con i criteri CASPAR (Classification Criteria for PsA). 3. Soggetto con malattia in fase attiva al Baseline definita in base alla presenza di = 3 articolazioni dolenti alla palpazione (su conta totale di 68 articolazioni) e = 3 articolazioni tumefatte (su conta totale di 66 articolazioni) alle Visite di Screening e Baseline. 4. Diagnosi di psoriasi a placche in fase attiva oppure storia documentata di psoriasi a placche. 5. Soggetto che ha avuto una risposta inadeguata o intolleranza al trattamento con almeno 1 bDMARD |
|
E.4 | Principal exclusion criteria |
1. Prior exposure to any Janus Kinase (JAK) inhibitor 2. Current treatment with > 2 non-biologic DMARDs; or use of DMARDs other than MTX, SSZ, LEF, apremilast, HCQ, bucillamine, or iguratimod; or use of MTX in combination with LEF. |
1. Pregressa esposizione a qualsiasi inibitore delle proteine Janus chinasi (JAK). 2. Trattamento in atto con > 2 DMARD non biologici oppure utilizzo di DMARD diversi da MTX, SSZ, LEF, apremilast, HCQ, bucillamina o iguratimod oppure utilizzo di MTX in combinazione con LEF al Baseline. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The proportion of subjects achieving ACR20 response |
percentuale di soggetti che ottengono la risposta ACR20 |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Week 12 |
12esima Settimana |
|
E.5.2 | Secondary end point(s) |
1. Change from baseline in HAQ-DI 2. Proportion of subjects achieving a static Investigator Global Assessment (sIGA) of Psoriasis of 0 or 1 and at least a 2-point improvement from baseline 3. Psoriasis Area Severity Index (PASI) 75 response (for subjects with = 3% BSA psoriasis at baseline) 4. Change from baseline in SF-36 PCS 5. Change from baseline in FACIT-Fatigue Questionnaire 6. Proportion of subjects achieving Minimal Disease Activity (MDA) 7. Change from baseline in Self-Assessment of Psoriasis Symptoms (SAPS) Questionnaire 8. ACR 50/70 response rate 9. ACR 20 response rate |
1.Variazione rispetto al baseline del punteggio HAQ-DI; 2. Punteggio sIGA (static Investigator Global Assessment) relativo alla Psoriasi pari a 0 o 1 ed un miglioramento di almeno 2 punti rispetto al baseline; 3. Risposta PASI 75 (Psoriasis Area Severity Index) (per soggetti con interessamento psoriasico = 3% del BSA al baseline); 4. Variazione rispetto al baseline del punteggio SF-36 PCS; 5. Variazione rispetto al baseline del punteggio del questionario FACIT-Fatigue 6. Percentuale di soggetti che ottengono la risposta Attivit¿ minima di malattia (MDA); 7. Variazione rispetto al baseline del punteggio SAPS (Self-Assessment of Psoriasis Symptoms). 8.Risposta ACR50/70; 9.Risposta ACR20; |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Week 12 2. Week 16 3. Week 16 4. Week 12 5. Week 12 6. Week 24 7. Week 16 8. Week 12 9. Week 2 |
1. Settimana12 2. Settimana 16 3. Settimana 16 4. Settimana 12 5. Settimana 12 6. Settimana 24 7. Settimana 16 8. Settimana 12 9. Settimana 2 |
|
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 | Yes |
E.6.10 | Pharmacogenetic | Yes |
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 | 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 | 4 |
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 | 9 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 55 |
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 |
Brazil |
Canada |
Chile |
Japan |
Korea, Democratic People's Republic of |
New Zealand |
Puerto Rico |
United States |
Austria |
|
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
|
|
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 | 1 |
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 | 1 |
E.8.9.2 | In all countries concerned by the trial days | 0 |