E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderately to Severely Active Psoriatic Arthritis |
Artritis psoriásica activa moderada o grave |
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E.1.1.1 | Medical condition in easily understood language |
Psoriatic Arthritis |
Artritis Psoriásica |
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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 | 10037160 |
E.1.2 | Term | Psoriatic arthritis |
E.1.2 | System Organ Class | 100000018188 |
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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 |
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. Comparar la eficacia de ABT-494 15 mg una vez al día (1 v/d) y 30 mg 1 v/d frente a placebo para el tratamiento de los síntomas y signos de la artritis psoriásica (APs) activa moderada o grave en pacientes que han tenido una respuesta insuficiente a FAME biológicos. 2. Comparar la seguridad y la tolerabilidad de ABT-494 15 mg una vez al día (1 v/d) y 30 mg 1 v/d frente a placebo en pacientes con APs activa moderada o grave que han tenido una respuesta insuficiente a FAME biológicos. |
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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. |
Evaluar la seguridad, tolerancia y eficacia a largo plazo de 15 mg 1 v/d y 30 mg 1 v/d de ABT-494 en los sujetos con APs que finalicen el período 1. |
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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. Varones o mujeres adultos con una edad mínima de 18 años. 2. Diagnóstico clínico de APs con síntomas aparecidos al menos 6 meses antes de la visita de selección y cumplimiento de los criterios CASPAR para la clasificación de la APs. 3. Enfermedad activa en el momento basal, definida por 3 o más articulaciones dolorosas (sobre un total de 68 articulaciones) y 3 o más articulaciones hinchadas a la palpación (sobre un total de 66) en las visitas de selección y basal. 4. Diagnóstico de psoriasis en placas activa o antecedentes documentados de psoriasis en placas. 5. Respuesta insuficiente (ineficacia después de 12 semanas como mínimo) o intolerancia al tratamiento con al menos un FAME biológico. |
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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. Exposición anterior a cualquier inhibidor de las janocinasas (JAK) 2. Tratamiento actual con más de dos FAME no biológicos, con FAME distintos de MTX, SSZ, LEF, apremilast, HCQ, bucilamina o iguratimod o con MTX en combinación con LEF. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The proportion of subjects achieving ACR20 response |
El porcentaje de pacientes con respuesta 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) |
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. Proportion of subjects achieving Minimal Disease Activity (MDA) 6. Change from baseline in FACIT-Fatigue Questionnaire; and Change from baseline in Self-Assessment of Psoriasis Symptoms (SAPS) Questionnaire 7. ACR 50/70 response rate 8. ACR 20 response rate |
1. Variación del HAQ-DI desde el momento basal 2. Porcentaje de pacientes alcanzando una Evaluación global realizada por el investigador estática (sIGA) de la psoriasis de 0 o 1 y mejoría de al menos 2 puntos desde el momento basal 3. Respuesta del Índice de gravedad y área de la psoriasis (PASI) 75 (en los pacientes con extensión de la psoriasis ≥ 3% de la SC en el momento basal) 4. Variación con respecto al valor basal de la puntuación SF-36 PCS 5. Porcentaje de pacientes con actividad mínima de la enfermedad (AME) 6. Variación del cuestionario FACIT-Fatigue desde el momento basal; y variación de la Autoevaluación de los síntomas de la psoriasis (SAPS) desde el momento basal 7. Respuesta ACRS0/70 8. Respuesta ACR20 |
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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 24 6. Week 12; 16 7. Week 12 8. Week 2 |
1. Semana 12 2. Semana 16 3. Semana 16 4. Semana 12 5. Semana 24 6. Semana 12; 16 7. Semana 12 8. Semana 2 |
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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 | 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 | 5 |
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 | No |
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 |
Brazil |
Canada |
Chile |
Japan |
Korea, Democratic People's Republic of |
New Zealand |
Puerto Rico |
United States |
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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 | 5 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | |
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 |