E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Psoriatic Arthritis |
artritis psoriásica |
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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 | 18.0 |
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 |
The primary objectives are to compare the efficacy of ABT-122 versus placebo in subjects on background methotrexate (MTX) as assessed by ACR20 at Week 12 and to assess the safety and tolerability of ABT-122 in subjects with the active psoriatic arthritis (PsA). |
Los objetivos principales son comparar la eficacia de ABT-122 con el placebo en sujetos con un tratamiento de base con metotrexato (MTX) mediante la evaluación del criterio ACR20 en la semana 12 y evaluar la seguridad y la tolerabilidad de ABT-122 en sujetos con artropatía psoriásica activa (Aps) |
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E.2.2 | Secondary objectives of the trial |
? To compare the efficacy of ABT-122 versus adalimumab as assessed by ACR20 at Week 12 ? To assess additional efficacy endpoints of ABT-122 as measured by: - ACR50/70 response rates at Week 12 - Empirical cumulative distribution function of ACRn at Week 12 - Change from baseline in the DAS28[hsCRP] and PASDAS at Week 12 - Change from baseline in the Psoriasis Target Lesion Scores at Week 12 |
?Comparación de la eficacia de ABT-122 frente a adalimumab en función del ACR20 en la semana 12. ?Criterios adicionales de valoración de la eficacia de ABT-122, determinados por: -tasa de respuesta de los criterios ACR50/70 en la semana 12; -función de distribución acumulada empírica del ACRn en la semana 12; -cambio desde el momento basal en la DAS28[hsCRP] y la PASDAS en la semana12; -cambio desde el momento basal en la puntuación de la lesión de referencia (Target Lesion Score) en la semana12; |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Adult male or female, 18 years of age or older. 2. PsA diagnosis of at least 3 months duration prior to the date of first Screening with CASPAR confirmed diagnosis at Screening. 3. Have active psoriasis defined by at least 1 psoriasis lesion ? 2 cm diameter in areas other than the axilla or groin. 4. Have active arthritis defined by minimum disease activity criteria: ? ? 3 swollen joints (based on 66 joint counts) at Screening. ? ? 3 tender joints (based on 68 joint counts) at Screening. 5. On a stable dose of MTX defined as: ? Oral or parenteral treatment ? 3 months, ? On a stable dose with an unchanged mode of application for at least 4 weeks prior to baseline ? Stable MTX dose of ? 10 mg/week and < the upper limit of the applicable approved local label. ? Subject can also be on stable doses of NSAIDs, sulfasalazine and/or hydroxychloroquine as long as they are also on methotrexate. |
1.Mujeres y hombres adultos de 18 años de edad o más. 2.Diagnóstico de Aps al menos 3 meses antes de la fecha de la primera selección confirmado por los criterios CASPAR en el momento de la selección. 3.Psoriasis activa definida como al menos 1 lesión psoriásica con?2 cm de diámetro en alguna zona que no sea la axila o la ingle. 4.Artropatía activa con una actividad mínima definida por los siguientes criterios: ??3articulaciones inflamadas (en función de un recuento de 66 articulaciones) en el momento de la selección. ??3articulaciones sensibles (en función de un recuento de 68 articulaciones) en el momento de la selección. 5.Dosis estable de MTX, definida como: ?tratamiento por vía oral o parenteral durante?3meses ?con una dosis estable y una misma vía de administración durante al menos 4 semanas antes del momento basal. ?Dosis estable de MTX?10 mg/semana y<el límite superior de la ficha técnica autorizada para el país correspondiente. ?Los sujetos podrán seguir un tratamiento con dosis estables de AINE, sulfasalazina y/o hidroxicloroquina siempre que reciban asimismo metotrexato. |
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E.4 | Principal exclusion criteria |
1. Prior exposure to any TNF inhibitors including adalimumab. ? Prior exposure to other non-TNF inhibitor biological DMARDs will be permitted if the subject is washed out at least 5 half-lives of these drugs prior to the Baseline visit. 2. Current treatment with traditional oral DMARDs, including csDMARDs, (except for concomitant treatment with sulfasalazine and/or hydroxychloroquine in addition to MTX). Oral DMARDs must be washed out for at least 5 half-lives of a drug apart from MTX prior to the Baseline visit. ? Subject may have prior exposure to JAK inhibitors or to PDE4 inhibitors as long as they have been off therapy for at least 5 half-lives. 3. Stable prescribed dose of oral prednisone or prednisone equivalent ? 10 mg/day within 30 days of the Baseline visit. 4. Intra-articular or parenteral administration of corticosteroids in the preceding 4 weeks of the Baseline visit. Inhaled corticosteroids for stable medical conditions are allowed. 5. Laboratory values of the following at the Screening visit: ? Confirmed hemoglobin < 9 g/dL for males and < 8.5 g/dL for females, ? Absolute neutrophil count (ANC) < 1500/mm3 (or < 1200 cells/µL for subjects of African descent who are black), ? AST or ALT > 1.5 × the upper limit of normal (ULN) or bilirubin ? 3 mg/dL, ? Serum creatinine > 1.5 × the ULN, ? Platelets < 100,000 cells/(mm3) (109/L), ? Clinically significant abnormal screening laboratory results as evaluated by the Investigator. |
1.Tratamiento previo con inhibidores del TNF, como adalimumab. ?El tratamiento previo con otros FAME biológicos diferentes a los inhibidores del TNF se permitirá si el sujeto se somete a un periodo de reposo farmacológico de al menos 5 semividas de estos fármacos antes de la visita basal. 2.Tratamiento actual con FAME tradicionales por vía oral, como los FAME sintéticos convencionales (excepto en los casos en los que se trate de tratamientos concomitantes con sulfasalazina y/o hidroxicloroquina en combinación con MTX). En el caso de FAME orales, deberá respetarse un reposo farmacológico de al menos 5 semividas del fármaco correspondiente diferente al MTX antes de la visita basal. ?Los sujetos podrán haber sido tratados previamente con inhibidores de JAK o con inhibidores de PDE4 siempre que respeten un reposo farmacológico de al menos 5 semividas. 3.Prescripción de dosis estable de prednisona oral o un equivalente?10 mg/día durante los 30 días previos a la visita basal. 4.Administración intrarticular o parenteral de corticoesteroides en las 4 semanas previas a la visita basal. Se permite el uso de corticoesteroides inhalados para el tratamiento de enfermedades estabilizadas. 5.Valores en las pruebas de laboratorio indicados a continuación en la visita de selección: ?hemoglobina confirmada<9 g/dl en hombres y<8,5 g/dl en mujeres; ?cifra absoluta de neutrófilos (CAN)<1500/mm3 (o<1200 células/µl en sujetos de raza negra o de ascendencia negra); ?ASAT o ALAT>1,5 veces el límite superior de la normalidad (LSN) o bilirrubina?3 mg/dl; ?Creatinina sérica?1,5 veces el LSN. ?Plaquetas<100 000 células/(mm3) (109/l); ?Anomalías en los resultados de las pruebas de laboratorio de la selección que, a juicio del investigador, sean clínicamente significativas. |
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E.5 End points |
E.5.1 | Primary end point(s) |
ACR20 response rate at Week 12 with a primary comparison between ABT-122 versus placebo. |
Tasa de respuesta del ACR20 en la semana 12; comparación principal entre ABT-122 y placebo. |
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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) |
? Comparison of efficacy of ABT-122 versus adalimumab as assessed by ACR20 at Week 12 ? Additional efficacy endpoints of ABT-122 as measured by: o ACR50/70 response rates at Week 12 o Empirical cumulative distribution function of ACRn at Week 12 o Change from baseline in the DAS28[hsCRP] and PASDAS at Week 12 o Change from baseline in the Target Lesion Score at Week 12 |
?Comparación de la eficacia de ABT-122 frente a adalimumab en función del ACR20 en la semana 12. ?Criterios adicionales de valoración de la eficacia de ABT-122, determinados por: otasa de respuesta de los criterios ACR50/70 en la semana 12; ofunción de distribución acumulada empírica del ACRn en la semana 12; ocambio desde el momento basal en la DAS28[hsCRP] y la PASDAS en la semana12; ocambio desde el momento basal en la puntuación de la lesión de referencia (Target Lesion Score) en la semana12; |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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) | Yes |
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 | 60 |
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 |
Bulgaria |
Czech Republic |
Denmark |
France |
Germany |
Hungary |
Latvia |
New Zealand |
Poland |
Romania |
Spain |
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 | 1 |
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 | 1 |
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 |