E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Arthritis, Psoriatic |
Artritis Psoriasica |
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E.1.1.1 | Medical condition in easily understood language |
Arthritis, Psoriatic |
Artritis Psoriasica |
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E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10037160 |
E.1.2 | Term | Psoriatic arthritis |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
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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 purpose of this study is to characterize the safety, efficacy and dose response of BMS-945429 in subjects with active Psoriatic Arthritis and an inadequate response to NSAIDs and non-biologic DMARDs |
El propósito de este estudio es evaluar la respuesta de seguridad, eficacia y dosis de BMS-945429 en pacientes con artritis psoriásica activa y una respuesta inadecuada a los AINE y FAME no biológicos |
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E.2.2 | Secondary objectives of the trial |
1) Proportion of subjects achieving PASI 75 response rate at Weeks 16 and 24 2) Proportion of subjects achieving ACR50 and ACR70 response rate at Weeks 16 and 24 3) Proportion of subjects achieving ACR20 response rate at Week 24 4) Proportion of subjects achieving a HAQ response at Weeks 16 and 24, as measured by a reduction of at least 0.3 unit from baseline in HAQ index 5) SF-36 changes from baseline to Weeks 16 and 24 6) AEs, vital signs, physical examinations, safety lab values, and immunogenicity during double-blind period |
1. Proporción de sujetos que alcanzaron la tasa de respuesta PASI 75 en las semanas 16 y 24 2. Proporción de sujetos que alcanzaron tasa de respuesta ACR50 y ACR70 en las semanas 16 y 24 3. Proporción de sujetos que alcanzaron tasa de respuesta ACR20 en la semana 24 4.Proporción de sujetos que alcanzaron una respuesta HAQ en las semanas 16 y 24, medida por una reducción de al menos 0,3 unidades respecto al valor basal en índice HAQ 5.Cambios respecto al valor SF-36 basal en las semanas 16 y 24 6. Efectos adversos, signos vitales, exploración fisica, valores de seguridad de laboratorio e inmunogeneicidad durante el periodo de doble ciego |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Skin Biopsy Substudy (see section 5.4.4.9 of the protocol): Skin biopsy is a standard diagnostic test performed for skin diseases, and has been used to characterize responses to therapeutic agents in patients diagnosed with psoriasis and psoriatic arthritis. Subjects from selected sites will enroll in the skin biopsy substudy. For additional details, refer to the protocol.
Intensive PK Sub study (see section 5.5.1 of the protocol): Approximately the first 32 subjects randomized will have blood samples collected for a full profile PK analysis over the dosing intervals from Week 20 to Week 24. For these subjects, in addition to obtaining a same sparse PK schedule as standard PK sampling , additional PK samples will be collected on Week 20 + 3 day, Week 20 + 5 day, Week 21, Week 22, and Week 23. For additional details, refer to the protocol. |
Subestudio de biopsia cutánea (vease sección 5.4.4.9 del protocolo)La biopsia cutánea es una prueba diagnóstica de práctica habitual en las enfermedades de la piel y se ha utilizado para caracterizar las respuestas a los agentes terapéuticos en pacientes diagnosticados de psoriasis y artritis psoriásica. Determinados sujetos de los centros seleccionados serán incluidos en el subestudio de biopsia de piel. Para mas detalles, vease protocolo. ?Subestudio de farmacocinética intensiva (vease seccion 5.5.1 del protocolo) Se obtendrán muestras de sangre de aproximadamente los primeros 32 sujetos aleatorizados para determinar el perfil farmacocinético completo a lo largo de los intervalos de administración entre la semana 20 y la semana 24. En estos sujetos, además de la misma pauta de muestreo reducido para farmacocinética que el calendario de recogida de muestras para farmacocinética estándar, se obtendrán muestras adicionales para farmacocinética en la semana 20 + 3 días, la semana 20 + 5 días, la semana 21, la semana 22 y la semana 23. |
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E.3 | Principal inclusion criteria |
? Inadequate response to NSAID or non-biologic DMARD ? Minimum of 3 swollen and 3 tender joints ? Active psoriatic skin lesions over minimum 3% body surface area ? hsCRP ? 0.3 mg/dL ? Subjects must have diagnosis of active PsA by Classification Criteria for Psoriatic Arthritis (CASPAR) for at least 12 weeks prior to screening |
. Sujetos que han presentado respuestas inadecuadas al tratamiento con AINE y/o FAME no biológicos. . Mínimo de 3 articulaciones sensibles hinchadas y 3 . Lesiones activas de la piel psoriásica en área mínima de 3% de la superficie del cuerpo . PCRhs ? 0.3 mg/dL . Sujetos con diagnóstico de APs activa (según los criterios de clasificación de artritis psoriásica, CASPAR) desde al menos 12 semanas antes de la selección. |
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E.4 | Principal exclusion criteria |
? Previously received or currently receiving concomitant biologic therapy |
Anteriormente recibió o está recibiendo tratamiento biológico concomitante |
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E.5 End points |
E.5.1 | Primary end point(s) |
American College of Rheumatology criteria (ACR20) |
Criterios del Colegio Norteamericano de Reumatología (ACR20) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At 16 weeks |
A las 16 semanas |
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E.5.2 | Secondary end point(s) |
1) Proportion of subjects achieving PASI 75 response rate 2) Proportion of subjects achieving ACR50 and ACR70 response rate 3) Proportion of subjects achieving ACR20 response rate 4) Proportion of subjects achieving a HAQ response, as measured by a reduction of at least 0.3 unit from baseline in HAQ index 5) SF-36 changes from baseline 6) AEs, vital signs, physical examinations, safety lab values, and immunogenicity during double-blind period |
1. Proporción de sujetos que alcanzaron la tasa de respuesta PASI 75 2. Proporción de sujetos que alcanzaron tasa de respuesta ACR50 y ACR70 3. Proporción de sujetos que alcanzaron tasa de respuesta ACR20 4.Proporción de sujetos que alcanzaron una respuesta HAQ en medida por una reducción de al menos 0,3 unidades respecto al valor basal en índice HAQ 5.Cambios respecto al valor SF-36 basal 6. Efectos adversos, signos vitales, exploración fisica, valores de seguridad de laboratorio e inmunogeneicidad durante el periodo de doble ciego |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Week 16 and Week 24 |
Semana 16 y Semana 24 |
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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 | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
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) | 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) | 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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 30 |
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 |
Argentina |
Australia |
Canada |
Czech Republic |
France |
Germany |
Hungary |
Italy |
Mexico |
Poland |
Russian Federation |
South Africa |
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
|
LVLS |
Ultima visita - Ultimo paciente |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |