E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
CP-690,550 se está desarrollando como fármaco antirreumático modificador de la enfermedad (FARME) para el tratamiento de la artritis reumatoide (AR).
CP 690,550 is being developed as a disease modifying antirheumatic drug (DMARD) for the treatment of rheumatoid arthritis (RA).
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10039073 |
E.1.2 | Term | Rheumatoid arthritis |
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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 |
Estimar la incidencia de TLP, linfoma e infecciones importantes durante 2 años, en pacientes con AR que hayan finalizado o hayan abandonado un ensayo clínico de CP-690,550 de calificación (ensayo clínico aleatorizado con o sin extensión abierta).
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E.2.2 | Secondary objectives of the trial |
• Comparar la incidencia de TLP, linfoma e infecciones importantes en estos pacientes estratificados según su exposición previa a CP-690,550. • Describir el empleo de tratamientos inmunosupresores e inmunomoduladores de todos los pacientes durante el periodo de seguimiento. • Describir el estado funcional de todos los pacientes durante el periodo de seguimiento.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Evidencia de documento de consentimiento informado firmado y fechado personalmente, indicando que el paciente ha sido informado de todos los aspectos pertinentes del ensayo. • Paciente que al menos haya recibido una dosis de fármaco de estudio y haya finalizado su participación en algún estudio controlado y aleatorizado de Fase 2B o 3 o un estudio abierto (estudio de calificación) de CP-690,550 para el tratamiento de la AR.
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E.4 | Principal exclusion criteria |
• Paciente que rechaze proporcionar su consentimiento. |
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E.5 End points |
E.5.1 | Primary end point(s) |
• Episodios de trastorno linfoproliferativo (TLP) confirmado por el patólogo local. • Episodios de linfoma confirmado por el patólogo local. • Episodios de trastorno linfoproliferativo (TLP) confirmado por el patólogo central. • Episodios de linfoma confirmado por el patólogo central. • Episodios de infección importante, definida como infección grave u oportunista. Una infección grave es una infección [viral, bacteriana y fúngica] que requiera hospitalización o tratamiento antimicrobiano parenteral. Un ejemplo de infección oportunista que no se calificaría de grave sería una candidiasis esofágica tratada ambulatoriamente con medicación oral. • Estado funcional evaluado mediante la puntuación del Cuestionario de Valoración de la Salud –Índice de Incapacidad (HAQ DI).
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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 | No |
E.6.6 | Pharmacokinetic | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 41 |
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 |
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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 | 4 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 5 |