E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
KIDNEY TRANSPLANT |
Transplante de Riñón |
|
E.1.1.1 | Medical condition in easily understood language |
KIDNEY TRANSPLANT |
Transplante de Riñón |
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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 | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10023438 |
E.1.2 | Term | Kidney transplant |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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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 objective of this study is to evaluate the clinical outcomes of eligible subjects through 12 months after discontinuation of tofacitinib. |
El objetivo primario del estudio es evaluar los resultados clínicos de los sujetos elegibles hasta 12 meses después de la suspensión de tofacitinib. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects must meet all of the following criteria to be eligible for enrollment into the trial: 1. Subject must meet at least 1 of the following 2 criteria:
a. Subjects have discontinued tofacitinib prior to the planned treatment duration of study A3921009 (6 months posttransplant) or study A3921030 (12 months posttransplant); or
b. Subjects have not enrolled in the extension studies A3921021 or A3921050.
2. Subjects must be willing and able to provide written informed consent with evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all the pertinent aspects of the study. |
Los sujetos deberán cumplir todos los criterios siguientes para poder participar en el ensayo: 1. El sujeto debe cumplir al menos 1 de los 2 criterios siguientes: a. Sujetos que hayan suspendido tofacitinib antes de la duración prevista del tratamiento del estudio A3921009 (6 meses después del trasplante) o el estudio A3921030 (12 meses después del trasplante); o b. Sujetos no incluidos en los estudios de extensión A3921021 o A3921050. 2. Los sujetos deberán estar dispuestos a (y ser capaces de) dar su consentimiento informado por escrito en forma de un documento de consentimiento informado firmado y fechado personalmente que indique que el sujeto (o su representante legal aceptable) ha recibido información de todos los aspectos pertinentes del estudio. |
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E.4 | Principal exclusion criteria |
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E.5 End points |
E.5.1 | Primary end point(s) |
The endpoints are the clinical outcome measures occurring within 12 months after discontinuation of tofacitinib. |
Los criterios de valoración son las variables clínicas que se produzcan en los 12 meses siguientes a la interrupción de tofacitinib. |
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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) |
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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 | Yes |
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 |
Observational Study |
Estudio Observacional |
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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 | 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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
regimen-controlado tofaciniib |
tofacitinib regimen-controlled |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 13 |
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 |
Belgium |
Brazil |
Canada |
Czech Republic |
France |
Germany |
Italy |
Netherlands |
Norway |
Spain |
United States |
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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
|
Last subject last visit |
último paciente Última visita. |
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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 | 0 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial months | 12 |
E.8.9.2 | In all countries concerned by the trial days | 0 |