E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Rheumatoid arthritis |
Artritis Reumatoide |
|
E.1.1.1 | Medical condition in easily understood language |
Rheumatoid arthritis |
Artritis Reumatoide |
|
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 | PT |
E.1.2 | Classification code | 10039073 |
E.1.2 | Term | Rheumatoid arthritis |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
|
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 |
To evaluate the long-term safety of mavrilimumab in adult subjects with moderate-to-severe active RA who were previously treated in a qualifying study. |
Evaluar la seguridad a largo plazo de mavrilimumab en pacientes adultos con artritis reumatoide (AR) activa moderada o grave que recibieron tratamiento previamente en un estudio de cualificación |
|
E.2.2 | Secondary objectives of the trial |
Evaluation of clinical efficacy and patient reported outcomes, pharmacodynamic effects and immunogenicity. |
Evaluar la eficaciaidad y otros resultados clinicos, efectos farmacodinamicos e inmunogenicidad. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
?Subjects who have completed the treatment period of the qualifying study or will have failed to respond adequately to investigational product at a predefined time point in the qualifying study regardless of their initial randomization. ?No evidence of clinically uncontrolled respiratory disease to be confirmed by a local pulmonologist |
- Los pacientes que hayan completado el periodo de tratamiento del estudio de cualificación o no hayan respondido adecuadamente al producto en investigación en un punto temporal predefinido en el estudio de cualificación independientemente de su asignación inicial - Sin indicios de enfermedad respiratoria clínicamente no controlada confirmada por un neumólogo local |
|
E.4 | Principal exclusion criteria |
?Subjects who have been permanently discontinued from investigational product in previous qualifying study. ?Any new conditions or worsening of any pre-existing conditions as defined in the protocol. |
- Pacientes que han interrumpido permanentemente el producto en investigación en el estudio de cualificación previo - Cualquier condicion nueva o el empeoramiento de las condiciones pre-existentes tal como se definen en el protocolo |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Long-term safety |
Seguridad a largo plazo |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
At protocol-scheduled evaluation visits, up to 5 years, commercial availability or discontinuation of development, whichever is sooner. |
Segun el calendario de visitas del protocolo, durante un máximo de 5 años, hasta que mavrilimumab se comercialice o hasta que se suspenda el desarrollo clínico posterior, lo que suceda antes |
|
E.5.2 | Secondary end point(s) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Yes |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 10 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 130 |
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 |
Bulgaria |
Chile |
Czech Republic |
Estonia |
France |
Germany |
Hungary |
Mexico |
Russian Federation |
Serbia |
South Africa |
Spain |
Ukraine |
|
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 6 |
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 | 6 |
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 |