E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Osteoarthritis of the hip or knee |
Artrosis de cadera o de rodilla |
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E.1.1.1 | Medical condition in easily understood language |
Osteoarthritis of the hip or knee |
Artrosis de cadera o de rodilla |
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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 | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10023476 |
E.1.2 | Term | Knee osteoarthritis |
E.1.2 | System Organ Class | 100000004859 |
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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 | 10020108 |
E.1.2 | Term | Hips osteoarthritis |
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 |
To describe the post-operative outcome of subjects who underwent a total knee, hip,or shoulder replacement while participating in tanezumab Study A4091056, A4091057 or A4091058 (treatment period and safety follow-up period). |
Describir el resultado posoperatorio de los pacientes que se sometieron a una sustitución total de rodilla, cadera u hombro mientras participaban en los estudios de tanezumab A4091056, A4091057 o A4091058 (período de tratamiento y período de seguimiento de la seguridad). |
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E.2.2 | Secondary objectives of the trial |
-To compare the post-operative outcome for tanezumab 2.5 mg and 5 mg versus NSAID for subjects who underwent a total knee, hip, or shoulder replacement while participating in tanezumab Study A4091058.
-To describe the post-operative outcome of subjects from the A4091059, A4091061 or A4091063 studies who underwent a total knee, hip, or shoulder replacement. |
- Comparar el resultado posoperatorio de tanezumab 2,5 mg y 5 mg frente a los fármacos antiinflamatorios no esteroideos (AINE) para los pacientes que se sometieron a una artroplastia total de rodilla, cadera u hombro, mientras participaban en el estudio de tanezumab A4091058. - Describir el resultado posoperatorio de los pacientes de los estudios de tanezumab A4091059, A4091061 o A4091063 que se sometieron a una sustitución total de rodilla, cadera u hombro. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study. 2. Subject has been randomized and treated with SC investigational product in tanezumab Study A4091056, A4091057, A4091058, A4091059, A4091061 or A4091063 and has completed the study or has been withdrawn from the study. 3. Actual or planned total knee, hip or shoulder replacement surgery during tanezumab Study A4091056, A4091057 or A4091058 or after the last subject in the study completes the treatment period in tanezumab Study A4091059, A4091061 or A4091063. 4. Subject is willing and able to comply with scheduled visits and other study procedures. |
1. Constancia de un documento de consentimiento informado firmado y fechado personalmente que indique que se ha informado al paciente (o a un representante legal) de todos los aspectos pertinentes del estudio. 2. El paciente ha sido aleatorizado y tratado con el producto en investigación SC en los estudios de tanezumab A4091056, A4091057, A4091058, A4091059, A4091061 o A4091063 y ha finalizado el estudio o ha sido retirado del estudio. 3. Cirugía de sustitución total, real o planeada, de rodilla, cadera u hombro durante los estudios de tanezumab A4091056, A4091057 o A4091058 o después de que el último paciente del estudio finalice el período de tratamiento del estudio de tanezumab A4091059, A4091061 o A4091063. Nota: se permitirán procedimientos adicionales en un paciente que se somete a cirugía de artroplastia total (p. ej., revisión de una articulación sustituida anteriormente además de una nueva artroplastia total), pero no serán aptos los pacientes que se someten solamente a procedimientos de artroplastia subtotal (p. ej., hemiatroplastia). 4. El paciente está dispuesto a y tiene la capacidad de cumplir con las visitas y otros procedimientos del estudio programados. |
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E.4 | Principal exclusion criteria |
Not reported in protocol |
No documentados en el protocolo |
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E.5 End points |
E.5.1 | Primary end point(s) |
-Surgeon?s Assessment of Procedural Difficulty: number and percentage of surgeries assessed as uneventful, minor complications or major complications. -Subject?s overall satisfaction with surgery as assessed by the Self-Administered Patient Satisfaction (SAPS) Scale: number and percentage of subjects satisfied vs. unsatisfied with their total joint replacement at Week 24. -Number and percentage of subjects with a post-surgical complication(s) up to Week 24 (derived from reported adverse events). - Number and percentage of subjects with additional or corrective procedures related to their total joint replacement up to Week 24. - Number and percentage of subjects participating in physical rehabilitation activities related to the replaced joint up to Week 24. -Change from Baseline to Week 24 in average pain in the replaced joint. -Change from Baseline to Week 24 in WOMAC Pain, Stiffness and Physical Function subscales in the replaced joint (subjects undergoing total hip or knee replacement surgery only). -Change from Baseline to Week 24 in the SPADI in the replaced shoulder (subjects undergoing total shoulder replacement surgery only). -Concomitant analgesic medication use. |
- Valoración del cirujano de la dificultad del procedimiento: número y porcentaje de cirugías evaluadas como sin incidencias, con complicaciones menores o con complicaciones mayores. - Satisfacción general del paciente con la cirugía según la evaluación de la escala de satisfacción del paciente autoadministrada (Self-Administered Patient Satisfaction, SAPS): número y porcentaje de pacientes satisfechos frente a no satisfechos con su artroplastia total en la semana 24. - Número y porcentaje de pacientes con complicaciones posquirúrgicas hasta la semana 24 (derivadas de los acontecimientos adversos notificados; consulte también la Sección 9). - Número y porcentaje de pacientes con procedimientos adicionales o correctivos relacionados con su artroplastia total hasta la semana 24. - Número y porcentaje de pacientes que participan en actividades de rehabilitación relacionadas con la articulación sustituida hasta la semana 24. - Cambio desde el momento inicial hasta la semana 24 en el dolor medio en la articulación sustituida. - Cambio desde el momento inicial hasta la semana 24 en las subescalas de dolor, rigidez y función física del WOMAC en la articulación sustituida (pacientes sometidos a una cirugía de sustitución total de la cadera o rodilla solamente). - Cambio desde el momento inicial hasta la semana 24 en el SPADI en el hombro sustituido (pacientes sometidos a una cirugía de sustitución total del hombro solamente). - Uso de medicación analgésica concomitante. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Please refer to the protocol |
Por favor, refiéranse al protocolo |
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E.5.2 | Secondary end point(s) |
not applicable |
no aplicable |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
not applicable |
no aplicable |
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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 |
pathology specimens from the total joint replacement surgery will be shipped to a central laboratory for processing and/or analysis. |
las muestras para patología de la cirugía de artroplastia total se enviarán a un laboratorio central para ser procesadas y/o analizadas. |
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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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | Yes |
E.8.1.7.1 | Other trial design description |
long-term observational study of subjects enrolled in A4091056, A4091057 or A4091058 |
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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.8.3 |
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 | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 68 |
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 |
Austria |
Brazil |
Bulgaria |
Colombia |
Hungary |
Italy |
Japan |
Korea, Republic of |
Mexico |
New Zealand |
Peru |
Philippines |
Poland |
Russian Federation |
Spain |
Taiwan |
Ukraine |
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 | 3 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 2 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 2 |