| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| CHRONIC LOW BACK PAIN |
| LUMBALGIA CRÓNICA |
|
| E.1.1.1 | Medical condition in easily understood language |
| CHRONIC LOW BACK PAIN |
| LUMBALGIA CRÓNICA |
|
| 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 | 18.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10024891 |
| E.1.2 | Term | Low back pain |
| E.1.2 | System Organ Class | 100000004859 |
|
| 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 |
| Demonstrate superior analgesic efficacy of tanezumab 10 mg and 5 mg administered subcutaneously (SC) every 8 weeks compared to placebo at Week 16. |
| Demostrar la eficacia analgésica superior de tanezumab 10 mg y 5 mg administrado por vía subcutánea (SC) cada 8 semanas en comparación con placebo en la semana 16. |
|
| E.2.2 | Secondary objectives of the trial |
-Evaluate the long-term safety of tanezumab 10 mg and 5 mg SC administered every 8 weeks (7 administrations);
-Estimate the long-term analgesic efficacy of tanezumab 10 mg and 5 mg SC administered every 8 weeks (7 administrations) up to Week 56;
- Compare the analgesic efficacy of tanezumab 10 mg SC administered every 8 weeks relative to an active comparator (oral tramadol PR) at Week 16. |
- Evaluar la seguridad a largo plazo de tanezumab 10 mg y 5 mg administrado por vía SC cada 8 semanas (7 administraciones).
- Estimar la eficacia analgésica a largo plazo de tanezumab 10 mg y 5 mg SC administrado cada 8 semanas (7 administraciones) hasta la semana 56.
- Comparar la eficacia analgésica de tanezumab 10 mg SC administrado cada 8 semanas en relación con un comparador activo (tramadol LP oral) en la semana 16. |
|
| 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 |
Long-term observational study of subjects from tanezumab Study A4091059 (regardless of treatment group) who undergo a total knee, hip or shoulder replacement during participation in the study (treatment period or safety follow-up period).
Objective:
To describe the post-operative outcome of subjects who underwent a total knee, hip, or shoulder replacement while participating in tanezumab Study A4091059 (treatment period or safety follow-up period). |
Este subestudio es un estudio observacional a largo plazo de sujetos del estudio A4091059 de tanezumab (independientemente del grupo de tratamiento) que se someten a una artroplastia total de rodilla, cadera u hombro durante la participación en el estudio (periodo de tratamiento o periodo de seguimiento de seguridad).
Objetivo:
Describir el resultado posoperativo de los sujetos que se sometieron a una artroplastia total de rodilla, cadera u hombro mientras participaban en el estudio A4091059 de tanezumab (periodo de tratamiento o periodo de seguimiento de seguridad). |
|
| E.3 | Principal inclusion criteria |
-Chronic low back pain ?3 months in duration, Quebec Task Force in Spinal Disorders class 1 or 2, with documented history of previous inadequate treatment response to at least 3 different categories of agents commonly used and generally considered effective for the treatment of chronic low back pain.
Refer to protocol for full list of inclusion criteria |
- Dolor lumbar crónico de ?3 meses de evolución, categoría 1 o 2 conforme a la clasificación del grupo de trabajo de Quebec de trastornos de la columna, historia documentada de respuesta previa inadecuada al tratamiento con al menos 3 categorías diferentes de medicamentos frecuentemente utilizados y que por lo general se consideran eficaces para el tratamiento del dolor lumbar crónico .
Refiéranse al protocolo para el listado completo de criterios de inclusión. |
|
| E.4 | Principal exclusion criteria |
-Diagnosis of osteoarthritis of the knee or hip as defined by the American College of Rheumatology (ACR) criteria.
Subjects who have Kellgren Lawrence Grade ?2 radiographic evidence of hip or Grade ?3 radiographic evidence of knee osteoarthritis will be excluded;
-History or radiographic evidence of other diseases that could confound efficacy or safety assessments (e.g., rheumatoid arthritis).
-History or radiographic evidence of orthopedic conditions that may increase the risk of, or confound assessment of joint safety conditions during the study.
-Signs and symptoms of clinically significant cardiac disease within 6 months of the study (e.g., unstable angina, myocardial infarction, resting bradycardia, poorly controlled or untreated hypertension) as defined in the protocol or subjects with any other cardiovascular illness that in the opinion of the Investigator would render a subject unsuitable to participate in the study
-History, diagnosis, or signs and symptoms of clinically significant neurological disease (e.g., transient ischemic attack, stroke, peripheral or autonomic neuropathy) as specified in the protocol
-Subjects with evidence or symptoms consistent with autonomic dysfunction (e.g., orthostatic hypotension and/or autonomic symptoms) as defined in the protocol.
Please refer to the protocol for the remaining exclusion criteria |
- Diagnóstico de artrosis de rodilla o cadera según la definición de los criterios del Colegio Americano de Reumatología (ACR)
Se excluirá a los sujetos con indicios radiográficos de artrosis de cadera de grado ?2 o artrosis de rodilla de grado ?3 en la clasificación de Kellgren y Lawrence.
- Historia de enfermedad que pueda afectar a la columna vertebral, entre ellas las enfermedades articulares inflamatorias como la espondiloartropatía seronegativa (p. ej., espondilitis anquilosante), la artritis reumatoide, las infecciones o los tumores de la médula espinal, o la enfermedad de Paget de la columna, la pelvis o el fémur.
- Signos radiográficos de cualquiera de las siguientes afecciones en cualquiera de las radiografías de selección según la determinación del revisor de radiología central y según la definición del atlas de imágenes del programa de tanezumab: desalineamiento excesivo de la rodilla, condrocalcinosis grave, otras artropatías (p. ej., artritis reumatoide), enfermedad ósea metabólica sistémica (p. ej., pseudogota, enfermedad de Paget, calcificaciones metastásicas), lesiones quísticas grandes, lesiones tumorales primarias o metastásicas, o fracturas por estrés o traumáticas.
- Sujetos con signos radiográficos de cualquiera de las siguientes afecciones según la determinación del revisor de radiología central y según la definición del atlas de imágenes del programa de tanezumab en la selección: 1) artrosis rápidamente destructiva 2) artrosis atrófica o hipotrófica 3) fracturas por insuficiencia subcondrales 4) osteonecrosis espontánea de la rodilla 5) osteonecrosis 6) fractura patológica.
- Signos y síntomas de enfermedad cardiaca clínicamente significativa en los 6 meses anteriores a la selección (ej., angina inestable, infarto de miocardio, bradicardia en reposo, hipertensión significativa sin tratar o no controlada) como se define en el protocolo o pacientes con cualquier otra enfermedad cardiovascular que en opinión del investigador haría que el paciente no fuera idóneo para participar en el estudio.
- Historia, diagnóstico o signos y síntomas de enfermedad neurológica clínicamente significativa (ej., ataque isquémico transitorio, ictus, neuropatía periférica o autonómica) como se especifica en el protocolo.
- Pacientes con signos de hipotensión ortostática en función de determinaciones repetidas de la tensión arterial ortostática.
Por favor, refiéranse al protocolo para el listado completo de criterios de inclusión. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| Change from Baseline to Week 16 in the daily average Low Back Pain Intensity (LBPI) score as measured by an 11-point Numeric Rating Scale for tanezumab vs placebo. |
| Cambio desde el valor basal hasta la semana 16 en la puntuación media diaria de la intensidad del dolor lumbar (LBPI) determinada en una escala numérica de 11 puntos para tanezumab frente a placebo. |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| Please refer to the protocol |
| Por favor, refiéranse al protocolo |
|
| E.5.2 | Secondary end point(s) |
-Key Secondary Endpoints:
-Change from Baseline to Week 16 in the Roland Morris Disability Questionnaire(RMDQ) for tanezumab vs placebo;
-Change from Baseline to Week 16 in the daily average LBPI score as measured by an 11-point Numeric Rating Scale for tanezumab vs. tramadol PR. |
- Cambio desde el valor basal hasta la semana 16 en el cuestionario de discapacidad de Roland Morris (RMDQ) para tanezumab frente a placebo.
- Cambio desde el valor basal hasta la semana 16 en la puntuación media diaria de la intensidad del dolor lumbar determinada en una escala numérica de 11 puntos para tanezumab frente a tramadol. |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
| Please refer to the protocol |
| Por favor, refiéranse al protocolo |
|
| 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 | Yes |
| 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 | Yes |
| E.6.13 | Others | Yes |
| E.6.13.1 | Other scope of the trial description |
| Blood samples for the assessment of ADA against tanezumab (anti-tanezumab antibodies) will be collected |
| Se obtendrán muestras de sangre para evaluar los anticuerpos frente al medicamento tanezumab. |
|
| 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 | 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) | Yes |
| 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 | 4 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 28 |
| 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 |
| Canada |
| Denmark |
| France |
| Hungary |
| Japan |
| Korea, Republic of |
| Spain |
| Sweden |
| United States |
|
| 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 |
| Última Visita del Último Paciente |
|
| 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 | 8 |
| E.8.9.1 | In the Member State concerned days | |
| 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 | 8 |
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