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 rodilla |
|
E.1.1.1 | Medical condition in easily understood language |
Osteoarthritis of the Hip or Knee |
Artrosis de cadera o rodilla |
|
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 |
|
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 |
|
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 is to demonstrate the efficacy using 2 co-primary endpoints (as measured by the changes from baseline to the end of Week 16 in Western Ontario and McMaster University Osteoarthritis Index [WOMAC] pain and physical function subscales), safety, and tolerability of fulranumab subcutaneous (SC) injections as monotherapy compared with placebo in subjects with signs and symptoms of osteoarthritis of the hip or knee. |
El objetivo principal es demostrar la eficacia usando 2 criterios de valoración principales (según la medición de los cambios del inicio al fin de la semana 16 en las subescalas de dolor y función física del índice de artrosis WOMAC [Western Ontario and McMaster University Osteoarthritis Index]), la seguridad y la tolerabilidad de fulranumab en inyecciones subcutáneas (s.c.) como monoterapia en comparación con placebo en sujetos con signos y síntomas de artrosis de cadera o rodilla. |
|
E.2.2 | Secondary objectives of the trial |
To evaluate the effect of fulranumab on:
- Patient Global Assessment (PGA) - Joint pain using Numerical Rating Scale (NRS) - Stiffness, sleep, functional status and well being as measured by the subject - Additional analgesic medication use - Pharmacokinetics and immunogenicity of fulranumab |
Evaluar el efecto de fulranumab sobre:
- La evaluación global por el paciente (PGA)
- El dolor articular, mediante la escala de puntuación numérica (Numerical Rating Scale, NRS) - La rigidez, el sueño, el estado funcional y el bienestar, medidos por el sujeto
- El uso adicional de analgésicos
- La farmacocinética e inmunogenicidad de fulranumab |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Clinical diagnosis of osteoarthritis (OA) of hip or knee based on criteria defined by the American College of Rheumatology and radiographic evidence of OA (Kellgren-Lawrence class ?2) of the study joint
-Scheduled joint replacement or planning to undergo a joint replacement surgery for the study joint
- Must have an unsatisfactory response that includes at least one each of the following 3 classes of analgesic medications (acetaminophen/paracetamol, NSAIDs, and opioids)
-Moderate to severe pain and functional impairment based on the NRS, WOMAC pain and physical function subscales, and PGA
-During treatment and within 24 weeks after the last injection of study drug: if female of childbearing potential, is not pregnant, breastfeeding, or planning to become pregnant, or if male, will not father a child |
- Diagnóstico clínico de artrosis de cadera o rodilla basado en los criterios definidos por el American College of Rheumatology (Sociedad estadounidense de reumatología, o ACR) y pruebas radiográficas de artrosis (clase Kellgren-Lawrence ? 2) de la articulación estudiada. |
|
E.4 | Principal exclusion criteria |
1) Increased risk of osteonecrosis (ON) or rapidly progressive osteoarthritis (RPOA);
2) Unstable or progressive neurologic disorders. |
1) Aumento del riesgo de osteonecrosis (ON) o artrosis de progresión rápida (rapidly progressive osteoarthritis, RPOA);
2) Trastornos neurológicos inestables o progresivos. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Changes from baseline to the end of the 16-week double-blind phase in the WOMAC pain and physical function subscale scores |
Cambios del inicio al fin de la fase de doble ciego de 16 semanas en las puntuaciones de la subescala WOMAC de dolor y función física. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Baseline, Week 16 |
Inicio, Semana 16 |
|
E.5.2 | Secondary end point(s) |
Change from baseline to the end of the 16-week double-blind phase in scores in:
- Patient Global Assessment (PGA) score - WOMAC Stiffness subscale - Daily NRS scores - MOS Sleep subscales - SF-36 subscales - EQ-5D-5L scales |
Cambio del inicio al fin de la fase de doble ciego de 16 semanas en las puntuaciones de:
- Puntuación PGA - Subescala de rigidez de WOMAC - NRS de la articulación estudiada - Escala del sueño del estudio de los resultados médicos (Medical Outcomes Study, MOS) - Subescalas del cuestionario de salud resumido de 36 elementos (Short-Form-36 Health Survey, SF-36) - Escalas EQ-5D-5L. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
End of Week 16 |
Final de la semana 16 |
|
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 | 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 |
Tolerability |
Tolerabilidad |
|
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 22 |
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 |
Germany |
Poland |
Spain |
United Kingdom |
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
|
LPLV |
Último Paciente de la Última Visita |
|
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 | 7 |
E.8.9.1 | In the Member State concerned days | 19 |
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 | 7 |
E.8.9.2 | In all countries concerned by the trial days | 19 |