E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Osteoarthritis of the Hip or Knee |
Osteoartrite dell¿anca o del ginocchio |
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E.1.1.1 | Medical condition in easily understood language |
Osteoarthritis of the Hip or Knee |
Osteoartrite dell¿anca o del ginocchio |
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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 | 21.1 |
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.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
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.1.3 | 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 safety and tolerability of fulranumab subcutaneous (SC) injections compared with SC placebo, in subjects with standard of care and who have signs and symptoms of osteoarthritis of the hip or knee. |
L¿obiettivo primario ¿ dimostrare la sicurezza e la tollerabilit¿ di iniezioni sottocutanee (SC) di fulranumab rispetto al placebo, in soggetti sottoposti a standard di cura e che presentano segni e sintomi di osteoartrite dell¿anca o del ginocchio. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the effect of fulranumab on:
- Efficacy as measured by the subject for pain, function, stiffness, health status and well-being
- Additional analgesic medication use
- Pharmacokinetics and immunogenicity of fulranumab |
Valutare l¿effetto di fulranumab su: ¿ - Efficacia come misurata dal soggetto relativamente a dolore, stato funzionale, rigidit¿, stato di salute e benessere ¿ - Utilizzo di farmaci analgesici supplementari ¿ - Farmacocinetica e immunogenicit¿ di fulranumab
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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
- Unsatisfactory response (inadequate efficacy or poor tolerability) on local standard of care that includes 3 medications from at least 2 of the following classes of analgesic medications (acetaminophen/paracetamol, NSAIDs, or opioid)
-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, breast-feeding, or planning to become pregnant, or if male, will not father a child |
- Diagnosi clinica di OA dell’anca o del ginocchio in base ai criteri definiti dal Collegio americano di reumatologia (American College of Rheumatology) ed evidenza radiografica di OA (Classe di Kellgren-Lawrence = 2) dell’articolazione in studio;
- Intervento di sostituzione articolare programmato per l’articolazione in studio = 20 settimane dopo la randomizzazione o intervento di sostituzione articolare previsto per l’articolazione in studio;
- Risposta insoddisfacente (efficacia inadeguata o scarsa tollerabilità) allo standard di cura locale che comprenda 3 farmaci da almeno 2 delle seguenti classi di farmaci analgesici orali (acetaminofene/paracetamolo, FANS od oppioidi);
- Dolore da moderato a grave e compromissione funzionale in base alle scale numeriche di valutazione (NRS), alle sottoscale del dolore secondo l’indice WOMAC e della funzionalità fisica e del punteggio PGA
- Durante il trattamento e nelle 24 settimane dopo l’ultima iniezione del farmaco in studio: se il soggetto è di sesso femminile in età fertile, non deve essere in gravidanza, allattamento al seno o non deve pianificare una gravidanza o se il soggetto è di sesso maschile, non deve concepire figli; |
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E.4 | Principal exclusion criteria |
- Increased risk of osteonecrosis (ON) or rapidly progressive osteoarthritis (RPOA)
- Unstable or progressive neurologic disorders |
- Aumento del rischio di osteonecrosi (ON) o di osteoartrite a progressione rapida (Rapidly Progressive Osteoarthritis, RPOA);
- Disturbi neurologici instabili o progressivi.
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E.5 End points |
E.5.1 | Primary end point(s) |
The number of participants with Adverse Events as a measure of safety and tolerability |
Il numero di partecipanti con Eventi Avversi in termini di sicurezza e tollerabilità |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Up to Week 52 |
Fino alla Settimana 52 |
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E.5.2 | Secondary end point(s) |
Change from baseline to the end of Week 16 in Western Ontario and McMaster University Arthritis Index (WOMAC) pain subscale score; Change from baseline to the end of Week 16 in Western Ontario and McMaster University Arthritis Index (WOMAC) physical function subscale score |
Variazioni dal basale alla fine della settimana 16 basati sulle sottoscale del dolore secondo l¿indice WOMAC (Western Ontario and McMaster University Arthritis Index); Variazioni dal basale alla fine della settimana 16 basati sulle sottoscale della funzionalit¿ fisica secondo l¿indice WOMAC (Western Ontario and McMaster University Arthritis Index) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
End of Week 16; End of Week 16 |
Fine della Settimana 16; Fine della settimana 16 |
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
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 | 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) | 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 | Yes |
E.8.1.7.1 | Other trial design description |
Terapia aggiuntiva |
Adjunctive Therapy |
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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 | 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 | 78 |
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 | Information not present in EudraCT |
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 |
Canada |
Korea, Republic of |
Mexico |
Russian Federation |
United States |
France |
Germany |
Hungary |
Italy |
Poland |
Romania |
Spain |
Sweden |
United Kingdom |
Czechia |
Argentina |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 5 |
E.8.9.2 | In all countries concerned by the trial days | 4 |