E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Axial Psoriatic Arthritis |
Artrite psoriasica con coinvolgimento dello scheletro assiale |
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E.1.1.1 | Medical condition in easily understood language |
Axial Psoriatic Arthritis |
Artrite psoriasica con coinvolgimento dello scheletro assiale |
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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 | 21.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10037160 |
E.1.2 | Term | Psoriatic arthritis |
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 demonstrate that secukinumab 300 mg s.c. is superior to placebo in the achievement of ASAS 20 response at Week 12. |
Dimostrare che secukinumab 300 mg s.c. ha un’efficacia superiore al placebo nel raggiungimento della risposta ASAS 20 alla settimana 12. |
|
E.2.2 | Secondary objectives of the trial |
To demonstrate that secukinumab 150 mg s.c. is superior to placebo in the achievement of ASAS 20 response at Week 12 after superiority of 300 mg is established.
To evaluate secukinumab 300 mg and 150 mg s.c. versus placebo at Week 12
- in the achievement of ASAS 40.
- in the achievement of Bath ankylosing spondylitis disease activity index (BASDAI) 50.
- in the reduction of spinal pain measured by visual analog scale (VAS).
- in achieving an improvement in Spondyloarthritis Research Consortium of Canada (SPARCC) enthesitis index.
- in achieving an improvement in health assessment questionnaire disability index (HAQ-DI©).
- in achieving an improvement in the functional assessment of chronic illness therapy fatigue scale (FACIT Fatigue©).
- in achieving an improvement in the ASAS health index.
- based on the proportion of patients achieving an American College of Rheumatology (ACR) 20 response.
To evaluate the safety and tolerability of secukinumab.
|
• Dimostrare che Secukinumab 150 mg s.c. ha un’efficacia superiore al placebo nel raggiungimento della risposta ASAS 20 alla settimana 12 dopo aver stabilito la superiorità del trattamento con 300 mg. • Valutare Secukinumab 300 mg/150 mg sottocute vs. placebo alla settimana 12 in: ¿ raggiungimento di ASAS 40 ¿ raggiungimento di BASDAI 50 ¿ riduzione del dolore spinale alla VAS ¿ miglioramento nell’indice di entesite SPARCC ¿ miglioramento dell’indice HAQ-DI ¿ miglioramento nella scala di FACIT-Fatigue ¿ miglioramento nel punteggio ASAS-HI ¿ proporzione di pazienti che raggiungono risposta ACR 20 • Valutare la sicurezza e la tollerabilità di Secukinumab |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Written informed consent must be obtained before any assessment is performed.
- Diagnosis of psoriatic arthritis classified by Classification criteria for psoriatic arthritis (CASPAR) criteria.
- Active spinal disease defined by Bath ankylosing spondylitis disease activity index (BASDAI) score = 4.
- Spinal Pain visual analog scale (VAS) = 40 (on a VAS 100 scale).
- Inadequate Response to at least 2 nonsteroidal anti-inflammatory drugs over a 4 weeks period.
Other protocol-defined inclusion criteria may apply. |
- Consenso informato scritto ottenuto prima dell’esecuzione di ogni valutazione. - Diagnosi di Artrite Psoriasica classificata secondo i criteri CASPAR. - Malattia spinale attiva definita da un punteggio BASDAI = 4. - Dolore spinale misurato mediante scala visuo-analogica VAS = 40 (scala da 0 a 100 mm). - Inadeguata riposta ad almeno 2 tipi di FANS per la durata di almeno 4 settimane. Ulteriori criteri di inclusione sono riportati in protocollo. |
|
E.4 | Principal exclusion criteria |
- History of exposure to other IL-17 or IL-23 inhibitor biologic drug.
- History of exposure to previous biologic disease modifying anti-rheumatic drugs (DMARDs) (Tumor necrosis factor (TNF) blockers or Ustekinumab).
- Current treatment with disease modifying anti-rheumatic drugs (DMARDs) other than Methotrexate.
- Subjects taking high potency opioid analgesics (e.g. methadone, hydromorphone, morphine).
- Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician.
Other protocol-defined exclusion criteria may apply. |
- Precedente assunzione di altri farmaci biologici inibitori di IL-17 e IL-23. - Precedente assunzione di farmaci biologici antireumatici modificanti la malattia (DMARDs) (anti-TNF o ustekinumab). - Trattamento concomitante con DMARDs diversi da metotressato. - Pazienti che assumono analgesici oppioidi ad elevata potenza (es. metadone, idromorfone, morfina). - RX torace o MRI torace, eseguito negli ultimi 3 mesi prima dello screening e da un medico qualificato, con evidenza di infezioni o processo neoplastico in corso. Ulteriori criteri di esclusione sono riportati in protocollo. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Assessment of spondyloarthritis international society (ASAS) 20 response |
Valutazione della risposta ASAS 20 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
- Assessment of spondyloarthritis international society (ASAS) 20 response. (a) - Assessment of spondyloarthritis international society (ASAS) 40 response. (a) - Bath ankylosing spondylitis disease activity index (BASDAI) 50 response. (a) - Spinal pain visual analog scale (VAS) scale. (b) - Spondyloarthritis Research Consortium of Canada (SPARCC) enthesitis index. (b) - Health assessment questionnaire – disability index (HAQ-DI). (b) - Functional assessment of chronic illness therapy fatigue scale (FACIT-Fatigue). (b) - Assessment of spondyloarthritis international society (ASAS) Health Index. (b) - American College of Rheumatology (ACR) 20 response. (a) - Percentage of patients with Adverse Events. (a) |
Risposta ASAS 20 (A) - Risposta ASAS 40 (A) - Risposta BASDAI 50 (A) - VAS (B) – Indice di entesite SPARCC (B) - Indice HAQ-DI (B) – Scala FACIT -Fatigue (B) – Punteggio ASAS-HI (B) – Risposta ACR 20 (A) - Percentuale di pazienti con eventi avversi. (A) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
a) at week 12 b) at baseline, at week 12 |
Settimana 12 end-point (A) Basale e settimana 12 end-point (B) |
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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 | 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 | 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 | 10 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 99 |
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 |
Belgium |
Bulgaria |
Czechia |
Denmark |
Estonia |
Finland |
France |
Germany |
Greece |
Hungary |
Ireland |
Israel |
Italy |
Norway |
Poland |
Romania |
Russian Federation |
Spain |
Sweden |
Switzerland |
United Kingdom |
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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
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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 | 2 |
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 | 8 |
E.8.9.2 | In all countries concerned by the trial days | 0 |