E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Psoriatic Arthritis |
Rhumatisme psoriasique |
|
E.1.1.1 | Medical condition in easily understood language |
Psoriatic Arthritis |
Rhumatisme psoriasique |
|
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 | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10037160 |
E.1.2 | Term | Psoriatic arthritis |
E.1.2 | System Organ Class | 100000004859 |
|
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 the efficacy of secukinumab monotherapy (300 mg s.c.) at Week 52 is superior to adalimumab monotherapy (40 mg s.c.) based on the proportion of subjects achieving an American College of Rheumatology 20 (ACR20) response. |
Démontrer que l’efficacité du sécukinumab en monothérapie 300 mg s.c est supérieure à celle de l’adalimumab en monothérapie (40 mg s.c.) sur la base de la proportion de patients atteignant une réponse ACR20 (American College of Rheumatology 20), à la semaine 52. |
|
E.2.2 | Secondary objectives of the trial |
To demonstrate that:
Secukinumab monotherapy (300 mg s.c.) is superior to adalimumab monotherapy (40 mg s.c.) at Week 52, based on the proportion of subjects achieving
- PASI90 response.
- ACR50 response.
The improvement (change) from baseline on secukinumab monotherapy (300 mg s.c.) is superior to adalimumab monotherapy (40 mg s.c.) at Week 52, for the Health Assessment Questionnaire – Disability Index (HAQ-DI©) score.
Secukinumab monotherapy (300 mg s.c.) is superior to adalimumab monotherapy (40 mg s.c.) at Week 52, based on the proportion of subjects achieving the resolution of enthesitis.
An additional secondary objective is to evaluate the safety and tolerability of secukinumab monotherapy (300 mg s.c.) compared with adalimumab monotherapy (40 mg s.c.) as assessed by vital signs, clinical laboratory values, and adverse events monitoring.
|
Démontrer que :
Le sécukinumab en monothérapie (300 mg s.c.) est supérieur à l’adalimumab en monothérapie (40 mg s.c.) , à la semaine 52, sur la base de la proportion de patients ayant obtenu
- une réponse PASI 90.
- une réponse ACR50. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Diagnosis of PsA classified by CASPAR; Rheumatoid factor and anti-CCP antibodies negative; diagnosis of active plaque psoriasis, with at least one psoriatic plaque of ≥2cm diameter or nail changes consistent with psoriasis or documented history of plaque psoriasis; inadequate control of symptoms with NSAIDs; inadequate control of symptoms with a conventional DMARD.
Other protocol-defined inclusion criteria may apply. |
- Diagnostic de RP classé selon les critères CASPAR;
- Facteur rhumatoïde (FR) et anticorps anti-peptides cycliques citrullinés (PCC) négatifs à la selection;
- Diagnostic de psoriasis en plaques actif, avec au moins une plaque psoriasique ayant un diamètre de ≥ 2 cm ou modifications unguéales classiques du psoriasis ou antécédents documentés de psoriasis en plaques;
- Contrôle insuffisant des symptômes avec un traitement par AINS
- Contrôle insuffisant des symptômes avec un traitement par un DMARD conventionnel.
D'autres critères d'inclusion définis dans le protocole peuvent s'appliquer. |
|
E.4 | Principal exclusion criteria |
- Pregnant or nursing women, evidence of ongoing infectious or malignant process; previous exposure to any biologic drug for Psoriatic Arthritis or Psoriasis; subjects taking high potency opioid analgesics; ongoing use of prohibited psoriasis treatments / medications; previous treatment with any cell-depleting therapies including but not limited to anti-CD20, investigational agents
Other protocol-defined exclusion criteria may apply. |
- Femmes enceintes ou allaitant, signes de processus infectieux ou cancéreux en cours;
- Exposition antérieure à des biomédicaments pour le traitement du RP actif et du psoriasis;
- Utilisation d’analgésiques opioïdes très puissants;
- Utilisation en cours de traitements/médicaments anti-psoriasis interdits;
- Traitement antérieur par toute thérapie induisant une déplétion des cellules, y compris, mais sans s’y limiter, les anti-CD20 ou des traitements expérimentaux.
D'autres critères d'exclusion définis dans le protocole peuvent s'appliquer. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
American College of Rheumatology 20 (ACR20) response |
Réponse ACR 20, (ACR, American College of Rheumatology, Collège américain de rhumatologie) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
- PASI90 (a)
- ACR50 response (a)
- Health Assessment Questionnaire - Disability Index (HAQDI score), relative to baseline (a)
- Resolution of enthesitis (a) |
- PASI90 (a)
- Réponse ACR 50 (a)
- Questionnaire de qualité de vie- Index du handicap (HAQDI score), (a)
- Score pour l'enthésite (a) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 149 |
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 |
Bulgaria |
Czech Republic |
Denmark |
Estonia |
Finland |
France |
Germany |
Greece |
Hungary |
Iceland |
India |
Ireland |
Israel |
Italy |
Korea, Republic of |
Latvia |
Lithuania |
Netherlands |
Poland |
Portugal |
Russian Federation |
Slovakia |
Spain |
Sweden |
United Kingdom |
United States |
|
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
|
LVLS |
Dernière visite du dernier patient |
|
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 | 4 |
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 | 4 |