Study on the efficacy and safety of Secukinumab administered subcutaneously compared to placebo in combination with a glucocorticoid tapering regimen in participants with polymyalgia rheumatica (PMR)
Descrizione riassuntiva dello studio
The purpose of this study is to find out whether the investigational drug AIN457 (Secukinumab) works in adult participants with polymyalgia rheumatica (PMR) who could not stop treatment with a certain class of medications, called glucocorticoids, without experiencing a worsening of symptoms (a so-called relapse). PMR is an inflammatory rheumatic disease in older adults characterized by pain and stiffness in the neck, shoulders, and pelvic girdle. It is the second most common inflammatory rheumatic disease in people over 50 years old after rheumatoid arthritis. Glucocorticoids such as prednisone are currently the only approved treatment for PMR. However, long-term efficacy is limited after discontinuation of treatment, and long-term use of glucocorticoids is not recommended due to side effects. Secukinumab is a medication intended to reduce inflammation by specifically blocking interleukin IL-17A (a signaling molecule involved in many immune processes that can trigger inflammation). The serum IL-17A level is elevated in the blood of PMR patients. Throughout this study, participants are expected to achieve and maintain a reduction in disease manifestations, even after discontinuation of glucocorticoids. It will be determined whether Secukinumab can reduce pain and inflammation in PMR patients. This study also aims to gain (further) insights into the safety of Secukinumab.
(BASEC)
Intervento studiato
Approximately 360 participants will be randomly assigned to one of three treatment groups. The study treatment will be administered subcutaneously (injection under the skin) with a pre-filled syringe weekly for the first 4 weeks of the study, then every 4 weeks over a period of 52 weeks. This will be followed by a treatment-free follow-up phase. The total study duration will be up to 76 weeks from the start of the study.
(BASEC)
Malattie studiate
Polymyalgia rheumatica (PMR)
(BASEC)
1. PMR diagnosis according to the preliminary ACR/EULAR classification criteria: participants ≥50 years with a history of bilateral shoulder pain associated with elevated CRP concentration (≥10 mg/ml) and/or elevated ESR (≥30 mm/h) and achieving at least 4 points of the following optional classification criteria: • Morning stiffness >45 min (2 points) • Hip pain or limited range of motion (1 point) • No evidence of rheumatoid factors and/or antibodies against anti-citrullinated proteins (2 points) • Absence of other joint involvement (1 point) 2. Participants must have been treated with prednisone (≥10 mg/day or equivalent) for at least 8 consecutive weeks prior to the screening visit. 3. Participants must have experienced at least one PMR relapse within the 12 weeks prior to the start of the study, during which an attempt was made to taper prednisone to a dose of ≥5 mg/day (or equivalent). (BASEC)
Criteri di esclusione
1. Evidence of giant cell arteritis through typical (cranial) symptoms (e.g., persistent or recurrent localized headaches, tenderness of the temporal artery or scalp, jaw pain, blurred or lost vision, stroke symptoms), limb pain, imaging results and/or temporal artery biopsy results. 2. Concomitant rheumatoid arthritis or other inflammatory arthritis or other connective tissue diseases, such as systemic lupus erythematosus, systemic sclerosis, vasculitis, myositis, mixed connective tissue diseases, and ankylosing spondylitis (Bechterew's disease). 3. Concomitant diagnosis or history of a neuropathic muscle disease. (BASEC)
Luogo dello studio
Basilea, Friburgo, San Gallo
(BASEC)
Sponsor
Novartis Pharma Schweiz AG
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Juliane Kühn
+41 41 763 71 11
juliane.kuehn@clutternovartis.comNovartis Pharma Schweiz AG
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Ethikkommission Ostschweiz EKOS
(BASEC)
Data di approvazione del comitato etico
16.02.2023
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
A randomized, parallel-group, double-blind, placebo-controlled, multicenter Phase III trial to evaluate efficacy and safety of secukinumab administered subcutaneously versus placebo, in combination with a glucocorticoid taper regimen, in patients with polymyalgia rheumatica (PMR) (BASEC)
Titolo accademico
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Titolo pubblico
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Malattie studiate
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Intervento studiato
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Tipo di studio
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Disegno dello studio
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Criteri di inclusione/esclusione
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Endpoint primari e secondari
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Data di registrazione
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Inclusione del primo partecipante
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Sponsor secondari
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Contatti aggiuntivi
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ID secondari
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Risultati-Dati individuali dei partecipanti
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Ulteriori informazioni sullo studio
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Risultati dello studio
Riepilogo dei risultati
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Link ai risultati nel registro primario
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