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)
Summary description of the study
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)
Intervention under investigation
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)
Disease under investigation
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)
Exclusion criteria
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)
Trial sites
Basel, Freiburg, St. Gallen
(BASEC)
Sponsor
Novartis Pharma Schweiz AG
(BASEC)
Contact
Contact Person Switzerland
Juliane Kühn
+41 41 763 71 11
juliane.kuehn@clutternovartis.comNovartis Pharma Schweiz AG
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethikkommission Ostschweiz EKOS
(BASEC)
Date of authorisation
16.02.2023
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
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)
Academic title
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Public title
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Disease under investigation
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Intervention under investigation
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Type of trial
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Trial design
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Inclusion/Exclusion criteria
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Primary and secondary end points
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Registration date
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Incorporation of the first participant
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Secondary sponsors
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Additional contacts
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Secondary trial IDs
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Results-Individual Participant Data (IPD)
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Further information on the trial
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Results of the trial
Results summary
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Link to the results in the primary register
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