Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucoco… (NCT05767034) | Clinical Trial Compass
CompletedPhase 3
Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Polymyalgia Rheumatica (PMR)
United States381 participantsStarted 2023-03-22
Plain-language summary
The purpose of this study is to demonstrate the efficacy and safety of secukinumab 300 milligram (mg) and 150 mg administered subcutaneously (s.c.) for 52 weeks in combination with prednisone tapered over 24 weeks in adult participants with PMR who have recently relapsed.
Who can participate
Age range50 Years – 100 Years
SexALL
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Inclusion Criteria:
* Signed informed consent must be obtained prior to participation in the study
* Male or non-pregnant, non-lactating female participants at least 50 years of age.
* Diagnosis of PMR according to the provisional American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria: Participants ≥ 50 years of age with a history of bilateral shoulder pain accompanied by elevated C-reactive protein (CRP) concentration (≥ 10 mg/L) and/or elevated erythrocyte sedimentation rate (ESR) (≥ 30 mm/hr) who scored at least 4 points from the following optional classification criteria:
* Morning stiffness \> 45 minutes (min) (2 points)
* Hip pain or restricted range of motion (1 point)
* Absence of rheumatoid factor and/or anti-citrullinated protein antibodies (2 points)
* Absence of other joint involvement (1 point)
* Participants must have a history of being treated for at least 8 consecutive weeks with prednisone ≥ 10 mg/day, or equivalent dose of another GC at any time prior to screening
* Participants must have had at least one episode of PMR relapse while attempting to taper prednisone at a dose that is ≥ 5 mg/day (or equivalent dose of another GC) within the past 12 weeks prior to BSL. Diagnosis of a PMR relapse is defined as participant meeting both of the following:
* Recurrence of bilateral shoulder girdle and/or bilateral hip girdle pain associated with inflammatory stiffness with or without additional symptoms …
What they're measuring
1
Proportion of participants achieving sustained remission