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.
This is a multicenter, randomized, double-blind, placebo-controlled, parallel group study with two secukinumab dose regimens in approximately 360 PMR patients who had recently relapsed. The study consists of: screening (up to 6 weeks); treatment period (52 weeks, with last IMP administration at 48 weeks, active drug or placebo) in combination with prednisone tapered over 24 weeks; treatment-free follow-up (up to 24 weeks). Adult males and females of at least 50 years of age with a recent PMR relapse (within 12 weeks from Baseline) will be included. Dosing will be once every week for the first 4 weeks, and once every 4 weeks thereafter via pre-filled syringe. The primary objective is to demonstrate the efficacy of secukinumab 300 mg subcutaneously in combination with a 24-week glucocorticoid (GC) taper regimen compared with placebo with respect to the proportion of patients in sustained remission at Week 52. Primary secondary objectives are to assess difference in proportion of patients achieving complete sustained remission at Week 52, adjusted annual cumulative GC dose and time to first use of escape treatment or rescue treatment through Week 52. Key safety data will be collected, along with Patient Reported Outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
381
Taken subcutaneously every 4 weeks until Week 48 in combination with a 24-week prednisone taper regimen
Taken subcutaneously every 4 weeks until Week 48 in combination with a 24-week prednisone taper regimen
Taken subcutaneously every 4 weeks until Week 48 in combination with a 24-week prednisone taper regimen
Proportion of participants achieving sustained remission
Sustained remission at Week 52 is defined as a participant meeting all of the following: ● achieved remission at Week 12 AND all of the following, sustained from Week 12 to Week 52: * no recurrence of signs or symptoms, attributable to PMR, that requires escape treatment or rescue treatment * no new diagnosis of Giant cell arteritis (GCA), that requires escape treatment or rescue treatment Remission at Week 12 is defined as a participant meeting all of the following at Week 12: * no use of escape treatment or rescue treatment prior to Week 12 * no signs or symptoms attributable to PMR, that requires escape treatment or use of rescue treatment, at Week 12 * no new diagnosis of GCA, that requires escape treatment or rescue treatment, at Week 12
Time frame: at Week 52
Proportion of patients achieving complete sustained remission
Complete sustained remission at Week 52 is defined as participant meeting all of the following: * achieved sustained remission * no clinically relevant elevation of Erythrocyte sedimentation Rate (ESR) and/or C-reactive protein (CRP) at ≥2 consecutive scheduled visits from Week 12 to Week 52
Time frame: 52 Weeks
Adjusted annual cumulative glucocorticoid (GC) dose adjusted by duration of study follow-up
Adjusted annual cumulative GC dose is cumulative GC dose through Week 52 adjusted by duration of study follow-up
Time frame: 52 Weeks
Time to first use of escape treatment or rescue treatment as measured in days
First use of escape treatment or rescue treatment is defined as the first time when the escape treatment or rescue treatment is used
Time frame: 52 Weeks
Change in FACIT-Fatigue Score
The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) is a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. The purpose of collecting available FACIT-Fatigue data is to assess the impact of fatigue on participants with PMR.
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Arizona Arthritis and Rheumatology Associates PLLC
Avondale, Arizona, United States
Sun Valley Arthritis Center Ltd
Peoria, Arizona, United States
AZ Arthritis and Rheumtlgy Rsh PLLC
Phoenix, Arizona, United States
Precn Comprehensive Clnl Rsch Solns
San Leandro, California, United States
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Santa Monica, California, United States
Center for Rheumatology Research
West Hills, California, United States
Millennium Clinical Trials
Westlake Village, California, United States
Rheumatology Associates of South Florida
Boca Raton, Florida, United States
UF Health Cancer Center
Gainesville, Florida, United States
Sarasota Arthritis Res Ctr
Sarasota, Florida, United States
...and 123 more locations
Time frame: 52 Weeks
Change in HAQ-DI score
The Health Assessment Questionnaire - Disability Index (HAQ-DI) is used to assess the long-term influence of chronic disease on a participant's level of functional ability and activity restriction. The purpose of the HAQ-DI is to assess the functional ability of subjects with PMR.
Time frame: 52 Weeks