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)

Conditions

Polymyalgia Rheumatica

Brief summary

Proportion of participants achieving sustained remission at Week 52

Detailed description

Proportion of participants achieving complete sustained remission at Week 52, Proportion of participants achieving sustained remission at Week 52, Proportion of participants achieving complete sustained remission at Week 52, Adjusted annual cumulative GC dose through Week 52 adjusted by duration of study follow-up, Time to first use of escape treatment or rescue treatment as measured in days through Week 52, Adjusted annual cumulative GC dose through Week 52 adjusted by duration of study follow-up, Time to first use of escape treatment or rescue treatment as measured in days through Week 52, Change from BSL FACIT-Fatigue score at Week 52, Change from BSL HAQ-DI score at Week 52, Change from BSL FACIT-Fatigue score at Week 52, Change from BSL HAQ-DI score at Week 52, Safety and tolerability demonstrated by assessing: - All adverse events (AEs) and all serious adverse events (SAEs) (incidence, severity, and relationship to study drug) - Clinically significant changes in clinical laboratory measures and vital signs, AEs that are related to GC use by investigator judgement

Related papers

No related papers found yet.

Interventions

DRUGPlacebo to AIN457 150 mg/1 mL Solution for injection in pre-filled syringe

DRUGPREDNISONE

DRUGSECUKINUMAB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Proportion of participants achieving sustained remission at Week 52	—

Secondary

Measure	Time frame
Proportion of participants achieving complete sustained remission at Week 52, Proportion of participants achieving sustained remission at Week 52, Proportion of participants achieving complete sustained remission at Week 52, Adjusted annual cumulative GC dose through Week 52 adjusted by duration of study follow-up, Time to first use of escape treatment or rescue treatment as measured in days through Week 52, Adjusted annual cumulative GC dose through Week 52 adjusted by duration of study follow-up, Time to first use of escape treatment or rescue treatment as measured in days through Week 52, Change from BSL FACIT-Fatigue score at Week 52, Change from BSL HAQ-DI score at Week 52, Change from BSL FACIT-Fatigue score at Week 52, Change from BSL HAQ-DI score at Week 52, Safety and tolerability demonstrated by assessing: - All adverse events (AEs) and all serious adverse events (SAEs) (incidence, severity, and relationship to study drug) - Clinically significant changes in clinical laborato	—

Measure

Time frame

Proportion of participants achieving complete sustained remission at Week 52, Proportion of participants achieving sustained remission at Week 52, Proportion of participants achieving complete sustained remission at Week 52, Adjusted annual cumulative GC dose through Week 52 adjusted by duration of study follow-up, Time to first use of escape treatment or rescue treatment as measured in days through Week 52, Adjusted annual cumulative GC dose through Week 52 adjusted by duration of study follow-up, Time to first use of escape treatment or rescue treatment as measured in days through Week 52, Change from BSL FACIT-Fatigue score at Week 52, Change from BSL HAQ-DI score at Week 52, Change from BSL FACIT-Fatigue score at Week 52, Change from BSL HAQ-DI score at Week 52, Safety and tolerability demonstrated by assessing: - All adverse events (AEs) and all serious adverse events (SAEs) (incidence, severity, and relationship to study drug) - Clinically significant changes in clinical laborato

—

Countries

Belgium, Czechia, Denmark, Finland, France, Germany, Hungary, Iceland, Ireland, Italy, Netherlands, Norway, Poland, Spain, Sweden

Outcome results

None listed