A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of each of two dose levels of sarilumab in adults with early polymyalgia rheumatica

Conditions

Musculoskeletal diseases

Brief summary

Sustained remission at Week 52 (yes/no) in participants with early relapsing polymyalgia rheumatica (PMR) who received sarilumab 200 mg q2w with 52-week prednisone taper

Detailed description

Sustained remission at Week 52 (yes/no) in all participants (newly diagnosed PMR and early relapsing PMR) who received sarilumab 200 mg q2w with prednisone taper, Sustained remission at Week 52 (yes/no) in participants with early relapsing PMR, as well as in all participants (newly diagnosed PMR and early relapsing PMR) who received sarilumab 150 mg q2w with prednisone taper, Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), abnormalities in laboratory values, anti-drug antibody, Corticosteroid-free remission at Week 52, Remission at Week 24, Time in remission through Week 52, Incidence rate of flare through Week 52, Change from baseline in PMR activity score and its components at Weeks 24 and 52, Changes from baseline at Weeks 24 and 52 in the physical component summary and mental component summary from Shortform 36-item questionnaire (SF-36v2)

Related papers

No related papers found yet.

Interventions

DRUGsarilumab

DRUGplacebo matching sarilumab

DRUGEncorton

DRUG1 mg

DRUGtabletki

DRUGPrednison 5 mg GALEN® Tabletten

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Sustained remission at Week 52 (yes/no) in participants with early relapsing polymyalgia rheumatica (PMR) who received sarilumab 200 mg q2w with 52-week prednisone taper	—

Secondary

Measure	Time frame
Sustained remission at Week 52 (yes/no) in all participants (newly diagnosed PMR and early relapsing PMR) who received sarilumab 200 mg q2w with prednisone taper, Sustained remission at Week 52 (yes/no) in participants with early relapsing PMR, as well as in all participants (newly diagnosed PMR and early relapsing PMR) who received sarilumab 150 mg q2w with prednisone taper, Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), abnormalities in laboratory values, anti-drug antibody, Corticosteroid-free remission at Week 52, Remission at Week 24, Time in remission through Week 52, Incidence rate of flare through Week 52, Change from baseline in PMR activity score and its components at Weeks 24 and 52, Changes from baseline at Weeks 24 and 52 in the physical component summary and mental component summary from Shortform 36-item questionnaire (SF-36v2)	—

Measure

Time frame

Sustained remission at Week 52 (yes/no) in all participants (newly diagnosed PMR and early relapsing PMR) who received sarilumab 200 mg q2w with prednisone taper, Sustained remission at Week 52 (yes/no) in participants with early relapsing PMR, as well as in all participants (newly diagnosed PMR and early relapsing PMR) who received sarilumab 150 mg q2w with prednisone taper, Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), abnormalities in laboratory values, anti-drug antibody, Corticosteroid-free remission at Week 52, Remission at Week 24, Time in remission through Week 52, Incidence rate of flare through Week 52, Change from baseline in PMR activity score and its components at Weeks 24 and 52, Changes from baseline at Weeks 24 and 52 in the physical component summary and mental component summary from Shortform 36-item questionnaire (SF-36v2)

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Outcome results

None listed