9 results
To document the long term safety and efficacy of sarilumab added to DMARDs.
To describe the pharmacokinetic (PK) profile and effectiveness of sarilumab in patients with sJIA in order to identifythe dose and regimen for continued development in this population.
To describe the pharmacokinetic (PK) profile and effectiveness of sarilumab in patients with pcJIA in order to identifythe dose and regimen for continued development in this population.
2.1 Primary ObjectiveDescribing the association between Handscan optical scores, markers of inflammation (levels of CRP, serum IL-6) and clinical swollen joint score in three treatment groups with different pharmacokinetic modes of action for RA…
Primary:-To evaluate the efficacy of KEVZARA (sarilumab) in patients with polymyalgia rheumatica (PMR) as assessed by the proportion of subjects with sustained remission for sarilumab with a shorter corticosteroid (CS) tapering regimen as compared…
Primary:To evaluate the efficacy of sarilumab in patients with giant cell arteritis (GCA) as assessed by the proportion of patients with sustained remission for sarilumab compared to placebo, in combination with a corticosteroid (CS) tapering course…
The primary objective is to evaluate whether a switching strategy using adalimumab concentration (TDM) is superior to usual care in rheumatoid arthritis patients failing adalimumab treatment with regard to response rates. The secondary objectives…
Primary objective:- Improvement of walking distance in 6MWT immediately after the first treatment and cumulatively after 3 consecutive treatments with PESFSecundary objectives:- improvement of oxygen saturation - improvement of quality of life-…
Primary ObjectivesIn the Dose Escalation Phase:• To assess the safety and pharmacokinetics (PK) in order to determine a maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of REGN4018 as monotherapy and in combination with cemiplimabIn…