10 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.
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…
Primary Objective*To assess the safety and tolerability of Patidegib Topical Gel, 2% inpatients who have completed PellePharm Study Pelle-926-201 or Pelle-926-301Secondary Objectives*To assess the efficacy of Patidegib Topical Gel, 2% in patients…
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…
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.
The primary objective of this study is to investigate whether the use of the EOS calculator safely reduces antibiotic exposure in newborns with suspected EOS in the first 24 hours after birth compared to the current Dutch guidelines.Secondary…
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 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…