12 results
The purpose of the study is to investigate the optimal dose combination of both drugs in healthy volunteers who will undergo a pain test.
Primary objectiveThe primary objective is to evaluate the effectiveness, safety, and tolerability of increasing doses of tapentadol PR (300 mg per day after run in, up titration to 500 mg per day) versus a combination of tapentadol PR (300 mg per…
The objective of this observational, randomized study is to examine the efficacy, safety and patient acceptance of the basal plus insulin regimen (i.e. one injection rapid acting insulin glulisine at the main meal added to once daily basal insulin…
To document the long term safety and efficacy of sarilumab added to DMARDs.
The primary objective is to investigate if there is an incremental inhibiting effect on MSNA by increasing dosage valsartan above the presently advised dosage. We hypothesize that there will be a further decrease in MSNA as compared to the MSNA…
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.
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…
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 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 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…