8 results
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:-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…
To determine the objective response rate of entrectinib, as assessed by BICR, in each patient population basket of solid tumors that harbor anNTRK1/2/3, ROS1, or ALK gene rearrangement
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…
To assess the safety and tolerability ofBNT141 at different dose levels.To identify the maximum tolerated dose (MTD) or maximally administered dose (MAD) /recommended Phase IIdose (RP2D) of BNT141 based on theoccurrence of dose-limiting toxicities(…
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…
This study will evaluate the efficacy and safety of multiple therapies that are selected using somatic alterations and potential predictive biomarkers identified via NGS assays in patients with solid tumors: