5 results
The primary objective of this endpoint study is to evaluate the safety of tofacitinib at two doses versus TNFi; the co-primary endpoints are adjudicated major adverse cardiovascular events (MACE) and adjudicated malignancies excluding non-melanoma…
Primary:To assess the safety and tolerability of MCLA-117, in order to determine the MTD/RP2D and frequency of administration.Secondary:- To assess the pharmacokinetic (PK) profile of MCLA-117 i.v. infusion- To investigate the pharmacodynamic (PD)…
To assess efficacy and safety of tofacitinib in the treatment of chronic, recurrent and/or antibiotic refractory pouchitis.
The objectives of this study, in patients with moderately to severely active UC who are administered JAKi SOC therapy are to evaluate the following (ranked according to priority), both for JAKi as a class of drugs and for each individual JAKi:1.…
To evaluate the tofacitinib and infliximab treatment-induced changes in plasma lipids and lipoproteins and to provide insight in the underlying mechanism in relation to the inflammatory status in patients with active UC.