6 results
To demonstrate that the infliximab serum concentration of Remsima* is non-inferior to the infliximab serum concentration of Remicade , 16 weeks after switch from Remicade to Remsima* in subjects with CD, UC or RA in stable remission for > 30…
Primary* To evaluate the effect of IW-6463 on cerebral blood flow (CBF) in healthy elderly participants* To assess the safety and tolerability of IW-6463 vs placebo when administered to healthy elderly participants for up to 15 daysExploratory* To…
To assess the number of patients in remission, 12 months after dose adjustment of IFX from 5mg/kg to 3 mg/kg. Secondary objectives include: number of relapses, defined by increase of fecal calprotectin and/or CRP and clinical activity, subsequently…
Stage 1* To assess the safety and tolerability of single-ascending-dose levels of IW-6463 when administered to healthy subjectsStage 2* To assess the safety and tolerability of multiple-ascending-dose levels of IW-6463 when administered to healthy…
To evaluate whether a faecal calprotectin guided strategy of anti-TNF dosing interval lengthening is non-inferior in maintaining remission in patients with IBD compared with an unchanged dosing interval.
The aim of this study is to investigate the efficacy of subcutaneous IFX in the treatment of moderate to severe Crohn*s disease with and without concomitant immunosuppression, as measured by the proportion of patients in corticosteroid-free clinical…