6 results
Primary Objective:The primary objective is to compare the radiographic progression-free survival (rPFS) ofapalutamide in combination with abiraterone acetate (AA) plus prednisone or prednisolone(AAP) and AAP in subjects with chemotherapy-naïve mCRPC…
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…
The primary objective of this study is:* To evaluate the effects of filgotinib versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) as measured by the proportion of subjects achieving an American College of…
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…
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…
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.