12 results
Objectives:Primary:- To evaluate efficacy as measured by overall survival (OS), with a goal of demonstrating the superiority of inotuzumab ozogamicin when administered in combination with rituximab, compared with an active comparator arm.Secondary…
The aim of this study is to describe pharmacokinetic parameters of the following golimumab regimens: 50 mg every month, 100 mg every one-and-a-half month and 100 mg every two months, in patients with a rheumatic disease.
- The primary objective of the Stratum 1A cohort is to establish the maximum tolerated dose of single agent InO when administered in children with CD22-positive relapsed/refractory BCPALL.- The primary objective of the phase 2 cohort is to establish…
To investigate whether tapering MTX first, then the TNFi golimumab (GOL), is more efficacious than tapering GOL first, then MTX, in sustaining remission and reaching drug free remission.
Primary objectives and hypotises: In adults with active nr-axSpA who attain inactive disease after receiving open-label golimumab during a 10-month run-in (Period 1):Primary Objective: To evaluate the effect of treatment withdrawal vs continued…
1) to demonstrate the safety and efficacy of golimumab + MTX versus MTX alone in DMARD naïve PsA patients2) to demonstrate that golimumab + MTX is superior to MTX alone to achieve low to very low disease activity in DMARD naïve PsA patients3) to…
The primary study objectives are as follows:-To evaluate the pharmacokinetics (PK) of golimumab in pediatric subjects aged 2 through 17 years with moderately to severely active UC.-To evaluate the safety of golimumab in pediatric subjects aged 2…
Until recently there were only few therapeutic options to treat AS. Efficacy is proven for several tumor necrosis factor (TNF)-blocking agents, including golimumab. 2-8 However, up to now, the efficacy of golimumab treatment on EAMs, like anterior…
Our main aim is to evaluate the effectiveness and cost-effectiveness of two tapering strategies:(i)DMARD tapering and (ii)anti-TNF tapering in RA patients with DMARD&anti-TNF(etanercept, adalimumab, certolizumab or golimumab) induced…
Primary Objectives Efficacy: To demonstrate the superiority of InO monotherapy vs ALLR3 induction in paediatric participants between 1 and < 18 years with HR first bone marrow relapse CD22-positive BCP ALL Secondary Objectives:Key Secondary…
The primary objective of this study is to assess the efficacy of Triumeq versus placebo on overall survival, defined as death from any cause, in participants with ALS at 24 months or after a minimum of 212 events.
The primary objective of ALLTogether is to improve survival and quality of survival in children and young adults with acute lymphoblastic leukaemia