11 results
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…
To evaluate the efficacy, safety and tolerability of QGE031 (24 mg, 72 mg, 240 mg s.c. q4w) compared to placebo on top of SoC in atopic patients with asthma.
Primary: To demonstrate the efficacy of QGE031 relative to placebo at 12 weeks in patients withatopic dermatitis (AD) as assessed by Eczema Area and Severity Index (EASI).Secondary: efficacy assessed by Investigator Global Assessment (IGA, 12 weeks…
Primary: To characterize the QGE031 dose response relationship for the increase in the threshold dose of peanut protein that induces objective hypersensitivity reactions after treatment.Secondary (only key parameters): The percentage of patients…
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…
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…
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…
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 Objective: To prove the hypothesis that Intradiscal Methylene blue is capable of longer pain reduction and better global perceived effect in patients suffering from chronic axial low back pain from discogenic origin then a placebo treatment…
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…
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.