13 results
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…
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…
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…
To assess the effects of 3-month NHT on the 3-year course of PSA and testosterone in patients treated with BT for low-intermediate risk clinically localized prostate carcinoma. In addition, we would like to assess the effects of 3-month NHT on…
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.
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…
Primary end points:Safety (>1 toxic death per arm) and tolerability (relevant grade 4 toxicities) in not more than 33% of patients for the three treatment arms.Secondary end points:* Reduction of grade 2-4 key side effects in the experimental…
The two main objectives of the study are:* To assess the efficacy of ADT in treatment naïve patients with recurrent and/or metastatic, androgen receptor (AR) expressing, SGCs. The primary measure of efficacy is Progression-Free Survival (PFS).* To…
Primary ObjectiveTo determine if JNJ-56021927 plus gonadotropin releasing hormone (GnRH) agonist in subjects with high-risk, localized or locally advanced prostate cancer receiving primary radiation therapy (RT) results in an improvement of…
Feasibility to detect a difference in uptake on 18F-FDHT scan after 4 weeks of treatment with bicalutamide in metastatic breast cancer patients.
This study aims to investigate the progression-free survival (PFS) according to RECIST 1.1 criteria on matched targeted therapy by STA-analysis (PFS2) in comparison to the PFS recorded on the therapy administered immediately prior to enrolment (PFS1…