30 results
The primary objective of this endpoint study is to evaluate the safety of tofacitinib at two doses versus TNFi; the co-primary endpoints are adjudicated major adverse cardiovascular events (MACE) and adjudicated malignancies excluding non-melanoma…
Primary Objective* To estimate the proportion of subjects who flare within 40 weeks followingwithdrawal of ETN in subjects who have achieved ASDAS CRP less than1.3 (inactive disease).Secondary Objectives* To estimate time to flare after withdrawal…
The primary objectives of the study are 1) to compare the efficacy of CP-690,550 (5 mg BID and 10 mg BID) versus etanercept (50 mg BIW) for the reduction in severity of plaque psoriasis after 12 weeks of treatment, and 2) to evaluate the safety and…
- The main hypothesis of this study is that JIA patients at risk of a flare due to subclinical inflammatory activity may be identified by analysis of the phagocyte activity marker S100A12 and hsCRP. The goal is a stratification of the therapeutic…
The objectives are to evaluate the degree of bilateral benefit gained from having a second implant with respect to speech perception, spatial hearing, and listening effort.
Primary ObjectiveThe primary objective of this study is to compare prospectively in patients treated with TCZ or etanercept (ETA), the time to first occurrence of any component of a composite of major adverse cardiovascular events (MACE) consisting…
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 effectiveness of bilateral implantation over unilateral implantation in children with severe-to-profound sensorineural hearing loss. Furthermore with this study we will investigate whether simultaneous bilateral implantation is…
The general aim of this project is the primary prevention of the development of AS in patients with IBP, additional (SpA) features and inflammation on MRI of the SI joint and/or spine (but still no sacroiliitis on X-ray) by giving them, a short…
The primary objective is to determine if intra-articular etanercept therapy reduces the clinical signs and symptoms of inflammatory arthritis and improve outcome (beneficial effect). The secondary objective is to study safety and to analyse…
What is the incremental cost effectiveness ratio of the use of etanercept versus infliximab?Are there subgroups of which infliximab or etanercept is more or less cost-effective in daily practice?Primary objectives: 1. To compare clinical efficacy of…
Primary* To monitor the occurrence of malignancy in pediatric subjects with extended oligoarticular JIA, ERA, or PsA.Secondary* To assess the long-term safety profile of etanercept.
The main objective of the present study is to investigate the optimal stimulation pattern for tinnitus suppression in a structured way. Our study will focus on two parameters: stimulus level and anatomical stimulation site inside the cochlea.
Primary Objectives: a. Optimization of the 99MTc-HABN SPECT/CT scanning protocol in the first 5 patients (Phase 0). b. Detection and characterization of primary prostate cancer (tumor uptake and tumor-to-background ratio) in patients with 99MTc-HABN…
The primary objectives of the study are to compare the efficacy of CNTO1275 to Etanercept and evaluate the safety of CNTO1275 and Etanercept.The secondary objective of this study is to evaluate the efficacy and safety of retreatment with CNTO1275.
To compare the efficacy of the combination of etanercept 50 mg once weekly with that of the combination of etanercept 25 mg and that of MTX monotherapy at week 88 in subjects with moderate RA who have achieved low disease activity or remission after…
The ENT clinic in Groningen has developed a new speech coding strategy: phase-lock speech (PLS) coding. This strategy distinguishes from existing strategies by the explicit coding of acoustic fine-structure. In normal hearing subjects, the…
To determine the minimal biologic drug serum trough concentration required to maintain stable disease activity in patientswith moderate to severe chronic plaque psoriasis.
The objectives of this study are to evaluate the clinical outcome of a cochlear implant (CI) over standard health care therapy with either BAHA or CROSS in patients with SSD and to examine the cost efficiency of cochlear implantation in these…
Co-Primary- to assess whether ixekizumab Q4W is superior to placebo at Week 12 (Visit 7) in the treatment of pediatric subjects(children and adolescents) with moderate-to-severe plaque psoriasis as measured by PASI 75 and by sPGA (0,1)Gated…