32 results
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…
5. Study objective(s) and hypothesis:The aim of this study is to assess the value of early, intensive and efficient treatment of patients with recent acquired arthritis, in preventing progression into destructive RA
Primary objectiveThe primary objective of this study is to compare the efficacy of ETN against placebo in improving symptoms of early non-radiographic axial SpA at 12 weeks when added to a background NSAID at the optimal anti-inflammatory dose.…
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…
- 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…
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:Part 1:To assess the relative bioavailability and bioequivalence of JZP-258 compared with Xyrem oral solution under fasting and fed conditions.To evaluate the pharmacokinetics (PK) of JZP-258 under fasting and fed conditions (food…
Primary Obejective:To evaluate the preliminary efficacy of 8 consecutive weeks of QBM076 in current or ex-smoking patients with stable COPD with spirometry grades I-III (according to the current GOLD strategy (GOLD 2013).Secondary Objectives:To…
To determine the minimal biologic drug serum trough concentration required to maintain stable disease activity in patientswith moderate to severe chronic plaque psoriasis.
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…
To investigate whether the dose of biologics can be reduced in patients with psoriasis with stable disease: is dose reduction non-inferior to the current practice regarding clinical effectiveness? Secondary aims are: to investigate what influence…
During the study, the 4 KEY-507 oral solutions (KEY-507-A, KEY-507-G, KEY-507-C, and KEY 507-D) will be investigated and compared to Xyrem. The purpose of the study is to investigate how quickly and to what extent KEY-507 oral solutions are absorbed…
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 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…
To evaluate the response to etanercept treatment in TNF-alpha blockade naïve patients and patients who failed prior other anti-TNF-alpha treatment and to understand the mechanisms underlying the clinical response to TNF-alpha blockade
We hypothesized that one of the key mechanisms explaining the differences in effect between adalumimab and etanercept on psoriatic skin is that adalumimab, by being a monoclonal antibody like infliximab, is a better inducer of apoptosis resulting in…
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…