26 results
This study has been transitioned to CTIS with ID 2024-518684-35-00 check the CTIS register for the current data. The current project proposal continues on our findings of the performed prospective cohort study, aiming to develop a biomarker guided…
To demonstrate that the infliximab serum concentration of Remsima* is non-inferior to the infliximab serum concentration of Remicade , 16 weeks after switch from Remicade to Remsima* in subjects with CD, UC or RA in stable remission for > 30…
The primary objective is to study changes in synovial inflammation in serial biopsy samples following the administration of tocilizumab in patients with active RA.The secondary objectives of this study are to:I. Assess clinical response at week 16;…
To determinate the efficacy and safety of golimumab in rheumatoid arthritis patients in daily clinical practice during 48 months. In addition, the effect of treatment with golimumab on the lipid profile will be monitored during this study.
To determinate the efficacy and safety of certolizumab pegol in rheumatoid arthritis patients in daily clinical practice during 48 months. In addition, the effect of treatment with certolizumab pegol on the lipid profile will be monitored during…
To determinate the efficacy and safety of golimumab in patients with psoriatic arthritis in daily clinical practice prospectively. In addition, the effect of treatment with golimumab on the lipid profile will be monitored during this study and…
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 objective is to study changes in synovial inflammation in serial biopsy samples following the administration of abatacept in patients with active rheumatoid arthritis.The secondary objectives of this study are to (I) assess clinical…
The objectives of this study are:* To determine the percentage of patients with recent-onset RA and UA who achieve and maintain clinical remission on treatment with a combination of methotrexate 25 mg/week and extended prednisone pulse (tapered high…
To determine the efficacy and safety of tocilizumab in the daily clinical practice situation for at least 36 months in comparison to the reported efficacy and safety in clinical trials.There will be a particular focus of the effect of tocilizumab on…
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
Primary objective:to study changes in synovial inflammation and cytokine expression in serial biopsy samples following the administration of adalimumab in patients with active rheumatoid arthritis.Secondary objectives: (i) assess clinical response…
-To evaluate the effects of IVIg on the humoral and cellular immune system.-To identify biomarkers which are associated with the effect (on muscle strength and sensory modalities) of IVIg. To investigate the value of these biomarkers in other…
Objectives:To assess the safety of transitioning subjects to Raptiva therapy from standard oral systemic or phototherapy by overlapping with Raptiva whilst tapering the initial systemic therapy or phototherapy dose. The secondary objective is to…
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 determinate the efficacy and safety of golimumab in patients with ankylosing spondylitis in daily clinical practice prospectively. In addition, the effect of treatment with golimumab on the lipid profile will be monitored during this study.
The main objective of this study is to assess effectiveness of the COVID-19 vaccinations, based on humoral (anti-coronavirus antibody) immunity, in GCA and PMR patients. Other objectives are assessing antigen-specific cellular (T-cell) immune…
To investigate, in RA patients, the role of different RTX doses (200, 500 and 1000mg) and timing of RTX on risk of obtaining adequate humeral response against COVID-19 vaccines, by performing a sensitivity analysis on response, using logistic…
The aim of this study is to investigate the efficacy of subcutaneous IFX in the treatment of moderate to severe Crohn*s disease with and without concomitant immunosuppression, as measured by the proportion of patients in corticosteroid-free clinical…
Primary objective: to investigate MPA exposure in a variety of autoimmune diseases in stable treated patients. Secondary objective: to develop predictive exposure models and evaluate the influence of population covariables on pharmacokinetics .The…