87 results
The objective of this study is to compare the efficacy of Infliximab-biosimilar to Infliximab-innovator and to demonstrate its noninferiority up to 30 weeks, in patients with ulcerative colitis or Crohn*s disease in remission under treatment with…
Here, we postulate that the balance between the effect of belatacept on regulatory T-cell function and the relative insensitivity of memory T-cells for belatacept leads to donor-specific alloreactivity. We plan to study the peripheral CD28-dependent…
Objective: The response over time on daytime alertness and performance will be assessed following a single oral dose of bilastine 20 mg in healthy volunteers performing flying ability tests in a hypobaric chamber with an ambient pressure of 75.2 kPa…
This trial will provide definitive answers with regard to the anti-inflammatory effects of Vitamin D in Crohn*s disease.
To evaluate the feasibility of the study after 20 weeks of follow-up, which includes the evaluation of the dose-reduction algorithm in tocilizumab-treated patients with RA.
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…
To generate a set of normal values in people over 60 that can be expected to have an normal immune system, in order to be able to interpret the immune system of eldery patients with repeated airway infections.
The primary objective is to investigate the association between residual disease activity at Baseline as detected by magnetic resonance imaging (MRI) and the occurrence of flares in RA subjects randomized to an adalimumab dose tapering regimen…
The follow-up study has two main research questions:o Is the treatment of early RA according to the COBRA-light schedule as effective (based on DAS44 score, ACR/EULAR remission criteria, HAQ score and the Sharp/van der Heijde score) as standard…
Objective: The primary goal of the current study is to study the immunogenicity and safety of HPV vaccination in patients with an autoimmune disease. Based on retrospective analysis with other vaccines we hypothesize that patients with autoimmune…
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…
To characterize the profile of low BMD in >= 50 years old male HIV-1 infected subjects andpost-menopausal female HIV-1 infected subjects taking TDF-based regimens relative tothose taking non-TDF-based regimens for HIV infection.
The objective of this study is to evaluate the efficacy and safety of continuing versus withdrawing therapy with adalimumab 40 mg given every other week (eow) SC in maintaining remission in subjects with nr-axSpA.
The present proposal seeks to compare the cardiovascular and gastrointestinal safety and effectiveness of a strategy of initial randomisation to treatment with the selective COX-2 inhibitor celecoxib or to *usual-care* with their current non-…
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…
Primary endpoint:- Successful desensitization for Mesalazine in ulcerative colitis patients with a presumed history of intolerance for Mesalazine. Secondary endpoint:- To investigate if a presumed intolerance for Mesalazine may be reproducible in a…
The primary objective of the study is to compare the efficacy of intravenous immunoglobulin product with the efficacy of antibiotic treatment in patients with recurrent respiratory infections and IgG-subclass deficiency and/or selective anti-…