674 results
Period 1: The first objective, of period 1, is to compare the safety and efficacy of ABT-494 30 mg (QD) and 15 mg QD versus placebo on a background of csDMARD(s) for the treatment of signs and symptoms of rheumatoid arthritis (RA) in bDMARD-…
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…
Period 1: The first objective, of period 1, is to compare the safety and efficacy of ABT-494 15 mg QD monotherapy, and 30 mg QD monotherapy versus weekly methotrexate (MTX) monotherapy for the treatment of signs and symptoms of rheumatoid arthritis…
In the present study we will evaluate the standardized care protocol developed in our outpatient clinic, intended to guide counselling for medication use prior to pregnancy. This protocol guides treatment decisions based on disease activity,…
The purpose of this study is to investigate to what extent GBR 830 is tolerated. It will also be investigated how quickly and to what extent GBR 830 is absorbed and eliminated from the body (this is called pharmacokinetics) and to what extent the…
The primary objectives of this study are to assess whether there is transfer of CZP into breastmilk of lactating mothers who are receiving an established dosing regimen of CZP by evaluatingthe concentration of CZP in mature breast milk, and to…
Primary Objective: Identification of rare variants in candidate genes and regulatory elements in pediatric IBD patients. Secondary Objective(s): To determine the functional consequences of identified genetic variants in IBD, we will correlate…
Primary objectives:The primary objectives of this trial are:• To show PK similarity of BI 695500 to MabThera® and Rituxan® and of Rituxan® to MabThera® (three-way PK similarity).• To establish statistical equivalence of efficacy of BI 695500 and…
(1) To determine the frequency of antibody-mediated encephalopathy in children with seizure-related or (sub)acute onset neuropsychiatric disorders. (2) To identify the target auto-antigens of selected seizure-related and (sub)acute onset…
Primary objective: To identify specific bacteria or a characteristic bacterial composition in the oral and gut microbiome of pSS patients compared to non-Sjögren*s syndrome sicca (non-SS sicca) patients, SLE patients and healthy controls.Secondary…
The purpose of the study is to investigate how quickly and to what extent an injection under the skin (subcutaneous [sc]) of UCB4940 is absorbed and eliminated from the body (this is called pharmacokinetics) in comparison with the absorption and…
Primary Objective: to study the differences in CD4+ T cell subsets (Th1/Th2/Th17/Tregulatory/Tsenescent) between GCA patients and healthy controls at diagnosis and during follow up and in remission. Secondary Objective(s): - To characterize the cell…
(1) To determine frequency of antibody-mediated encephalopathy in adults with new-onset epilepsy/status epilepticus or chronic epilepsy. (2) To assess outcome of antibody-mediated encephalopathy in adults with epilepsy, and identify markers for good…
The primary aim of the current proposal is to get a better understanding of how CeD risk genes contribute to disease aetiology. To achieve this, we will apply a holistic approach in which we will study the behaviour of immune cells and the…
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…
This study aims to enhance pharmacotherapeutic effects in patients with recent-onset RA by means of conditioning (via a variable reinforcement schedule).
Does humoral and/or cellular rejection play a role in recurrent miscarriage of unknown etiology?Can biomarkers of humoral and/or cellular rejection be used for the detection of patients who are likely to suffer a miscarriage in a next pregnancy?
Primary Objective: To gain more insight in the genetic susceptibility for AIH. For this we will study the presence of candidate genes in AIH patients, study genetic similarities with other auto-immune diseases and perform a whole genome association…
The primary objective of CDfuture is to provide duodenal biopsies of patients with and without CD, and venous blood samples, to continue CD research as described above.
Primary Objective: 1. Determine if assessment of mucosal and serological immunological characteristics in combination with clinical indicators of disease behaviour and response to therapy can identify immune-based phenotypes with implications for…