242 results
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 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 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…
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:To evaluate if the proportion of patients in clinical remission on canakinumab 4mg/kg (+/- concomitant NSAID only) who are able toremain on a reduced canakinumab dose (2mg/kg every 4 weeks) or prolonged canakinumab dose interval (4mg/kg…
The objective of this study is twofold. First, we want to investigate the effectiveness of a COBRA-plus therapy after incomplete response on COBRA-light therapy after 13 weeks to improve the percentage of RA-patients with a high disease activity and…
To examine if intravenous administration of iron ismore efficacious than oral iron in improvement offitness scores, iron status and reduction of fatigue
Primary objective- To explore the pharmacodynamic effects of topically applied IMQ (in combination with or without TS) - To identify dose-response relationship of topically applied IMQ Secondary objective- To assess safety and tolerability of…
To investigate whether an add-on mindset & physical therapy program based on the *Wim Hof Method* can safely and efficaciously be applied in patients with active axial spondyloarthritis.
Primary Efficacy ObjectiveThe primary efficacy objective is to determine the long term efficacy of vagal nerve stimulation as assessed by the DAS28 score.Secondary Efficacy ObjectivesThe secondary efficacy objectives are to determine the long term…
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…
Primary objectiveTo evaluate the safety and tolerability of a single intra-articular administration of ART-I02, a recombinant adeno-associated virus (AAV) type 2/5 vector in subjects with RA and active arthritis in the wrist.Secondary objectives1.…
> Can fatigue in pSS patients be explained by force decline during a fatiguing task, muscle activation, mood, and the serum levels of proinflammatory cytokines? > What is the contribution of central factors (muscle activation) and…
Hypothesis - Our hypothesis is that TNF blocking medication improves cardiac function in patients with active RA. Objectives - Primary objective: to investigate the effect of TNF blocking therapy on diastolic left ventricular (LV) function in RA…
Primary Objective: - To assess the effectiveness of a sports program on fatigue and quality of life in IBD patients with quiescent disease and chronic fatigue.Secondary Objectives: - To assess the influence of a sport program on the physical fitness…
To contrast jaw exercises and corticosteroid injection via arthrocentesis in children with JIA and MRI confirmed TMJ arthritis despite 1 year regular treatment by the rheumatologist, in a randomized clinical trial, both in combination with continued…
ln this study the effect of 1 novel compound on the development of psoriasis in the humanized mouse model isinvestigated. The efficacy is compared to a registered drug, Ustekinumab.
Primary objective:To evaluate the long-term safety of BI 695500 in adult patients with moderate tosevere active rheumatoid arthritis (RA) who have successfully completed treatment inTrial 1301.1.Secondary objective:* To assess the long-term efficacy…
The primary aim of this study is to investigate the recovery of the circadian rhythm of the hypothalamic-pituitary-adrenal axis during a glucocorticoid tapering regime. Secondary objectives include the effect of a tapering regime on melatonin rhythm…