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PreCARA: Preconception Counselling in Active Rheumatoid Artritis and other chronic inflammatory arthritides;
Preconception counselling for women with rheumatoid arthritis (RA) or another chronic inflammatory arthritis and a pregnancy wish, which is evaluated in a prospective observational study monitoring pregnancy, delivery, postpartum period of the mother, and (growth) parameters of the child.

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 effect of Alphabodies® against human lnterleukin lL23 in the transplant model of psoriasis, in which a psoriatic lesion is induced in non-lesional skin transplanted onto immune-deficient (BNX) mice by injecting super-antigen activated peripheral blood cells intradermally into the transplant.

Are Alphabodies against IL23 effecive in the transplant model of psoriasis

The effect of Spherical Nucleic Acids on target gene expression in full thickness biopsies taken from lesional skin of volunteers with psoriasis vulgaris.

The specific aim of the project is to determine the efficacy of Spherical Nucleic Acids (SNAs) on psoriasis skin biopsy gene expression in vitro.

A MULTICENTER, POSTMARKETING STUDY TO EVALUATE
THE CONCENTRATION OF CERTOLIZUMAB PEGOL IN THE
BREAST MILK OF MOTHERS RECEIVING TREATMENT WITH
CIMZIA® (CERTOLIZUMAB PEGOL)
PHASE 1B (CLINICAL PHARMACOLOGY)

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…

PET imaging of arthritis by specific macrophage targeting in Rheumatoid Arthritis patients - clinical proof of concept studies

Primary aim: Stepwise feasibility study to investigate whether intravenously administered macrophage tracers [11C]DPA-713, [18F]DPA-714 and/or [18F]PEG-folate accumulate in inflamed joints of rheumatoid arthritis patients using PET(-CT).Secondary…

Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial.

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…

Children*s Autoimmunity related to Neuropsychiatric symptoms, Chorea and Epilepsy

(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…

An open-label, parallel-group, single-dose study to evaluate the absolute bioavailability and tolerability of subcutaneous UCB4940 in healthy subjects

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…

Antibodies Causing Epilepsy Syndromes

(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…

Immunogenetic and therapeutic aspects of Autoimmune Hepatitis

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…

Immunological profiles in Inflammatory Bowel Disease

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…

Hemodynamic response assessed by the *HandScan* in hand and wrist joints of patients with osteoarthritis compared to patients with rheumatoid arthritis

The aim of this exploratory study is to compare the hemodynamic response as determined by the HandScan between patients with OA and RA, and to study these hemodynamic responses in relation to disease specific underlying joint pathology (synovial…

An open-label canakinumab (ACZ885) dose reduction or dose interval prolongation efficacy and safety study in patients with Systemic Juvenile Idiopathic Arthritis (SJIA)

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…

International CIDP Outcome Study
A prospective study on clinical and biological predictors of disease course and outcome in CIDP

De lnternational CIDP Outcome Study (ICOS) aims to describe in detail the variation in clinical and electrophysiological subtypes, current practice of treatment, clinical course and outcom in CIDP. The second objective is to define the clinical and…

Is there a role for duplex ultrasound in patients with a clinical suspicion of temporal arteritis?

Determining the role of duplex ultrasound in patients with a clinical suspicion for temporal arteritis.Determing the sensitivity, specificity, negative predictive value and positive predictive value of duplex ultrasound in patients with a clinical…

COBRA treat-to-target trial

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…

Linking inflammation and hypoxia to disease subtype and course in systemic sclerosis by exploratory analysis of SMAD-linker domains study

This investigation aims to investigate connective tissue fibroblast activation in detail in the inflamed fibrotic connective tissue. By analyzing these cells in detail we hope to understand better how they are activated, so we can develop better and…

A randomized, open-label, vehicle-controlled, parallel-cohort, dose-ranging study to explore the pharmacodynamics of topically applied imiquimod in healthy volunteers

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…

Long Term Observational Study Of The Safety And Efficacy Of An Active Implantable Vagal Nerve Stimulation Device In Patients With Rheumatoid Arthritis

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…

Biomarker-guided treatment-and-stop-strategy for recombinant IL-1receptor antagonist (anakinra) in patients with systemic Juvenile Idiopathic Arthritis.

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…