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Peanut protein detection in serum

The primary objective is to set-up a well-defined sandwich ELISA method to measure the levels of Ara h6 in blood after peanut consumption.

Effects of BCG vaccination on immunological characteristics of hematopoetic stem cells: an explorative study

To examine the effect of BCG vaccination on the composition and function of the bone marrow.

Biomarkers of the HIV reservoir

Primary objectivesLongitudinal quantification of the total latent HIV reservoir with determination of the size of the replication competent HIV reservoir and investigate potential biomarkers of the HIV reservoir size and nature.Cross compare the…

DEfective HUman SAlivary gland stem cells: the cause of Primary Sjögren*s syndrome?
-DEHUSAPS study-

To assess whether salivary gland stem cell (SGCS) defects are key to salivary gland pathogenesis in pSS.

A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)

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-…

SIMILAR Trial: Santeon InflixMab biosimILAr Research
A randomized, controlled, double blind, phase 4 noninferiority trial to assess efficacy of Infliximab-biosimilar (Inflectra) compared to Infliximab-innovator (Remicade) in patients with inflammatory bowel disease in remission

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…

A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis

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…

FAST * Food Allergy Specific ImmunoTherapy
A multinational phase IIb study to investigate the efficacy and safety of subcutaneous immunotherapy with a modified fish- parvalbumin given in single rising and maintenance doses to subjects allergic to fish

To evaluate the efficacy and safety of a SCIT-treatment with a mutant recombinant fish-parvalbumin (mCyp c1) quantified in mass units and formulated in a solution with alum, in subjects with fish-allergy.

Dose range finding pilot study for diagnostic patch testing with ME-PPD

Primary Objective: Pilot study to identify the optimal patch test concentration for detecting contact allergy to ME-PPD in subjects with a proven contact allergy to PPD, who may be allergic to ME-PPD. Hypothesis: In this study subjects will be…

Peanut protein detection in serum and exercise

De objective of this study is to analyse the effect of exercise on the levels of Ara h6 in the blood after peanut consumption. Next to this we would like to know whether these levels found are in associated with the measure of intestinal…

A novel class of regulators: the potential of IL-10 producing B cells in decreasing allergic inflammation in asthmatic patients.

Conditions that promote IL-10 producing B cells in humans are still ill defined. In this project our aim is to investigate the frequnecy of IL-10 producing B cells in healthy volunteers. Next, we aim to compare this to the frequency of IL-10…

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,…

Immune monitoring to characterize T-cell responses of kidney transplant patients during co-stimulation blockade by belatacept

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…

Characterization and localization of microstructural changes in brain tissue in Neuropsychiatric Systemic Lupus Erythematosus (NPSLE)

• To increase the sensitivity of the current MRI methods for detecting the changes caused by NPSLE through the scans made on the 7 Tesla scanner, since the higher field strength will lead to a higher signal to noise ratio and higher resolution. • To…

A phase IIb, Double Blind, Randomized, placebo- controlled, Double-Dummy, Dose Rangining Study To Evaluate the Clinical Efficacy and Safety of Induction and Maintenance therapy with BMS- 945429 in subjects with Moderate to Severe Crohn's Disease.

Objectives1.3.1 Primary ObjectiveCompare the efficacy of BMS-945429 versus placebo for induction of clinical remission (defined by an absolute Crohn*s Disease Activity Index [CDAI] score < 150) at Week 8 (IP-57).1.3.2 Secondary Objectives•…

A two part, phase 1, randomised, placebo-controlled, single ascending dose study to evaluate the safety, tolerability and pharmacokinetics of GBR 830 in adult healthy volunteers (Part 1) and a randomised, placebo-controlled, pharmacodynamic study to evaluate the effect of single dose of GBR 830 on vaccination response in adult, healthy volunteers (Part 2)

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…

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…

Effects of Single Dose of Bilastine 20mg on Flying Ability in Healthy Volunteers Under Conditions of Simulated Cabin Pressure

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…

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…