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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…

Immune response after Human Papillomavirus vaccination in patients with automimmune disease

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…

An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2).

Part 1: To assess the safety and effectiveness of subcutaneous golimumab 50 mg (SC-GLM50), administered by autoinjection once monthly during 6 months, when combined with different DMARD regimens used in daily rheumatology. Part 2: In subjects who…

Double-blind, placebo-controlled, multiple ascending-dose study to investigate the safety and tolerability of AZ01 in healthy volunteers.

Primary:- assess safety and tolerability and determine the maximum tolerated dose (MTD) of repeated doses or a single dose of AZ01 given as a subcutaneous (SC) or intravenous (IV) dose in healthy subjects. Dosing will not exceed the maximum feasible…

A multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, preliminary clinical activity and immunogenicity of multiple doses of MOR103 administered intravenously to patients with active rheumatoid arthritis.

Primary objective:To determine the safety and tolerability of multiple doses of MOR103 in patients with active rheumatoid arthritis, at ascending dose levels.Secondary objectives:- to evaluate signs of efficacy of MOR103 in patients with active…

A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and
Safety of CNTO 328 (Anti-IL-6 Monoclonal Antibody) Plus Best Supportive Care
Compared With Best Supportive Care in Subjects With Multicentric Castleman*s
Disease

Primary Objective:The primary objective of this study is to demonstrate that CNTO 328 in combination with BSC is superiorto BSC in terms of objective response (complete response [CR] + partial response [PR]) among subjectswith multicentric Castleman…

An open-label non-randomized extension study to evaluate the safety and tolerability of AIN457 (anti interleukin-17 monoclonal antibody) in patients with moderate to severe ankylosing spondylitis

This study is designed as an extension study to the proof-of-concept trial CAIN457A2209 in patients with ankylosing spondylitis and aims to provide continuous treatment with AIN457 for patients in the core trial, to obtain safety and tolerability…

A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations

The primary objective of this study is:To demonstrate that the percentage of patients who meet the adapted ACR Pediatric 30 criteria at Day 15 is higher with canakinumab compared to placebo.Secondary objectives of this study are:* To evaluate the…

Differences in gene expression profile between Glucocorticoid-responsive and Glucocorticoid-nonresponsive patients with rheumatoid arthritis

It is our goal to predict the efficacy of glucocorticoid-treatment of RA patients by means of a list of markers predicting the reponse to GC treatment in order to avoid ineffective but potentially harmful treatment in the glucocorticoid non-…

Can the sensitization profile towards hazelnut, peanut and birch pollen be used to predict the severity of clinical symptoms of hazelnut allergy in both children and adults?

To analyze whether the sensitization profile towards hazelnut, peanut and birch pollen and their major individual allergens can be used to predict whether the hazelnut allergy is associated without/with mild clinical symptoms or severe clinical…

A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations

The primary objectives of this study are:Part II: to demonstrate that the time to flare in Part II is higher with canakinumab than with placebo.Part I: to assess if canakinumab allows tapering of steroids as per protocol in at least 25% of…

An open label non-randomized extension study to evaluate the safety and tolerability of AIN457 (anti interleukin-17 monoclonal antibody) in patients with psoriatic arthritis

This study is designed as an extension study to the proof-of-concept trial CAIN457A2206 in patients with psoriatic arthritis and aims to provide continuous treatment with AIN457 for patients in the core trial, to obtain safety and tolerability…

A Phase 3, Randomized, Double-Blind, Multinational, Placebo-Controlled Study to Evaluate Efficacy and Safety of Teplizumab (MGA031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Children and Adults with Recent-Onset Type 1 Diabetes Mellitus

Primary: The primary objective of this study is to assess relative to placebo, the efficacyof teplizumab when administered according to 3 different teplizumab dosing regimens in subjects with recent-onset T1DM (within 12 weeks of presentation of…

TECOS: A Randomized, Placebo Controlled Clinical Trial to Evaluate Cardiovascular Outcomes after Treatment with Sitagliptin in Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control

To compare the impact of adding sitagliptin to usual care vs. usual care without sitagliptin with regard to the risk of developing cardiovascular events.

The role of persistent gastrointestinal viral infections in the development of
enteropathy in children with Common Variable Immunodeficiency and secundary immunodeficiencies

To describe the prevalence of enteropathogenic viruses in children with primary (CVID and CVID-like disease) and secundary immunodeficiencies and a potential relation between this prevalence and the development of auto-/allo-immune enteropathy.

An open label extension study of canakinumab (ACZ885) in patients with systemic juvenile idiopathic arthritis (SJIA) and active systemic manifestations who participated in studies ACZ885G2301 and ACZ885G2305; and response characterization study in canakinumab treatment-naive patients with active SJIA with and without fever.

The purpose of this open-label phase III extension study is to collect additional long term safety and efficacy data on canakinumab in the treatment of SJIA from patients who qualify to roll-over into this study from the CACZ885G2305 and…

Cost-effectiveness of subcutaneous immunotherapy in adults with allergic rhinitis

First, to estimate the cost-effectiveness of SCIT with tree pollen (TP), grass pollen (GP), and house dust mites (HDM) - the most prevalent allergies treated with SCIT - or combinations compared with UC. Second, to estimate the clinical efficacy of…

Screening first-degree relatives of Celiac Disease patients, does it affect gastro-intestinal symptoms and quality of life?

The aim of this randomized controlled trial is to determine the affect of screening on the Gastrointestinal symptoms (GIS) and Health Related Quality of Life (HRQL) in asymptomatic first degree relatives of CD patients. On the basis of the results,…

Response to hepatitis A and B vaccine among children with immunesuppression due to either hiv or immunesuppressive medication

To protect children with hiv and children using immune-suppressive medication against hepatitis A and B, and to determine the immunogenicity of the combined hepatitis A and B vaccine in these children.

MOODINFLAME - Early diagnosis, treatment and prevention of mood disorders targeting the activated inflammatory response system - Bipolar patients cohort

To evaluate two biomarker tests (characterized by an activated inflammatory response system (IRS) as reflected by an aberrant monocyte gene expression signature and/or a disturbed metabolism of tryptophan) by comparing patients with BD with healthy…