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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…

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 MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN COMBINATION WITH METHOTREXATE FOR INDUCING AND SUSTAINING CLINICAL RESPONSE IN THE TREATMENT OF DMARD-NAÏVE ADULTS WITH EARLY ACTIVE RHEUMATOID ARTHRITIS

The study has the following 3 main objectives pertaining to the treatment of DMARD-naïve subjects with adult-onset, early, active, RA, diagnosed within 1 year before Screening using the 2010 ACR/EULAR RA classification criteria:1.To show that…

B7 Coreceptor Molecules as Clinically-Relevant Surrogate Biomarkers in the Hyper IgD Syndrome (HIDS) form of Mevalonate Kinase Deficiency (MKD)

The objective of this study is to assess potentially new and unique biomarkers that will be specific to patients with HIDS as surrogate outcomes for eventual larger, cohort-controlled clinical studies. Our longitudinal design in a small pilot group…

Complement activation defects in pediatric oncology patients: hidden factors contributing to the increased risk of infection.

1: Elucidation of the factors that cause the complement deficiency in pediatric oncology patients. First, we will characterize the inhibitor of MASP-2 activity in patients during chemotherapy. 2: Identification of the complement component(s) causing…

Immune development in early life

1. To describe the development of the nature of the immune system in early life in a profile of cytokines, chemokines and adipokines. 2. To evaluate less invasive methods like the use of saliva or less demanding methods like the use of dried bloods…

A multicenter, double-blind, randomized, active controlled, parallel-group study
to evaluate the efficacy, safety, tolerability, and pharmacodynamic profiles of TL011 infusions
compared with MabThera® (rituximab) in subjects with severe, active rheumatoid arthritis
treated with methotrexate (MTX)

Primary objective: to demonstrate equivalence of the efficacy of TL011 in comparison with the reference product MabThera(rituximab) in subjects with severe, active RA treated with MTX.• Secondary objective: To assess the pharmacodynamics (PD),…

SCONE Study
Studies on Complement regulation in atypical hemolytic uremic syndrome following hemodialysis, plasmapheresis and treatment with Eculizumab

Objective: To analyze in more detail the complement activation and regulation and especially the functional CFH activity following three types of interventions in patients known with HUS and correlate these to clinical findings. The three…

Effects of orally administered Beta-Glucan on leukocyte function in humans, a pilot study

The primary objective of the study is to evaluate the systemic effects of orally administered Beta-glucan on innate immune responses of leukocytes. The effects of Beta-glucan will be determined by measuring the ex-vivo responsiveness of leukocytes…