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A randomised, double-blind, placebo-controlled,
multicentre prospective dose-finding Phase II/III study
with atacicept given subcutaneously to subjects having
recently experienced a flare of systemic lupus
erythematosus (SLE)

PRIMAIRYThe primary objective of this trial is to evaluate the efficacy of atacicept compared to placeboin preventing new flares in subjects with SLE.SECONDARYSecondary objectives of the trial are:• To evaluate the safety and tolerability profile 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.

Development of Tools (and prediction rules) to time and select therapy in treatment of pre-clinical, early and established Rheumatoid Arthritis: Creating Enhanced Remedy (TRACER): established reumatoid arthritis

to combine and validate diagnostic tests for the prediction of clinical response to therapy with biologics in patients with reumatoid artritis.

Mesenchymal stromal cell (MSC) transplantation in septic shock.

Evaluation of therapeutic safety and clinical efficacy of MSC transplantation in septic shock.

Muscles in Motion: Exercise rehabilitation for children and adolescents with Juvenile Dermatomyositis

In this study, we want to investigate the effects of a 12 weeks home-based exercise program (treadmill trained and strengthening) aimed to improve the aerobic fitness and muscle strength of patients with JDM. Furthermore, we want to investigate the…

Phase IIb study on the safety and efficacy of BM32, a recombinant hypoallergenic vaccine for immunotherapy of grass pollen allergy

ObjectivesPrimary Efficacy Objective• To assess the sustained clinical effect of BM32 during 2 consecutive treatment years compared to placebo. The clinical effect of BM32 is evaluated by a combined Symptom-Medication-Score (SMS) which is recorded…

A randomized double blind, placebo-controlled study of fluoxetine in progressive multiple sclerosis (FLUOX-PMS)

We expect that in people with multiple sclerosis the processing of energy substances such as sugars (energy metabolism)i n the brains is not optimal . In our view this could explain the progressive deterioration of the disease. Currently there are…

A randomized, double-blind, placebo-controlled PK/PD guided, phase I study in healthy volunteers given escalating, single intravenous doses of NI-0101 in the absence or presence of a systemic LPS challenge.

Part 1:- To assess tolerability, safety and PK of escalating single Intravenous (IV) doses of NI-0101 in healthy volunteers with the aim of covering a wide range of plasma concentrations up to those theoretically reflecting a potential therapeutic…

COBRA-light study, an open randomised trial comparing a modified COBRA therapy with the COBRA therapy according to BeSt in early rheumatoid arthritis.

Are there differences is efficacy, side effects, tolerance en costs in patients with early RA in treatment with COBRA-light compared with COBRA according to BeSt?

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…

BeSt for kids: A randomized clinical trial to test the effectiveniss of different treatment strategies in patients with Juvenile Idiopathic Arthritis

The aim of this study is to investigate, by direct comparison, which of 3 treatment strategies is the most effective and safe. The treatment goal in all strategy arms will be inactive disease. When inactive disease is achieved according (to the…

A study to evaluate the response of whole blood stimulation with lipopolysaccharide or other inducers and its in vitro inhibition in healthy volunteers, and patients with a chronic inflammatory condition

At CHDR, experience has been gained with the assessment of the in vitro inhibition by MAP kinases of the LPS-induced TNFα release in healthy male volunteers. However, relatively little is known on the inhibition by MAP-kinases in other populations.…

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate Efficacy and Safety of Treatment with CNTO 136 Administered Intravenously in Subjects with Active Lupus Nephritis

Primary Objective(s)The primary objective is to evaluate the efficacy and safety of CNTO 136 administered intravenously in subjects with active, ISN/RPS Class III and IV LN.Secondary ObjectivesThe secondary objectives are:Evaluate the…

A multi-centre, randomized, double-blind, placebo-controlled, dose range finding study to identify the optimal (i.e. safe and effective) dose of PURETHAL® Mites SCIT in patients with house dust mites-induced persistent allergic rhinitis/rhinoconjunctivitis.

The objective of the present study is to characterize the dose-response relationship of PURETHAL® Mites (PM) with a nasal provocation test in order to identify the optimal dose in terms of highest clinical efficacy and safety.

ANTI-IGE THERAPY (OMALIZUMAB)
IN IGE-ACPA POSITIVE RHEUMATOID ARTHRITIS
Addendum: An open label extension study to provide continuation of anti-IgE therapy to Rheumatoid Arthritis patients who participated in the TIGER study P10.161

- To evaluate the safety and efficacy of anti-IgE therapy with respect to:Clinical disease activity (DAS44), laboratory parameters and adverse events. - To evaluate whether disease activity correlates with immunological parameters, including…

Efficacy analysis of a novel compound in a humanized mouse model of psoriasis

In this study the effect of a novel compound on the development of psoriasis in the humanized mouse model is investigated.

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…

SubCutaneous Immunotherapy Treatment Effect (CITE) study

We seek to elucidate the immune mechanism(s) that are relevant for clinical tolerance to inhalant and food allergens. For this purpose, patients suffering from allergy to birch pollen and/or house dust mite who receive routine-SIT will be assessed…

An open-label, multiple-dose, two-treatment period study to evaluate the effect of oral BAF312 on
the pharmacokinetics and pharmacodynamics of a monophasic oral contraceptive in healthy
female volunteers.

Objectives:- To investigate whether BAF312 administered daily at a dose of 4 mg can affect exposure (Cmax,ss and/or AUCtau) to a daily administered monophasic oral contraceptive (OC) regimen containing 30 µg of ethinylestradiol (EE) and 150 µg of…

AN OPEN LABEL EXTENSION STUDY TO ASSESS THE LONG TERM SAFETY OF ETANERCEPT IN CHILDREN AND ADOLESCENTS WITH EXTENDED OLIGOARTICULAR JUVENILE IDIOPATHIC ARTHRITIS, ENTHESITIS RELATED ARTHRITIS, OR PSORIATIC ARTHRITIS WHO WERE PREVIOUSLY ENROLLED IN PROTOCOL 0881A1 3338 WW(B1801014)

Primary* To monitor the occurrence of malignancy in pediatric subjects with extended oligoarticular JIA, ERA, or PsA.Secondary* To assess the long-term safety profile of etanercept.