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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…

A Phase II Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Immunogenicity of V212 in Adult Patients with Autoimmune Disease

The primary objective of the study is to assess the safety and immunogenicity of V212 in a population of adults with autoimmune disease.

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?

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 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…

Multicenter randomized clinical trial in Patients with Juvenile Idiopathic Athritis: Safety and efficacy of vaccination with live attenuated Measles, Mumps, Rubella vaccine

The primary goal of the current study is to study the safety of and serological response to the MMR booster vaccination in JIA patients. Based on a retrospective analysis we hypothesize that MMR vaccination does not aggravate JIA disease and that…

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…

Optimising outpatient care in mild to moderate psoriasis by a newly developed *Topical Treatment Optimising Programme* - an international study using Daivobet®/Dovobet® Gel (*PSO-TOP*)

The objective of the study is to assess the value of the *Topical Treatment Optimising Programme* in the topical treatment, which will be use together with the standard treatment, of insufficiently treated mild to moderate psoriasis after 8 weeks of…

A Single-Center, Phase I, Randomized, Double- Blind, Placebo-Controlled, First-In-Man Trial to Assess the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of
Single Ascending Doses of Subcutaneous MSB0010841 (Anti-IL-17A/F Nanobody) in Healthy Male Subjects

The purpose of this research study is to investigate how safe the compound is and how well the compound is tolerated. The study will also investigate how quickly and to what extent the compound is absorbed and eliminated from the body (this is…

A randomized, double-blind, placebo-controlled study of ascending single low doses of LPS administered intravenously to healthy volunteers to assess the dose-response relation.

To assess the relationship between administration of low doses of LPS (0.5, 1 and 2 ng/kg bodyweight) and the inflammatory response (cytokine levels and hs-CRP) in healthy male volunteers;To assess the duration of tolerance/paralysis of the immune…

A DOUBLE-BLIND, PLACEBO-CONTROLLED DOSE ESCALATION STUDY OF THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF A SUBCUTANEOUS DOSE OF SHK-186 IN HEALTHY SUBJECTS

The purpose of the study is to investigate to what extent ShK-186 is tolerated. How quickly and to what extent ShK-186 is absorbed and eliminated from the body (this is called pharmacokinetics) will be investigated.

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,…

Dose-to-target of etanercept treatment: a dose-tapering randomized controlled trial in patients with rheumatoid arthritis, ankylosing spondylitis or psoriatic arthritis.

To determine the proportion of patients with RA, AS or PsA maintaining minimal disease activity (MDA) after dose interval prolongation of etanercept. Secondary objectives: To study the cost-effectiveness of tapering down etanercept treatment, to…

Phase IIa, 2:2:1 randomised, double-blind, placebocontrolled, parallel group, multi-centre clinical trial to investigate the safety, efficacy and pharmacokinetics of recombinant human soluble Fc-gamma receptor IIb (SM101) for intravenous application in the treatment of systemic lupus erythematosus (SLE) patients with or without a history of lupus nephritis

The primary objective of the study is:Evaluate the safety of 6.0 mg/kg and 12 mg/kg SM101 per week in SLE patients with or without a history of lupus nephritis.The Secondary objective is:Evaluate the efficacy and pharmacokinetics (PK) of 6.0 mg/kg…

A Single-Center, Phase I, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of Subcutaneous MSB0010841 (Anti-IL-17A/F Nanobody) in Healthy Male Subjects

The purpose of this research is to investigate the safety and tolerability of MSB0010841. This study will also investigate how quickly and to what extent the study medication is absorbed and eliminated from the body (this is called pharmacokinetics…

Phase IIB, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active
Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous
Injection With or Without Methotrexate in Subjects with Moderate to Severe Rheumatoid
Arthritis with Inadequate Response to Methotrexate.

Primary Objective During Double-Blind Period:To compare the efficacy of BMS-945429 SC versus placebo on a background of methotrexate as assessed by ACR20 response rates at 12 weeks.Secondary Objectives During Double-Blind Period:1) To assess…

An open label, single dose study to assess the pharmacokinetics of a microdose of recombinant human placental alkaline phosphatase (hRESCAP, part 1) followed by a randomized, double-blind, placebo-controlled, parallel, single ascending dose, first-in-human study to assess safety and tolerability of hRESCAP (part 2) in healthy male volunteers

Part 1:- To assess the PK of a single iv microdose (<=30 nmol) of recombinant human placental alkaline phosphatase (hRESCAP);- To assess if microdosing is a suitable technique to predict the PK of recombinant proteins using hRESCAP as model…

A randomized, double-blind, placebo-controlled, phase 2 study to evaluate the safety and efficacy of CCX354-C in subjects with rheumatoid arthritis partially responsive to methotrexate therapy.

The primary objective of the study is to evaluate the safety and tolerability of CCX354-C in subjects with rheumatoid arthritis (RA) who had an inadequate response to methotrexate treatment.The secondary objectives of the study are to evaluate the…