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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…

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.

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.

A Phase I, Randomized, Single-Center Study to Investigate the
Safety, Tolerability, Pharmacodynamic and Pharmacokinetic Profiles of Single and Multiple Doses of R924548 in Healthy Human Subjects

Primary: to investigate the safety and tolerability in healthy subjects of single and multiple ascending oral doses of R548 formulated and dosed as an aqueous suspension or aqueous solutionSecondary: - to characterize the single dose and steady…

Prospective follow-up study of golimumab treatment in psoriatic arthritis

To determinate the efficacy and safety of golimumab in patients with psoriatic arthritis in daily clinical practice prospectively. In addition, the effect of treatment with golimumab on the lipid profile will be monitored during this study and…

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…

Efficacy analysis of a novel compound in a humanized mouse model for psoriasis and development of the humanized mouse model

In this study the effect of a novel compound on the development of psoriasis in the humanized mouse model is investigated. In addition, the material of 3 donors wil be used to develop the mouse model further and train technicians. The focus will be…

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 Phase I Study to Investigate the Absorption, Metabolism, and Excretion of Radiolabeled [14C] R924548 Following Single Oral Dose Administration in Healthy Male Subjects

- To assess the absorption, distribution, metabolism and excretion of R924548 after a single oral dose- To assess the safety and tolerability of R924548 after a single oral dose

A Phase 1, Randomized, Placebo- and Active-Controlled, Double-Blind, 4-Period Crossover ECG Study to Evaluate the Effect of VX 509 on QT/QTc Interval in Healthy Adult Subjects

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

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.

SOM230 Graves Orbitopathy pilot trial

Therefore, we aim to investigate in a pilot trial the effect of SOM230 on predefined endpoints in patients with moderate to severe GO whom have contraindications for prednisolone therapy or decline from prednisolone therapy for other reasons.