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Bright light therapy in rheumatoid arthritis to improve symptoms of fatigue and other disease outcomes: a randomized controlled pilot trial.

The primary objective of this pilot trial is to explore the difference between the intervention and control group in change from baseline (T0) to the end of therapy (T1) in therapy efficacy of the primary study outcome fatigue assessed by Checklist…

A randomized, 2-part, placebo controlled phase 1 study to evaluate safety, tolerability, pharmacokinetics and immunogenicity following single ascending doses (Part 1) and multiple ascending doses (Part 2) of GBR 830 in adult healthy subjects

The purpose of the study is to investigate to what extent GBR 830 is tolerated. It will also be investigated how quickly and to what extent GBR 830 is absorbed and eliminated from the body (this is called pharmacokinetics). In addition, the effect…

Nutrition-based approach to support antigen-specific immunotherapy in subjects with cow's milk or peanut allergy

To study the immunomodulatory effects of non-digestible oligosaccharides using peripheral blood mononucleated cells isolated from blood of healthy controls and patients with peanut or cow*s milk allergy.

A single dose clinical trial to study the safety of ART-I02 in patients with rheumatoid arthritis

Primary objectiveTo evaluate the safety and tolerability of a single intra-articular administration of ART-I02, a recombinant adeno-associated virus (AAV) type 2/5 vector in subjects with RA and active arthritis in the wrist.Secondary objectives1.…

A Randomized, Double blind, Placebo Controlled Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX 113 in Patients with Myasthenia Gravis who have Generalized Muscle Weakness

Primary Objective:* To evaluate the safety and tolerability of ARGX-113.Secondary Objectives:* To evaluate the clinical effect of ARGX-113 using:-Myasthenia Gravis-Activities of Daily Living (MG-ADL) score.-Quantitative-Myasthenia Gravis score (QMG…

Fatigue in patients with primary Sjögren*s syndrome

> Can fatigue in pSS patients be explained by force decline during a fatiguing task, muscle activation, mood, and the serum levels of proinflammatory cytokines? > What is the contribution of central factors (muscle activation) and…

A Nutritional intervention study to evaluate the effect Of Bovine Lactoferrin on innate immunity in Elderly people

Aim of the current study is to evaluate the effect of lactoferrin on the innate immune response in elderly in a pilot study. Furthermore, support of this effect by GOS and Vitamin D will be studied.

Phase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects with Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate with or without TNF Inhibitors.

Primary Objective:To compare the efficacy of BMS-986142 versus placebo on a background of MTX as assessed by ACR20 and ACR70 response rates at week 12.Secondary Objectives:1) Assess additional efficacy outcomes of BMS-986142 at week 12 and over 12…

A randomized, double-blind, two-way crossover study to compare the pharmacokinetics, pharmacodynamics and safety of a single subcutaneous administration of LA-EP2006 and a single subcutaneous administration of Neulasta® (EU-authorized) in healthy subjects

The purpose of the study is to compare LA-EP2006 and Neulasta® with respect to how quickly and to what extent the compounds are absorbed and eliminated from the body after injection under the skin of the abdomen (this is called pharmacokinetics). It…

The effect of TNF blocking therapy on cardiac function in patients with active rheumatoid arthritis

Hypothesis - Our hypothesis is that TNF blocking medication improves cardiac function in patients with active RA. Objectives - Primary objective: to investigate the effect of TNF blocking therapy on diastolic left ventricular (LV) function in RA…

Multicenter, open-label extension study to investigate the long-term safety and efficacy of IgPro20 in maintenance treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) in subjects completing study IgPro20_3003.

Primary objective: To evaluate the long-term safety of IgPro20.Secondary objectives: * To evaluate the long-term safety of IgPro20 by dose. * To evaluate the efficacy of IgPro20.Exploratory objectives:* To evaluate health-related quality of life (…

Randomized, double-blind, placebo-controlled phase III study (ASAP III study) to assess the efficacy and safety of Abatacept treatment in patients with primary Sjögren*s syndrome
(ASAP III study = Abatacept Sjögren Active Patients phase III study)

Primary: to assess efficacy of weekly subcutaneous (SC) administration of Abatacept vs. placebo on disease activity assessed with ESSDAI at in patients with pSS. Secondary: to assess efficacy of Abatacept on clinical, functional, subjective, and…

The effectiveness of a sports program on fatigue and QoL in IBD patients with quiescent disease

Primary Objective: - To assess the effectiveness of a sports program on fatigue and quality of life in IBD patients with quiescent disease and chronic fatigue.Secondary Objectives: - To assess the influence of a sport program on the physical fitness…

Compromised mandibular function in Juvenile Idiopathic Arthritis: intervention

To contrast jaw exercises and corticosteroid injection via arthrocentesis in children with JIA and MRI confirmed TMJ arthritis despite 1 year regular treatment by the rheumatologist, in a randomized clinical trial, both in combination with continued…

A Phase 4 Trial Assessing the ImPact of Residual inflammation detected via imaging tEchniques, Drug levels and patient characteristics on the outcome of dose taperIng of adalimumab in Clinical remission rheumatoid arThritis (RA) subjects (PREDICTRA)

The primary objective is to investigate the association between residual disease activity at Baseline as detected by magnetic resonance imaging (MRI) and the occurrence of flares in RA subjects randomized to an adalimumab dose tapering regimen…

A randomized, double-blind, placebo and positive controlled, parallel group study to investigate the QTc exposure response, pharmacokinetics, safetyand tolerability after multiple therapeutic and supratherapeutic dosing of etrasimod (APD334) in healthy adult subjects

The purpose of the study is to investigate the effect of etrasimod on the values of specific ECG parameters. Importantly, the study will assess whether there is a prolongation of the QT interval following etrasimod treatment. When the QT interval is…

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults with Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura).

Core Study:Primary objective: • To demonstrate that the efficacy of E5501 (in addition to standard of care) is superior to placebo (in addition to standard of care) for the treatment of adult subjects with chronic immune thrombocytopenia (idiopathic…

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…

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

ln this study the effect of 1 novel compound on the development of psoriasis in the humanized mouse model isinvestigated. The efficacy is compared to a registered drug, Ustekinumab.

A phase Ib double-blind, placebo-controlled, randomized, dose-escalating trial to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of repeated subcutaneous injections of MT203 in patients with mild to moderate rheumatoind arthritis (RA) on treatment with methotrexate.

Primary objective: Safety and tolerability of repeated subcutaneous injections of MT203 in patients with mild to moderate RA.Secondary objectives: Pharmacokinetics, pharmacodynamics, including explorative biomarker assessments and efficacy of…