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Diagnostics and mechanisms of titanium allergy

Primary Objective:Pilot study: Selection of the titanium derivatives which are capable of penetrating the skin, and thus can be used in the full study as patch test materials.Full study: To compare the results of three different diagnostic tests…

Dose range finding pilot study for diagnostic patch testing with ME-PPD

Primary Objective: Pilot study to identify the optimal patch test concentration for detecting contact allergy to ME-PPD in subjects with a proven contact allergy to PPD, who may be allergic to ME-PPD. Hypothesis: In this study subjects will be…

A randomized, open-label, vehicle-controlled, parallel-cohort, dose-ranging study to explore the pharmacodynamics of topically applied imiquimod in healthy volunteers

Primary objective- To explore the pharmacodynamic effects of topically applied IMQ (in combination with or without TS) - To identify dose-response relationship of topically applied IMQ Secondary objective- To assess safety and tolerability of…

A randomized, double-blind, placebo-controlled study to compare the immune effects of multiple doses of vitamin D3 in patients with allergic rhinitis/rhino-conjunctivitis caused by birch pollen and in healthy control subjects.

The primary objective is to evaluate whether 2.5 µg VD3 analogue (Zemplar® * Abbvie) in multiple subcutaneously administered doses induces a more favourable (read: anti-inflammatory) systemic immune modulation both in general parameters and allergen…

Long Term Observational Study Of The Safety And Efficacy Of An Active Implantable Vagal Nerve Stimulation Device In Patients With Rheumatoid Arthritis

Primary Efficacy ObjectiveThe primary efficacy objective is to determine the long term efficacy of vagal nerve stimulation as assessed by the DAS28 score.Secondary Efficacy ObjectivesThe secondary efficacy objectives are to determine the long term…

Biomarker-guided treatment-and-stop-strategy for recombinant IL-1receptor antagonist (anakinra) in patients with systemic Juvenile Idiopathic Arthritis.

This study has been transitioned to CTIS with ID 2024-518684-35-00 check the CTIS register for the current data. The current project proposal continues on our findings of the performed prospective cohort study, aiming to develop a biomarker guided…

An open-label, multicentre, phase IV study to investigate the infliximab serum concentration of Remsima* (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn*s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission.

To demonstrate that the infliximab serum concentration of Remsima* is non-inferior to the infliximab serum concentration of Remicade , 16 weeks after switch from Remicade to Remsima* in subjects with CD, UC or RA in stable remission for > 30…

A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive

Primary ObjectiveThe primary objective for this study is to compare the clinical efficacy of weekly abatacept in combination with methotrexate to methotrexate alone in achieving Remission, defined as SDAI less than or equal to 3, at Week 24.…

PreCARA: Preconception Counselling in Active Rheumatoid Artritis and other chronic inflammatory arthritides;
Preconception counselling for women with rheumatoid arthritis (RA) or another chronic inflammatory arthritis and a pregnancy wish, which is evaluated in a prospective observational study monitoring pregnancy, delivery, postpartum period of the mother, and (growth) parameters of the child.

In the present study we will evaluate the standardized care protocol developed in our outpatient clinic, intended to guide counselling for medication use prior to pregnancy. This protocol guides treatment decisions based on disease activity,…

Photoacoustic detection and monitoring of synovitis in finger joints with rheumatoid arthritis.

-To determine the feasibility of detection of synovitis by photoacoustic imaging using three discrete wavelengths of pulsed light as an early indicator of the presence of RA.-To correlate the photoacoustic markers that are indicative for…

A Phase II, Double-Blind, Randomized, Placebo-Controlled, Parallel Group
Pilot Study to Evaluate the Safety and Efficacy of FFP104 in the Treatment of
Subjects with Moderate to Severely Active Crohn*s Disease

To evaluate the safety and efficacy of intravenously administered FFP104 in subjects with active Crohn*s disease following repeat doses of FFP104.

A phase 1, open-label, 2-period, fixed sequence, study to investigate the absorption, metabolism and excretion of 14C-PF-06650833 and to assess the absolute bioavailability and fraction absorbed of PF-06650833 in healthy male subjects using a 14C-microdose approach.

The purpose of this study is to investigate how quickly and to what extent PF-06650833 is absorbed, distributed, metabolized (broken down) and eliminated from the body (this is called pharmacokinetics). PF-06650833 is not registered as a drug, but…

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…

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 (…

Identification of multiple potential triggers in sarcoidosis patients

To determine the prevalence of mycobacterial, propionibacterial and beryllium, aluminium and zirconium sensitized patients within a well-defined Dutch cohort of biopsy proven sarcoidosis patients.New clinico-pathological phenotypes within the group…

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…

Immunological characteristics in UC patients that predict response on Vedolizumab

Determine if there are immunological or patient characteristics in UC patients that predict the endoscopic response on Vedolizumab treatment.

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…

Systemic sclerosis: CT-derived evaluation of interstitial lung disease and pulmonary vasculopathy for assessment of progression of disease.
Research protocol for extended volume HRCT-thorax in patients with systemic sclerosis participating in a 2 *day multidisciplinary team care program of the department of Rheumatology and Pulmonology

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