Search for a trial

A multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, preliminary clinical activity and immunogenicity of multiple doses of MOR103 administered intravenously to patients with active rheumatoid arthritis.

Primary objective:To determine the safety and tolerability of multiple doses of MOR103 in patients with active rheumatoid arthritis, at ascending dose levels.Secondary objectives:- to evaluate signs of efficacy of MOR103 in patients with active…

Long term prospective observational cohort study of the safety and efficacy of golimumab in the daily clinical practice of rheumatoid arthritis with emphasis on the lipid profile

To determinate the efficacy and safety of golimumab in rheumatoid arthritis patients in daily clinical practice during 48 months. In addition, the effect of treatment with golimumab on the lipid profile will be monitored during this study.

Proof-of-concept double-blind, placebo-controlled, randomized clinical trial with nilotinib in spondyloarthritis

To evaluate the efficacy and safety of nilotinib in spondyloarthritis

500NL project

The aim of the study is to test the hypothesis that susceptibility to and severity of certain infectious and inflammatory diseases can be explained by the interaction between the genome, microbiome and immunological responses: i.e. presence of…

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…

Endoscopic treatment of salivary glands affected by Sjögren Syndrome; A pilot study

The focus of this pilot study is to investigate the results of a sialendoscopy (with or without rinsing with hydrocortisone 100mg) on the unstimulated whole mouth (UWS) and stimulated parotid (SP) (ml/min) flow of saliva, oral dryness, reported…

Effect of Tocilizumab on subclinical arterial inflammation and stiffness in patients with active rheumatoid arthritis (DAS28 > 3.2)

To investigate the effect of anti-IL6 therapy with tocilizumab on subclinical arterial inflammation (endothelial dysfunction) and stiffness in patients with treatment resistant rheumatoid arthritis at baseline and after 6 months treatment

An exploratory, open-label, single centre, phase II, proof of concept study of gevokizumab treatment in patients with Schnitzler syndrome.

The objective of this study is to explore the efficacy and safety of gevokizumab in patients with Schnitzler syndrome.

A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T)

Primary Objective is to evaluate the long-term safety of sirukumab in subjects with RA who are refractory to DMARDs or anti-TNF* agents.The secondary objectives are to observe the following long-term effects of sirukumab in subjects with RA who are…

In vitro investigation into the potential regulating role of sphingolipids in lymphocyte proliferation.

More sustained knowledge of the intracellular processes regarding S1P in lymphocytes could be beneficial in modulating specific immune responses in transplantation medicine, autoimmune diseases and sepsis. Therefore, in this study, we will…

Sandostatin therapy in sarcoidosis

Primary Objective: To evaluate efficacy of SST looking at the change in uptake on SRS in a subset of chronically active patients in which intensification of corticosteroid therapy is not indicated. . Secondary Objective(s): To study the composite…

A novel class of regulators: the potential of IL-10 producing B cells in decreasing allergic inflammation in asthmatic patients.

Conditions that promote IL-10 producing B cells in humans are still ill defined. In this project our aim is to investigate the frequnecy of IL-10 producing B cells in healthy volunteers. Next, we aim to compare this to the frequency of IL-10…

A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)

Period 1: The first objective, of period 1, is to compare the safety and efficacy of ABT-494 30 mg (QD) and 15 mg QD versus placebo on a background of csDMARD(s) for the treatment of signs and symptoms of rheumatoid arthritis (RA) in bDMARD-…

FAST * Food Allergy Specific ImmunoTherapy
A multinational phase IIb study to investigate the efficacy and safety of subcutaneous immunotherapy with a modified fish- parvalbumin given in single rising and maintenance doses to subjects allergic to fish

To evaluate the efficacy and safety of a SCIT-treatment with a mutant recombinant fish-parvalbumin (mCyp c1) quantified in mass units and formulated in a solution with alum, in subjects with fish-allergy.

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…

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…

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,…

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.