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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.

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 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…

Therapeutic drug monitoring in tocilizumab-treated rheumatoid arthritis patients: Pilot study of a double-blind randomised controlled trial

To evaluate the feasibility of the study after 20 weeks of follow-up, which includes the evaluation of the dose-reduction algorithm in tocilizumab-treated patients with RA.

The effect of Vitamin D3 to prevent postoperative relapse of Crohn*s Disease: a placebo-controlled randomized trial (DETECT)

This trial will provide definitive answers with regard to the anti-inflammatory effects of Vitamin D in Crohn*s disease.

The Clinical Efficacy And Subclinical Effects on arterial STIFFNESS of bosentan therapy added to usual care in patients with systemic sclerosis with digital ulcers.

To investigate whether bosentan added to usual care improves arterial stiffness after 3 months as measured as the pulse wave velocity (PWV) of the medium and large arteries corrected for blood pressure changes in patients with SSc with digital…

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

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

The Standard care versus Celecoxib Outcome Trial
(SCOT trial)
A Large Streamlined Safety Study

The present proposal seeks to compare the cardiovascular and gastrointestinal safety and effectiveness of a strategy of initial randomisation to treatment with the selective COX-2 inhibitor celecoxib or to *usual-care* with their current non-…

Effects of Tocilizumab (RoACTEMRA) on biomarkers in synovial tissue of patients with rheumatoid arthritis

The primary objective is to study changes in synovial inflammation in serial biopsy samples following the administration of tocilizumab in patients with active RA.The secondary objectives of this study are to:I. Assess clinical response at week 16;…

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?

International Second Immunoglobulin Dose in Guillain-Barre Syndrome patients with poor prognosis.

Primary objectiveTo determine whether a second IVIg dose in GBS patients with a poor prognosis improves functional outcome after 4 weeks.Secondary objectives To investigate whether: - a second IVIg dose in GBS patients with a poor prognosis improves…

Double dose treatment: Corticosteroid injection therapy in arthritis

To determine whether doubling the dose of corticosteroid injections in the treatment of arthritis in knee joints is more effective in the relief of symptoms as measured by change in the assessment of arthritis burden by the patient on a Likert 5-…

Dose response trial of IV immunoglobulin in chronic inflammatory demyelinating polyradiculoneuropathy

The primary objective is:1. To investigate whether high frequency low dosage IVIg treatment is more effective than low frequency high dosage as maintenance treatment for CIDP. Secondary objectives are:2. To investigate whether high frequency low…

Brimonidine Tartrate for the Treatment of Injection Related Erythema Associated with Sub-cutaneous Administration of Peginterferon beta-1a

Primary ObjectivesTo evaluate the IRE intensity/color mitigation effect of a single administration of Brimonidine tartrate in comparison with a vehicle gel (placebo).Secondary ObjectiveTo evaluate the IRE intensity/color mitigation effect of a…

Prospective follow-up study of golimumab treatment in ankylosing spondylitis.

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

A Multicenter, Randomized, Double-Blind, Study Comparing the Efficacy and Safety of Continuing Versus Withdrawing Adalimumab Therapy in Maintaining Remission in Subjects with Non Radiographic Axial Spondyloarthritis

The objective of this study is to evaluate the efficacy and safety of continuing versus withdrawing therapy with adalimumab 40 mg given every other week (eow) SC in maintaining remission in subjects with nr-axSpA.

A MULTICENTER OPEN LABEL STUDY OF ETANERCEPT WITHDRAWAL AND RETREATMENT IN SUBJECTS WITH NON RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS WHO ACHIEVED ADEQUATE 24 WEEK RESPONSE

Primary Objective* To estimate the proportion of subjects who flare within 40 weeks followingwithdrawal of ETN in subjects who have achieved ASDAS CRP less than1.3 (inactive disease).Secondary Objectives* To estimate time to flare after withdrawal…

Effects of abatacept (Orencia®) on biomarkers in synovial tissue in patients with rheumatoid arthritis

The primary objective is to study changes in synovial inflammation in serial biopsy samples following the administration of abatacept in patients with active rheumatoid arthritis.The secondary objectives of this study are to (I) assess clinical…

Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with Raptiva (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST).

PrimaryTo assess the prevalence of anti-efalizumab positivity in two sub-populations of psoriatic subjects trated with Raptiva® in the framework of the CLEARESTTM study:- Subjects developing adverse events (AEs) corresponding to pre-specified newly…