Search for a trial

SIMILAR Trial: Santeon InflixMab biosimILAr Research
A randomized, controlled, double blind, phase 4 noninferiority trial to assess efficacy of Infliximab-biosimilar (Inflectra) compared to Infliximab-innovator (Remicade) in patients with inflammatory bowel disease in remission

The objective of this study is to compare the efficacy of Infliximab-biosimilar to Infliximab-innovator and to demonstrate its noninferiority up to 30 weeks, in patients with ulcerative colitis or Crohn*s disease in remission under treatment with…

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.

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…

Long term effectiveness of COBRA-light and COBRA treatment in early rheumatoid arthritis

The follow-up study has two main research questions:o Is the treatment of early RA according to the COBRA-light schedule as effective (based on DAS44 score, ACR/EULAR remission criteria, HAQ score and the Sharp/van der Heijde score) as standard…

Immune response after Human Papillomavirus vaccination in patients with automimmune disease

Objective: The primary goal of the current study is to study the immunogenicity and safety of HPV vaccination in patients with an autoimmune disease. Based on retrospective analysis with other vaccines we hypothesize that patients with autoimmune…

A clinical outcomes study to evaluate the effects of IL-6 receptor blockade with tocilizumab (TCZ) in comparison with etanercept (ETA) on the rate of cardiovascular events in patients with moderate to severe rheumatoid arthritis (RA).

Primary ObjectiveThe primary objective of this study is to compare prospectively in patients treated with TCZ or etanercept (ETA), the time to first occurrence of any component of a composite of major adverse cardiovascular events (MACE) consisting…

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.

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;…

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.

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…

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-…

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…

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?

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…

Open-label, Phase 4 Study, investigating the Incidence of Extra-Articular Manifestations in Subjects with Ankylosing Spondylitis treated with Golimumab

Until recently there were only few therapeutic options to treat AS. Efficacy is proven for several tumor necrosis factor (TNF)-blocking agents, including golimumab. 2-8 However, up to now, the efficacy of golimumab treatment on EAMs, like anterior…

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…