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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…

Lengthening Adalimumab Dosing Interval in IBD patients in long term remission, the LADI study.

To assess the safety of lengthening the adalimumab dosing interval from 2 to 3 weeks, in patients with Crohn*s disease or ulcerative colitis in long term (6 months) remission.

A randomized controlled withdrawal trial in Crohn's disease patients in long-term remission on mesalazine: the CROWN study

Primary objectives1. What is the effect of stopping mesalazine in the maintenance setting of patients with quiescent CD?2. Can subgroups of CD patients, for example based on prior treatment (medical vs. surgical), localization of disease, disease…

Hepatic histology of IBD patients following one year of combination therapy with allopurinol and low-dose conventional thiopurines

To determine the percentage of patients with nodular regenerative hyperplasia of the liver after at least 1 year of combination therapy of allopurinol and low dose AZA or MP and to compare this with the reported findings of 6TG induced NRH

Liver toxicity of azathioprine and 6-mercaptopurine in IBD patients.

The primary goal of the study is the prevalence of NRH in patients with IBD, who have been treated for at least five years with azathioprin or 6-mercaptopurin. A MRI of the liver, using the Seiderer protocol, and a percutaneous liver biopsy will be…

Precision dosing of infliximab (IFX): the efficacy and economic effect of *precision dosing* of maintenance treatment with IFX in comparison with standard IFX maintenance treatment in inflammatory bowel disease.

Aim of this study is to investigate the efficacy of *precision dosing* IFX maintenance treatment in comparison with standard IFX maintenance treatment in IBD patients in clinical remission.

A Multicenter, Prospective, Long-term Registry of Pediatric
Patients with Crohn*s Disease and Ulcerative Colitis

The objective of this registry is to obtain long-term safety and clinical statusinformation on pediatric patients with IBD (ie, CD, UC, or IC).

A proSpective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheRapy and infliximab monothErapy in Crohn*s disease patients in sustained steroid-free remission on combination therapy.

To assess the effect of two withdrawal strategies over two years in patients with stable remission for more than 8 months on combination therapy with infliximab and antimetabolites, and demonstrate that continued combination of infliximab and…

The antibody response to pneumococcal vaccination in patients
with inflammatory bowel disease patients treated with immunosuppressive agents

Primary objective: to determine the vaccine efficacy of PCV13 plus PPV23 (2-month series) in cases, i.e. IBD patients treated with immunosuppressive agents, vs controls. Secondary objectives: - To assess if the use of a TNF-alpha inhibitor affects…

Non-inferiority multicentre randomized controlled trial comparing short versus standard course postoperative antibiotic treatment for complex acute appendicitis

The goal of this study is to evaluate efficacy and safety of stopping postoperative antibiotic treatment after 48 hours of intravenous therapy versus continuing for three more days (to complete a total of five days which is common practice),…

Randomized, Multicenter Study to Investigate the Efficacy of Dashboard Driven Individualized Dosing of Infliximab Compared To Standard Dosing During the Induction in Patients with Acute Severe Ulcerative Colitis

The primary objective of this randomized controlled trial is to investigate the efficacy of dashboard driven dosing of infliximab compared to standard dosing during the induction phase in patients with acute severe ulcerative colitis, as evaluated…

De-escalation of anti-TNF therapy in adolescents and young adults with IBD with tight faecal calprotectin and trough level monitoring

To evaluate whether a faecal calprotectin guided strategy of anti-TNF dosing interval lengthening is non-inferior in maintaining remission in patients with IBD compared with an unchanged dosing interval.

An open label interventional phase 4 study to Evaluate Efficacy, Safety and Mucosal Healing of early versus late use of vedolizumab in ulcerative colitis: the LOVE-UC study (LOw countries VEdolizumab in UC study)

The primary objective of this prospective open label study is to assess the ability of vedolizumab to promote clinical, endoscopic and histological remission in patients with active UC in an 'early' and a 'late' disease…

Top-Down Infliximab Study in Kids with Crohn's disease (TISKids)

The primary objective of our study is to determine the efficacy and safety of top-down IFX treatment in moderate-to-severe pediatric CD. Secondary objectives are determination of the pharmacokinetic/-dynamic profile of IFX and finding predictors of…

Control Crohn Safe with episodic adalimumab monotherapy as first line treatment study.

This study has been transitioned to CTIS with ID 2024-516002-33-01 check the CTIS register for the current data. The aim of this study is to compare the long-term efficacy and safety of periodic adalimumab as initial treatment in newly diagnosed CD…

Lengthening Adalimumab Dosing Interval in quiescent Crohn*s disease patients: the LADI study.

To assess non-inferiority of extending the adalimumab dosing interval, under strict disease monitoring in CD patients in sustained (>9months) clinical remission, compared to standard care.

Subcutaneous vedolizumab drug de-escalation using therapeutic drug monitoring in inflammatory bowel disease: a randomized controlled pilot study

This study has been transitioned to CTIS with ID 2024-517502-28-01 check the CTIS register for the current data. Our explorative pilot study wants to observe whether TDM can attribute to an efficient dose de-escalation strategy of SC vedolizumab in…

An open-label interventional phase 4 study to evaluate efficacy , safety and mucosal healing of early versus late use of vedolizumab in Crohn's disease: the LOVE-CD study (LOw countries VEdolizumab in CD study)

Primary ObjectiveThe primary objective of this prospective open label study is to assess the ability of vedolizumab to promote clinical, endoscopic and histological remission in patients with active Crohn's disease in an 'early' and a…

Prospective Analysis of Pharmacokinetic Infliximab data in Paediatric Inflammatory Bowel Disease patients

This study has been transitioned to CTIS with ID 2023-507352-72-00 check the CTIS register for the current data. The primary study objective of our study is to assess the efficacy of an IFX intensified induction scheme vs. a standard dosing schedule…

A Prospective Multicenter Randomized Controlled, Open-label Study to Compare the Efficacy of Subcutaneous Infliximab Monotherapy with Subcutaneous Infliximab and Concomitant Immunosuppression in the Treatment of Moderate to Severe Crohn's Disease.

The aim of this study is to investigate the efficacy of subcutaneous IFX in the treatment of moderate to severe Crohn*s disease with and without concomitant immunosuppression, as measured by the proportion of patients in corticosteroid-free clinical…