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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.

A randomized controlled trial investigating tailored treatment with infliximab for active luminal Crohn's disease

To investigate whether sustained trough levels of IFX can be achieved using IFX trough level measurements and adjustment of dosing based upon these levels by means of two different standardized algorithms in comparison with *standard of care* IFX…

Trough level-based dose reduction during infliximab maintenance treatment in Crohn*s disease

To evaluate the efficacy and safety of infliximab dose reduction guided by serial trough level measurements, compared to treatment as usual (no dose reduction), in Crohn*s disease patients who are in stable remission with infliximab maintenance…

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…

A randomized double-blind, placebo-controlled, parallel group clinical study of pregabalin in patients with chronic pancreatitis

The effect of pregabalin treatment on patients with chronic pancreatitis

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.

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.

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…

Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Determine the Efficacy and Safety of Vedolizumab in Prevention of Endoscopic Recurrence of Crohn's Disease in Patients with Ileo-colonic Surgical Resection and Ileocolonic Anastamosis : REPREVIO (recurrence prevention with Entyvio)

The primary objective of this prospective placebo-controlled study is to assess the ability of vedolizumab to prevent postoperative endoscopic recurrence of Crohn*s disease in the neoterminal ileum.

Risk-stratified randomized controlled trial in paediatric Crohn*s Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively * a treatment strategy

To compare the effectiveness of weekly subcutaneously administered MTX for maintaining relapse-free sustained steroid/EN-free 1-year remission compared with:- daily oral AZA/6MP in low risk paediatric CD- subcutaneously administered adalimumab in…

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…

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.

A Randomized, Double-Blind, Placebo-Controlled Phase 4 Study to Evaluate the Efficacy and Safety of Entyvio (Vedolizumab IV) in the Treatment of Chronic Pouchitis (EARNEST)

Primary Objective:To compare the efficacy of vedolizumab IV and placebo in terms of the percentage of subjects with chronic or recurrent pouchitis achieving clinically relevant remission.Secondary Objectives:To assess the efficacy of vedolizumab IV…

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…

A Randomized DoubleBlind Phase 4 Study to Evaluate the Safety and Proportion of Subjects With
Fistula Healing in 2 Dose Regimens of Entyvio (Vedolizumab IV) in the Treatment of Fistulizing
Crohn*s Disease (ENTERPRISE)

Primary Objectives:To evaluate the proportion of subjects with fistula healing at Week 30 with 2 different dose regimens of vedolizumab IV 300 mg in subjects with perianal fistulizing CD.Secondary Objective:To evaluate fistula healing over a 30-week…

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),…