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APPLE study (APPendicitis and Laparoscopic Evaluation) study;
Multicenter prospective validation of the Laparoscopic APPendicitis (LAPP) score

The main aim of this study is to validate the LAPP score. We hypothesize that the use of this score will lead to a 50% reduction of the total number of negative appendectomies, compared to the retrospective cohort of each participating center.

Hepatitis B vaccine efficacy in children exposed to anti-TNF in utero

Primary Objective: - Antibodies to the hepatitis B surface antigen (anti-HBs) levels 30 days after the last hepatitis B vaccine dose (11 months) in children from IBD mothers treated with anti-TNF compared to children from IBD mothers not treated…

A Phase 1 Double-blind, Randomized, Placebo-Controlled, Staggered,
Single and Multiple Ascending Dose, Multicenter Study Evaluating the
Safety, Tolerability, Pharmacokinetics and Efficacy of GS-5745 in Subjects
with Moderate to Severe Ulcerative Colitis

The primary objectives of this study are as follows:* To assess the safety and tolerability of escalating single and multiple doses of GS-5745 in subjects with moderate to severe ulcerativecolitis (UC) as assessed by adverse events (AEs), and…

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL
GROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY AND
EFFICACY OF CP-690,550 FOR INDUCTION THERAPY IN SUBJECTS WITH
MODERATE TO SEVERE CROHN'S DISEASE

Primary objective: The primary objective of the study is to evaluate the dose-response of tofacitinib in inducing clinical remission in subjects with moderate to severe Crohn*s disease and to select effective doses. Secondary objectives: -To…

Assessment of inflammatory markers in patients with ulcerative colitis treated with tofacitinib

To investigate inflammatory markers in blood en colon biopsies of UC patients who respond to treatment with tofacitinib within the OCTAVE induction study (METC2012_072) and patients who do not show response to treatment within the OCTAVE induction…

An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease

The primary objective of this efficacy and safety study is to demonstrate that tight control of disease activity using stringent criteria based on CDAI, hs-CRP, fecal Calprotectin, and corticosteroid use improves the rate of mucosal healing 48 weeks…

A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study Evaluating the Efficacy and Safety of JNJ-54781532 in Subjects with Moderately to Severely Active Ulcerative Colitis

The primary hypothesis of this study is that a dose-response relationship exists between disease activity as measured by the change from baseline in the Mayo score at Week 8 and JNJ-54781532 treatment regimens in subjects with moderately to severely…

Double-blind, double-dummy, randomised, placebo-controlled, multi-centre phase III study on the efficacy and tolerability of a 8-week treatment with 9 mg budesonide vs. 3 g mesalazine vs. placebo in patients with lymphocytic colitis

To evaluate the efficacy of 9mg budesonide/day and 3g mesalazine/day compared to placebo for the induction of remission in lymphocitic colitis.

A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of
Subcutaneously Administered Golimumab, a Human anti-TNFα Antibody, in Pediatric
Subjects With Moderately to Severely Active Ulcerative Colitis

The primary study objectives are as follows:-To evaluate the pharmacokinetics (PK) of golimumab in pediatric subjects aged 2 through 17 years with moderately to severely active UC.-To evaluate the safety of golimumab in pediatric subjects aged 2…

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Crohn*s Disease

To evaluate the efficacy of AMG 181 as measured by the proportion of subjects achieving Crohn*s Disease Activity Index (CDAI) remission (CDAI < 150) at week 8.

Randomized placebo-controlled multicenter exploratory Phase IIA study to assess the safety and efficacy of PEG-liposomal prednisolone sodium phosphate (Nanocort) in subjects with active ulcerative colitis.

The primary objective is to evaluate the safety of PEG-liposomal prednisolone sodium phosphate (Nanocort) The secondary objectives of this study are:To explore the efficacy of PEG-liposomal prednisolone sodium phosphate (Nanocort) To evaluate the…

Modulation of immune function by parenteral fish oil in patients with Crohn*s disease and high inherent Tumor Necrosis Factor-alfa production, a randomized, single blinded, cross-over study

To evaluate the effect of parenteral supplementation of fishoil based emulsion (rich in omega-3 fatty acids) compared with a soy bean oil emulsion (rich in omega-6 fatty acids) on the leukocyte functions (amongst others production of TNF-α and other…

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 FOR MAINTENANCE THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN'S DISEASE

Primary objectiveThe primary objective of the study is to estimate the effects of tofacitinib in maintaining a clinical response or being in remission in subjects with moderate to severe Crohn*s disease previously achieving clinical response or…

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Primary Objective* To demonstrate the efficacy of tofacitinib in inducing remission in subjects with moderately to severely active UC.Secondary Objectives* To evaluate the safety and tolerability of tofacitinib in subjects with moderately to…

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.

Trough level related side-effects of adalimumab therapy in patients with inflammatory bowel disease in clinical and biochemical remission, a cross-sectional cohort study

Primary ObjectiveThe primary objective of this study is to assess whether high ADA serum levels lead to more side effects compared to therapeutic ADA levels in CD and UC patients who are in clinical and biochemical remission.Secondary ObjectiveThe…

Predicting trough levels in patients receiving infliximab maintenance therapy using interval (non-trough) serum infliximab levels

Aim of this prospective study is to investigate the relation between non-trough serum IFX levels (4 and 6 weeks after infusion) and IFX trough levels (8 weeks after infusion) in patients with Crohn*s disease

A phase II, multicenter, randomized, double-blind, multiple dose, placebo-controlled, parallel-group study to evaluate the efficacy, pharmacokinetics, and safety of BI 655066, an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease, who are naïve to, or were previously treated with anti-TNF therapy.

the main objectives of the study are to evaluate the efficacy of different doses of BI655066 + to evaluate the pharmacokinetics (how the body handles the study drug) and pharmacokinetics (interaction of the study drug with the body) for subjects…

A study to investigate the safety, tolerability and absorption and elimination of CCX507-B, a new drug for the treatment of patients with inflammatory bowel diseases, in healthy male and female subjects.

The purpose of the study is to investigate to what extent CCX507-B is safe and tolerated. It will also be investigated how quickly and to what extent CCX507-B is absorbed and eliminated from the body (this is called pharmacokinetics). In addition,…

Assessment of the Photopill Capsule Treatment for Safety and Feasibility in Patients with Ulcerative Proctitis, a Pilot Study

The evaluation of the safety and feasibilty of the Photopill capsule treatment in patients with Ulcerative Proctitis