208 results
The aim is to investigate the feasibility of DBS from finger prick for measuring infliximab drug levels and ATIs compared with the results of venepuncture serum sample measurements. As a secondary objective, measurements of albumin and CRP will also…
To determine the correlation between concetrations of inflextra/ infliximab as measured using finger prick blood and lateral-flow assay and using venous blood and the standard sanquin ELISA.
Primary: The primary objective of the Double-blind Acute Phase of the study is to assess clinical response to MMX mesalamine/mesalazine between a low and high dose in children and adolescents aged 5-17 years with mild to moderate UC.The primary…
1. To confirm established and identify new risk factors for colorectal cancer in a prospective cohort of IBD patients undergoing regular surveillance. Dysplasia or colorectal cancer will be the primary outcome.2. To provide evidence that mucosal…
Primary Objective: 1. Determine if assessment of mucosal and serological immunological characteristics in combination with clinical indicators of disease behaviour and response to therapy can identify immune-based phenotypes with implications for…
To compare accumulation of liver fat (as measured using CAP) and liver fibrosis (as measured using fibroscan) between patients with quiescent and active inflammatory bowel disease
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…
The primary objective of this study is to monitor the safety and tolerability of PF 00547659 during long term treatment. Secondary objectives: * The secondary objective is to assess pharmacokinetics and immunogenicity of PF 00547659.* Exploratory…
ObjectiveTo identify biomarkers for CAL in drain fluid and serum, in addition to RT-PCR for E. faecalis, that increase specificity and positive predictive value.
Study Objectives:Primary Objective* To determine the safety profile of long-term MLN0002 treatmentResource Utilization and Patient-Reported Outcome Objectives* To determine the effect of long-term MLN0002 treatment on time to major inflammatory…
Primary Objectives: - To test the feasibility of culturing patient-derived Barrett*s esophagus organoids- To test pharmacological and chemotherapeutical agents in vitro on the cultured organoidsSecondary Objectives: - To create a small Biobank (of…
Primary Objective: - To assess the effectiveness of a sports program on fatigue and quality of life in IBD patients with quiescent disease and chronic fatigue.Secondary Objectives: - To assess the influence of a sport program on the physical fitness…
Determine if there are immunological or patient characteristics in UC patients that predict the endoscopic response on Vedolizumab treatment.
Primary Objective:* To evaluate the long-term safety and tolerability of MT-1303 in subjects with moderate to severe active CDSecondary Objectives:* To evaluate the long-term effects of MT-1303 on clinical outcomes in subjects with moderate to…
Primary Efficacy ObjectiveThe primary efficacy objective is to determine the effect of NCAP delivered by the implanted device on clinical signs and symptoms of Crohn*s disease, as assessed by the Crohn*s Disease Activity Index (CDAI)Secondary…
To gain insights in the pharmacokinetics of golimumab in moderate to severe Ulcerative Colitis after subcutaneous administration, during induction and maintenance treatment.
To evaluate the long term maintenance of response, safety and tolerability of repeatedadministration of adalimumab in subjects with Ulcerative Colitis who participated in and successfullycompleted Protocol M06-826 or Protocol M06-827.The secondary…
The main goal of this pilot study is to test feasibility of the present commercially available near-infrared fluorescence cholangiography (NIRFC) laparoscopic device during the laparoscopic cholecystectomy.
The overall objectives of this proposal are to develop two indices capable of measuring intestinal damage, and, separately, inflammatory disease activity in Pediatric Crohn's disease by means of Magnetic Resonance Imaging with Enterography…
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…