IDeaL Pilot Study - Infliximab Dose to Level: Pilot Study
Inflammatory Bowel DiseaseCrohn's DiseaseCrohn's disease (CD) is a lifelong condition of inflammation in the bowel. CD can affect any part of the gastrointestinal tract from mouth to anus. Symptoms can include: tiredness, stomach pain, diarrhea (which may be bloody if the disease is severe), fever, weight loss, skin rashes, arthritis and inflammation of the eye. Infliximab-IFX (Remicade®) is a medication that is used to treat CD in adults and children. In adults it has been shown that the amount of this drug a person has in their blood can show how well it is working for them. Health Canada has approved Infliximab -IFX for the treatment of CD in children 9 and older. In Canada, doctors may prescribe Inflixmab to younger children when other therapies do not resolve their disease symptoms. This is called "off-label" use of Infliximab. IFX levels in the body and consequently its efficacy can be influenced by many biological characteristics within the patient's body. In about 17% of those treated with IFX, the patient's immune response against IFX may lead to a three to fivefold increased risk of loss of response. This immune response to the medication often occurs when drug levels are undetectable in the body. Thus it is in order to achieve best results with this treatment, physicians need to be able to adjust dosing specific to each patient. A recent study has shown that 29% of children have an undetectable IFX level at the 4th medication infusion. Up to 40% of patients receiving scheduled IFX have undetectable drug level prior to their next infusion. In order to minimize the loss of response, we hope to conduct an observational cohort study of pediatric patients treated with IFX. This open label, cohort study aims to: Determine the pharmacokinetics of IFX in children with CD and the factors that affect IFX levels during the first three loading infusions Obtain data to create a model that can guide and adjust the IFX dose and frequency to achieve optimal trough level between 5 and 10 ug /ml at 14 weeks.
Search for New Genetic Mutations Major Effect in Crohn's Disease
Crohn DiseaseThis study highlight genetics mutations with major effect in Crohn's Disease (CD) by WES in individuals affected and healthy individuals from EPIMAD Inserm InVS registry families.
A Study of Infliximab in the Treatment of Chinese Children With Crohn's Disease
Crohn DiseaseThe main purpose of this study is to record the use of Infliximab (IFX) in the treatment of Chinese children with Crohn's disease (CD) in routine clinical practice and to summarize the clinical efficacy and safety of IFX in the treatment of pediatric CD.
A Study of Real-World Outcomes of People With Crohn's Disease (CD)
Crohn DiseaseThe main aim of this study is to compare long-term remission in participants receiving vedolizumab (VDZ) and those receiving ustekinumab (UST). In this study, the study doctors will review each participant's past medical records. This study is about collecting existing information only; participants will not receive treatment or need to visit a study doctor during this study.
Anal Human Papillomavirus in Inflammatory Bowel Disease Study
Inflammatory Bowel Disease (IBD)Ulcerative Colitis (UC)2 moreThis is an observational cohort study with two time points (baseline and after at least 6 months of treatment with a non-corticosteroid immunosuppressive agent for inflammatory bowel disease (IBD)). Approximately 40 participants, both male and female, 18 years of age and older will be recruited from the Pittsburgh IBD Cohort. Participants will have a histological diagnosis of IBD (Ulcerative Colitis (UC) or Crohn's Disease (CD)) and will be attending for colonoscopy prior to starting a non-corticosteroid immunosuppressive agent as part of standard medical care. Immediately following the colonoscopy, an anal exam will be performed for research purposes to include: Perianal inspection Anal canal HPV swab Anal cytology Digital anal examination High resolution anoscopy (HRA) and biopsy of all lesions with visual criteria consistent with high-grade anal dysplasia For female participants a self- or clinician-taken vaginal swab for HPV typing. These procedures will be repeated at routine colonoscopy following at least 6 months but within 12 months of non-corticosteroid immunosuppressive treatment.
Endomicroscopy in IBD Patients
Crohn's DiseaseUlcerative ColitisThe aim of the study is to analyze the mechanism of action of infliximab at the endomicroscopic level and to analyze mucosal healing - i.e. structural and functional changes in the mucosa in IBD patients - and associated processes such as permeability and bacterial invasion of the mucosa. In this study the role of the above mentioned parameters and further the establishment of endomicroscopic scores will serve to define new prognostic markers in view of long term remission upon infliximab treatment.
Prebiotic Effect on Metabolites in Crohn's Disease
Crohn DiseaseThe purpose of this study is to investigate the influence of the prebiotic oligofructose enriched inulin on the metabolite pattern in Crohn's disease patients.
Study to Determine Relationship Between Serum Infliximab and Efficacy in Luminal Crohn's Disease...
Crohn's DiseaseTo assess the relationship between the change in Crohn's Disease Activity Index (CDAI) scores and trough serum infliximab concentration in subjects who are scheduled to receive infliximab infusions at an interval of 8 weeks.
Pregnancy Exposure Registry for Tysabri®
Crohn's DiseasePrenatal Exposure2 moreThe primary objective of the Registry was to evaluate the outcomes of pregnancy in women with Multiple Sclerosis (MS) or Crohn's Disease (CD) who were exposed to TYSABRI® at any time within 90 days prior to first day of Last Menstrual Period (LMP) or during pregnancy.
Glucocorticoid-induced Osteopenia in Children
Crohn's DiseaseNephrotic SyndromeThe purpose of this study is to characterize the skeletal deficits and risk factors for impaired skeletal development in children requiring glucocorticoid therapy. We will compare the bone health of children treated with prednisone for nephrotic syndrome (NS with those treated with prednisone for Crohn's Disease (CD). Childhood NS usually responds to prednisone and is not characterized by pathologies that can impact on bone. In contrast, CD is treated with prednisone, but is independently associated with poor growth and maturation, nutritional deficiencies and inflammation. Due to the differences in the diseases, this comparison will allow us to distinguish between the prednisone-related and disease-related effects on bone in the two disease states.