|drug3877||TD-1473 [Tablet B] Wiki||0.50|
|drug3876||TD-1473 [Tablet A] Wiki||0.50|
|drug3008||Plasma from a volunteer donor Wiki||0.50|
|D015212||Inflammatory Bowel Diseases NIH||0.67|
|D003093||Colitis, Ulcerative NIH||0.15|
There are 4 clinical trials
Breastfeeding is beneficial to both mother and baby. However, many breastfeeding women are affected by long-term health conditions and need to take medications. Sometimes, concerns about transfer of drugs to infants via breast milk lead the mothers to either avoid breastfeeding or stop their medication. Inflammatory Bowel Disease (IBD) is a chronic condition that is marked by an abnormal response of the body's immune system, and high levels of certain proteins that cause inflammation (Cytokines like Tumor Necrosis Factor-alpha or TNFα). A group of drugs called "biologics" target and stop these proteins from causing inflammation, and have been successfully used to treat this condition. Inflammatory proteins may be present in breast milk of healthy women in variable levels, and may play a role in development of infant's brain and immune system. This study is being conducted to investigate: - Concentration of some of the inflammatory proteins in breast milk of mothers with IBD and healthy controls - Interaction between these proteins and biologics in breast milk of women with IBD - Potential role of these proteins (and their interaction with biologics) on development of infant learning and memory function It has been presumed that concentrations of TNFα and some other cytokines are higher in breast milk of women with IBD, and the biologics can normalize these high levels. Due to precautions for COVID-19, the study now consists of only two mandatory study visits and two optional study visits. The mandatory visits include two home visits in the first 4 months postpartum to complete a participant questionnaire and collect a small sample of breast milk at each visit. The optional study visits consist of two visits at the Hospital for Sick Children for evaluation of learning and memory function of the infant at the ages of 12 and 18 months. Additionally, mothers will be required to complete for their infant subscales of The Ages and Stages Questionnaires®, Third Edition (ASQ®-3) either in person or over the telephone at the ages of 12 months and 18 months.
Description: Multiplex assay will be used to measure TNFα and downstream chemokines including CCL2, CCL4, CCL7, CXCL10 in breast milk of two groups of participants (women with IBD and healthy controls). (The unit of measurement is the same for all these cytokines)Measure: Levels of TNFα and its downstream chemokines (CCL2, CCL4, CCL7, and CXCL10) in breast milk of women with IBD and healthy controls by Multiplex assay Time: 4 years
Description: ELISA assay will be used to measure total and free drug levels (bound and unbound to TNFα) in breast milk of lactating women with IBD. (The unit of measurement is the same for infliximab and adalimumab).Measure: Milk concentration of TNFα inhibitors (infliximab, adalimumab) at different time-points between two doses of medication, in lactating women with IBD by ELISA assay Time: 4 years
Description: The infants of women with IBD and healthy controls will be examined for cognitive development using Bayley-IIIMeasure: Scores on cognitive subset of Bayley Scales of Infant and Toddler development- Third Version (Bayley-III) in infants of healthy controls and women with IBD Time: 4 years
Description: Infants of healthy controls and women with IBD will be examined for communication and problem-solving development using the ASQ®-3. This supplementary measure is intended to provide additional data as an alternative to Bayley test under unprecedented circumstances which preclude participants to complete Bayley test at the Hospital for Sick ChildrenMeasure: Scores on the "Problem-solving" and "Communication" subscales of The Ages and Stages Questionnaire (ASQ®-3) in infants of healthy controls and women with IBD Time: 4 years
Description: An estimation of the population distribution of anti-TNFα antibodies (infliximab and adalimumab) in breast milk of women with IBD will be made, using population pharmacokinetic modellingMeasure: Simulated/predicted profiles of TNFα inhibitors (infliximab, adalimumab) in breast milk in a large population of lactating women with IBD by population pharmacokinetic modelling Time: 4 years
To find out what adaptations have been made by Inflammatory bowel disease physicians and patients in relation to therapies in flaring IBD patients during severe acute respiratory syndrome 2-COV and what the impact of these is on IBD patients with no symptomatic COVID-19 and in suspected/confirmed COVID-19. Also whether there any IBD related factors impacting the outcome of patients with COVID-19 symptoms or COVID-19 disease
Most of the inflammatory bowel disease (IBD: Crohn's disease and ulcerative colitis) in a tertiary expert Centre are on immunosuppressive and/or biological therapy. Theoretically, these treatments may increase patients' risk of infection, in particular viral infection. Therefore, the current SARS-Cov-2 pandemia, with its unprecedent worldwide morbidity and mortality, may have a negative impact on IBD patients' clinical course. Identifying an increased risk in this particular patients' population as well as the risk/protective factors is of outstanding importance, in order to adapt their treatment and surveillance. As a consequence, our aims were (i) to measure retrospectively the risk of SARS-CoV-2 (proven by biological testing or suspected due to record of potential clinical symptoms of COVID-19 infection) in this patients' cohort (principal objective), (ii) to identify risk or protective factors for SARS-CoV-2 infection in IBD, and (iii) to analyze the outcome of patients in case of suspected or confirmed COVID-19. The results of this study may be important to adjust our surveillance and therapeutic strategy in these patients, in particular if high virus circulation will occur in the future.
This is a Phase 1, 2-part, open-label study. Part A will be a formulation bridging and food effect study in healthy adult subjects. Part B will be an assessment of pharmacokinetics (PK) in healthy adult Chinese subjects.
Description: Area under the concentration-time curve, from time 0 to the last observed non-zero concentration (AUC0-t) of TD-1473 in PlasmaMeasure: AUC0-t Time: Predose and at prespecified time points up to 5 days after dosing on Day 1 of each period
Description: Area under the concentration-time curve, from time 0 extrapolated to infinity (AUC0-inf) of TD-1473 in PlasmaMeasure: AUC0-inf Time: Predose and at prespecified time points up to 5 days after dosing on Day 1 of each period
Description: Maximum observed concentration (Cmax) of TD-1473 in PlasmaMeasure: Cmax Time: Predose and at prespecified time points up to 5 days after dosing on Day 1 of each period
Description: Number and severity of treatment emergent adverse events.Measure: Adverse events Time: Day 1 through Day 7 of each period
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.Drug Reports MeSH Reports HPO Reports