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| Name (Synonyms) | Correlation |
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Navigate: Correlations HPO
There is one clinical trial.
The study participants are patients which have been diagnosed with Guillain-Barré Syndrome (GBS) and are planned to receive treatment with intravenous immunoglobulin (IVIg). IVIg is a standard of care treatment for GBS patients. The patients in this study will be treated with the study medicine imlifidase on day 1, and with IVIg on days 3-7. The purpose of this study is to investigate the safety and effectiveness of imlifidase in patients diagnosed with GBS.
Description: Safety is assessed as type, frequency and intensity of Adverse Events (AE)/Serious Adverse Events (SAEs)
Measure: Safety as measured by Adverse Events (AEs) Time: Screening up to Day 360Description: Efficacy is assessed as proportion of subjects with improvement of one (1) or more grades in disability outcome on the 6-point GBS DS at 4 weeks. The 6-point Guillain-Barré Syndrome disability score (GBS DS) is a widely accepted and easily obtainable scoring system used to assess disability status of GBS subjects. The DS score is as follows: 0=Healthy, 1=Minor symptoms and capable of running (subjects must be asked to run), 2=Able to walk independently 10 meters or more but unable to run, 3=Able to walk more than 10 meters across an open space with help, 4=Bedridden or chair bound, 5=Needing mechanical ventilation, 6=Dead
Measure: Changed disability outcome at 4 weeks assessed by the 6-point GBS disability score (DS) Time: Screening and Day 29Description: Efficacy is assessed as mean change from screening in GBS DS grade (on the 6-points GBS DS) at 4 weeks. The 6-point Guillain-Barré Syndrome disability score (GBS DS) is a widely accepted and easily obtainable scoring system used to assess disability status of GBS subjects. The DS score is as follows: 0=Healthy, 1=Minor symptoms and capable of running (subjects must be asked to run), 2=Able to walk independently 10 meters or more but unable to run, 3=Able to walk more than 10 meters across an open space with help, 4=Bedridden or chair bound, 5=Needing mechanical ventilation, 6=Dead
Measure: Mean change in disability outcome at week 4 as assessed by the 6-point GBS DS Time: Screening and Day 29Description: Efficacy is assessed as proportion of subjects able to walk unaided (i.e. GBS DS=2) at 4, 8 and 26 weeks
Measure: Ability to walk unaided at 4, 8 and 26 weeks Time: Day 29, Day 57, and Day 180Description: Efficacy is assessed as time to improvement by at least one (1) GBS DS grade. The 6-point Guillain-Barré Syndrome disability score (GBS DS) is a widely accepted and easily obtainable scoring system used to assess disability status of GBS subjects. The DS score is as follows: 0=Healthy, 1=Minor symptoms and capable of running (subjects must be asked to run), 2=Able to walk independently 10 meters or more but unable to run, 3=Able to walk more than 10 meters across an open space with help, 4=Bedridden or chair bound, 5=Needing mechanical ventilation, 6=Dead
Measure: Time to improvement by at least one (1) GBS DS grade Time: Screening until Day 360Description: Efficacy is assessed as time to walk unaided (i.e. GBS DS=2)
Measure: Time to walk unaided Time: Screening until Day 360Description: Efficacy is assessed as proportion of subjects with an increase from baseline in Rasch-built Overall Disability scale (R-ODS) by at least 6 Points on the centile metric score at 4, 8 and 26 weeks R-ODS is a linearly weighted disease specific scale, which captures activities and social participation limitation in patients with immune-mediated neuropathies, including GBS. The questionnaire comprises 24 items ranging from ability to read a book or newspaper (as the easiest item to accomplish) to ability to run (most difficult item to accomplish). The response options for each item are: 0=Not possible, 1=Possible with effort, 2=Easy to perform. The obtained raw summed score is subsequently translated to a centile metric ranging from 0 (most severe disability) to 100 (no disability at all).
Measure: Change from baseline in R-ODS by at least 6 Points at 4, 8, and 26 weeks Time: Screening, Day 29, Day 57, and Day 180Description: Efficacy is assessed as proportion of subjects requiring ventilator support (i.e. GBS DS=5)
Measure: Requirement for ventilator support Time: Screening until Day 360Description: Efficacy is assessed as time in ventilator (counted only if at least 12 hours/day)
Measure: Time in ventilator Time: Screening until Day 360Description: Efficacy is assessed as time in an intensive care unit (ICU)
Measure: Time in an ICU Time: Screening until Day 360Description: Efficacy is assessed as change in Medical Research Council (MRC) sum score. The MRC sum score is widely used to assess the motor impairment in subjects with peripheral neuropathies. It is a sum score of power in 6 muscle groups on each side (abduction of arm, flexion of forearm, extension of the wrist, hip flexion, and extension of knee and dorsal flexion of the foot). The sum of these scores ranges from 0 (total paralysis) to 60 (normal power). It provides valuable information about the muscle strength. Change in MRC sum score helps in identification of GBS patients with treatment related fluctuation or exacerbation. The individual MRC grades are defined as follows: 0=No visible contraction,1=Visible contraction without movement of the limb, 2=Movement of the limb but not against gravity, 3=Movement against gravity (almost full range), 4=Movement against gravity and resistance, 5=Normal
Measure: Changes in MRC sum score Time: Screening until Day 180Description: Cmax=Maximum observed plasma concentration of imlifidase following dosing
Measure: PK profile of imlifidase: Cmax Time: Within 2 hours before imlifidase dose until Day 15Description: Tmax=Time point for maximum observed plasma concentration of imlifidase following dosing
Measure: PK profile of imlifidase: Tmax Time: Within 2 hours before imlifidase dose until Day 15Description: AUC=Area under the imlifidase plasma concentration versus time curve
Measure: PK profile of imlifidase: AUC Time: Within 2 hours before imlifidase dose until Day 15Description: t1/2=Terminal half-life of imlifidase
Measure: PK profile of imlifidase: t1/2 Time: Within 2 hours before imlifidase dose until Day 15Description: CL=Clearance of imlifidase
Measure: PK profile of imlifidase: CL Time: Within 2 hours before imlifidase dose until Day 15Description: V=Volume of distribution
Measure: PK profile of imlifidase: V Time: Within 2 hours before imlifidase dose until Day 15Description: The PD effect on IgG will be described qualitatively on a scale. The scale range from score=0 (no intact IgG, single cleaved IgG (scIgG) or F(ab')2 to score=5 (only intact IgG)
Measure: PD effect on IgG Time: Within 2 hours before imlifidase dose until Day 15Description: Proportion of patients with anti-imlifidase antibodies (ADAs) at different time-points during the study
Measure: Presence of ADAs Time: Within 2 hours before imlifidase dose until Day 180Description: Quality of Life will be assessed using the EurQol group's EurQol - 5 dimension (EQ-5D) Health questionnaire. The EQ-5D consists of 2 parts: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient indicates health state in each of the 5 dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the 5 dimensions are combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.
Measure: Patient's health state as assessed by EQ-5D Quality of Life questionnaire Time: Day 8, Day 15, Day 29, Day 57, Day 92, Day 180, and Day 360Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on December 13, 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.
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