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There are 4 clinical trials
This is a Phase 3, randomized, double-blind, placebo-controlled study to explore the effect of oral ozanimod as an induction treatment for subjects with moderately to severely active Crohn's Disease.
Description: The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.
Measure: Proportion of subjects with a CDAI score < 150 Time: Week 12Description: Abdominal pain scores and stool frequency scores are patient reported outcomes collected from the patient diary.
Measure: Proportion of subjects with average daily abdominal pain score ≤ 1 point, and average daily stool frequency score ≤ 3 points with abdominal pain and stool frequency no worse than baseline Time: Week 12Description: The SES-CD assesses the degree of inflammation. The SES-CD assesses the following 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing.
Measure: Proportion of subjects with a Simple Endoscopic Score for Crohn's Disease (SES-CD) score decrease from baseline of ≥ 50% Time: Week 12Description: The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.
Measure: Proportion of subjects with CDAI reduction from baseline of ≥ 100 points or CDAI score < 150 Time: Week 12Description: The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD and the SES-CD assesses the degree of inflammation.
Measure: Proportion of subjects with CDAI reduction from baseline of ≥ 100 points or CDAI score < 150 and SES-CD decrease from baseline of ≥ 50% Time: Week 12Description: The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD and the SES-CD assesses the degree of inflammation.
Measure: Proportion of subjects with CDAI score < 150 at Week 12 and SES-CD decrease from baseline of ≥ 50% Time: Week 12Description: Abdominal pain scores and stool frequency scores are patient reported outcomes collected from the patient diary. The SES-CD assesses the degree of inflammation.
Measure: Proportion of subjects with an average daily abdominal pain score ≤ 1 point, and average daily stool frequency score ≤ 3 points and both no worse than baseline AND an SES-CD ≤ 4 points and decrease ≥2 points at week 12 Time: Up to approximately week 12Description: Abdominal pain scores and stool frequency scores are patient reported outcomes collected from the patient diary. The SES-CD assesses the degree of inflammation.
Measure: Proportion of subjects with an average daily abdominal pain score ≤ 1 point, and average daily stool frequency score ≤ 3 points and both no worse than baseline AND an SES-CD decrease from baseline of ≥ 50% at week 12. Time: Up to approximately week 12Description: Global Histologic Disease Activity score is a measure of histologic inflammation.
Measure: Histologic Improvement based on differences between ozanimod and placebo in histologic disease activity scores (ie, Global Histologic Disease Activity Score changes (Geboes, 2000) Time: Week 12Description: The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.
Measure: Proportion of subjects with CDAI reduction from baseline of ≥ 70 points Time: Week 12Description: Ulcer size will be measured during endoscopy, and assesses the degree of endoscopic inflammation.
Measure: Proportion of subjects with absence of ulcers ≥ 0.5 cm with no segment with any ulcerated surface ≥ 10% Time: Week 12Description: The CDEIS assesses the degree of endoscopic inflammation.
Measure: Proportion of subjects with a Crohn's Disease Endoscopic Index of Severity (CDEIS) decrease from baseline of ≥ 50% Time: Week 12Description: The PCDAI is an instrument that was developed and validated for numerical assessment of disease activity in children and adolescents with CD (Hyams, 1991). The PCDAI includes subjective patient historical information, physical examination findings, objective laboratory parameters, data on weight gain/loss, and height velocity.
Measure: Proportion of adolescent subjects with clinical remission, defined as Pediatric Crohn's Disease Activity Index (PCDAI) ≤ 10 points at week 12 Time: Up to approximately week 12Description: The PCDAI is an instrument that was developed and validated for numerical assessment of disease activity in children and adolescents with CD (Hyams, 1991). The PCDAI includes subjective patient historical information, physical examination findings, objective laboratory parameters, data on weight gain/loss, and height velocity.
Measure: Proportion of adolescent subjects with clinical response, defined as a decrease in PCDAI ≥ 15 points from baseline Time: Up to approximately week 12Description: T and B cell panels consisting of Treg cells, naïve T and B cells, memory cells and plasmablasts are evaluated for assessment of immune status.
Measure: Assessment of circulating lymphocyte concentration Time: Up to approximately week 12Description: Interferon signature are assessed in the blood and in colon biopsies to evaluate differences based on disease activity.
Measure: Assessment of gene expression Time: Up to approximately week 12Description: Protein biomarkers such as high-density lipoprotein, C-reactive protein, fecal calprotectin, Immunoglobulin A (IgA) are measured in addition to assessing clinical endpoints to help evaluate disease activity.
Measure: Assessment of protein biomarker concentration Time: Up to approximately week 12Description: Markers such as Interferon Regulatory Factor 5 are evaluated to better understand genetic variations that could lead to differences in response to Ozanimod.
Measure: Assessment of pharmacogenetics Time: Up to approximately week 12Description: SARS-CoV-2 serology (anti-SARS-CoV-2 total or IgG) from serum samples are measured to support advancing the understanding of the impact of SARS-CoV-2 on ozanimod and Crohn's disease. It may also be used to support health authority requests for analysis and advancement of pharmacodiagnostic development to better target drugs to the right patients
Measure: Assessment of impact of SARS-CoV-2 serologic status on subjects receiving ozanimod and CD Time: Up to approximately week 12This is a Phase 3, randomized, double-blind, placebo-controlled study to explore the effect of oral ozanimod as an induction treatment for subjects with moderately to severely active Crohn's Disease.
Description: The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.
Measure: Proportion of subjects with a CDAI score < 150 Time: Week 12Description: Abdominal pain scores and stool frequency scores are patient reported outcomes collected from the patient diary.
Measure: Proportion of subjects with average daily abdominal pain score ≤ 1 point, and average daily stool frequency score ≤ 3 points with abdominal pain and stool frequency no worse than baseline Time: Week 12Description: The SES-CD assesses the degree of inflammation. The SES-CD assesses the following 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing.
Measure: Proportion of subjects with a Simple Endoscopic Score for Crohn's Disease (SES-CD) score decrease from baseline of ≥ 50% Time: Week 12Description: The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.
Measure: Proportion of subjects with CDAI reduction from baseline of ≥ 100 points or CDAI score < 150 Time: Week 12Description: The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD and the SES-CD assesses the degree of inflammation.
Measure: Proportion of subjects with CDAI reduction from baseline of ≥ 100 points or CDAI score < 150 and SES-CD decrease from baseline of ≥ 50% Time: Week 12Description: The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD and the SES-CD assesses the degree of inflammation.
Measure: Proportion of subjects with CDAI score < 150 at Week 12 and SES-CD decrease from baseline of ≥ 50% Time: Week 12Description: Abdominal pain scores and stool frequency scores are patient reported outcomes collected from the patient diary. The SES-CD assesses the degree of inflammation.
Measure: Proportion of subjects with an average daily abdominal pain score ≤ 1 point, and average daily stool frequency score ≤ 3 points and both no worse than baseline AND an SES-CD ≤ 4 points and decrease ≥2 points Time: Up to approximately week 12Description: Abdominal pain scores and stool frequency scores are patient reported outcomes collected from the patient diary. The SES-CD assesses the degree of inflammation.
Measure: Proportion of subjects with an average daily abdominal pain score ≤ 1 point, and average daily stool frequency score ≤ 3 points and both no worse than baseline AND an SES-CD decrease from baseline of ≥ 50% Time: Up to approximately week 12Description: Global Histologic Disease Activity score is a measure of histologic inflammation.
Measure: Histologic Improvement based on differences between ozanimod and placebo in histologic disease activity scores (ie, Global Histologic Disease Activity Score changes (Geboes, 2000) Time: Week 12Description: The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.
Measure: Proportion of subjects with CDAI reduction from baseline of ≥ 70 points Time: Week 12Description: Ulcer size will be measured during endoscopy, and assesses the degree of endoscopic inflammation.
Measure: Proportion of subjects with absence of ulcers ≥ 0.5 cm with no segment with any ulcerated surface ≥ 10% Time: Week 12Description: The CDEIS assesses the degree of endoscopic inflammation.
Measure: Proportion of subjects with a Crohn's Disease Endoscopic Index of Severity (CDEIS) decrease from baseline of ≥ 50% Time: Week 12Description: The PCDAI is an instrument that was developed and validated for numerical assessment of disease activity in children and adolescents with CD (Hyams, 1991). The PCDAI includes subjective patient historical information, physical examination findings, objective laboratory parameters, data on weight gain/loss, and height velocity.
Measure: Proportion of adolescent subjects with clinical remission, defined as Pediatric Crohn's Disease Activity Index (PCDAI) ≤ 10 points Time: Up to approximately week 12Description: The PCDAI is an instrument that was developed and validated for numerical assessment of disease activity in children and adolescents with CD (Hyams, 1991). The PCDAI includes subjective patient historical information, physical examination findings, objective laboratory parameters, data on weight gain/loss, and height velocity.
Measure: Proportion of adolescent subjects with clinical response, defined as a decrease in PCDAI ≥ 15 points from baseline Time: Up to approximately week 12Description: T and B cell panels consisting of Treg cells, naïve T and B cells, memory cells and plasmablasts are evaluated for assessment of immune status.
Measure: Assessment of circulating lymphocyte concentration Time: Up to approximately week 12Description: Interferon signature are assessed in the blood and in colon biopsies to evaluate differences based on disease activity.
Measure: Assessment of gene expression Time: Up to approximately week 12Description: Protein biomarkers such as high-density lipoprotein, C-reactive protein, fecal calprotectin, Immunoglobulin A (IgA) are measured in addition to assessing clinical endpoints to help evaluate disease activity.
Measure: Assessment of protein biomarker concentration Time: Up to approximately week 12Description: Markers such as Interferon Regulatory Factor 5 are evaluated to better understand genetic variations that could lead to differences in response to Ozanimod.
Measure: Assessment of pharmacogenetics Time: Up to approximately week 12Description: SARS-CoV-2 serology (anti-SARS-CoV-2 total or IgG) from serum samples are measured to support advancing the understanding of the impact of SARS-CoV-2 on ozanimod and Crohn's disease. It may also be used to support health authority requests for analysis and advancement of pharmacodiagnostic development to better target drugs to the right patients
Measure: Assessment of impact of SARS-CoV-2 serologic status on subjects receiving ozanimod and CD Time: Up to approximately week 12This is a Phase 3, randomized, double-blind, placebo-controlled study to demonstrate the effect of oral ozanimod as maintenance therapy in subjects with moderately to severely active Crohn's Disease.
Description: The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.
Measure: Proportion of subjects with a CDAI score of < 150 Time: Up to approximately week 52Description: The SES-CD assesses the degree of endoscopic inflammation.
Measure: Proportion of subjects with a Simple Endoscopic Score for Crohn's Disease (SESCD) score decrease from baseline of ≥ 50% Time: Up to approximately week 52Description: Abdominal pain scores and stool frequency scores are patient reported outcomes collected from the patient diary
Measure: Proportion of subjects with average daily abdominal pain score ≤ 1 point and average daily stool frequency ≤ 3 points with abdominal pain and stool frequency no worse than baseline Time: Up to approximately week 52Description: The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.
Measure: Proportion of subjects with CDAI reduction from baseline of ≥ 100 points or CDAI score of < 150 Time: Up to approximately week 52Description: The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.
Measure: Proportion of subjects with a CDAI score < 150 at Week 52, while remaining corticosteroid-free in the prior 12 weeks Time: Up to approximately week 52Description: The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.
Measure: Proportion of subjects with a CDAI score of < 150 in subjects with a CDAI score < 150 at pre-randomization Time: Up to approximately week 52Description: The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.
Measure: Proportion of subjects with a CDAI score of < 150 at Week 52 and at ≥ 80% of visits between Week 8 and Week 52, inclusive, in subjects with a CDAI score <150 at pre-randomization Time: Up to approximately week 52Description: Ulcer size will be measured during endoscopy, and assesses the degree of endoscopic inflammation.
Measure: Proportion of subjects with absence of ulcers ≥ 0.5 cm with no segment with any ulcerated surface ≥10% Time: Up to approximately week 52Description: Global Histologic Disease Activity score is a measure of histologic inflammation.
Measure: Histologic improvement based on differences between ozanimod and placebo in histologic disease activity scores (ie, Global Histologic Disease Activity Score [GHAS] changes (Geboes, 2000)) Time: Up to approximately week 52Description: Abdominal pain scores and stool frequency scores are patient reported outcomes collected from the patient diary. The SES-CD assesses the degree of endoscopic inflammation
Measure: Proportion of subjects with average daily abdominal pain score ≤ 1 point, and average daily stool frequency score ≤ 3 points with abdominal pain and stool frequency no worse than baseline and an SES-CD decrease from baseline of ≥ 50% Time: Up to approximately week 52Description: The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD and the SES-CD assesses the degree of endoscopic inflammation.
Measure: Proportion of subjects with CDAI score of < 150 and SES-CD decrease from baseline of ≥ 50% Time: Up to approximately week 52Description: Abdominal pain scores and stool frequency scores are patient reported outcomes collected from the patient diary. The SES-CD assesses the degree of endoscopic inflammation.
Measure: Proportion of subjects with average daily abdominal pain score ≤ 1 point, and average daily stool frequency score ≤ 3 points with abdominal pain and stool frequency no worse than baseline and an SES-CD ≤ 4 points and a SES-CD decrease ≥2 points Time: Up to approximately week 52Description: The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD and the SES-CD assesses the degree of endoscopic inflammation.
Measure: Proportion of subjects with CDAI reduction from baseline of ≥ 100 points or CDAI score < 150 and SES-CD decrease from baseline of ≥ 50% Time: Up to approximately week 52Description: The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD and the SES-CD assesses the degree of endoscopic inflammation.
Measure: Proportion of subjects with CDAI score < 150 at Week 12 and SES-CD decrease from baseline of ≥ 50% Time: Up to approximately week 52Description: The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD and the SES-CD assesses the degree of endoscopic inflammation
Measure: Proportion of subjects with CDAI reduction from baseline of ≥ 70 points Time: Up to approximately week 52Description: Global Histologic Disease Activity score is a measure of histologic inflammation
Measure: Proportion of subjects with mucosal healing (SES-CD ≤ 4 points and a SES-CD decrease ≥ 2 points) and histologic improvement by GHAS or Robarts Histologic Index (RHI) Time: Up to approximately week 52Description: Time to relapse is defined as an increase in the CDAI score from Maintenance Day 1 of ≥ 100 points and a CDAI score > 220, SES-CD score ≥ 6 [or ≥ 4 if isolated ileal disease.
Measure: Time to relapse and exclusion of other causes of an increase in disease activity unrelated to underlying CD (eg, infections, change in medication) Time: Up to approximately week 52Description: The CDEIS assesses the degree of endoscopic inflammation.
Measure: Proportion of subjects with a Crohn's Disease Endoscopic Index of Severity (CDEIS) decrease from baseline of ≥ 50% Time: Up to approximately week 52Description: The PCDAI is an instrument that was developed and validated for numerical assessment of disease activity in children and adolescents with CD (Hyams, 1991). The PCDAI includes subjective patient historical information, physical examination findings, objective laboratory parameters, data on weight gain/loss, and height velocity.
Measure: Proportion of adolescent subjects with Pediatric Crohn's Disease Activity Index (PCDAI) ≤ 10 points Time: Up to approximately week 52Description: The PCDAI is an instrument that was developed and validated for numerical assessment of disease activity in children and adolescents with CD (Hyams, 1991). The PCDAI includes subjective patient historical information, physical examination findings, objective laboratory parameters, data on weight gain/loss, and height velocity.
Measure: Proportion of adolescent subjects with decrease from baseline in PCDAI score ≥15 points Time: Up to approximately week 52Description: The IBDQ is a self-administered, 32-item questionnaire concerning 4 dimensions of quality of life (Hlavaty, 2006).
Measure: Change from baseline (Induction) in Inflammatory Bowel Disease Questionnaire (IBDQ) scores (adult subjects only) Time: Up to approximately week 52Description: The medical outcomes SF-36 questionnaire provides a measure of the subject's health status. The SF-36 consists of either scaled scores, which are the weighted sums of the questions in their section.
Measure: Change from baseline (Induction) in 36-Item Short Form-36 Survey (SF-36) scores (adult subjects only) Time: Up to approximately week 52Description: The WPAI-CD (Reilly, 1993) is a validated, reliable and responsive instrument that assesses the impact of CD on work and activity during the past 7 days (Reilly, 2008).
Measure: Change from baseline (Induction) in Work Productivity and Activity Impairment questionnaire for Crohn's disease (WPAI-CD) scores (adult subjects only) Time: Up to approximately week 52Description: The EQ-5D (The EuroQol Group, 1990) is a validated, 6-item, self-administered instrument designed to measure generic health status.
Measure: Change from baseline (Induction) in EuroQol 5 dimensions questionnaire (EQ-5D) scores Time: Up to approximately week 52Description: The PGIC scale evaluates all aspects of patient's health and assesses if there has been an improvement or decline in clinical status. The self-report measure PGIC reflects a patient's belief about the efficacy of treatment.
Measure: Patient Global Impression of Change (PGIC) scores (adult subjects only) Time: Up to approximately week 52Description: Healthcare resource utilization will be evaluated in this study to assess the impact of CD and health-related outcomes (hospitalizations, emergency department or urgent care clinic visits, procedures, and physician visits).
Measure: Differences in CD-related hospitalizations, procedures, and surgery Time: Up to approximately week 52Description: T and B cell panels consisting of Treg cells, naïve T and B cells, memory cells and plasmablasts are evaluated for assessment of immune status.
Measure: Assessment of circulating lymphocyte concentration Time: Up to approximately week 52Description: Interferon signature are assessed in the blood and in colon biopsies to evaluate differences based on disease activity.
Measure: Assessment of gene expression Time: Up to approximately week 52Description: Protein biomarkers such as high-density lipoprotein, C-reactive protein, fecal calprotectin, Immunoglobulin A (IgA) are measured in addition to assessing clinical endpoints to help evaluate disease activity.
Measure: Assessment of protein biomarker concentration Time: Up to approximately week 52Description: Markers such as Interferon Regulatory Factor 5 are evaluated to better understand genetic variations that could lead to differences in response to Ozanimod.
Measure: Assessment of pharmacogenetics Time: Up to approximately week 52Description: SARS-CoV-2 serology (anti-SARS-CoV-2 total or IgG) from serum samples are measured to support advancing the understanding of the impact of SARS-CoV-2 on ozanimod and Crohn's disease. It may also be used to support health authority requests for analysis and advancement of pharmacodiagnostic development to better target drugs to the right patients
Measure: Assessment of impact of SARS-CoV-2 serologic status on subjects receiving ozanimod and CD Time: Up to approximately week 52The virus SARS-CoV-2 causes severe pneumonia which, in a proportion of patients progresses towards an Acute Respiratory Distress Syndrome (ARDS) mainly related to the antiviral immune response. To date, there is no available treatment that significantly improves outcome of patients with COVID-19 pneumonia. Sphingosine-1-phosphate receptor 1 (S1P1) ligands control vascular leakage in the airways and sphingosine-1-phosphate (S1P) receptor ligands devoid of activity on sphingosine-1-phosphate receptor 3 (S1P3) show an excellent safety profile, including ozanimod. Critically, S1P1 ligands mildly impact, but do not compromise viral clearance and they reduced lung injury in the highly pathogenic H1N1-ferret model, even without concomitant use of antivirals and with a synergistic effect when associated to antiviral agents. Ozanimod was approved by the FDA for the treatment of relapsing multiple sclerosis at the end of March 2020. The investigators believe that this immune modulator is at the top of the list of agents that should be trialed in order to mitigate the morbidity and mortality of COVID-19. The primary objective is to substantiate the impact of ozanimod on key outcomes of COVID-19 patient progression, which will guide decision making around sample size and the choice of endpoints for future clinical trial.
Description: Clinical improvement until hospital discharge
Measure: Daily Patient progression assessed with the World Health Organization-adapted 6-points ordinal scale Time: through whole duration of the hospitalization, an average of 14 daysDescription: Titrated every second with automated oxygen titration device (FreeO2)
Measure: The mean oxygen flow required to maintain the oxygen saturation (SpO2) target at 92% Time: First 7 days of the trialDescription: Sepsis-related organ failure assessment (SOFA), national early warning score (NEWS2), early warning score for oxygen therapy (EWS.O2), decrease of at least 2 points on the 6-point ordinal scale
Measure: Severity index measurement Time: through whole duration of the hospitalization, an average of 14 daysAlphabetical 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.
Drug Reports MeSH Reports HPO Reports