Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
Navigate: Correlations HPO
There is one clinical trial.
A multicenter study to evaluate the efficacy and safety of maintenance and long-term treatment administration of upadacitinib, an orally administered Janus kinase 1 inhibitor, in adult participants with Crohn's Disease.
Description: Clinical remission is defined based on average daily stool frequency (SF) AND average daily abdominal pain (AP) score.
Measure: Sub-Study 1: Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI) Time: Week 52Description: Endoscopic response is defined as decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) from Baseline.
Measure: Sub-Study 1: Percentage of Participants with Endoscopic Response Time: Week 52Description: An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. For more details on adverse events please see the Adverse Event section.
Measure: Sub-Study 2: Number of Participants with Adverse Events Time: Through Week 240Description: Clinical remission is defined based on average daily stool frequency (SF) AND average daily abdominal pain (AP) score.
Measure: Sub-Study 1: Percentage of Participants with Clinical Remission per Patient-Reported Outcomes (PROs) Time: Week 52Description: Decrease of at least 100 points in CDAI from Baseline.
Measure: Sub-Study 1: Percentage of Participants Achieving Clinical Response 100 (CR-100) Time: Week 52Description: This is assessed in participants taking corticosteroids at Baseline. Clinical remission is defined based on average daily stool frequency (SF) AND average daily abdominal pain (AP) score.
Measure: Sub-Study 1: Percentage of Participants who Discontinue Corticosteroid Use at Least 90 Days Prior to Week 52 and Achieve Clinical Remission, in Participants Taking Corticosteroids at Baseline. Time: Week 52Description: Clinical remission is defined based on average daily stool frequency (SF) AND average daily abdominal pain (AP) score. Endoscopic remission is defined per SES-CD.
Measure: Sub-Study 1: Percentage of Participants with Clinical Remission per CDAI and Endoscopic Remission Time: Week 52Description: CDAI remission is defined as CDAI < 150.
Measure: Sub-Study 1: Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI) Time: Through Week 52Description: Endoscopic remission is defined per Simplified Endoscopic Score for Crohn's Disease (SES-CD).
Measure: Sub-Study 1: Percentage of Participants with Endoscopic Remission Time: Week 52Description: The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.
Measure: Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Time: Baseline (Week 0) to Week 52Description: The FACIT-F questionnaire was developed to assess fatigue.
Measure: Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Time: Baseline (Week 0) to Week 52Description: This is assessed by reviewing participant's hospitalization data.
Measure: Sub-Study 1: Percentage of Participants with Hospitalizations due to Crohn's Disease (CD) Time: Week 52Description: EIMs are defined as manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver.
Measure: Sub-Study 1: Percentage of Participants with Resolution of Extra-Intestinal Manifestation (EIMs) , in Participants with EIMs at Baseline Time: Week 52Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
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