Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug3913 | hyperimmune plasma Wiki | 1.00 |
| drug120 | ATI-450 Wiki | 0.71 |
| Name (Synonyms) | Correlation |
|---|
Navigate: Correlations HPO
There is one clinical trial.
This is a Phase 2 study to investigate the safety and efficacy of ATI-450 for the Maintenance of Remission in Patients with Cryopyrin-Associated Periodic Syndrome (CAPS) Previously Managed with Anti-IL-1 Therapy.
Description: Adverse Events (AEs) will be coded with the Medical Dictionary for Regulatory Activities (MedDRA). AEs will be presented by system organ class and preferred term in frequency tables.
Measure: Assess the safety and tolerability of ATI-450 to maintain remission in patients with CAPS previously managed with anti-IL-1 therapy: Adverse Events (AEs) Time: Baseline to week 12Description: Remission is defined as a high sensitivity C-reactive protein (hsCRP) within normal range (≤10 mg/L).
Measure: Total Number of participants who maintain disease remission (hsCRP) Time: Baseline to week 12Description: Remission is defined as a serum amyloid A (SAA) value within the normal range (≤10 mg/L).
Measure: Total Number of participants who maintain disease remission (SAA) Time: Baseline to week 12Description: Remission is defined as a Physician Global Assessment (PGA) score of absent or minimal. The Physician's Global Assessment of Autoinflammatory Disease Activity (PGA) is a measure to be completed by the investigator or designee. The PGA uses a 5-point rating scale: absent, minimal, mild, moderate, and severe. The investigator will select a rating based on the patient's current disease activity at the time of the visit. Lower PGA scores represent better outcomes.
Measure: Total number of participants who maintain disease remission (PGA) Time: Baseline to week 12Description: Relapse is defined as a two-point worsening on the PGA scale. The Physician's Global Assessment of Autoinflammatory Disease Activity (PGA) is a measure to be completed by the investigator or designee. The PGA uses a 5-point rating scale: absent, minimal, mild, moderate, and severe. The investigator will select a rating based on the patient's current disease activity at the time of the visit. Lower PGA scores represent better outcomes.
Measure: Time to relapse Time: Baseline to week 12Description: Re-emergence is defined as a daily Key Symptom Score (KSS) ≥ 3 points higher than baseline for at least 2 consecutive days. The KSS is derived from the patient-administered DHAF, and is the average on a 0 to 10 scale (0 = None, 10 = Very Severe) of 5 separate scales - rash, feeling of fever and chills, joint pain, eye redness and pain, and fatigue. Lower KSS scores represent better outcomes.
Measure: Total number of participants who experience re-emergence of disease symptoms after discontinuation of ATI-450 Time: Follow-up day 1 to follow-up day 7Description: Key Symptom Score (KSS). The KSS is derived from the patient-administered DHAF, and is the average on a 0 to 10 scale (0 = None, 10 = Very Severe) of 5 separate scales - rash, feeling of fever and chills, joint pain, eye redness and pain, and fatigue. Lower KSS scores represent better outcomes.
Measure: Total number of participants with a mean KSS no more than 2 points higher than baseline for at least 6 out of 8 weeks during the treatment period Time: Baseline to week 12Description: Physician Global Assessment (PGA). The Physician's Global Assessment of Autoinflammatory Disease Activity (PGA) is a measure to be completed by the investigator or designee. The PGA uses a 5-point rating scale: absent, minimal, mild, moderate, and severe. The investigator will select a rating based on the patient's current disease activity at the time of the visit. Lower PGA scores represent better outcomes.
Measure: Change from baseline in PGA Time: Baseline to week 12Description: Key Symptom Score (KSS). The KSS is derived from the patient-administered DHAF, and is the average on a 0 to 10 scale (0 = None, 10 = Very Severe) of 5 separate scales - rash, feeling of fever and chills, joint pain, eye redness and pain, and fatigue. Lower KSS scores represent better outcomes.
Measure: Change from baseline in KSS Time: Baseline to week 12Description: C-reactive protein (CRP). CRP values ≤10 mg/L are considered normal range.
Measure: Change from baseline in CRP Time: Baseline to week 12Description: serum amyloid A (SAA). SAA values ≤10 mg/L are considered normal range.
Measure: Change from baseline in SAA Time: Baseline to week 12Description: Exploratory endpoint to assess the change from baseline in serum cytokines IL-1β ATI-450 in patients with CAPS.
Measure: Change from baseline in serum cytokines IL-1β Time: Baseline to week 12Description: Exploratory endpoint to assess the change from baseline in serum cytokines IL-1α of ATI-450 in patients with CAPS.
Measure: Change from baseline in serum cytokines IL-1α Time: Baseline to week 12Description: Exploratory endpoint to assess the change from baseline in serum cytokines IL-6 of ATI-450 in patients with CAPS.
Measure: Change from baseline in serum cytokines IL-6 Time: Baseline to week 12Description: Exploratory endpoint to assess the change from baseline in serum cytokines IL-18 of ATI-450 in patients with CAPS.
Measure: Change from baseline in serum cytokines IL-18 Time: Baseline to week 12Description: Exploratory endpoint to assess the change from baseline in serum cytokines TNF-α of ATI-450 in patients with CAPS.
Measure: Change from baseline in serum cytokines TNF-α Time: Baseline to week 12Alphabetical 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