Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| D017565 | Sarcoidosis, Pulmonary NIH | 1.00 |
| D012507 | Sarcoidosis NIH | 0.71 |
| Name (Synonyms) | Correlation |
|---|
Navigate: Correlations HPO
There is one clinical trial.
The purpose of this study is to find out if Acthar Gel is safe and effective to treat pulmonary sarcoidosis. Participants will be randomly assigned (like flipping a coin) to receive a shot under their skin of Acthar Gel or a matching placebo gel that has no drug in it. They will receive their assigned shot twice a week for 24 weeks. All participants who complete the 24-week treatment period will be eligible to receive Acthar Gel for 24 more weeks, even if they were originally in the placebo group.
Description: Based on absolute change of percent predicted, FVC is evaluated to determine if the condition is: Improved (+1) [≥ 5% absolute change] Unchanged (0) [>- 5% to < 5% absolute change], or Worse (-1) [≤ -5% absolute change]
Measure: Number of Participants in each Category of Assessment based on Forced Vital Capacity, a Pulmonary Function Test Parameter Time: 24 weeksDescription: Based on absolute change of percent predicted, FVC is evaluated to determine if the condition is: Improved (+1) [≥ 5% absolute change] Unchanged (0) [>- 5% to < 5% absolute change], or Worse (-1) [≤ -5% absolute change]
Measure: Number of Participants in each Category of Assessment based on Forced Vital Capacity, a Pulmonary Function Test Parameter Time: 48 weeksDescription: Based on absolute change of percent predicted, DLCO is evaluated to determine if the condition is: Improved (+1) [≥ 5% absolute change] Unchanged (0) [>- 5% to < 5% absolute change], Worse (-1) [≤ -5% absolute change]
Measure: Number of Participants in each Category of Assessment based on the Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO), a Pulmonary Function Test Parameter Time: 24 weeksDescription: Based on absolute change of percent predicted, DLCO is evaluated to determine if the condition is: Improved (+1) [≥ 5% absolute change] Unchanged (0) [>- 5% to < 5% absolute change], Worse (-1) [≤ -5% absolute change]
Measure: Number of Participants in each Category of Assessment based on the Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO), a Pulmonary Function Test Parameter Time: 48 weeksDescription: HRCT imaging will be evaluated by the investigator/radiology and the central reader to determine if the condition is improved (+1), unchanged (0), or worse (-1).
Measure: Number of Participants in each Category of Assessment based on High Resolution Computer Tomography (HRCT) Time: 24 weeksDescription: HRCT imaging will be evaluated by the investigator/radiology and the central reader to determine if the condition is improved (+1), unchanged (0), or worse (-1).
Measure: Number of Participants in each Category of Assessment based on High Resolution Computer Tomography (HRCT) Time: 48 weeksDescription: King's Sarcoidosis Questionnaire (General Health) is a 28-item questionnaire for participants to indicate the status of their sarcoidosis and treatment. Higher scores indicate improvement, and a change of 4 points is considered clinically meaningful. The score on the scale is evaluated to determine if the condition is: Improved (+1) based on a change of ≥ 4 points Unchanged (0) based on a change of >- 4 to < 4 points Worse (-1) based on a change of ≤ -4 points
Measure: Number of participants in each Category of Assessment based on the King's Sarcoidosis Questionnaire (General Health), a Quality of Life Parameter Time: 24 weeksDescription: King's Sarcoidosis Questionnaire (General Health) is a 28-item questionnaire for participants to indicate the status of their sarcoidosis and treatment. Higher scores indicate improvement, and a change of 4 points is considered clinically meaningful. The score on the scale is evaluated to determine if the condition is: Improved (+1) based on a change of ≥ 4 points Unchanged (0) based on a change of >- 4 to < 4 points Worse (-1) based on a change of ≤ -4 points
Measure: Number of participants in each Category of Assessment based on the King's Sarcoidosis Questionnaire (General Health), a Quality of Life Parameter Time: 48 weeksDescription: The FAS is a 10-item checklist for participants to indicate the level of their fatigue. Lower scores indicate improvement (less fatigue) and a change of 4 points is considered clinically meaningful. The score on the scale is evaluated to determine if the condition is: Improved (+1) based on a change of ≤ -4 points Unchanged (0) based on a change of >- 4 to < 4 points Worse (-1) based on a change of ≥ 4 points
Measure: Number of participants in each Category of Assessment based on the Fatigue Assessment Score (FAS), a Quality of Life Parameter Time: 24 weeksDescription: The FAS is a 10-item checklist for participants to indicate the level of their fatigue. Lower scores indicate improvement (less fatigue) and a change of 4 points is considered clinically meaningful. The score on the scale is evaluated to determine if the condition is: Improved (+1) based on a change of ≤ -4 points Unchanged (0) based on a change of >- 4 to < 4 points Worse (-1) based on a change of ≥ 4 points
Measure: Number of participants in each Category of Assessment based on the Fatigue Assessment Score (FAS), a Quality of Life Parameter Time: 48 weeksDescription: Corticosteroids are typically the first-line when treatment of sarcoidosis is required. Concerns of significant corticosteroid toxicity results in efforts to taper as early as possible. Participants are evaluated at each visit following randomization, and an algorithm is used to taper them off prednisone using incremental doses of 40, 30, 20, 10, 7.5, 5, 2.5 and 0 mg. When the clinical status is: Improvement, they go down by one level First stable visit without toxicity, they continue the same dose Second stable visit without toxicity, the go down by one level Stable visit with toxicity, their toxicity is treated and they may go down by one level Worsening, they go up by one or two levels, but do not exceed 40 mg/day
Measure: Number of Participants Receiving each Dose of Prednisone Time: 24 weeksDescription: Corticosteroids are typically the first-line when treatment of sarcoidosis is required. Concerns of significant corticosteroid toxicity results in efforts to taper as early as possible. Participants are evaluated at each visit following randomization, and an algorithm is used to taper them off prednisone using incremental doses of 40, 30, 20, 10, 7.5, 5, 2.5 and 0 mg. When the clinical status is: Improvement, they go down by one level First stable visit without toxicity, they continue the same dose Second stable visit without toxicity, the go down by one level Stable visit with toxicity, their toxicity is treated and they may go down by one level Worsening, they go up by one or two levels, but do not exceed 40 mg/day
Measure: Number of Participants Receiving each Dose of Prednisone Time: 48 weeksAlphabetical 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