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Report for D012507: Sarcoidosis NIH

(Synonyms: Sarcoidos, Sarcoidosis)

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (2)


Name (Synonyms) Correlation
drug116 Acthar Gel Wiki 1.00
drug1822 Placebo Wiki 0.06

Correlated MeSH Terms (1)


Name (Synonyms) Correlation
D017565 Sarcoidosis, Pulmonary NIH 1.00

Correlated HPO Terms (0)


Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials


1 A Phase 4, Multicenter, Randomized, Double Blind, Placebo Controlled Pilot Study to Assess the Efficacy and Safety of Acthar Gel in Subjects With Pulmonary Sarcoidosis

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.

NCT03320070 Sarcoidosis, Pulmonary Drug: Acthar Gel Drug: Placebo
MeSH:Sarcoidosis, Pulmonary Sarcoidosis

Primary Outcomes

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 weeks

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: 48 weeks

Description: 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 weeks

Description: 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 weeks

Description: 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 weeks

Description: 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 weeks

Description: 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 weeks

Description: 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 weeks

Description: 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 weeks

Description: 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 weeks

Description: 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 weeks

Description: 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 weeks


HPO Nodes