Trial · NCT04008069
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Without Sarcoidosis Flare (Flare-Free Survival) | Week 16 to Week 28 | The primary outcome was flare-free survival of sarilumab-treated patients compared to placebo-treated controls. Patients will be considered to have flared if they receive rescue medication including increased glucocorticoids, or if they discontinue the study treatment in order to start a different therapy. |
| Secondary | Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted | Baseline and week 16 | FVC is a pulmonary function test, and is defined as the volume of air that can forcibly be blown out after taking a full breath. FVC% predicted is defined as FVC% of the patient divided by the average FVC% in the population for any person of similar age, sex and body composition. |
| Secondary | Change From Baseline in Hemoglobin-corrected Diffusing Capacity for Carbon Monoxide (DLCO) Percent Predicted | Baseline, and week 16 | DLCO is a pulmonary function test, and measures the partial pressure difference between inspired and expired carbon monoxide. DLCO% predicted is defined as DLCO% of the patient divided by the average DLCO% in the population for any person of similar age, sex and body composition. |
| Secondary | Change in Pulmonary Function (FEV1) Percent Predicted | Baseline and week 16 | FEV1 percent predicted is a normalized value of FEV1 calculated using the Knudson equation and based upon participant age, gender, and height. |
| Secondary | Change From Baseline in Extrapulmonary Physician Organ Severity Tool (ePOST) Scale Score | Baseline, week 16, and week 28 | Physician and patient assessments assessed using the extrapulmonary physician organ severity tool (ePOST). Score Description: 0: Not affected 1. Slight 2. Mild 3. Moderate 4. Moderate to severe 5. Severe 6. Very Severe 17 organ domains were rated and summed to create a total score (range 0-102, higher scores correspond with more severity). |
| Secondary | Change From Baseline in Physician Disease Activity Visual Analogue Scale (VAS) | Baseline, week 16, and week 28 | Physician rates patient's disease on a 100 mm VAS. Score range: 0 to 100, higher scores correspond to worse disease state. |
| Secondary | Change From Baseline in Patient Disease Activity Visual Analogue Scale (VAS) | Baseline, week 16, and week 28 | Patient rates their disease on a 100 mm VAS. Score range: 0 to 100, higher scores correspond to worse disease state. |
| Secondary | Change From Baseline in FACIT-F Score (Fatigue Scale) | Baseline, week 16, and week 28 | FACIT-F score Total score range: 0-52, lower scores correspond with more fatigue. |
| Secondary | Number of Tender and Swollen Joints Per 68/66 Joint Evaluation | Baseline, week 16, and week 28 | The 66/68 Joint Count evaluates 68 joints for tenderness and pain with movement and 66 joints for swelling (hip joints can be evaluated for tenderness only, not for swelling. Joint evaluation score: 0: Absent 1: Present 9: Not applicable |
| Secondary | Sarcoidosis Activity and Severity Index for Cutaneous Sarcoidosis | Baseline, week 16, and week 28 | Sarcoidosis Activity and Severity Index evaluates 7 parameters on a 0 to 4 scale, summed for an overall scale score of 0 to 28 (higher values indicate higher activity/severity). |
| Secondary | Change in Size of Sarcoidosis Lesions | Baseline, week 16, and week 28 | |
| Secondary | Change From Baseline in Serum Angiotensin Converting Enzyme | Baseline, week 16, and week 28 | ACE is a serum marker that is increased in sarcoidosis. ACE is produced by epithelioid cells that are derived from recently-activated macrophages in granulomas; thus, ACE is an appropriate representative of whole-body granuloma. |
| Secondary | Change From Baseline in Serum C-Reactive Protein (CRP) | Baseline, week 16, and week 28 | CRP is a protein made by the liver. The level of CRP increases when there's inflammation in the body. |
| Secondary | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) | Baseline, week 16, and week 28 | ESR is the rate at which red blood cells in anticoagulated whole blood descend in a standardized tube over a period of one hour. |
| Secondary | Change in Prednisone Dose | Baseline, week 16, and week 28 | |
| Secondary | Number of Participants With Alanine Aminotransferase (ALT) Outside Normal Range | Baseline, week 16, and week 28 | Normal range as calculated by the local laboratory. |
| Secondary | Number of Participants With Aspartate Aminotransferase (AST) Outside Normal Range | Baseline, week 16, and week 28 | Normal range as calculated by the local laboratory. |
| Secondary | Number of Participants With Serum Creatinine Outside Normal Range | Baseline, week 16, and week 28 | Normal range as calculated by the local laboratory. |
| Secondary | Number of Participants With Urine Protein Outside Normal Range | Baseline, week 16, and week 28 | Normal range as calculated by the local laboratory. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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