Trial Outcomes & Findings for Genomic Effects of Glucocorticoids in Patients With Systemic Lupus Erythematosus (NCT NCT04233164)
NCT ID: NCT04233164
Last Updated: 2024-08-06
Results Overview
Number of of SLE patients that were sampled for RNA-seq differential gene expression analysis in glucocorticoid-treated immune cells. The analysis employed a cutoff value of \< 5% false-discovery rate (FDR) to select the transcripts that were considered differentially expressed at each time point. The resulting gene lists were contrasted to determine which genes were uniquely differentially expressed in different cell types.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
47 participants
Primary outcome timeframe
2 hours and 4 hours post infusion
Results posted on
2024-08-06
Participant Flow
of the 47 participants consented, six were screen failure so were not randomized to any arm in the study.
Participant milestones
| Measure |
Group A: Glucocorticoids 1 mg/kg Dose
Participants with Systemic Lupus Erythematosus (SLE) received a single intravenous dose of methylprednisolone 1 mg/kg and blood was collected two hours and four hours after the start of the infusion.
|
Group B: Glucocorticoids 250 mg Dose
Participants with Systemic Lupus Erythematosus (SLE) received a single intravenous dose of 250 mg of methylprednisolone and blood was collected two hours and four hours after the start of the infusion.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
21
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Group A: Glucocorticoids 1 mg/kg Dose
Participants with Systemic Lupus Erythematosus (SLE) received a single intravenous dose of methylprednisolone 1 mg/kg and blood was collected two hours and four hours after the start of the infusion.
|
Group B: Glucocorticoids 250 mg Dose
Participants with Systemic Lupus Erythematosus (SLE) received a single intravenous dose of 250 mg of methylprednisolone and blood was collected two hours and four hours after the start of the infusion.
|
|---|---|---|
|
Overall Study
Unable to obtain specimen
|
0
|
1
|
Baseline Characteristics
Genomic Effects of Glucocorticoids in Patients With Systemic Lupus Erythematosus
Baseline characteristics by cohort
| Measure |
Group A: Glucocorticoids 1 mg/kg Dose
n=20 Participants
Participants with Systemic Lupus Erythematosus (SLE) received a single intravenous dose of methylprednisolone 1 mg/kg and blood was collected two hours and four hours after the start of the infusion.
|
Group B: Glucocorticoids 250 mg Dose
n=21 Participants
Participants with Systemic Lupus Erythematosus (SLE) received a single intravenous dose of 250 mg of methylprednisolone and blood was collected two hours and four hours after the start of the infusion.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
37 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 2 hours and 4 hours post infusionPopulation: Participants who completed the study
Number of of SLE patients that were sampled for RNA-seq differential gene expression analysis in glucocorticoid-treated immune cells. The analysis employed a cutoff value of \< 5% false-discovery rate (FDR) to select the transcripts that were considered differentially expressed at each time point. The resulting gene lists were contrasted to determine which genes were uniquely differentially expressed in different cell types.
Outcome measures
| Measure |
Group A: Glucocorticoids 1 mg/kg Dose
n=20 Participants
Participants with Systemic Lupus Erythematosus (SLE) received a single intravenous dose of methylprednisolone 1 mg/kg and blood was collected two hours and four hours after the start of the infusion.
|
Group B: Glucocorticoids 250 mg Dose
n=20 Participants
Participants with Systemic Lupus Erythematosus (SLE) received a single intravenous dose of 250 mg of methylprednisolone and blood was collected two hours and four hours after the start of the infusion.
|
|---|---|---|
|
Number of SLE Patients That Were Sampled for RNA-seq Differential Expression Analysis (Biological Replicates)
2 hours post infusion
|
20 Participants
|
20 Participants
|
|
Number of SLE Patients That Were Sampled for RNA-seq Differential Expression Analysis (Biological Replicates)
4 hours post infusion
|
20 Participants
|
20 Participants
|
Adverse Events
Group A: Glucocorticoids 1 mg/kg Dose
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Group B: Glucocorticoids 250 mg Dose
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group A: Glucocorticoids 1 mg/kg Dose
n=20 participants at risk
Participants with Systemic Lupus Erythematosus (SLE) received a single intravenous dose of methylprednisolone 1 mg/kg and blood was collected two hours and four hours after the start of the infusion.
|
Group B: Glucocorticoids 250 mg Dose
n=21 participants at risk
Participants with Systemic Lupus Erythematosus (SLE) received a single intravenous dose of 250 mg of methylprednisolone and blood was collected two hours and four hours after the start of the infusion.
|
|---|---|---|
|
Cardiac disorders
Palpitations
|
10.0%
2/20 • 7 days
|
0.00%
0/21 • 7 days
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/20 • 7 days
|
4.8%
1/21 • 7 days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/20 • 7 days
|
4.8%
1/21 • 7 days
|
|
General disorders
Fatigue
|
10.0%
2/20 • 7 days
|
4.8%
1/21 • 7 days
|
|
General disorders
Thirst
|
5.0%
1/20 • 7 days
|
0.00%
0/21 • 7 days
|
|
Infections and infestations
Nasopharyngitis
|
5.0%
1/20 • 7 days
|
0.00%
0/21 • 7 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
1/20 • 7 days
|
0.00%
0/21 • 7 days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/20 • 7 days
|
14.3%
3/21 • 7 days
|
|
Nervous system disorders
Headache
|
20.0%
4/20 • 7 days
|
9.5%
2/21 • 7 days
|
|
Psychiatric disorders
Tearfulness
|
0.00%
0/20 • 7 days
|
4.8%
1/21 • 7 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/20 • 7 days
|
4.8%
1/21 • 7 days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/20 • 7 days
|
4.8%
1/21 • 7 days
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/20 • 7 days
|
4.8%
1/21 • 7 days
|
Additional Information
Franco, Luis
National Inst of Arthritis and Musculoskeletal and Skin Diseases
Phone: +1 240 220 4366
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place