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Corticosteroid
Glucocorticoids for Lupus
Phase < 1
Waitlist Available
Led By Luis M Franco, M.D.
Research Sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged 18-80 years
Has a diagnosis of SLE based on the 1997 Update of the 1982 American College of Rheumatology Revised Criteria for Classification of SLE
Timeline
Screening 3 weeks
Treatment Varies
Follow Up infusion visit
Awards & highlights
Study Summary
This trial is investigating how GCs affect the immune system in people with SLE in order to develop new and better drugs for treating the disease. Eligible participants will undergo screening tests and then have a methylprednisolone infusion. Blood will be collected at various times afterwards and participants will be contacted afterwards to discuss any health problems.
Who is the study for?
Adults aged 18-80 with Systemic Lupus Erythematosus (SLE) can join this trial. They must be willing to undergo genetic testing, have a stable dose of certain medications if used, and have a primary care physician. Exclusions include severe allergies or reactions to glucocorticoids, untreated osteoporosis or high fracture risk osteopenia, uncontrolled diabetes, recent major surgery or infections requiring IV antibiotics, certain viral infections like HIV/hepatitis, and specific medication use.Check my eligibility
What is being tested?
The study is examining the effects of two doses of Solu-Medrol (a type of glucocorticoid), either 250 mg or 1mg/kg on gene expression in SLE patients. Participants will receive an infusion and undergo blood tests before and after treatment to see how their immune system responds at the genomic level.See study design
What are the potential side effects?
Glucocorticoids like Solu-Medrol may cause side effects such as increased blood sugar levels which could affect diabetics more severely; mood swings; increased risk of infection; possible elevation in blood pressure; weight gain; thinning bones leading to osteoporosis over time.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 80 years old.
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I have been diagnosed with SLE according to specific criteria.
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I am on a low dose of steroids for my lupus flare, not more than 15mg/day.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ infusion visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~infusion visit
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of SLE Patients That Were Sampled for RNA-seq Differential Expression Analysis (Biological Replicates)
Secondary outcome measures
A comparison of the transcriptional response to glucocorticoids between the 2 dose groups.
A list of protein-coding or non-coding transcripts, their corresponding proteins, and the molecular pathways representing the best candidates for targeted therapeutic alternatives to glucocorticoids.
For each cell type, a list of protein-coding or non-coding transcripts that are shared and a list of transcripts that are different, between patients with SLE and the previously studied healthy controls, at baseline or in response to glucocortic...
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Group B: Glucocorticoids 250 mg doseExperimental Treatment1 Intervention
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.
Group II: Group A: Glucocorticoids 1 mg/kg doseExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Lead Sponsor
484 Previous Clinical Trials
1,086,960 Total Patients Enrolled
2 Trials studying Lupus
270 Patients Enrolled for Lupus
Luis M Franco, M.D.Principal InvestigatorNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
1 Previous Clinical Trials
33 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have diabetes or my fasting blood sugar is 125 mg/dL or higher.I have been taking a low dose of steroids recently.I have been diagnosed with an active cancer.I have not taken nafcillin, rifabutin, rifampin, St. John's wort, or troglitazone in the last 30 days.I am between 18 and 80 years old.I have not needed IV antibiotics for an infection in the last 30 days.I have been diagnosed with SLE according to specific criteria.I have had cancer chemotherapy in the last 5 years.I have not taken clarithromycin, itraconazole, or ketoconazole in the last 30 days.I have not been vaccinated in the last 30 days.I am on a low-dose steroid treatment and agree to reduce it if required.I have a history of untreated chronic infections.I am on a low dose of steroids for my lupus flare, not more than 15mg/day.I have not used belimumab or rituximab in the last 6 months.I've been on a stable dose of my immunosuppressive medication, excluding steroids for lupus, for the last 60 days.I've had a serious heart or mental health issue from taking steroids.I am willing to undergo genetic testing.I have not had surgery under general anesthesia in the last 8 weeks.I have not used desmopressin in the last 30 days.I have been diagnosed with osteoporosis and have not received treatment.I have been diagnosed with osteopenia and am at high risk for fractures.
Research Study Groups:
This trial has the following groups:- Group 1: Group B: Glucocorticoids 250 mg dose
- Group 2: Group A: Glucocorticoids 1 mg/kg dose
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who is the ideal pool of volunteers for this clinical experiment?
"This clinical trial is accepting a maximum of 100 patients who have lupus erythematosus, systemic and fall in the age range between 18 and 80."
Answered by AI
Are there any past studies that have used SOLU-MEDROL for their research?
"At present, there are 150 clinical trials in progress that focus on SOLU-MEDROL. Of these trials, 39 have entered Phase 3 of the research process. The majority of studies for this treatment occur in Houston, Texas and beyond with a total count of 6845 sites running tests."
Answered by AI
What medical conditions is SOLU-MEDROL typically indicated for?
"SOLU-MEDROL is typically prescribed to patients suffering from ophthalmia, sympathetic and related conditions such as temporal arteritis, scalp structure, and lupus erythematosus."
Answered by AI
Is this experiment actively seeking participants?
"Clinicaltrials.gov states that this clinical investigation is actively recruiting patients, with the original posting on March 4th 2020 and most recent update on October 22nd 2022."
Answered by AI
Are minors qualified to take part in the experiment?
"This research project has been designed for participants aged 18 to 80. Those younger than 18 are able to apply to 51 different experiments, while those over 65 can select from 228 studies."
Answered by AI
What is the participant population for this research experiment?
"Affirmative, according to information on clinicaltrials.gov this medical trial is actively recruiting participants. It was first posted on March 4th 2020 and has been refreshed for the last time on October 22nd 2022, with an aim of enrolling 100 study subjects from a single research centre."
Answered by AI
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