SOLU-MEDROL for Lupus Erythematosus, Systemic

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Lupus Erythematosus, Systemic+1 More
SOLU-MEDROL - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Lupus Erythematosus, Systemic

Treatment Effectiveness

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: Infusion visit

Infusion visit
A comparison of the transcriptional response to glucocorticoids between the 2 dose groups.
A list of human protein-coding genes and non-coding RNAs that are differentially expressed in response to glucocorticoids in patients with SLE, for each of the studied cell types and doses.
A list of human proteincoding genes and non-coding RNAs that are differentially expressed in response to glucocorticoids in patients with SLE, for each of the studied cell types and doses.
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...
Validation of the targets identified by functional studies.

Trial Safety

Trial Design

2 Treatment Groups

1 mg/kg
1 of 2
250 mg
1 of 2

Experimental Treatment

100 Total Participants · 2 Treatment Groups

Primary Treatment: SOLU-MEDROL · No Placebo Group · Phase < 1

1 mg/kg
Drug
Experimental Group · 1 Intervention: SOLU-MEDROL · Intervention Types: Drug
250 mg
Drug
Experimental Group · 1 Intervention: SOLU-MEDROL · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: infusion visit

Who is running the clinical trial?

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Lead Sponsor
445 Previous Clinical Trials
1,071,312 Total Patients Enrolled
30 Trials studying Lupus Erythematosus, Systemic
22,334 Patients Enrolled for Lupus Erythematosus, Systemic
Luis M Franco, M.D.Principal InvestigatorNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
1 Previous Clinical Trials
35 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a primary care physician or other healthcare provider who will manage all health conditions related or unrelated to the study objectives.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 24th, 2021

Last Reviewed: November 26th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.