Study Summary
This trial examines the effects of a new drug on SLE patients' disease activity, immune system, and response to a flu vaccine. 10 patients will get the drug and 10 won't, to compare.
- Lupus
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
1 Primary · 2 Secondary · Reporting Duration: 6 weeks after vaccination (8 weeks after baseline)
Trial Safety
Phase-Based Safety
Side Effects for
Awards & Highlights
Trial Design
2 Treatment Groups
Anifrolumab plus Standard of Care
1 of 2
Standard of Care
1 of 2
Experimental Treatment
Non-Treatment Group
20 Total Participants · 2 Treatment Groups
Primary Treatment: Anifrolumab · Has Placebo Group · Phase < 1
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 70 · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Battafarano DF, Battafarano NJ, Larsen L, Dyer PD, Older SA, Muehlbauer S, Hoyt A, Lima J, Goodman D, Lieberman M, Enzenauer RJ. Antigen-specific antibody responses in lupus patients following immunization. Arthritis Rheum. 1998 Oct;41(10):1828-34.
- Crowe SR, Merrill JT, Vista ES, Dedeke AB, Thompson DM, Stewart S, Guthridge JM, Niewold TB, Franek BS, Air GM, Thompson LF, James JA. Influenza vaccination responses in human systemic lupus erythematosus: impact of clinical and demographic features. Arthritis Rheum. 2011 Aug;63(8):2396-406. doi: 10.1002/art.30388.
- Abu-Shakra M, Press J, Buskila D, Sukenik S. Influenza vaccination of patients with systemic lupus erythematosus: safety and immunogenecity issues. Autoimmun Rev. 2007 Sep;6(8):543-6. Epub 2007 Jan 9. Review.
- Abu-Shakra M, Press J, Buskila D, Sukenik S. Influenza vaccination of patients with systemic lupus erythematosus: safety and immunogenecity issues. Autoimmun Rev. 2007 Sep;6(8):543-6. doi: 10.1016/j.autrev.2006.12.004. Epub 2007 Jan 9.
- Battafarano DF, Battafarano NJ, Larsen L, Dyer PD, Older SA, Muehlbauer S, Hoyt A, Lima J, Goodman D, Lieberman M, Enzenauer RJ. Antigen-specific antibody responses in lupus patients following immunization. Arthritis Rheum. 1998 Oct;41(10):1828-34. doi: 10.1002/1529-0131(199810)41:103.0.CO;2-T.
- 2021. "Nature of Anifrolumab Impact on Vaccine-Emergent Immunity in SLE". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04726553.
Frequently Asked Questions
What prior research has been done involving Anifrolumab?
"Presently, there are 331 Anifrolumab studies in progress. 78 of these trials have reached Phase 3 and are based primarily out of Philadelphia, Pennsylvania; yet 8054 sites across the globe offer medical research into this new medication." - Anonymous Online Contributor
How is Anifrolumab usually applied to aid patients?
"Anifrolumab is most frequently administered to individuals with lupus erythematosus, systemic. Nonetheless, it also has applications in battling bladder cancer, pericarditis, and meningeal leukemia." - Anonymous Online Contributor
Who meets the prerequisites to participate in this trial?
"Eligible patients must demonstrate a diagnosis of lupus, and they should be in the 18-70 age range. This trial will enrol 20 participants total." - Anonymous Online Contributor
How many individuals have signed up to participate in this experiment?
"The Piedmont Heart Institute, Inc., Atlanta, GA is responsible for carrying out the trial from two distinct settings: Piedmont Hospital in Atlanta and New York University Medical Center. To undertake this study there needs to be 20 individuals that adhere to its inclusion criteria." - Anonymous Online Contributor
Is the age limit for participating in this experiment restricted to those under 40 years old?
"The study is open to applicants aged between 18 and 70, although there are more trials available for younger (149) or elderly (340) patients." - Anonymous Online Contributor
Is this scientific research accepting volunteers at the present time?
"As can be found on clinicaltrials.gov, this medical trial is actively looking for participants to take part in their program. The initial post was uploaded on January 20th 2021 and the most recent update occurred on March 21st 2023." - Anonymous Online Contributor
Are any North American centers conducting this research experiment?
"Currently, this medical trial is enrolling participants in Piedmont Hospital of Atlanta (GA), New York University Medical Center (NY) and Columbia Unversity Medical Center (OKC) as well as 5 additional sites." - Anonymous Online Contributor