Anifrolumab for Lupus
(NAIVE Trial)
Trial Summary
What is the purpose of this trial?
This study to examines the impact of anifrolumab on disease activity, immune phenotypes, and development of neutralizing antibodies to quadrivalent influenza vaccine in patients with Systemic Lupus Erythematosus (SLE). 10 patients with moderately to severely active SLE will be treated with anifrolumab in addition to standard of care lupus treatments and 10 will receive only standard of care medications. All will receive influenza vaccine.
Research Team
Joan T Merrill, M.D.
Principal Investigator
Member
Cristina Arriens, M.D.
Principal Investigator
Clinical Assistant Member
Eligibility Criteria
This trial is for adults aged 18-70 with moderate to severely active Systemic Lupus Erythematosus (SLE), as indicated by specific disease activity scores. Participants may be on stable doses of certain lupus medications, including steroids and antimalarials. Women must use two forms of contraception, men must use condoms, and participants cannot be pregnant or have had recent severe infections or cancer.Inclusion Criteria
Exclusion Criteria
Treatment Details
Interventions
- Anifrolumab
- Standard of Care
Anifrolumab is already approved in United States, European Union for the following indications:
- Moderate to severe systemic lupus erythematosus (SLE)
- Moderate to severe systemic lupus erythematosus (SLE)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Oklahoma Medical Research Foundation
Lead Sponsor
Piedmont Heart Institute, Inc., Atlanta, GA
Industry Sponsor
NYU Langone Health
Collaborator
Yale University
Collaborator
Columbia University
Collaborator