What side effects are associated with this type of intervention?

Common treatments for Lupus, such as corticosteroids, antimalarials like hydroxychloroquine, immunosuppressants, and biologics, have various side effects. Corticosteroids can cause weight gain, high blood pressure, diabetes, and osteoporosis. Hydroxychloroquine may lead to gastrointestinal upset and, rarely, retinal damage. Immunosuppressants can increase the risk of infections, liver damage, and bone marrow suppression. Biologics may also raise infection risk and can cause injection site reactions and allergic responses. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of systemic lupus erythematosus (SLE). Hydroxychloroquine, an antimalarial drug, is widely used and recommended for all patients with SLE due to its efficacy in managing symptoms and preventing flares. Belimumab, a monoclonal antibody, was the first new drug approved for lupus in over 50 years and is used to treat patients with active, autoantibody-positive SLE. Additionally, corticosteroids and immunosuppressive agents like azathioprine and mycophenolate mofetil are commonly used to control inflammation and immune response. These treatments, along with patient education and support, form the cornerstone of lupus management.

What other types of research exist?

Promising novel alternatives for lupus patients considering treatment in 2024 include interactive digital interventions, such as video game-like activities that improve cognitive functions, and telemedicine/mobile health applications for continuous monitoring and personalized feedback.

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Behavioral Intervention

Education and Navigation Program for Lupus (LEAP Trial)

N/A

Recruiting

Led By David H Chae, Sc.D., M.A.

Research Sponsored by Tulane University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 18 years of age

Living with systemic lupus erythematosus (SLE)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 months

Awards & highlights

No Placebo-Only Group

Summary

This trial examines the impact of different types of support on COVID-19 testing and vaccination for people with systemic lupus erythematosus.

Who is the study for?

This trial is for adults over 18 living with systemic lupus erythematosus (SLE) in metropolitan Birmingham, Alabama. Participants must be able to speak and understand English. Those without a confirmed SLE diagnosis, under 18, or living outside the specified area cannot join.

What is being tested?

The study aims to compare the effectiveness of two approaches: one that provides only education about COVID-19 testing and vaccination, and another that includes navigation assistance to help people with SLE get tested or vaccinated against COVID-19.

What are the potential side effects?

Since this trial focuses on education and navigation interventions rather than medical treatments, there are no direct side effects associated with drugs or medical procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I have systemic lupus erythematosus (SLE).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of COVID testing

Incidence of COVID-19 Vaccination

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: NavigationExperimental Treatment1 Intervention

COVID education for people with lupus and tailored guidance in vaccination and testing for COVID and making appointments.

Group II: EducationActive Control1 Intervention

COVID education for people with lupus.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Navigation

2013

Completed Phase 4

~3660

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for lupus, such as hydroxychloroquine, corticosteroids, and immunosuppressants, work by modulating the immune system to reduce inflammation and prevent flare-ups. Hydroxychloroquine interferes with communication between cells in the immune system, corticosteroids reduce inflammation by suppressing immune responses, and immunosuppressants inhibit the activity of the immune system to prevent it from attacking the body's own tissues. Understanding these mechanisms is crucial for lupus patients as it helps them comprehend how their treatments work, the importance of adherence, and the potential side effects, which can be better managed with proper education and support.

The Role of Neutrophils and Neutrophil Extracellular Traps in Vascular Damage in Systemic Lupus Erythematosus.Healthcare and Research Priorities of Adolescents and Young Adults with Systemic Lupus Erythematosus: A Mixed-methods Study.New Trials in Lupus and where Are we Going.