Clearwater, FLNCT07607964Now EnrollingIRB Ready

Systemic Lupus Erythematosus Clinical Trial in Clearwater, FL

Access cutting-edge systemic lupus erythematosus treatment through this clinical trial at a research site in Clearwater. Study-provided care at no cost to qualified participants.

Sponsored by AbbVie

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Expert Care in Clearwater

Access systemic lupus erythematosus specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related systemic lupus erythematosus treatment provided free

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Check if you qualify for this systemic lupus erythematosus clinical trial in Clearwater, FL

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Why Participate?

  • No-Cost Study Care

  • Local to Clearwater

    Convenient for FL residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Clearwater site if eligible
  4. 4Begin participation

About This Systemic Lupus Erythematosus Study in Clearwater

Systemic lupus erythematosus (SLE) is a chronic, systemic autoimmune disease characterized by B cell hyperactivity. Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. The purpose of this study is to assess the pharmacokinetics, pharmacodynamics and safety of ABBV-519 in adult participants with SLE or RA. This is a single ascending dose study in an estimated 30 adult participants with moderate SLE or RA. The total duration of the study will be approximately 425 days (60-day Screening Period, 1-day Treatment Period, and a 52 week Follow-up Period) at approximately 15 to 20 sites globally. There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Sponsor: AbbVie

Who Can Participate

Inclusion Criteria

Key Inclusion Criteria:
Individuals between 18 and 75 years of age inclusive at the time of Screening.
Minimum baseline B-cell count of 50 cells/mcL. Inclusion Criteria for SLE Participants:
Clinical diagnosis of SLE and fulfilling the 2019 EULAR/ACR classification criteria.
Positive ANA ≥ 1:80 and the presence of at least one of the following autoantibodies above the upper limit of normal (ULN): anti-double-stranded DNA (dsDNA), anti-Smith (Sm), anti-ribonucleoprotein (RNP), or anti-Sjogren's syndrome antigen A (SSA).
Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) score of ≥ 4 (excluding anti-dsDNA and C3/C4). Lupus headache or organic brain syndrome do not count towards the hSLEDAI points required for eligibility.
Participants must have an inadequate response to ≥ 1 immunosuppressant therapies, used for at least 3 months. Inclusion Criteria for RA Participants:
Clinical diagnosis of RA and fulfilling the 2010 ACR/EULAR classification criteria for RA.
Presence of rheumatoid factor (RF) or anti-citrullinated peptide antibodies (ACPA) above the ULN.
Presence of at least 6 swollen and 6 tender joints
High-sensitivity C-reactive protein (hs-CRP) ≥ 3 mg/L.
Failed at least 1 conventional synthetic disease-modifying antirheumatic drug (DMARD) and ≥ 1 biological or targeted DMARDs of different classes.

Exclusion Criteria

Key Exclusion Criteria:
Participants with a history of infection.
Participants with uncontrolled hypertension Exclusion for SLE Participants:
Active neuropsychiatric SLE, or signs or symptoms of neuropsychiatric SLE within the 6 months prior to Screening (lupus headache permissible). \- Unstable or progressive glomerulonephritis (active class III or IV).
SLE overlap syndromes including, but not limited to RA, Sjogren's disease (SjD), SSc, polymyositis, dermatomyositis, or mixed connective tissue disease. Exclusion for RA Participants: \-- History of RA overlap syndromes, including but not limited to SLE, SjD, scleroderma, mixed connective tissue disorder or polymyositis.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Clearwater?

Yes, this clinical trial (NCT07607964) has an active research site in Clearwater, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Systemic Lupus Erythematosus Treatment Options in Clearwater, FL

If you're searching for systemic lupus erythematosus treatment options in Clearwater, FL, this clinical trial (NCT07607964) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Clearwater research site is actively enrolling participants for this clinical trial. You'll receive care from experienced systemic lupus erythematosus specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all systemic lupus erythematosus clinical trials near you to find additional studies recruiting in your area.

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