Bay Pines, FLNCT07388498Now EnrollingIRB Ready

Uncontrolled Gout Clinical Trial in Bay Pines, FL

Access cutting-edge uncontrolled gout treatment through this clinical trial at a research site in Bay Pines. Study-provided care at no cost to qualified participants.

Sponsored by Amgen

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Expert Care in Bay Pines

Access uncontrolled gout specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related uncontrolled gout treatment provided free

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Check if you qualify for this uncontrolled gout clinical trial in Bay Pines, FL

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Why Participate?

  • No-Cost Study Care

  • Local to Bay Pines

    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 Bay Pines site if eligible
  4. 4Begin participation

About This Uncontrolled Gout Study in Bay Pines

The primary objective of this trial is to evaluate the effect of pegloticase 18 mg subcutaneously (SC) every two weeks with methotrexate (MTX) versus pegloticase 8 mg intravenously (IV) every two weeks with MTX on the response rate during Month 6, as measured by the sustained normalization of serum uric acid (sUA) to \< 6 mg/dL for at least 80% of the time during Month 6.

Sponsor: Amgen

Who Can Participate

Inclusion Criteria

Participant has provided informed consent before initiation of any trial-specific activities/procedures.
Age ≥ 18 years or ≥ legal age within the country if it is older than 18 years.
Participants willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial.
Participants with uncontrolled gout, as meeting the protocol defined criteria.

Exclusion Criteria

Glucose-6-phosphate dehydrogenase deficiency (tested at the screening visit).
Liver transaminase levels (aspartate aminotransferase \[AST\] or alanine aminotransferase \[ALT\]) \> 1.25 x upper limit of normal (ULN) or albumin \< the lower limit of normal (LLN) at the screening visit.
Uncontrolled diabetes mellitus and/or hemoglobin A1c (HbA1c) \> 8%.
Known intolerance to MTX.
Participant received prior treatment with pegloticase, another recombinant uricase (ie, rasburicase or pegadricase), or concomitant therapy with a polyethylene glycol (PEG)-conjugated drug.
A known intolerance to all protocol standard gout flare prophylaxis regimens (ie, participant must be able to tolerate at least 1 of the following: colchicine and/or non-steroidal anti-inflammatory drug and/or low-dose prednisone ≤ 10 mg/day or equivalent dose of other corticosteroid).
Chronic renal impairment defined as estimated glomerular filtration rate (eGFR) based on Modification of Diet in Renal Disease (MDRD) calculations \< 40 mL/min/1.73 m\^2 or currently on dialysis.

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 Bay Pines?

Yes, this clinical trial (NCT07388498) has an active research site in Bay Pines, 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.

Uncontrolled Gout Treatment Options in Bay Pines, FL

If you're searching for uncontrolled gout treatment options in Bay Pines, FL, this clinical trial (NCT07388498) 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 Bay Pines research site is actively enrolling participants for this clinical trial. You'll receive care from experienced uncontrolled gout 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 uncontrolled gout clinical trials near you to find additional studies recruiting in your area.

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