Uncontrolled Gout study: Pegloticase vs Methotrexate
Official title A Double-blind, Randomized Controlled Trial to Investigate the Efficacy, Safety, and Pharmacokinetics of Pegloticase Administration Via Subcutaneous and Intravenous Routes Both With Methotrexate in Participants With Uncontrolled Gout
ClinicalTrials.gov ID: NCT07388498
What this study is testing
What is Pegloticase?
This is an investigational injectable medicine being studied as a potential treatment for uncontrolled gout. It is designed to break down uric acid in the body.
Also referred to as Krystexxa.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if giving pegloticase under the skin is as effective as giving it through a vein for keeping uric acid levels low.
- Who it's for
- The study is looking for people with uncontrolled gout.
- What's involved
- Participants will receive pegloticase and methotrexate every two weeks, either as an injection under the skin or through an IV line.
- Time commitment
- The study lasts at least six months, with visits every two weeks for treatment.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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 \<...
- 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...
- A known intolerance to all protocol standard gout flare prophylaxis regimens (ie, participant must be able to tolerate at least 1 of the following...
See the full eligibility 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Anchorage, Alaska, United States
- Searcy, Arkansas, United States
- Anaheim, California, United States
- Chula Vista, California, United States
- Long Beach, California, United States
- Tustin, California, United States
- Walnut Creek, California, United States
- Denver, Colorado, United States
- Aventura, Florida, United States
- Bay Pines, Florida, United States
- Coral Springs, Florida, United States
- DeLand, Florida, United States
- Hialeah, Florida, United States
- Homestead, Florida, United States
- Largo, Florida, United States
- Miami, Florida, United States
- Plantation, Florida, United States
- Tamarac, Florida, United States
- Tampa, Florida, United States
+ 42 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Anchorage, Alaska, United States; Searcy, Arkansas, United States; Anaheim, California, United States; Chula Vista, California, United States; Long Beach, California, United States and 56 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.