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Tests treatment safety and results for Uncontrolled Gout
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?
Pegloticase is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for uncontrolled gout.
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
- 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.
- 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's taking place
- Birmingham, Alabama, United States
- Anchorage, Alaska, United States
- Chula Vista, California, United States
- Tustin, California, United States
- Denver, Colorado, United States
- Aventura, Florida, United States
- Bay Pines, Florida, United States
- DeLand, Florida, United States
- Hialeah, Florida, United States
- Homestead, Florida, United States
- Miami, Florida, United States
- Pinellas Park, Florida, United States
- Plantation, Florida, United States
- Tamarac, Florida, United States
- Tampa, Florida, United States
- Winter Park, Florida, United States
- Marietta, Georgia, United States
- Newnan, Georgia, United States
- Chicago, Illinois, United States
- Schaumburg, Illinois, United States
+ 24 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 - 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?
Study sites include Birmingham, Alabama, United States; Anchorage, Alaska, United States; Chula Vista, California, United States; Tustin, California, United States; Denver, Colorado, United States; Aventura, Florida, United States and 38 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.