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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pegloticase, Methotrexate.
- Who it may be relevant to
- Registry conditions: Uncontrolled Gout. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Puerto Rico
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 3, Multicenter, Double-blind, Randomized Controlled Study Evaluating the Efficacy and Safety of Pegloticase Administered by Subcutaneous Injection Compared With Pegloticase Administered by Intravenous Injection, Both Administered Concurrently With Methotrexate Weekly, in Participants With Uncontrolled Gout
Overview
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.
Interventions
- Drug Pegloticase
Participants will receive pegloticase either SC or IV. - Drug Methotrexate
MTX will be administered orally.
Primary outcome measures
- Number of Participants Achieving Month 6 Response at Weeks 20, 21, 22, 23, and 24 [Time frame: Month 6 (Weeks 20, 21, 22, 23, and 24)]
Secondary outcome measures (4)
- Number of Participants With Serious Injection Site Reactions Through Week 48 [Time frame: Up to Week 48]
- Number of Participants With Serious Adjudicated Infusion Reactions (Including Adjudicated Anaphylaxis) Through Week 48 [Time frame: Up to Week 48]
- Number of Participants With Adjudicated Anaphylaxis Through Week 48 [Time frame: Up to Week 48]
- Serum Concentrations of Pegloticase Following SC and IV Administration [Time frame: Up to Week 48]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 62 centers
- University of Alabama at Birmingham — Birmingham
- Orthopedic Physicians Alaska — Anchorage
- Precision Rheumatology — Anaheim
- Advanced Clinical Research Center, LLC dba TriWest Research Associates — Chula Vista
- Solace Clinical Research — Tustin
- Denver Arthritis Clinic PC — Denver
- D and H Pompano Research Center — Aventura
- Bay Pines Veterans Affairs Healthcare System — Bay Pines
- … and 54 more centers
Puerto Rico · 1 center
- Caribbean Health Research Center — San Juan
Identifiers
NCT: NCT07388498 · 20230219