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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Pegloticase SC with MTX 		Participants will receive pegloticase SC every two weeks with MTX.
  • Drug: Pegloticase
    Participants will receive pegloticase either SC or IV.
    Other names:
    • KRYSTEXXA
  • Drug: Methotrexate
    MTX will be administered orally.
    Other names:
    • MTX
Experimental
Pegloticase IV with MTX 		Participants will receive pegloticase IV every two weeks with MTX.
  • Drug: Pegloticase
    Participants will receive pegloticase either SC or IV.
    Other names:
    • KRYSTEXXA
  • Drug: Methotrexate
    MTX will be administered orally.
    Other names:
    • MTX

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35294

More Details

Status
Recruiting
Sponsor
Amgen

Study Contact

Amgen Call Center
866-572-6436
medinfo@amgen.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.