Actively Recruiting
A Phase 3, Multicenter, Double-blind, Randomized Controlled Study Evaluating Pegloticase by Subcutaneous Injection Versus Intravenous Injection with Methotrexate in Adults with Uncontrolled Gout
Led by Amgen · Updated on 2026-05-04
270
Participants Needed
37
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial focuses on adults with uncontrolled gout, investigating the effects of pegloticase given with methotrexate (MTX). Researchers aim to compare two ways of delivering pegloticase: subcutaneous (under the skin) and intravenous (into a vein). The main goal is to see how well each method maintains normal levels of serum uric acid during the sixth month of treatment. Participants will be randomly assigned to receive either pegloticase 18 mg by subcutaneous injection every two weeks with MTX or pegloticase 8 mg by intravenous infusion every two weeks with MTX. MTX is taken orally weekly. Both groups are monitored under a double-blind design, meaning neither participants nor researchers know which treatment is given to ensure unbiased results. During the study, participants will have their serum uric acid levels checked regularly, especially at weeks 20 through 24 to assess response. Researchers will also monitor for serious injection site reactions and infusion reactions, including anaphylaxis, up to week 48. The study includes assessments of drug levels in the blood and safety monitoring throughout. Participation lasts at least six months with ongoing evaluations to track efficacy and safety.
CONDITIONS
Brief 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant has provided informed consent before any trial-specific activities.
- Age 18 years or older (or legal age in country if older than 18).
- Willing and able to follow the treatment plan and evaluations for the trial duration.
- Diagnosis of uncontrolled gout meeting protocol criteria.
You will not qualify if you...
- Glucose-6-phosphate dehydrogenase deficiency.
- Liver enzyme levels (AST or ALT) greater than 1.25 times the upper limit of normal or low albumin at screening.
- Uncontrolled diabetes or hemoglobin A1c above 8%.
- Known intolerance to methotrexate.
- Prior treatment with pegloticase, other recombinant uricase drugs, or PEG-conjugated drugs.
- Intolerance to all standard gout flare prevention treatments (colchicine, NSAIDs, or low-dose corticosteroids).
- Severe chronic kidney impairment (eGFR below 40 mL/min/1.73 m²) or on dialysis.
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks
Participants receive pegloticase either by subcutaneous injection or intravenous infusion every two weeks, along with oral methotrexate.
Biweekly visits for treatment administration
Duration - Up to 24 weeks after treatment
Participants are monitored for safety and pharmacokinetics after completing treatment.
Visits as scheduled for safety assessments up to Week 48
Trial Site Locations
Total: 37 locations
1
Solace Clinical Research
Tustin, California, United States, 92780
Actively Recruiting
2
Denver Arthritis Clinic PC
Denver, Colorado, United States, 80230
Actively Recruiting
3
D and H Pompano Research Center
Aventura, Florida, United States, 33180
Actively Recruiting
4
New Generation of Medical Research
Hialeah, Florida, United States, 33016
Actively Recruiting
5
Homestead Associates In Research Inc
Homestead, Florida, United States, 33033
Actively Recruiting
6
Well Pharma Medical Research Corp
Miami, Florida, United States, 33143
Actively Recruiting
7
D and H National Research Centers
Miami, Florida, United States, 33155
Actively Recruiting
8
Advanced Clinical Research
Miami, Florida, United States, 33156
Actively Recruiting
9
Felicidad Medical Research
Miami, Florida, United States, 33184
Actively Recruiting
10
Decision Management International Research
Pinellas Park, Florida, United States, 33782
Actively Recruiting
11
Integral Rheumatology and Immunology Specialists
Plantation, Florida, United States, 33324
Actively Recruiting
12
D and H Tamarac Research Center
Tamarac, Florida, United States, 33321
Actively Recruiting
13
GCP Clinical Research, LLC
Tampa, Florida, United States, 33609
Actively Recruiting
14
ClinPro Research Solutions LLC
Tampa, Florida, United States, 33613
Actively Recruiting
15
Conquest Research - Winter Park
Winter Park, Florida, United States, 32789
Actively Recruiting
16
Spatium Urgent Care
Marietta, Georgia, United States, 30066
Actively Recruiting
17
Vista Clinical Research
Newnan, Georgia, United States, 30265
Actively Recruiting
18
Charter Research
Chicago, Illinois, United States, 60618
Actively Recruiting
19
Flourish Research Ravenswood
Chicago, Illinois, United States, 60640
Actively Recruiting
20
Greater Chicago Specialty Physicians
Schaumburg, Illinois, United States, 60195
Actively Recruiting
21
Willow Rheumatology and Wellness
Willowbrook, Illinois, United States, 60527
Actively Recruiting
22
Kur Research at Columbia Medical Practice
Columbia, Maryland, United States, 21045
Actively Recruiting
23
MD Medical Research
Oxon Hill, Maryland, United States, 20745
Actively Recruiting
24
Buffalo Rheumatology and Medicine
Orchard Park, New York, United States, 14127
Actively Recruiting
25
Joint and Muscle Research Institute
Charlotte, North Carolina, United States, 28204
Actively Recruiting
26
Cape Fear Arthritis Care, PLLC
Leland, North Carolina, United States, 28451
Actively Recruiting
27
Accellacare Salisbury
Salisbury, North Carolina, United States, 28144
Actively Recruiting
28
Carolina Research Center Inc
Shelby, North Carolina, United States, 28150
Actively Recruiting
29
Shelby Clinical Research
Shelby, North Carolina, United States, 28150
Actively Recruiting
30
Paramount Medical Research and Consulting LLC
Middleburg Heights, Ohio, United States, 44130
Actively Recruiting
31
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
Actively Recruiting
32
Articularis Healthcare Group Inc dba Low Country Rheumatology
Summerville, South Carolina, United States, 29486
Actively Recruiting
33
Pioneer Research Solutions Inc
Houston, Texas, United States, 77099
Actively Recruiting
34
Epic Clinical Research
Lewisville, Texas, United States, 75057
Actively Recruiting
35
Be Well Clinical Studies
Round Rock, Texas, United States, 78681
Actively Recruiting
36
Overlake Arthritis and Osteoperosis Center
Bellevue, Washington, United States, 98004
Actively Recruiting
37
Caribbean Health Research Center
San Juan, Puerto Rico, 00917
Actively Recruiting
Research Team
A
Amgen Call Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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