NCT03994731

Study of KRYSTEXXA® (Pegloticase) Plus Methotrexate in Participants With Uncontrolled Gout

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy and Safety Study of Methotrexate to Increase Response Rates in Patients With Uncontrolled Gout Receiving KRYSTEXXA® (Pegloticase) (MIRROR Randomized Controlled Trial [RCT])

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 152 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the potential for pegloticase with methotrexate (MTX) to increase the response rate seen with pegloticase alone, and to characterize the safety, tolerability and pharmacokinetics (PK) of the concomitant use of pegloticase with MTX, by comparing pegloticase co-administered with MTX to pegloticase co-administered with placebo for MTX in adults with uncontrolled gout.

Detailed description

Study acquired from Horizon in 2024.

Conditions

• Gout

Interventions

Type	Name	Description
BIOLOGICAL	Pegloticase	IV pegloticase 8 mg Q2W
DRUG	methotrexate	Oral MTX 15 mg weekly
DRUG	placebo	Oral placebo for MTX
DIETARY_SUPPLEMENT	folic acid	Folic acid 1 mg orally every day beginning at Week -6 until prior to the Week 52 Visit.
DRUG	gout flare prophylaxis regimen	Prior to beginning the Pegloticase + IMM Period, participants must have been taking at least 1 protocol-standard gout flare prophylaxis regimen (i.e. colchicine and/or nonsteroidal anti-inflammatory drugs and/or low-dose prednisone ≤ 10 mg/day) for ≥ 1 week before the first dose of pegloticase and to continue flare prophylaxis per American College of Rheumatology guidelines \[Khanna D et al. 2012\] for the greater of 1) 6 months, 2) 3 months after achieving target serum urate (sUA \< 6 mg/dL) for participants with no tophi detected on physical exam, or 3) 6 months after achieving target serum urate (sUA \< 5 mg/dL) for participants with one or more tophi detected on initial physical exam that then resolved.
DRUG	fexofenadine	For IR prophylaxis, fexofenadine (180 mg orally) taken the day before each infusion and on the morning of each infusion.
DRUG	acetaminophen	For IR prophylaxis, acetaminophen (1000 mg orally) taken the morning of each infusion.
DRUG	methylprednisolone	For IR prophylaxis, methylprednisolone (125 mg IV) given over an infusion duration between 10 - 30 minutes, immediately prior to each infusion.

Timeline

• Start date: 2019-06-13
• Primary completion: 2021-03-17
• Completion: 2022-04-11
• First posted: 2019-06-21
• Last updated: 2024-06-26
• Results posted: 2022-05-16

Locations

60 sites across 1 country: United States

Regulatory

• FDA-regulated drug study