CompletedPhase 4

Pegloticase and Methotrexate Co-administered in Participants With Uncontrolled Gout Who Previously Failed Pegloticase Monotherapy

United States11 participantsStarted 2021-03-08

Plain-language summary

This is a Phase 4, multicenter, open-label trial of pegloticase with methotrexate (MTX) in adult participants with uncontrolled gout who were previously treated with pegloticase without a concomitant immunomodulator and stopped pegloticase due to failure to maintain serum uric acid (sUA) response and/or a clinically mild infusion reaction (IR). Approximately 30 participants will be enrolled. Pegloticase + MTX will be administered for approximately 24 weeks, with an optional extension up to 48 weeks. The trial design will include 5 distinct components: 1. Screening Period, lasting up to 42 days; 2. 6-week MTX Tolerability Assessment Period (hereafter referred to as the MTX Run-in Period); 3. 24-week Pegloticase + MTX Treatment Period, which will include a Week 24/End of Trial/Early Termination Visit (subjects that end MTX and pegloticase treatment prior to the Week 24 will remain on trial for follow up until the Week 24 visit) 4. Optional Pegloticase + MTX Extension Period up to 24 weeks 5. 30-Day Post Treatment Follow -up

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Willing and able to give informed consent.
✓. Willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial.
✓. Adult men or women ≥18 years of age.
✓. Uncontrolled gout, defined by the following criteria:
✓. Subject was previously treated with pegloticase without concomitant immunomodulation and stopped pegloticase due to failure to maintain sUA reduction response (had ≥1 sUA \>6 mg/dL within 2 weeks post pegloticase infusion) and did not experience an IR (Cohort 1) and/or stopped pegloticase treatment due to pegloticase-related clinically mild IR (Cohort 2).
✓. Subject for whom the last pegloticase infusion occurred \>6 months prior to Screening.
✓. Willing to discontinue any oral urate-lowering therapy for at least 7 days prior to Day 1 and remain off other urate-lowering therapy during the Pegloticase + MTX Treatment Period.
✓. Women of childbearing potential (including those with an onset of menopause \<2 years prior to Screening, non-therapy-induced amenorrhea for \<12 months prior to Screening or not surgically sterile \[absence of ovaries and/or uterus\]) must have negative serum pregnancy tests during Screening:

Exclusion criteria

What they're measuring

Percentage of Serum Uric Acid (sUA) Responders (sUA < 6 mg/dL) During Month 6

Timeframe: Month 6

Trial details

NCT IDNCT04772313

SponsorAmgen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-08-23

Results submitted2023-08-16

View on ClinicalTrials.gov More Uncontrolled Gout trials