A Phase 4, Open-label Study of KRYSTEXXA® (Pegloticase) Co-administered With Methotrexate (MTX) i… (NCT04762498) | Clinical Trial Compass
CompletedPhase 4
A Phase 4, Open-label Study of KRYSTEXXA® (Pegloticase) Co-administered With Methotrexate (MTX) in Patients With Uncontrolled Gout (FORWARD OL)
United States54 participantsStarted 2021-01-26
Plain-language summary
This trial is to assess efficacy, safety, blood levels and bodily effects of up to 2 dose levels of intravenous (IV) pegloticase (KRYSTEXXA) infusions at every 4 week intervals (Q4 Weeks) for up to 6 months (Day 1 to 24 weeks with an optional 24 - 48 weeks treatment duration) when given in combination with weekly oral doses of methotrexate (MTX). The goal is to identify an appropriate dose to be administered every 4 weeks to be used for future clinical trials for patients with chronic gout that does not adequately respond to conventional therapy.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 and \<80 years of age.
. Uncontrolled gout, defined as meeting the following criteria:
. Willing to discontinue any oral urate lowering therapy for at least 7 days prior to MTX dosing at Week -4 and remain off while receiving pegloticase treatments.
. 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/urine pregnancy tests during Screening and Week -4; subjects must agree to use 2 reliable forms of contraception during the trial, one of which is recommended to be hormonal, such as an oral contraceptive. Hormonal contraception must be started ≥1 full cycle prior to Week -4 (start of MTX) and continue for 4 weeks/30 days after the last dose of pegloticase, or at least one ovulatory cycle after the last dose of MTX (whichever is the longest duration after the last dose of pegloticase or MTX). Highly effective contraceptive methods (with a failure rate \<1% per year), when used consistently and correctly, include implants, injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence, or vasectomized partner.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial combined KRYSTEXXA (pegloticase) with methotrexate — since methotrexate is typically used for conditions like rheumatoid arthritis, can you explain why adding it to pegloticase might help with uncontrolled gout, and whether that combination would be appropriate for my situation?
2The trial measured how long patients were able to keep their uric acid below 6 mg/dL after first reaching that level — based on the results of this completed study, how well did the combination actually maintain uric acid control over 24 weeks, and what does that mean for someone like me?
3Since this is a Phase 4 study, meaning pegloticase is already FDA-approved, what does the safety profile from this trial look like compared to what was already known, and are there any risks I should be specifically aware of before considering this drug?
4KRYSTEXXA is given as an intravenous infusion — how often would I need to come in for infusions, and are the logistics of that kind of treatment schedule realistic for my life right now?
5Before considering something like pegloticase combined with methotrexate, are there standard gout medications I haven't tried yet that might bring my uric acid under control first, without the complexity of an infusion regimen?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants Who Were Serum Uric Acid (sUA) Responders (sUA < 6 mg/dL) During Month 6
Timeframe: Month 6 (Weeks 20, 21, 22, 23, and 24)
2
Time to First sUA ≥6 mg/dL After First Achieving sUA <6 mg/dL, From the First Pegloticase Infusion Until Week 24
. Men who are not vasectomized must agree to use appropriate contraception so as to not impregnate a female partner of reproductive potential during the trial, beginning with the initiation of MTX at Week -4 and continuing and for at least 3 months after the last dose of MTX.
. Able to tolerate MTX 15 mg orally for 4 weeks (Week -4 through Day 1) prior to enrollment.
Exclusion criteria
. Weight \>160 kg (352 pounds) at Screening.
. Any serious acute bacterial infection, unless treated and completely resolved with antibiotics at least 2 weeks prior to the Day 1 Visit.
. Severe chronic or recurrent bacterial infections, such as recurrent pneumonia or chronic bronchiectasis.
. Current or chronic treatment with systemic immunosuppressive agents such as MTX, azathioprine, or mycophenolate mofetil; prednisone ≥10 mg/day or equivalent dose of other corticosteroid on a chronic basis (3 months or longer) would also meet exclusion criteria.
. History of any transplant surgery requiring maintenance immunosuppressive therapy.
. Known history of hepatitis B virus surface antigen positivity or hepatitis B DNA positivity.
. Known history of hepatitis C virus RNA positivity, unless treated and viral load is negative.
. Known history of Human Immunodeficiency Virus (HIV) positivity.