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Pegloticase + Methotrexate for Gout (FORWARD OL Trial)
FORWARD OL Trial Summary
This trial is testing a new drug for gout. The goal is to find a safe and effective dose to be given every 4 weeks.
FORWARD OL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowFORWARD OL Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.FORWARD OL Trial Design
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Who is running the clinical trial?
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- You have long-term liver problems.You have had any type of cancer, other than non-melanoma skin cancer or in situ cervical cancer, within the past 5 years.You have had hepatitis C, unless it has been treated and the virus is no longer in your body.You should not take methotrexate (MTX) or it is not recommended for you.You have a known intolerance to methotrexate (MTX).Your blood counts are not normal.You have severe heart failure, recent hospitalization for heart failure, uncontrolled irregular heartbeat, recent treatment for heart attack, or uncontrolled high blood pressure.You weigh more than 160 kilograms (352 pounds) at the time of screening.You had a serious bacterial infection, but it was treated and completely cured with antibiotics at least 2 weeks before the start of the study.You have severe and ongoing bacterial infections.You are currently taking medications that weaken your immune system.You had a transplant and need to take medicine to lower your immune system.You are currently getting treatment for cancer, except for non-melanoma skin cancer.You are between 18 and 80 years old.You are between 18 and 80 years old.You have been diagnosed with HIV in the past.You cannot tolerate the standard treatments to prevent gout flare-ups.You have a known history of hypoxanthine-guanine phosphoribosyl-transferase deficiency.You drink more than 3 alcoholic beverages every week.You can handle taking 15 mg of MTX by mouth for 4 weeks before joining the study.You have been treated with pegloticase or a similar medication before.You have a history of testing positive for hepatitis B virus.You have long-term kidney problems.You are 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.You have lung conditions like pulmonary fibrosis, bronchiectasis, or interstitial pneumonitis.Your liver enzyme levels are higher than normal or your albumin levels are lower than normal.You have been diagnosed with osteomyelitis.You have long-term gout with symptoms of joint swelling or typical gout-related bone damage in your hands or feet.You have a condition called glucose-6-phosphate dehydrogenase deficiency.You have gout that is not under control, which means your blood has too much uric acid and you have gout symptoms.You have taken a new, unapproved medication within the last 4 weeks, or it has not completely left your body yet.You are willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial.You have high levels of uric acid in your blood during the screening period, defined as sUA ≥6 mg/dL.
- Group 1: Pegloticase 16mg cohort
- Group 2: Pegloticase 24/32mg cohort
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Could you provide me with a summary of earlier experiments concerning Pegloticase and MTX?
"Currently, 220 clinical trials are underway to evaluate the efficacy of Pegloticase and Methotrexate (MTX). Of those studies, 67 have advanced into Phase 3. Most of these trials originate from New york City but there are 7699 sites conducting research on this medication globally."
Are there any health care facilities in this city that are currently implementing this medical trial?
"This clinical trial has 12 locations, among them Spokane, Tampa and Wheaton. If you wish to enrol in the study it is advised that you choose a location nearby so as to reduce your travelling burden."
Could I be enrolled in this clinical experiment?
"This clinical trial seeks participants aged 18 to 80 with uncontrolled gout. To be eligible, the patient must demonstrate a willingness and ability to comply with treatment regimens and assessments throughout the study period; they are required to discontinue all oral urate-lowering medications 7 days prior to drug administration at Week -4 and remain off while receiving pegloticase treatments. Additionally, their medical record or interview should confirm chronic gouty arthritis symptoms—signs consistent with synovitis on physical examination or typical erosions visible in x-ray shots of hands/feet—as well as hyperuricemia (serum uric"
Has the FDA authorized Pegloticase in conjunction with Methotrexate (MTX) for public use?
"Pegloticase and Methotrexate (MTX) have been approved, so we placed it on the high end of our safety scale with a score of 3."
Is recruitment underway for this research project?
"As evidenced on clinicaltrials.gov, this trial is recruiting participants at the moment. It was initially posted to the site on January 26th 2021 and its details were last revised on May 10th 2022."
What medical conditions have been remedied through the combination of Pegloticase and Methotrexate (MTX)?
"Pegloticase and MTX are traditionally administered to treat meningeal leukemia, but have also been used to deal with active pauciarticular juvenile rheumatoid arthritis, small cell lung cancer (sclc), as well as head and neck carcinoma."
Is eligibility for this research study restricted to individuals under a certain age?
"As specified by the eligibility requirements, individuals between 18 and 80 years old are allowed to participate in this clinical trial."
How many individuals are being recruited for this experiment?
"This study necessitates 40 eligible participants from two separate states. Enrolment is available at Arthritis Northwest PLLC in Spokane and GCP Clinical Research in Tampa."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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