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Enzyme Inhibitor

Pegloticase for Gout

Phase 4
Waitlist Available
Research Sponsored by Horizon Therapeutics Ireland DAC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 6
Awards & highlights

Study Summary

This trial is testing a medication for people with uncontrolled gout who have previously tried another medication without success. Up to 30 people will be enrolled and will receive the medication for 24 weeks. There is an optional extension for another 24 weeks.

Eligible Conditions
  • Gout Flare

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Serum Uric Acid (sUA) Responders (sUA < 6 mg/dL) During Month 6
Secondary outcome measures
Mean Change From Baseline in HAQ Health Score at Weeks 14 and 24
Mean Change From Baseline in Health Assessment Questionnaire (HAQ) Pain Score at Weeks 14 and 24
Mean Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Weeks 14 and 24
+3 more

Side effects data

From 2021 Phase 4 trial • 20 Patients • NCT04087720
45%
Gout
10%
Conjunctival haemorrhage
10%
Arthralgia
10%
Pyrexia
10%
Nasal congestion
5%
Haemoglobin decreased
5%
Hypoaesthesia
5%
Melaena
5%
Atrial fibrillation
5%
Inner ear disorder
5%
Abdominal hernia
5%
Oedema
5%
Ocular hyperaemia
5%
Muscle spasms
5%
Blood calcium decreased
5%
Post procedural haemorrhage
5%
Haemorrhoids
5%
Hyperglycaemia
5%
Presyncope
5%
Wound
5%
Aspartate aminotransferase increased
5%
Cellulitis
5%
Tachycardia
5%
Subcutaneous abscess
5%
Osteonecrosis
5%
Oropharyngeal pain
5%
Diverticulitis
5%
Tinnitus
5%
Blister
5%
Vertigo
5%
Duodenal ulcer
5%
Enterocolonic fistula
5%
Localised infection
5%
Alanine aminotransferase increased
5%
Photophobia
5%
Pneumonia
5%
Skin bacterial infection
5%
Eye injury
5%
Gouty tophus
5%
Asthenia
5%
Stomatitis
5%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pegloticase

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pegloticase plus Methotrexate (MTX)Experimental Treatment2 Interventions
Pegloticase (8 mg) intravenous (IV) every two weeks. Methotrexate (15 or 25 mg weekly) SC.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methotrexate (MTX)
2005
Completed Phase 4
~6970
Pegloticase
2021
Completed Phase 4
~560

Find a Location

Who is running the clinical trial?

Horizon Therapeutics Ireland DACLead Sponsor
20 Previous Clinical Trials
2,465 Total Patients Enrolled
6 Trials studying Gout
667 Patients Enrolled for Gout
Medical DirectorStudy DirectorHorizon Therapeutics
2,777 Previous Clinical Trials
8,063,729 Total Patients Enrolled
12 Trials studying Gout
5,977 Patients Enrolled for Gout
Colleen CanavanStudy DirectorHorizon Therapeutics

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what medical conditions has Pegloticase been known to be efficacious?

"Typically, pegloticase is employed to tackle meningeal leukemia. Additionally, it has been found effective in treating small cell lung cancer (sclc), active pauciarticular juvenile rheumatoid arthritis, and head and neck carcinoma."

Answered by AI

How many administrative hubs are in charge of this research project?

"Currently, 15 clinical sites are running the trial including Arizona Arthritis and Rheumatology Associates in Mesa, East Bay Rheumatology Medical Group in San Leandro, Providence St. John's Health Clinic in Santa Monica, as well as a further dozen facilities."

Answered by AI

What other experiments have been conducted to study Pegloticase's efficacy?

"Currently, 220 clinical trials researching the effectiveness of Pegloticase are live with 67 in their final phase. Of these studies, eight are based out of New york City while 7,699 other locations offer access to this trial."

Answered by AI

Has Pegloticase received the sanction of the FDA?

"Due to its Phase 4 status, indicating that it is approved for use by the public, pegloticase was given a score of 3 in regards to safety."

Answered by AI

Is there still an opportunity to join this research endeavor?

"Clinicaltrials.gov shows that this medical study, initially posted on March 8th 2021 and last revised on November 10th 2022 is not enlisting participants at present. However, there are currently 249 other clinical trials actively seeking patients for participation."

Answered by AI

How many participants have enrolled in the research project thus far?

"At this juncture, the medical trial is not actively searching for participants. The initial posting was March 8th 2021 and the last update was November 10th 2022. However, there are presently 29 studies that seek individuals afflicted with gout while 220 trials require Pegloticase patients as well."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
East Bay Rheumatology Medical Group
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Pegloticase and Methotrexate Co-administered in Participants With Uncontrolled Gout Who Previously Failed Pegloticase Monotherapy
2021. "Pegloticase and Methotrexate Co-administered in Participants With Uncontrolled Gout Who Previously Failed Pegloticase Monotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04772313.
~3 spots leftby Apr 2025
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