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Pegloticase and Methotrexate Co-administered in Participants With Uncontrolled Gout Who Previously Failed Pegloticase Monotherapy
Phase 4 trial testing Pegloticase in Uncontrolled Gout in 11 participants. Completed in 24 April 2023.
| Lead sponsor | Amgen |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 11 |
| Start date | 8 March 2021 |
| Primary completion | 23 August 2022 |
| Estimated completion | 24 April 2023 |
| Sites | 15 locations across United States |
Amgen — full company profile →
18 and older, any sex, with Uncontrolled Gout. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
An sUA responder is defined as a participant achieving and maintaining sUA \<6 mg/dL for at least 80% of the time during Month 6 (Weeks 20, 21, 22, 23 and 24).
| Group | Value | 95% CI |
|---|---|---|
| Pegloticase Plus Methotrexate | 9.1 | 0.2 – 41.3 |
An sUA responder is defined as a participant achieving and maintaining sUA \<6 mg/dL for at least 80% of the time during Month 3 (Weeks 10 to 14).
| Group | Value | 95% CI |
|---|---|---|
| Pegloticase Plus Methotrexate | 9.1 | 0.2 – 41.3 |
Individual participant sUA discontinuation criteria are met when the lowest available interim sUA value after the pegloticase infusion at Week 2, 4, 6, 8, 10 or 12 is less than a 50% reduction from the highest sUA value measured between Screening and pre-infusion on Day 1.
| Group | Value | 95% CI |
|---|---|---|
| Pegloticase Plus Methotrexate | 81.8 | 48.2 – 97.7 |
DECT scans measure urate deposition volume. DECT scans at Week 24 were taken for hands, foot/ankle, and knees.
| Group | Value | 95% CI |
|---|---|---|
| Pegloticase Plus Methotrexate | -0.073 | ± 0.1270 |
| Group | Value | 95% CI |
|---|---|---|
| Pegloticase Plus Methotrexate | -1.540 | ± 1.7545 |
| Group | Value | 95% CI |
|---|---|---|
| Pegloticase Plus Methotrexate | -1.207 | ± 0.9073 |
HAQ-DI is a self-report functional status instrument that is filled out by the participant and measures disability over the past week via 20 questions relating to 8 domains of function: dressing grooming, arising, eating, walking, hygiene, reach, grip, usual activities. For each of the categories, participants reported the amount of difficulty they had in performing 2 or 3 specific subcategory items. The standard disability score is calculated from the 8 categories by dividing the sum of the individual categories by the number of categories answered, yielding a score from 0 (without any diffic
| Group | Value | 95% CI |
|---|---|---|
| Pegloticase Plus Methotrexate | 0.25 | ± 0.617 |
| Group | Value | 95% CI |
|---|---|---|
| Pegloticase Plus Methotrexate | 0.10 | ± 0.163 |
The HAQ pain scale asks participants to record how much pain they have had in the past week on a scale of 0-100 where zero represents no pain and 100 represents severe pain.
| Group | Value | 95% CI |
|---|---|---|
| Pegloticase Plus Methotrexate | 10.67 | ± 19.664 |
| Group | Value | 95% CI |
|---|---|---|
| Pegloticase Plus Methotrexate | -4.00 | ± 15.166 |
The HAQ health scale is a measure of overall health. Participants are asked to rate how well they are doing on a scale of 0 to 100, where zero represents very well and 100 represents very poor health.
| Group | Value | 95% CI |
|---|---|---|
| Pegloticase Plus Methotrexate | 8.00 | ± 45.343 |
| Group | Value | 95% CI |
|---|---|---|
| Pegloticase Plus Methotrexate | -11.40 | ± 24.389 |
Time frame: From enrollment (all-cause mortality) or first dose of study drug (adverse events) up to Week 48 + 30 days (±3 days). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | MTX Run-In Period | Pegloticase + MTX Treatmen… |
|---|---|---|---|
| Perineal abscess | Infections and infestations | — | — |
| Septic shock | Infections and infestations | — | — |
| Reaction | System | MTX Run-In Period | Pegloticase + MTX Treatmen… |
|---|---|---|---|
| Gout | Metabolism and nutrition disorders | — | — |
| Fatigue | General disorders | — | — |
| Infusion related reaction | Injury, poisoning and procedural complications | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — |
| Angina pectoris | Cardiac disorders | — | — |
| Vertigo | Ear and labyrinth disorders | — | — |
| Cataract | Eye disorders | — | — |
| Vision blurred | Eye disorders | — | — |
| Abdominal discomfort | Gastrointestinal disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Injection site bruising | General disorders | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — |
| Contusion | Injury, poisoning and procedural complications | — | — |
| Muscle strain | Injury, poisoning and procedural complications | — | — |
| Blood glucose increased | Investigations | — | — |
| Lymphocyte count decreased | Investigations | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — |
| Foot deformity | Musculoskeletal and connective tissue disorders | — | — |
| Muscle spasms | Musculoskeletal and connective tissue disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Paraesthesia | Nervous system disorders | — | — |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — |
| Urticaria | Skin and subcutaneous tissue disorders | — | — |
| Flushing | Vascular disorders | — | — |
| Hypertension | Vascular disorders | — | — |
Most-reported serious reactions: Perineal abscess, Septic shock.
Data from ClinicalTrials.gov NCT04772313 adverse events section.
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
2 peer-reviewed publications reference this trial (live from Europe PMC):
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