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NCT03635957 · ClinicalTrials.gov registry record · Phase 4
Study of Pegloticase (KRYSTEXXA®) Plus Methotrexate in Patients With Uncontrolled Gout
A Phase 4 study of Gout, sponsored by Amgen.
- Completed
- Registry status
- Phase 4
- Development phase
- 14
- Enrollment target
- 6
- Study locations
NCT03635957: Completed Phase 4 study of Gout, sponsored by Amgen.
NCT03635957 is a Phase 4 study of Gout that has completed, run by Amgen. The registered enrollment target is 14 participants, below the 8,888-participant average among 34 other Gout trials with a reported enrollment target (100% lower). The trial reports 6 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03635957, a Phase 4 study of Gout, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 14 participants
- Enrollment target
- 6
- Study locations
Study Summary
The overall objective of the study is to assess the efficacy, safety, tolerability, and pharmacokinetics (PK) of the concomitant use of pegloticase with methotrexate (MTX) to enhance the response rate seen with pegloticase alone in adults with uncontrolled gout.
Primary Outcome
Serum uric acid (sUA \< 6 mg/dL) responders are defined as participants achieving and maintaining sUA \< 6 mg/dL for at least 80% of the time during Month 6 (Weeks 20, 22, and 24). Month 6 includes pre-infusion and post-infusion sUA assessments at Week 20, pre-infusion and post-infusion sUA assessments at Week 22, pre-infusion assessments at Week 24, and unscheduled sUA assessments between Week 20 and Week 24.
Conditions Studied
Interventions
- DRUG Methotrexate (MTX)
- BIOLOGICAL Pegloticase
- DIETARY_SUPPLEMENT Folic Acid
- DRUG Standard Gout Flare Prophylaxis
- DRUG Infusion Reaction (IR) Prophylaxis
Study Locations (6)
Arizona
- Arizona Arthritis & Rheumatology -West Valley - Glendale
- Arizona Arthritis & Rheumatology -East Valley - Mesa
Washington
- Western Washington Arthritis Clinic - Bothell
- Arthritis Northwest PLLC - Spokane
Alaska
- Orthopedic Physicians Alaska - Anchorage
Florida
- Avail Clinical Research - DeLand
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2018-09-26 |
| Est. Completion | 2020-10-26 |
| Phase | Phase 4 |
What the finished NCT03635957 record still lists
NCT03635957 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 8,888-participant average among 34 other Gout trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Gout appearing as the primary indexed condition, and to 5 interventions - of which Methotrexate (MTX) is the first listed.
NCT03635957 lists 6 locations in 4 states (Arizona, Washington, Alaska).
Frequently Asked Questions
What is clinical trial NCT03635957 about?
NCT03635957 is a clinical study titled "Study of Pegloticase (KRYSTEXXA®) Plus Methotrexate in Patients With Uncontrolled Gout". The overall objective of the study is to assess the efficacy, safety, tolerability, and pharmacokinetics (PK) of the concomitant use of pegloticase with methotrexate (MTX) to enhance the response rate seen with pegloticase alone in adults with uncontrolled gout.
What is the current status of trial NCT03635957?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 14 participants. The study started on 2018-09-26. Estimated completion is 2020-10-26.
What conditions does trial NCT03635957 study?
This clinical trial studies the following conditions: Gout.
What interventions are being tested in trial NCT03635957?
The interventions under investigation include: Methotrexate (MTX) (DRUG), Pegloticase (BIOLOGICAL), Folic Acid (DIETARY_SUPPLEMENT), Standard Gout Flare Prophylaxis (DRUG), Infusion Reaction (IR) Prophylaxis (DRUG).
Who is sponsoring clinical trial NCT03635957?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03635957 being conducted?
This trial has 6 study locations across Alaska, Arizona, Florida, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03635957's enrollment target sits among peer trials
14 32nd of 34 higher than 3 of 34 other Gout trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gout trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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