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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03635957
The ClinicalTrials.gov registry entry for NCT03635957 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 8,888-participant average among 34 other Gout trials with a reported enrollment target (100% lower). The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
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 reports 6 study locations spanning 4 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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