Study Complete
Sponsor ID
HZNP-KRY-403

Infusion Duration Study To Assess Tolerability of Pegloticase Administered With a Shorter Infusion Duration in Subjects with Uncontrolled Gout Receiving Methotrexate

Sponsor ID
HZNP-KRY-403
Clinicaltrials.gov ID
NCT04511702
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

The purpose of this study is to assess the safety, tolerability and efficiency of pegloticase administered with a shorter infusion duration in participants with uncontrolled gout receiving methotrexate.

Additional Study Details

Phase
Phase 4
Product
N/A
Type
Interventional
Masking
None (Open Label)
Enrollment
191
Additional Study Details

Protocol Summary

Primary Outcome Measures

The incidence of participants experiencing Infusion Reactions (IRs), including anaphylaxis related to pegloticase

Timeframe: Day 1 through Week 24.

Secondary Outcome Measures

Proportion of Serum Uric Acid (sUA) Responders (sUA < 6 mg/dL) During Month 6

Timeframe: Month 6 (Weeks 20, 22, 24)

The proportion of participants who experienced any of the following events: IR leading to discontinuation of treatment, anaphylaxis, or meeting Individual participant sUA Discontinuation Criteria.

Timeframe: Day 1 to Week 24

Time to any of the following events: IR leading to discontinuation of treatment, anaphylaxis, or meeting individual participant sUA Discontinuation Criteria (two consecutive pre-infusion sUAs > 6mg/dL).

Timeframe: Day 1 to Week 24

Locations

Location
Status
Contact Us
Location
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Status
Active, not recruiting
Location
Orthopedic Physicians Alaska
Anchorage, Alaska, United States, 99508
Status
Active, not recruiting
Location
Arizona Arthritis & Rheumatology Research
Gilbert, Arizona, United States, 85297
Status
Active, not recruiting
Location
Arthritis & Rheumatology Research
Mesa, Arizona, United States, 85210
Status
Active, not recruiting
Location
Arizona Arthritis & Rheumatology Research
Phoenix, Arizona, United States, 85037
Status
Active, not recruiting
Location
Medvin Clinical Research
Covina, California, United States, 91722
Status
Active, not recruiting
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