This is a randomized, parallel-arm, multicenter study to compare the safety and efficacy profiles of SEL-212 and KRYSTEXXA®. Participants will be randomized 1:1 to receive treatment with SEL-212 or KRYSTEXXA® for 6 months. Efficacy assessments, as measured by serum uric acid (SUA) levels, will be conducted at intervals that are appropriate to determine treatment effect differences. Safety will be monitored throughout the study.
This is a randomized, parallel-arm, multicenter study to compare the safety and efficacy profiles of SEL-212 and KRYSTEXXA®. Participants will be randomized 1:1 to receive treatment with SEL-212 \[a combination of pegadricase (SEL-037) and ImmTOR (SEL-110)\] or KRYSTEXXA® for 6 months. Study participants in the SEL-212 arm will receive study drug every 28 days for a total of up to 6 infusions of SEL-212. Study participants in the KRYSTEXXA® arm will receive study drug according to the manufacturer's prescribing information, i.e., every 14 days for a total of up to 12 infusions of KRYSTEXXA®. Efficacy assessments, as measured by SUA levels, will be conducted at intervals that are appropriate to determine treatment effect differences. Safety will be monitored throughout the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
170
Administered as specified in the treatment arm
Administered as specified in the treatment arm
Number of Participants With Serum Uric Acid (SUA) Reduction of < 6 mg/dL for at Least 80% of the Time
The average of the data collected during Month 3 and Month 6 was reported.
Time frame: Up to Month 6
Number of Participants With SUA Reduction of < 6 mg/dL for At Least 80% of the Time During Month 6
Time frame: Month 6
Number of Participants With SUA Reduction of < 6 mg/dL for 100% of the Time During Month 6
Time frame: Month 6
Quality of Life (QoL) as Assessed by Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Scale
Eight categories were assessed by the HAQ-DI: 1) dressing and grooming, 2) arising, 3) eating, 4) walking, 5) hygiene, 6) reaching, 7) gripping, and 8) common daily activities. There were 2 or 3 questions for each category. Scoring within each category was on a 4-point Likert scale from 0 (without any difficulty) to 3 (unable to do). The score given to each section was the worst (highest) score within the section. The HAQ-DI total score was calculated if 6 or more sections were available. The average of the 8 category scores was reported as the HAQ-DI total score on a scale of 0 to 3. Reduction from baseline, and lower scores indicated better QoL.
Time frame: Baseline to End of Month 3, Baseline to End of Month 6
QoL as Assessed by Change From Baseline in Provider Global Assessment of Disease Activity (PrGA) Scale
The PrGA was administered to assess the severity of the participant's disease on a scale from 0 (participant feels "very well") to 100 (participant feels "very poor"). Reduction from baseline, and lower scores indicated less severe disease.
Time frame: Baseline to End of Month 3, Baseline to End of Month 6
QoL as Assessed by Change From Baseline in Short Form Health Survey 36 (SF-36) Scale
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Pinnacle Research Group, LLC
Anniston, Alabama, United States
Arizona Arthritis & Rheumatology Research, PLLC
Sun City, Arizona, United States
Baptist Health Center for Clinical Research
Little Rock, Arkansas, United States
Medvin Clinical Research
Covina, California, United States
Valerius Medical Group and Research Center of Greater Long Beach, Inc.
Los Alamitos, California, United States
Arthritis Care and Research Center
Poway, California, United States
MD Strategies Research Centers
San Diego, California, United States
Clinical Research of West Florida
Clearwater, Florida, United States
QPS-Medical Research Assoc LLC
Miami, Florida, United States
Well Pharma Medical Research Corp.
Miami, Florida, United States
...and 33 more locations
The SF-36 is a 36-item questionnaire to assesses a participant's health status using 8 health concepts: limitations in physical activities because of health problems; limitations in social activities because of physical or emotional problems; limitations in usual role activities because of physical health problems; bodily pain; general mental health (psychological distress and well-being); limitations in usual role activities because of emotional problems; vitality (energy and fatigue); and general health perceptions. The mental component reports the average of all the emotionally relevant items and the physical component reports the average of all the physical relevant items. Each component is directly transformed into a 0 to 100 scale on the assumption that each question carries equal weight. A score of 0 is equal to maximum disability, and a score of 100 indicates no disability. Median change can range from -100 to 100. A positive median change indicated an improved outcome.
Time frame: Baseline to End of Month 3, Baseline to End of Month 6
Number of Participants With Gout Flares Per 3-Month Period
Time frame: Month 1 to Month 3, Month 4 to Month 6
Number of Gout Flares Per 3-Month Period
Time frame: Month 1 to Month 3, Month 4 to Month 6
Change From Baseline in Number of Tender Joints
Time frame: Baseline to End of Month 6
Change From Baseline in Number of Swollen Joints
Time frame: Baseline to End of Month 6