NCT03905512|CompletedPhase 2ResultsFDA Drug
A Study to Compare the Efficacy of SEL-212 to KRYSTEXXA® in Gout Participants Refractory to Conventional Therapy
COMPARE
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Sponsor study identifier
interventional
170
1 country
43
Study Start
May 7, 2019
Actual (reported)Primary Completion
August 5, 2020
Actual (reported)Study Completion
August 5, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 5, 2020
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 1, 2019
Actual (reported)April 5, 2019
Actual (reported)May 7, 2019
Actual (reported)August 5, 2020
Actual (reported)August 5, 2020
Actual (reported)October 17, 2023
Actual (reported)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.
Up to Month 6
Number of Participants With SUA Reduction of < 6 mg/dL for At Least 80% of the Time During Month 6
Month 6
Number of Participants With SUA Reduction of < 6 mg/dL for 100% of the Time During Month 6
Month 6
Quality of Life (QoL) as Assessed by Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Scale
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
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
Baseline to End of Month 3, Baseline to End of Month 6
Intravenous (IV) infusion of SEL-212 every 28 days for up to 6 infusions
IV infusion of KRYSTEXXA® according to the manufacturer's prescribing information every 14 days for up to 12 infusions
Pinnacle Research Group, LLC
Anniston, Alabama, 36207, United States
Arizona Arthritis & Rheumatology Research, PLLC
Sun City, Arizona, 85351, United States
Baptist Health Center for Clinical Research
Little Rock, Arkansas, 72205, United States
Medvin Clinical Research
Covina, California, 91722, United States
Valerius Medical Group and Research Center of Greater Long Beach, Inc.
Los Alamitos, California, 90720, United States
Arthritis Care and Research Center
Poway, California, 92064, United States
MD Strategies Research Centers
Baraf HSB, Khanna PP, Kivitz AJ, Strand V, Choi HK, Terkeltaub R, Dalbeth N, DeHaan W, Azeem R, Traber PG, Keenan RT. The COMPARE head-to-head, randomized controlled trial of SEL-212 (pegadricase plus rapamycin-containing nanoparticle, ImmTOR) versus pegloticase for refractory gout. Rheumatology (Oxford). 2024 Apr 2;63(4):1058-1067. doi: 10.1093/rheumatology/kead333.
Medical Director
Selecta Biosciences, Inc.
170 participants (actual enrollment reported by the registry).
First Submitted
April 1, 2019
First Posted
April 5, 2019
Study Start
May 7, 2019
Actual (reported)REduCing Immunogenicity to PegloticasE (RECIPE) Study
Contact the study team to confirm eligibility.
San Diego, California, 92119, United States
Clinical Research of West Florida
Clearwater, Florida, 33765, United States
QPS-Medical Research Assoc LLC
Miami, Florida, 33143, United States
Well Pharma Medical Research Corp.
Miami, Florida, 33143, United States
Panax Clinical Research
Miami Lakes, Florida, 33014, United States
Accelerated Enrollment Solutions (AES)
Orlando, Florida, 32806, United States
Rheumatology Associates of Central Florida, PA
Orlando, Florida, 32806, United States
Clinical Research of West Florida, Inc.
Tampa, Florida, 33603, United States
Advent Health Group Multispecialty at Habana and Bruce B. Downs
Tampa, Florida, 33614, United States
Arthritis Center of North Georgia
Gainesville, Georgia, 30501, United States
Better Health Clinical Research, Inc.
Newnan, Georgia, 30265, United States
Institute of Arthritis Research
Idaho Falls, Idaho, 83404, United States
Great Lakes Clinical Trials
Chicago, Illinois, 60640, United States
L-MARC Research Center
Louisville, Kentucky, 40213, United States
Klein & Associates, M.D., P.A.
Cumberland, Maryland, 21502, United States
Klein & Associates, M.D., P.A.
Hagerstown, Maryland, 21740, United States
The Center for Rheumatology and Bone Research
Wheaton, Maryland, 20902, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, 01605, United States
University Hospital
Ann Arbor, Michigan, 48109, United States
Elite Clinical Research, LLC
Jackson, Mississippi, 39202, United States
TEST
Blue Springs, Missouri, 64014, United States
NYU Langone Ambulatory Care Brooklyn Heights
Brooklyn, New York, 11201, United States
DJL Clinical Research
Charlotte, North Carolina, 28210, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Cape Fear Arthritis Care PLLC
Leland, North Carolina, 28451, United States
Cape Fear Arthritis Care PLLC
Leland, North Carolina, 28541, United States
New Horizons Clinical Research
Cincinnati, Ohio, 45242, United States
Arthritis & Rheumatology Center of Oklamhoma, PLLC
Oklahoma City, Oklahoma, 73102, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Clinical Research Center of Reading, LLC
Wyomissing, Pennsylvania, 19610, United States
West Tennessee Research Institute, LLC
Jackson, Tennessee, 38305, United States
Amarillo Center for Clinical Research
Amarillo, Texas, 79124, United States
Austin Regional Clinic
Austin, Texas, 78731, United States
Tekton Research
Austin, Texas, 78745, United States
Metroplex Clinical Research Center
Dallas, Texas, 75231, United States
Pioneer Research Solutions, Inc.
Houston, Texas, 77099, United States
Southwest Rheumatology Research, LLC
Mesquite, Texas, 75150, United States
Primary Completion
August 5, 2020
Actual (reported)Study Completion
August 5, 2020
Actual (reported)Last Updated
October 17, 2023
Results First Posted
October 17, 2023
Record last verified: 2023-09
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