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A Study to Compare the Efficacy of SEL-212 to KRYSTEXXA® in Gout Patients Refractory to Conventional Therapy
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.
Age
21 - 80 years
Sex
ALL
Healthy Volunteers
No
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
Start Date
May 7, 2019
Primary Completion Date
August 5, 2020
Completion Date
August 5, 2020
Last Updated
October 17, 2023
170
ACTUAL participants
SEL-212
DRUG
KRYSTEXXA®
DRUG
Lead Sponsor
Selecta Biosciences, Inc.
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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