Covid 19 Research using Clinical Trials (Home Page)
Report for D006073: Gout NIH
(Synonyms: Gout)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (3)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug2516 | SEL-212A Wiki | 1.00 |
| drug2517 | SEL-212B Wiki | 1.00 |
| drug1919 | Normal Saline Wiki | 0.58 |
Correlated MeSH Terms (0)
| Name (Synonyms) | Correlation |
|---|
There is one clinical trial.
Clinical Trials
1 A Randomized Double-Blind, Placebo-Controlled Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy
This is one of two replicate randomized, double-blind, placebo-controlled, parallel arm trials to determine the safety and efficacy of two different dose levels of SEL-212 compared to placebo. Approximately 105 patients, stratified as to the presence or absence of tophi, will be randomized in a 1:1:1 allocation ratio prior to Baseline to receive treatment with one of two dose levels of SEL-212 or placebo every 28 days for approximately 6 months in each trial (SEL-212/301 and SEL-212/302). Analysis of efficacy will be performed at Day 28 of Treatment Period 6. Safety will be monitored throughout the study.
NCT04513366 Chronic Gout Drug: SEL-212A Drug: SEL-212B Other: Normal Saline MeSH:Gout
HPO:Gout
Primary Outcomes
Description: The percentage of patients who achieve and maintain reduction in serum uric acid (sUA) < 6 mg/dL for at least 80% of the time during month 6 in patients with gout refractory to conventional treatment treated with two different dose levels of SEL-212 compared to placebo
Measure: Serum uric acid control during month 6 Time: 6 months
Secondary Outcomes
Description: To assess changes in number of tender and swollen joints in patients with gout refractory to conventional treatment treated with two different dose levels of SEL-212 compared to placebo
Measure: Tender and Swollen Joint Counts Time: 6 months
Description: To assess change in tophus burden by photographic area assessment in patients with gout refractory to conventional treatment treated with two different dose levels of SEL-212 compared to placebo
Measure: Tophus burden Time: 6 months
Description: To assess change in Patient Reported Outcomes (PROs) including assessments of: activity limitation (HAQ-DI) in patients with gout refractory to conventional treatment treated with two different dose levels of SEL-212 compared to placebo
Measure: HAQ-DI Time: 6 months
Description: To assess change in Patient Reported Outcomes (PROs) including assessments of: patients' quality of life (QoL) (SF-36) in patients with gout refractory to conventional treatment treated with two different dose levels of SEL-212 compared to placebo
Measure: SF-36 Time: 6 months
Description: To assess changes in gout flare incidence in patients with gout refractory to conventional treatment treated with two different dose levels of SEL-212 compared to placebo
Measure: Gout Flare Incidence Time: 6 months
HPO Nodes
Primary Outcomes
Description: The percentage of patients who achieve and maintain reduction in serum uric acid (sUA) < 6 mg/dL for at least 80% of the time during month 6 in patients with gout refractory to conventional treatment treated with two different dose levels of SEL-212 compared to placebo
Measure: Serum uric acid control during month 6 Time: 6 monthsSecondary Outcomes
Description: To assess changes in number of tender and swollen joints in patients with gout refractory to conventional treatment treated with two different dose levels of SEL-212 compared to placebo
Measure: Tender and Swollen Joint Counts Time: 6 monthsDescription: To assess change in tophus burden by photographic area assessment in patients with gout refractory to conventional treatment treated with two different dose levels of SEL-212 compared to placebo
Measure: Tophus burden Time: 6 monthsDescription: To assess change in Patient Reported Outcomes (PROs) including assessments of: activity limitation (HAQ-DI) in patients with gout refractory to conventional treatment treated with two different dose levels of SEL-212 compared to placebo
Measure: HAQ-DI Time: 6 monthsDescription: To assess change in Patient Reported Outcomes (PROs) including assessments of: patients' quality of life (QoL) (SF-36) in patients with gout refractory to conventional treatment treated with two different dose levels of SEL-212 compared to placebo
Measure: SF-36 Time: 6 monthsDescription: To assess changes in gout flare incidence in patients with gout refractory to conventional treatment treated with two different dose levels of SEL-212 compared to placebo
Measure: Gout Flare Incidence Time: 6 months