Trial · NCT03905512
A Study to Compare the Efficacy of SEL-212 to KRYSTEXXA® in Gout Participants Refractory to Conventional Therapy
NCT03905512, Phase 2, Completed, Selecta Biosciences, Inc.; results first posted 2023-10-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Compare the Efficacy of SEL-212 to KRYSTEXXA® in Gout Participants Refractory to Conventional Therapy. Trials, record NCT03905512. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03905512
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Compare the Efficacy of SEL-212 to KRYSTEXXA® in Gout Participants Refractory to Conventional Therapy
- NCT number
- NCT03905512
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 170 participants, actual
- Lead sponsor
- Selecta Biosciences, Inc.
- Conditions
- Chronic Gout
- Interventions
- SEL-212, KRYSTEXXA®
- First posted
- 2019-04-05
- Last updated
- 2023-10-17
- Results first posted
- 2023-10-17
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Serum Uric Acid (SUA) Reduction of < 6 mg/dL for at Least 80% of the Time | Up to Month 6 | The average of the data collected during Month 3 and Month 6 was reported. |
| Secondary | Number of Participants With SUA Reduction of < 6 mg/dL for At Least 80% of the Time During Month 6 | Month 6 | |
| Secondary | Number of Participants With SUA Reduction of < 6 mg/dL for 100% of the Time During Month 6 | Month 6 | |
| Secondary | 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 | 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. |
| Secondary | 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 | 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. |
| Secondary | 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 | 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. |
| Secondary | Number of Participants With Gout Flares Per 3-Month Period | Month 1 to Month 3, Month 4 to Month 6 | |
| Secondary | Number of Gout Flares Per 3-Month Period | Month 1 to Month 3, Month 4 to Month 6 | |
| Secondary | Change From Baseline in Number of Tender Joints | Baseline to End of Month 6 | |
| Secondary | Change From Baseline in Number of Swollen Joints | Baseline to End of Month 6 |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Serum Uric Acid (SUA) Reduction of < 6 mg/dL for at Least 80% of the Time | Up to Month 6 | ITT set included all randomized participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With SUA Reduction of < 6 mg/dL for At Least 80% of the Time During Month 6 | Month 6 | ITT set included all randomized participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With SUA Reduction of < 6 mg/dL for 100% of the Time During Month 6 | Month 6 | ITT set included all randomized participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | ITT set included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants evaluable at the specified timeframe. | score on a scale | MEAN |
| SECONDARY | 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 | ITT set included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants evaluable at the specified timeframe. | score on a scale | MEAN |
| SECONDARY | 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 | ITT set included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants evaluable at the specified timeframe. | score on a scale | MEAN |
| SECONDARY | Number of Participants With Gout Flares Per 3-Month Period | Month 1 to Month 3, Month 4 to Month 6 | ITT set included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants evaluable at the specified timeframe. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Gout Flares Per 3-Month Period | Month 1 to Month 3, Month 4 to Month 6 | ITT set included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants evaluable at the specified timeframe. | number of flares | MEAN |
| SECONDARY | Change From Baseline in Number of Tender Joints | Baseline to End of Month 6 | ITT set included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants evaluable at the specified timeframe. | number of tender joints | MEAN |
| SECONDARY | Change From Baseline in Number of Swollen Joints | Baseline to End of Month 6 | ITT set included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants evaluable at the specified timeframe. | number of swollen joints | MEAN |
Source ClinicalTrials.gov
Results by group46
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Serum Uric Acid (SUA) Reduction of < 6 mg/dL for at Least 80% of the Time | SEL-212 | 44 | Participants | ||
| Number of Participants With Serum Uric Acid (SUA) Reduction of < 6 mg/dL for at Least 80% of the Time | KRYSTEXXA | 40 | Participants | ||
| Number of Participants With SUA Reduction of < 6 mg/dL for At Least 80% of the Time During Month 6 | SEL-212 | 45 | Participants | ||
| Number of Participants With SUA Reduction of < 6 mg/dL for At Least 80% of the Time During Month 6 | KRYSTEXXA | 41 | Participants | ||
| Number of Participants With SUA Reduction of < 6 mg/dL for 100% of the Time During Month 6 | SEL-212 | 38 | Participants | ||
| Number of Participants With SUA Reduction of < 6 mg/dL for 100% of the Time During Month 6 | KRYSTEXXA | 36 | Participants | ||
| Quality of Life (QoL) as Assessed by Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Scale | SEL-212 | Baseline | 0.78 | Standard Deviation 0.774 | score on a scale |
| Quality of Life (QoL) as Assessed by Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Scale | KRYSTEXXA | Baseline | 0.79 | Standard Deviation 0.834 | score on a scale |
| Quality of Life (QoL) as Assessed by Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Scale | SEL-212 | Change at End of Month 3 | -0.14 | Standard Deviation 0.725 | score on a scale |
| Quality of Life (QoL) as Assessed by Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Scale | KRYSTEXXA | Change at End of Month 3 | -0.10 | Standard Deviation 0.795 | score on a scale |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SEL-212 | 83 | |
| Overall Study | STARTED | KRYSTEXXA | 87 | |
| Overall Study | Received At Least 1 Dose of Study Drug | SEL-212 | 83 | |
| Overall Study | Received At Least 1 Dose of Study Drug | KRYSTEXXA | 87 | |
| Overall Study | COMPLETED | SEL-212 | 62 | |
| Overall Study | COMPLETED | KRYSTEXXA | 70 | |
| Overall Study | NOT COMPLETED | SEL-212 | 21 | |
| Overall Study | NOT COMPLETED | KRYSTEXXA | 17 |
Source ClinicalTrials.gov
Adverse events42
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | SEL-212 | 5 | 83 | |
| other | Diarrhoea | Gastrointestinal disorders | KRYSTEXXA | 0 | 87 | |
| other | Infusion Related reaction | Injury, poisoning and procedural complications | SEL-212 | 13 | 83 | |
| other | Infusion Related reaction | Injury, poisoning and procedural complications | KRYSTEXXA | 9 | 87 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | SEL-212 | 6 | 83 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | KRYSTEXXA | 6 | 87 | |
| other | Headache | Nervous system disorders | SEL-212 | 6 | 83 | |
| other | Headache | Nervous system disorders | KRYSTEXXA | 0 | 87 | |
| other | Hematuria | Renal and urinary disorders | SEL-212 | 5 | 83 | |
| other | Hematuria | Renal and urinary disorders | KRYSTEXXA | 0 | 87 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SEL-212 | 0 | 83 |
| Total, all-cause mortality | KRYSTEXXA | 0 | 87 |
| Total, other adverse events | SEL-212 | 60 | 83 |
| Total, other adverse events | KRYSTEXXA | 53 | 87 |
| Total, serious adverse events | SEL-212 | 7 | 83 |
| Total, serious adverse events | KRYSTEXXA | 8 | 87 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37449908 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| SEL-212 vs KRYSTEXXA: Number of Participants With SUA Reduction of < 6 mg/dL for 100% of the Time During Month 6 | Trial comparisons |
| SEL-212 vs KRYSTEXXA: Number of Participants With SUA Reduction of < 6 mg/dL for At Least 80% of the Time During Month 6 | Trial comparisons |
| SEL-212 vs KRYSTEXXA: Number of Participants With Serum Uric Acid (SUA) Reduction of < 6 mg/dL for at Least 80% of the Time | Trial comparisons |
| SEL-212 vs KRYSTEXXA: deaths from any cause | Trial comparisons |
| SEL-212 vs KRYSTEXXA: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03905512
GET https://conductscience.org/api/trials/v1/NCT03905512/results?page=2