Trial · NCT03769168
An Extension Study of Subcutaneous Secukinumab in Patients With Juvenile Psoriatic Arthritis (JPsA) and Enthesitis Related Arthritis (ERA)
NCT03769168, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2025-05-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Extension Study of Subcutaneous Secukinumab in Patients With Juvenile Psoriatic Arthritis (JPsA) and Enthesitis Related Arthritis (ERA). Trials, record NCT03769168. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03769168
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Extension Study of Subcutaneous Secukinumab in Patients With Juvenile Psoriatic Arthritis (JPsA) and Enthesitis Related Arthritis (ERA)
- NCT number
- NCT03769168
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 55 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Juvenile Psoriatic Arthritis, Enthesitis Related Arthritis
- Interventions
- Secukinumab
- First posted
- 2018-12-07
- Last updated
- 2025-10-16
- Other registries' IDs
- eudract:2018-002521-30
- Results first posted
- 2025-05-23
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response | Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study. | The JIA ACR response criteria consisted of 6 core criteria: * Physician global assessment of disease activity on a 0-100 mm VAS (0=very good and 100=very poor). * Parent's or patients' global assessment of overall well-being on a 0-100 mm VAS (0=very well and 100=very poor). * Functional ability (CHAQ: Childhood Health Assessment Questionnaire): 30 questions across 8 domains assessing the child's functional abilities. The total score was calculated as the average of the scores for each domain. It ranged from 0 (no disability) to 3 (very severe disability). * Number of joints with active arthritis (as per ACR definition), ranging from 0 to 73. * Number of joints with limited range of motion, ranging from 0 to 69. * Index of inflammation: C-reactive Protein (CRP) levels The JIA ACR 30 response was achieved if 3 of any 6 core set variables improved by at least 30% from baseline of the core study, and no more than 1 variable worsening more than 30% |
| Secondary | Percentage of Participants With JIA ACR 50 Response | Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study. | The JIA ACR response criteria consisted of 6 core criteria: * Physician global assessment of disease activity on a 0-100 mm VAS (0=very good and 100=very poor). * Parent's or patients' global assessment of overall well-being on a 0-100 mm VAS (0=very well and 100=very poor). * Functional ability (CHAQ): 30 questions across 8 domains assessing the child's functional abilities. The total score was calculated as the average of the scores for each domain (0 \[no disability\] to 3 \[very severe disability\]). * Number of joints with active arthritis (as per ACR definition), ranging from 0 to 73. * Number of joints with limited range of motion, ranging from 0 to 69. * Index of inflammation: CRP levels The JIA ACR 50 responses were achieved if 3 of any 6 core set variables improved by at least 50% from baseline of the core study, and no more than 1 variable worsening \> 30% |
| Secondary | Percentage of Participants With JIA ACR 70 Response | Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study. | The JIA ACR response criteria consisted of 6 core criteria: * Physician global assessment of disease activity on a 0-100 mm VAS (0=very good and 100=very poor). * Parent's or patients' global assessment of overall well-being on a 0-100 mm VAS (0=very well and 100=very poor). * Functional ability (CHAQ): 30 questions across 8 domains assessing the child's functional abilities. The total score was calculated as the average of the scores for each domain (0 \[no disability\] to 3 \[very severe disability\]). * Number of joints with active arthritis (as per ACR definition), ranging from 0 to 73. * Number of joints with limited range of motion, ranging from 0 to 69. * Index of inflammation: CRP levels The JIA ACR 70 responses were achieved if 3 of any 6 core set variables improved by at least 70%, from baseline of the core study, and no more than 1 variable worsening \> 30% |
| Secondary | Percentage of Participants With JIA ACR 90 Response | Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study. | The JIA ACR response criteria consisted of 6 core criteria: * Physician global assessment of disease activity on a 0-100 mm VAS (0=very good and 100=very poor). * Parent's or patients' global assessment of overall well-being on a 0-100 mm VAS (0=very well and 100=very poor). * Functional ability (CHAQ): 30 questions across 8 domains assessing the child's functional abilities. The total score was calculated as the average of the scores for each domain (0 \[no disability\] to 3 \[very severe disability\]). * Number of joints with active arthritis (as per ACR definition), ranging from 0 to 73. * Number of joints with limited range of motion, ranging from 0 to 69. * Index of inflammation: CRP levels The JIA ACR 90 responses were achieved if 3 of any 6 core set variables improved by at least 90% from baseline of the core study, and no more than 1 variable worsening \> 30% |
| Secondary | Percentage of Participants With JIA ACR 100 Response | Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study. | The JIA ACR response criteria consisted of 6 core criteria: * Physician global assessment of disease activity on a 0-100 mm VAS (0=very good and 100=very poor). * Parent's or patients' global assessment of overall well-being on a 0-100 mm VAS (0=very well and 100=very poor). * Functional ability (CHAQ): 30 questions across 8 domains assessing the child's functional abilities. The total score was calculated as the average of the scores for each domain (0 \[no disability\] to 3 \[very severe disability\]). * Number of joints with active arthritis (as per ACR definition), ranging from 0 to 73. * Number of joints with limited range of motion, ranging from 0 to 69. * Index of inflammation: CRP levels The JIA ACR 100 responses were achieved if 3 of any 6 core set variables improved with 100% from baseline of the core study, and no more than 1 variable worsening \> 30% |
| Secondary | Number of Participants With Inactive Disease Status | Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study. | Inactive disease status was confirmed in a patient when all the following conditions were met: * No joints with active arthritis * No uveitis * CRP value within normal limits for the laboratory where tested or, if elevated, not attributable to JIA * Physician's global assessment of disease activity score ≤ 10mm * Duration of morning stiffness attributable to JIA lasting ≥15 minutes. |
| Secondary | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Physician Global Assessment of Disease Activity | Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study. | The JIA ACR response criteria consisted of 6 core criteria, one of which was the physician global assessment of disease activity. this assessment was conducted using a 100 mm VAS score, where 0 represented the best disease activity and 100 the worst. The change from baseline of the core study of the physician global assessment of disease activity was measured, with a negative change indicating improvement. |
| Secondary | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Parent's or Patients' Global Assessment of Overall Well-being | Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study. | The JIA ACR response criteria included six core components, one of which was the parent's or patients' global assessment of overall well-being. This assessment was conducted using a 100 mm VAS score, where 0 represented "very well" and 100 "very poor". The change from baseline of the core study in the parent's or patients' global assessment of overall well-being was measured, with a negative change indicating improvement |
| Secondary | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Functional Ability (CHAQ) | Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study. | The JIA ACR response criteria included six core components, one of which was the functional ability, measured by the CHAQ. The CHAQ questionnaire consisted of 30 questions across 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Each domain was scored on a 4-point scale, and the total score was calculated as the average of the scores for each domain. The total score ranged from 0 (no disability) to 3 (very severe disability). The change from baseline of the core study in the CHAQ was measured, with a negative change indicating improvement. |
| Secondary | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Active Arthritis | Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study. | The JIA ACR response criteria included six core components, one of which was the number of joints with active arthritis. This was determined using the ACR definition, which identifies active arthritis as any joint with swelling or, in the absence of swelling, limitation of motion accompanied by either pain on motion or tenderness not due to deformity. The active joint count ranged from 0 to 73. The change from baseline of the core study in the number of active joints was measured, with a negative change indicating improvement. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response | Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study. | Participants who enrolled in the extension study. One patient enrolled with planned treatment secukinumab150 mg discontinued the study before receiving study treatment. This patient was not included in the analysis. At each time point, only participants with non-missing values were included in the analysis | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With JIA ACR 50 Response | Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study. | Participants who enrolled in the extension study. One patient enrolled with planned treatment secukinumab150 mg discontinued the study before receiving study treatment. This patient was not included in the analysis. At each time point, only participants with non-missing values were included in the analysis | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With JIA ACR 70 Response | Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study. | Participants who enrolled in the extension study. One patient enrolled with planned treatment secukinumab150 mg discontinued the study before receiving study treatment. This patient was not included in the analysis. At each time point, only participants with non-missing values were included in the analysis | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With JIA ACR 90 Response | Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study. | Participants who enrolled in the extension study. One patient enrolled with planned treatment secukinumab150 mg discontinued the study before receiving study treatment. This patient was not included in the analysis. At each time point, only participants with non-missing values were included in the analysis | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With JIA ACR 100 Response | Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study. | Participants who enrolled in the extension study. One patient enrolled with planned treatment secukinumab150 mg discontinued the study before receiving study treatment. This patient was not included in the analysis. At each time point, only participants with non-missing values were included in the analysis | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Inactive Disease Status | Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study. | Participants who enrolled in the extension study. One patient enrolled with planned treatment secukinumab150 mg discontinued the study before receiving study treatment. This patient was not included in the analysis. At each time point, only participants with non-missing values were included in the analysis | Percentage of Participants | NUMBER |
| SECONDARY | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Physician Global Assessment of Disease Activity | Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study. | Participants who enrolled in the extension study. One patient enrolled with planned treatment secukinumab150 mg discontinued the study before receiving study treatment. This patient was not included in the analysis. At each time point, only participants with non-missing values were included in the analysis | Score on a Scale | MEAN |
| SECONDARY | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Parent's or Patients' Global Assessment of Overall Well-being | Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study. | Participants who enrolled in the extension study. One patient enrolled with planned treatment secukinumab150 mg discontinued the study before receiving study treatment. This patient was not included in the analysis. At each time point, only participants with non-missing values were included in the analysis | Score on a Scale | MEAN |
| SECONDARY | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Functional Ability (CHAQ) | Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study. | Participants who enrolled in the extension study. One patient enrolled with planned treatment secukinumab150 mg discontinued the study before receiving study treatment. This patient was not included in the analysis. At each time point, only participants with non-missing values were included in the analysis | Score on a Scale | MEAN |
| SECONDARY | Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Active Arthritis | Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study. | Participants who enrolled in the extension study. One patient enrolled with planned treatment secukinumab150 mg discontinued the study before receiving study treatment. This patient was not included in the analysis. At each time point, only participants with non-missing values were included in the analysis | Joints | MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group606
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response | Group 1- Secukinumab 75 mg | Week 104 | 100 | 95% Confidence Interval 79.1 to 100 | Percentage of Participants |
| Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response | Group 2 - Secukinumab 150 mg | Week 104 | 100 | 95% Confidence Interval 87.7 to 100 | Percentage of Participants |
| Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response | Total Secukinumab Dose | Week 104 | 100 | 95% Confidence Interval 91.7 to 100 | Percentage of Participants |
| Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response | Group 1- Secukinumab 75 mg | Week 116 | 100 | 95% Confidence Interval 79.1 to 100 | Percentage of Participants |
| Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response | Group 2 - Secukinumab 150 mg | Week 116 | 96.9 | 95% Confidence Interval 82.0 to 99.8 | Percentage of Participants |
| Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response | Total Secukinumab Dose | Week 116 | 98.9 | 95% Confidence Interval 88.2 to 99.9 | Percentage of Participants |
| Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response | Group 1- Secukinumab 75 mg | Week 128 | 100 | 95% Confidence Interval 78.1 to 100 | Percentage of Participants |
| Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response | Group 2 - Secukinumab 150 mg | Week 128 | 100 | 95% Confidence Interval 86.3 to 100 | Percentage of Participants |
| Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response | Total Secukinumab Dose | Week 128 | 100 | 95% Confidence Interval 90.9 to 100 | Percentage of Participants |
| Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response | Group 1- Secukinumab 75 mg | Week 140 | 100 | 95% Confidence Interval 78.1 to 100 | Percentage of Participants |
1 to 10 of 606Source ClinicalTrials.gov
See all 606 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1- Secukinumab 75 mg | 19 | |
| Overall Study | STARTED | Group 2 - Secukinumab 150 mg | 36 | |
| Overall Study | Secukinumab Escalated to 150 mg | Group 1- Secukinumab 75 mg | 6 | |
| Overall Study | Secukinumab Escalated to 150 mg | Group 2 - Secukinumab 150 mg | 0 | |
| Overall Study | Secukinumab Escalated to 300 mg | Group 1- Secukinumab 75 mg | 2 | |
| Overall Study | Secukinumab Escalated to 300 mg | Group 2 - Secukinumab 150 mg | 14 | |
| Overall Study | Treated | Group 1- Secukinumab 75 mg | 19 | |
| Overall Study | Treated | Group 2 - Secukinumab 150 mg | 35 | |
| Overall Study | COMPLETED | Group 1- Secukinumab 75 mg | 10 | |
| Overall Study | COMPLETED | Group 2 - Secukinumab 150 mg | 12 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events384
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 | Iron deficiency anaemia | Blood and lymphatic system disorders | Any Secukinumab 75 mg | 1 | 19 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Any Secukinumab 150 mg | 1 | 43 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Any Secukinumab 300 mg | 0 | 16 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Any Secukinumab | 2 | 54 | |
| other | Neutropenia | Blood and lymphatic system disorders | Any Secukinumab 75 mg | 1 | 19 | |
| other | Neutropenia | Blood and lymphatic system disorders | Any Secukinumab 150 mg | 0 | 43 | |
| other | Neutropenia | Blood and lymphatic system disorders | Any Secukinumab 300 mg | 0 | 16 | |
| other | Neutropenia | Blood and lymphatic system disorders | Any Secukinumab | 1 | 54 | |
| other | Familial mediterranean fever | Congenital, familial and genetic disorders | Any Secukinumab 75 mg | 1 | 19 | |
| other | Familial mediterranean fever | Congenital, familial and genetic disorders | Any Secukinumab 150 mg | 0 | 43 |
1 to 10 of 384Source ClinicalTrials.gov
See all 384 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Any Secukinumab 75 mg | 0 | 19 |
| Total, all-cause mortality | Any Secukinumab 150 mg | 0 | 43 |
| Total, all-cause mortality | Any Secukinumab 300 mg | 0 | 16 |
| Total, all-cause mortality | Any Secukinumab | 0 | 54 |
| Total, other adverse events | Any Secukinumab 75 mg | 15 | 19 |
| Total, other adverse events | Any Secukinumab 150 mg | 28 | 43 |
| Total, other adverse events | Any Secukinumab 300 mg | 11 | 16 |
| Total, other adverse events | Any Secukinumab | 43 | 54 |
| Total, serious adverse events | Any Secukinumab 75 mg | 0 | 19 |
| Total, serious adverse events | Any Secukinumab 150 mg | 4 | 43 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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