Trial · NCT02396212
Study of Efficacy and Safety of Canakinumab in Japanese Patients With SJIA
NCT02396212, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2019-09-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Efficacy and Safety of Canakinumab in Japanese Patients With SJIA. Trials, record NCT02396212. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02396212
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Efficacy and Safety of Canakinumab in Japanese Patients With SJIA
- NCT number
- NCT02396212
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 19 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Systemic Juvenile Idiopathic Arthritis
- Interventions
- Canakinumab
- First posted
- 2015-03-24
- Last updated
- 2019-09-13
- Other registries' IDs
- eudract:2018-002355-15
- Results first posted
- 2019-09-13
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Achieved a Minimum Adapted American College of Rheumatology (ACR) Pediatric 30 Criteria | Week 8 | Minimum Adapted ACR Pediatric 30 criteria is defined as improvement from baseline at least 30% in at least 3 of response variables 1 to 6 in Adapted ACR Pediatric response variables and no intermittent fever (i.e. axillary, oral, or rectal body temperature ≤ 38°C) in the preceding week (variable 7), with no more than one variable 1-6 worsening by more than 30%. Adapted ACR Pediatric response variables consists of following 7 variables: 1. Physician's Global Assessment of disease activity on a 0-100 mm VAS; 2. Parent's or Patient's (if appropriate in age) Global Assessment of Patient's overall wellbeing based upon the 0-100 mm VAS in the Child Health Assessment Questionnaire (CHAQ); 3. Functional ability: CHAQ; 4. Number of joints with active arthritis; 5. Number of joints with limitation of motion; 6. Laboratory measure of inflammation: CRP (mg/L); 7. Absence of intermittent fever due to SJIA during the preceding week. |
| Primary | Percentage of Participants With Canakinumab Treatment Who Were Able to Taper Corticosteroids Successfully | Week 28 | To evaluate the percentage of participants with canakinumab treatment who were able to taper corticosteroids successfully at Week 28 |
| Secondary | Percentage of Participants Who Met the Adapted ACR Pediatric 30/50/70/90/100 Criteria of Canakinumab Over Time | Weeks 4, 8, 28, 48, 96, 144, end of study (EOS) (up to Week 164) | Adapted ACR Pediatric 30/50/70/90/100 criteria was assessed based on the following 7 variables: 1. Physician's Global Assessment of disease activity on a 0-100 mm VAS; 2. Parent's or Patient's (if appropriate in age) Global Assessment of Patient's overall wellbeing based upon the 0-100 mm VAS in the CHAQ; 3. Functional ability: CHAQ; 4. Number of joints with active arthritis; 5. Number of joints with limitation of motion; 6. Laboratory measure of inflammation: CRP (mg/L); 7. Absence of intermittent fever due to SJIA during the preceding week. Response was defined as more than or equal to (≥) 30%/50%/70%/90% or 100% improvement in at least 3 of 6 response variables and no intermittent fever in the preceding week (variable 7) with no more than one variable 1-6 worsening by more than 30%. |
| Secondary | Absolute Change From Baseline in the Adapted ACR Pediatric Criteria of Canakinumab Over Time: ACR Component: Physician's Global Assessment of Disease Activity | Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS (up to Week 164) | ACR component, Physician's Global Assessment of disease activity on a 0 - 100 mm VAS by visit is the first response ACR variable in the ACR pediatric criteria. The VAS scale ranges from no disease activity (0 mm) to very severe disease activity (100 mm). Lower scale indicates decreased disease activity. Change from baseline was calculated by subtracting baseline value from post baseline value. |
| Secondary | Absolute Change From Baseline in the Adapted ACR Pediatric Criteria of Canakinumab Over Time: ACR Component: CHAQ: Parent's or Patient's Global Assessment of Patient's Overall Well-being as Part of CHAQ | Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS up to Week 164 | ACR component, Parent's or Patient's (if appropriate in age)Global Assessment of patient's overall well-being as part of CHAQ on a 0 - 100 mm VAS by visit is the second response variable in the ACR pediatric criteria. The VAS scale ranges from 0-100 mm, from very well (0 mm) to very poor (100 mm). Lower scale indicates improvement of patient's overall well-being. Absolute change is calculated by subtracting baseline value from post baseline value. |
| Secondary | Absolute Change From Baseline in the Adapted ACR Pediatric Criteria of Canakinumab Over Time: ACR Component: CHAQ: Functional Ability Score | Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS (up to Week 164) | Disability Score as part of CHAQ per functional ability score (range from 0 to 3) is one of the variable in the ACR ped criteria. The CHAQ was used to assess physical ability \& functional status of patients as well as quality of life. The disability dimension consists of 20 multiple choice items concerning difficulty in performing 8 common activity categories of daily living: dressing \& grooming, arising, eating, walking, reaching, personal hygiene, gripping \& other "activities". Subjects choose from 4 responses, ranging from 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty) \& 3 (unable to do). Standard Disability Index (SDI) was computed by summing up the computed scores for each activity category and dividing by the number of categories answered. The lower the response the more positive the results \& the higher the response, the less positive the results. Change from baseline was calculated by subtracting baseline value from post baseline value. |
| Secondary | Absolute Change From Baseline in the Adapted ACR Pediatric Criteria of Canakinumab Over Time: ACR Component: Number of Joints With Active Arthritis | Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS (up to Week 164) | ACR component, Number of joints with active arthritis was assessed as the forth response variables of ACR Pediatric Criteria. |
| Secondary | Absolute Change From Baseline in the Adapted ACR Pediatric Criteria of Canakinumab Over Time: ACR Component: Number of Joints With Limitation of Motion | Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS (up to Week 164) | ACR component, Number of joints with limitation of motion is the fifth response variable in the ACR ped criteria. |
| Secondary | Number of Participants Having Fever in the Adapted ACR Pediatric Criteria of Canakinumab Over Time | Baseline, Day 3, Weeks 2, 8, 28, 48, 56, 96, 124, 144, EOS (up to Week 164) | ACR component, Number of participants having fever is the seventh response variable in the ACR ped criteria. |
| Secondary | Percentage Change From Baseline in the Adapted ACR Pediatric Criteria of Canakinumab Over Time: ACR Component: Standardized C-Reactive Protein (CRP) | Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS (up to Week 164) | ACR component, Standardized CRP is the sixth response variable in the ACR ped criteria. CRP values were standardized to a normal range of 0 to 10 mg/L. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Achieved a Minimum Adapted American College of Rheumatology (ACR) Pediatric 30 Criteria | Week 8 | The Full Analysis Set (FAS) consisted of all 19 patients who were enrolled and received at least one dose of canakinumab. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants With Canakinumab Treatment Who Were Able to Taper Corticosteroids Successfully | Week 28 | The FAS consisted of all 19 patients who were enrolled and received at least one dose of canakinumab. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Who Met the Adapted ACR Pediatric 30/50/70/90/100 Criteria of Canakinumab Over Time | Weeks 4, 8, 28, 48, 96, 144, end of study (EOS) (up to Week 164) | The FAS consisted of all 19 patients who were enrolled and received at least one dose of canakinumab. | Percentage of Participants | NUMBER |
| SECONDARY | Absolute Change From Baseline in the Adapted ACR Pediatric Criteria of Canakinumab Over Time: ACR Component: Physician's Global Assessment of Disease Activity | Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS (up to Week 164) | The FAS consisted of all 19 patients who were enrolled and received at least one dose of canakinumab. | units on a scale | MEAN |
| SECONDARY | Absolute Change From Baseline in the Adapted ACR Pediatric Criteria of Canakinumab Over Time: ACR Component: CHAQ: Parent's or Patient's Global Assessment of Patient's Overall Well-being as Part of CHAQ | Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS up to Week 164 | The FAS consisted of all 19 patients who were enrolled and received at least one dose of canakinumab. | units on a scale | MEAN |
| SECONDARY | Absolute Change From Baseline in the Adapted ACR Pediatric Criteria of Canakinumab Over Time: ACR Component: CHAQ: Functional Ability Score | Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS (up to Week 164) | The FAS consisted of all 19 patients who were enrolled and received at least one dose of canakinumab. | units on a scale | MEAN |
| SECONDARY | Absolute Change From Baseline in the Adapted ACR Pediatric Criteria of Canakinumab Over Time: ACR Component: Number of Joints With Active Arthritis | Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS (up to Week 164) | The FAS consisted of all 19 patients who were enrolled and received at least one dose of canakinumab. | joints | MEAN |
| SECONDARY | Absolute Change From Baseline in the Adapted ACR Pediatric Criteria of Canakinumab Over Time: ACR Component: Number of Joints With Limitation of Motion | Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS (up to Week 164) | The FAS consisted of all 19 patients who were enrolled and received at least one dose of canakinumab. | joints | MEAN |
| SECONDARY | Number of Participants Having Fever in the Adapted ACR Pediatric Criteria of Canakinumab Over Time | Baseline, Day 3, Weeks 2, 8, 28, 48, 56, 96, 124, 144, EOS (up to Week 164) | The FAS consisted of all 19 patients who were enrolled and received at least one dose of canakinumab. | participants | NUMBER |
| SECONDARY | Percentage Change From Baseline in the Adapted ACR Pediatric Criteria of Canakinumab Over Time: ACR Component: Standardized C-Reactive Protein (CRP) | Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS (up to Week 164) | The FAS consisted of all 19 patients who were enrolled and received at least one dose of canakinumab. | Percentage change | MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group129
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Achieved a Minimum Adapted American College of Rheumatology (ACR) Pediatric 30 Criteria | Canakinumab 4 mg/kg Every 4 Weeks | 100.0 | Percentage of Participants | ||
| Percentage of Participants With Canakinumab Treatment Who Were Able to Taper Corticosteroids Successfully | Canakinumab 4 mg/kg Every 4 Weeks | 73.7 | Percentage of Participants | ||
| Percentage of Participants Who Met the Adapted ACR Pediatric 30/50/70/90/100 Criteria of Canakinumab Over Time | Canakinumab 4 mg/kg Every 4 Weeks | Week 4 adapted ACR Pediatric 30 | 94.7 | Percentage of Participants | |
| Percentage of Participants Who Met the Adapted ACR Pediatric 30/50/70/90/100 Criteria of Canakinumab Over Time | Canakinumab 4 mg/kg Every 4 Weeks | Week 4 adapted ACR Pediatric 50 | 94.7 | Percentage of Participants | |
| Percentage of Participants Who Met the Adapted ACR Pediatric 30/50/70/90/100 Criteria of Canakinumab Over Time | Canakinumab 4 mg/kg Every 4 Weeks | Week 4 adapted ACR Pediatric 70 | 94.7 | Percentage of Participants | |
| Percentage of Participants Who Met the Adapted ACR Pediatric 30/50/70/90/100 Criteria of Canakinumab Over Time | Canakinumab 4 mg/kg Every 4 Weeks | Week 4 adapted ACR Pediatric 90 | 84.2 | Percentage of Participants | |
| Percentage of Participants Who Met the Adapted ACR Pediatric 30/50/70/90/100 Criteria of Canakinumab Over Time | Canakinumab 4 mg/kg Every 4 Weeks | Week 4 adapted ACR Pediatric 100 | 47.4 | Percentage of Participants | |
| Percentage of Participants Who Met the Adapted ACR Pediatric 30/50/70/90/100 Criteria of Canakinumab Over Time | Canakinumab 4 mg/kg Every 4 Weeks | Week 8 adapted ACR Pediatric 30 | 100.0 | Percentage of Participants | |
| Percentage of Participants Who Met the Adapted ACR Pediatric 30/50/70/90/100 Criteria of Canakinumab Over Time | Canakinumab 4 mg/kg Every 4 Weeks | Week 8 adapted ACR Pediatric 50 | 100.0 | Percentage of Participants | |
| Percentage of Participants Who Met the Adapted ACR Pediatric 30/50/70/90/100 Criteria of Canakinumab Over Time | Canakinumab 4 mg/kg Every 4 Weeks | Week 8 adapted ACR Pediatric 70 | 100.0 | Percentage of Participants |
1 to 10 of 129Source ClinicalTrials.gov
See all 129 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Canakinumab 4 mg/kg Every 4 Weeks | 19 | |
| Overall Study | COMPLETED | Canakinumab 4 mg/kg Every 4 Weeks | 16 | |
| Overall Study | NOT COMPLETED | Canakinumab 4 mg/kg Every 4 Weeks | 3 |
Source ClinicalTrials.gov
Adverse events116
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 | Anaemia | Blood and lymphatic system disorders | Canakinumab 4 mg/kg Every 4 Weeks | 1 | 19 | |
| other | Leukopenia | Blood and lymphatic system disorders | Canakinumab 4 mg/kg Every 4 Weeks | 1 | 19 | |
| other | Lymphadenitis | Blood and lymphatic system disorders | Canakinumab 4 mg/kg Every 4 Weeks | 1 | 19 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Canakinumab 4 mg/kg Every 4 Weeks | 1 | 19 | |
| other | Ventricular extrasystoles | Cardiac disorders | Canakinumab 4 mg/kg Every 4 Weeks | 1 | 19 | |
| other | Motion sickness | Ear and labyrinth disorders | Canakinumab 4 mg/kg Every 4 Weeks | 1 | 19 | |
| other | Adrenal insufficiency | Endocrine disorders | Canakinumab 4 mg/kg Every 4 Weeks | 2 | 19 | |
| other | Chalazion | Eye disorders | Canakinumab 4 mg/kg Every 4 Weeks | 1 | 19 | |
| other | Conjunctivitis allergic | Eye disorders | Canakinumab 4 mg/kg Every 4 Weeks | 2 | 19 | |
| other | Abdominal pain | Gastrointestinal disorders | Canakinumab 4 mg/kg Every 4 Weeks | 2 | 19 |
1 to 10 of 116Source ClinicalTrials.gov
See all 116 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Canakinumab 4 mg/kg Every 4 Weeks | 0 | 19 |
| Total, other adverse events | Canakinumab 4 mg/kg Every 4 Weeks | 19 | 19 |
| Total, serious adverse events | Canakinumab 4 mg/kg Every 4 Weeks | 10 | 19 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32552266 | 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 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.
For software
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