Trial · NCT00886769
Single-dose Study to Assess Efficacy of Canakinumab (ACZ885) in Patients With Active Juvenile Idiopathic Arthritis (SJIA)
NCT00886769, Phase 3, Terminated, Novartis Pharmaceuticals; results first posted 2012-04-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Single-dose Study to Assess Efficacy of Canakinumab (ACZ885) in Patients With Active Juvenile Idiopathic Arthritis (SJIA). Trials, record NCT00886769. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00886769
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Single-dose Study to Assess Efficacy of Canakinumab (ACZ885) in Patients With Active Juvenile Idiopathic Arthritis (SJIA)
- NCT number
- NCT00886769
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 84 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Systemic Juvenile Idiopathic Arthritis
- Interventions
- Canakinumab, Placebo
- First posted
- 2009-04-23
- Last updated
- 2017-03-29
- Other registries' IDs
- eudract:2008-005476-27
- Results first posted
- 2012-04-09
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients Who Meet the Adapted American College of Rheumatology (ACR) Pediatric 30 Criteria | Baseline, Day 15, Day 29 | Adapted ACR Pediatric 30 criteria determined responders (improved from baseline of at least 30% in at least 3 response variables 1-6 and no intermittent fever in preceding week \[variable 7\], with no more than one variable 1-6 worsening \> 30% ) 1. Physician's Global Assessment of disease activity: 0-100 mm VAS 2.Parent/Patient's Global Assessment of Patient's overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4.Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation CRP (mg/L) |
| Secondary | Percentage of Patients Achieving the Adapted ACR Pediatric 50 Criteria | Baseline, Day 15, Day 29 | Adapted ACR Pediatric 50 criteria determined responders (improved from baseline of at least 50% in at least 3 response variables 1-6 and no intermittent fever in preceding week \[variable 7\], with no more than one variable 1-6 worsening \> 30%) 1. Physician's Global Assessment of disease activity: 0-100 mm VAS 2. Parent/Patient's Global Assessment of Patient's overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4. Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation CRP (mg/L) |
| Secondary | Percentage of Patients Achieving the Adapted ACR Pediatric 70 | Baseline, Day 15, Day 29 | Adapted ACR Pediatric 70 criteria determined responders (improved from baseline of at least 70% in at least 3 response variables 1-6 and no intermittent fever in preceding week \[variable 7\], with no more than one variable 1-6 worsening \> 30% ) 1. Physician's Global Assessment of disease activity: 0-100 mm VAS 2. Parent/Patient's Global Assessment of Patient's overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4. Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation CRP(mg/L) |
| Secondary | Percentage of Patients Achieving the Adapted ACR Pediatric 90 | Baseline, Day 15, Day 29 | Adapted ACR Pediatric 90 criteria determined responders (improved from baseline of at least 90% in at least 3 response variables 1-6 and no intermittent fever in preceding week \[variable 7\], with no more than one variable 1-6 worsening \> 30% ) 1. Physician's Global Assessment of disease activity: 0-100 mm VAS 2. Parent/Patient's Global Assessment of Patient's overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4. Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation CRP(mg/L) |
| Secondary | Percentage of Patients Achieving the Adapted ACR Pediatric 100 | baseline, Day 15, Day 29 | Adapted ACR Pediatric 100 criteria determined responders (ie improved from baseline of at least 100% in at least 3 response variables 1-6 and no intermittent fever in preceding week \[variable 7\], with no more than one variable 1-6 worsening \> 30% ) 1. Physician's Global Assessment of disease activity: 0-100 mm VAS 2. Parent/Patient's Global Assessment of Patient's overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4. Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation |
| Secondary | Change in Patient's Pain Intensity as Assessed on a 100-mm Visual Analog Scale (VAS)as Part of the Childhood Health Assessment Questionnaire(CHAQ) | Baseline, Day 15 | CHAQ assessed physical ability and functional status of patients as well as quality of life. The disability dimension consisted of 20 multiple choice items about difficulty in doing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Four response categories range from 'without any difficulty' (0) to 'unable to do' (3). The parent's or patient's pain assessment was on VAS that was part of CHAQ. The VAS scale ranges from no pain (0 mm) to very severe pain (100 mm). Negative change indicates improvement. |
| Secondary | Change in Patient's Pain Intensity as Assessed on a 100-mm Visual Analog Scale (VAS) as Part of CHAQ | Baseline, Day 29 | CHAQ, assessed physical ability and functional status of patients as well as quality of life. The disability dimension consisted of 20 multiple choice items about difficulty in doing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Four response categories range from 'without any difficulty'(0) to 'unable to do' (3). The parent's or patient's pain assessment was on VAS that was part of CHAQ. The VAS scale ranges from no pain (0 mm) to very severe pain (100 mm). Negative change indicates improvement. |
| Secondary | Percentage of Patients Who Had Body Temperature ≤ 38°C | Day 3 | Body temperature was derived from vital signs evaluation. No conversion of body temperature was performed, no matter how it was measured. |
| Secondary | Change in Health-related Quality of Life (HRQoL)Over Time by Use of the Child Health Questionnaire - Parent Form (CHQ-PF50) | Over 4 week study period (Baseline, Day 15, Day 29) | CHQ-PF50 measures HRQoL in children 5-18 years old from parent's perspective. Questionnaire completed by parent without input from patient. Total score ranges from 0-100. Increases in scores represent improved well-being in subjects as assessed by their parents. Mixed linear model on change from baseline in CHQ-PF50 score with treatment group, stratification factors, day of assessment and interaction between group and day as covariates. Covariance analysis used a repeated measures approach, so all timepoints over time were taken into account. |
| Secondary | Change in Disability Score Over Time by Use of the CHAQ | At 4 week study period | The disability dimension of CHAQ consisted of 20 multiple choice items about difficulty in doing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Four response categories range from 'without any difficulty'(0) to 'unable to do' (3). Mixed linear model on change from baseline in CHAQ score included treatment group, stratification factors, day of assessment and interaction between group and day as covariates. Negative change indicates improvement. |
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 | Percentage of Patients Who Meet the Adapted American College of Rheumatology (ACR) Pediatric 30 Criteria | Baseline, Day 15, Day 29 | The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Patients Achieving the Adapted ACR Pediatric 50 Criteria | Baseline, Day 15, Day 29 | The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Patients Achieving the Adapted ACR Pediatric 70 | Baseline, Day 15, Day 29 | The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug. | percent of participants | NUMBER |
| SECONDARY | Percentage of Patients Achieving the Adapted ACR Pediatric 90 | Baseline, Day 15, Day 29 | The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug. | percent of participants | NUMBER |
| SECONDARY | Percentage of Patients Achieving the Adapted ACR Pediatric 100 | baseline, Day 15, Day 29 | The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug. | percent of participants | NUMBER |
| SECONDARY | Change in Patient's Pain Intensity as Assessed on a 100-mm Visual Analog Scale (VAS)as Part of the Childhood Health Assessment Questionnaire(CHAQ) | Baseline, Day 15 | The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug. Only observed cases were used in the analysis. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Patient's Pain Intensity as Assessed on a 100-mm Visual Analog Scale (VAS) as Part of CHAQ | Baseline, Day 29 | The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug. Only observed cases were used in the analysis. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Patients Who Had Body Temperature ≤ 38°C | Day 3 | The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug. Only observed cases were used in the analysis. | Percent of participants | NUMBER |
| SECONDARY | Change in Health-related Quality of Life (HRQoL)Over Time by Use of the Child Health Questionnaire - Parent Form (CHQ-PF50) | Over 4 week study period (Baseline, Day 15, Day 29) | The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug. Observed cases only were analyzed. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Disability Score Over Time by Use of the CHAQ | At 4 week study period | The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug. Only observed cases were used in the analysis. | Units on a Scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients Who Meet the Adapted American College of Rheumatology (ACR) Pediatric 30 Criteria | Canakinumab | Day 15 | 83.7 | percentage of participants | |
| Percentage of Patients Who Meet the Adapted American College of Rheumatology (ACR) Pediatric 30 Criteria | Placebo | Day 15 | 9.8 | percentage of participants | |
| Percentage of Patients Who Meet the Adapted American College of Rheumatology (ACR) Pediatric 30 Criteria | Canakinumab | Day 29 | 79.1 | percentage of participants | |
| Percentage of Patients Who Meet the Adapted American College of Rheumatology (ACR) Pediatric 30 Criteria | Placebo | Day 29 | 9.8 | percentage of participants | |
| Percentage of Patients Achieving the Adapted ACR Pediatric 50 Criteria | Canakinumab | Day 15 | 67.4 | percentage of participants | |
| Percentage of Patients Achieving the Adapted ACR Pediatric 50 Criteria | Placebo | Day 15 | 4.9 | percentage of participants | |
| Percentage of Patients Achieving the Adapted ACR Pediatric 50 Criteria | Canakinumab | Day 29 | 76.7 | percentage of participants | |
| Percentage of Patients Achieving the Adapted ACR Pediatric 50 Criteria | Placebo | Day 29 | 4.9 | percentage of participants | |
| Percentage of Patients Achieving the Adapted ACR Pediatric 70 | Canakinumab | Day 15 | 60.5 | percent of participants | |
| Percentage of Patients Achieving the Adapted ACR Pediatric 70 | Placebo | Day 15 | 2.4 | percent of participants |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Canakinumab | 43 | |
| Overall Study | STARTED | Placebo | 41 | |
| Overall Study | COMPLETED | Canakinumab | 37 | |
| Overall Study | COMPLETED | Placebo | 4 | |
| Overall Study | NOT COMPLETED | Canakinumab | 6 | |
| Overall Study | NOT COMPLETED | Placebo | 37 |
Source ClinicalTrials.gov
Adverse events30
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 | Canakinumab | 3 | 43 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 1 | 41 | |
| other | Abdominal pain | Gastrointestinal disorders | Canakinumab | 2 | 43 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 0 | 41 | |
| other | Pyrexia | General disorders | Canakinumab | 2 | 43 | |
| other | Pyrexia | General disorders | Placebo | 0 | 41 | |
| other | Nasopharyngitis | Infections and infestations | Canakinumab | 3 | 43 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 1 | 41 | |
| other | Upper respiratory tract infection | Infections and infestations | Canakinumab | 3 | 43 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 0 | 41 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Canakinumab | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Canakinumab | 17 | 43 |
| Total, other adverse events | Placebo | 3 | 41 |
| Total, serious adverse events | Canakinumab | 2 | 43 |
| Total, serious adverse events | Placebo | 2 | 41 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Canakinumab vs Placebo: serious adverse events |
Source 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.
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