Trial · NCT00889863
Flare Prevention Study of Canakinumab in Patients With Active Systemic Juvenile Idiopathic Arthritis (SJIA)
NCT00889863, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2012-10-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Flare Prevention Study of Canakinumab in Patients With Active Systemic Juvenile Idiopathic Arthritis (SJIA). Trials, record NCT00889863. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00889863
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Flare Prevention Study of Canakinumab in Patients With Active Systemic Juvenile Idiopathic Arthritis (SJIA)
- NCT number
- NCT00889863
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 177 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Systemic Juvenile Idiopathic Arthritis With Active Flare
- Interventions
- canakinumab, placebo
- First posted
- 2009-04-29
- Last updated
- 2012-10-16
- Other registries' IDs
- eudract:2008-005479-82
- Results first posted
- 2012-10-16
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part I: Percentage of Patients Who Were on Steroids at Entry Into Part I and Who Were Able to Taper Steroid as Per Protocol in at Least 25% of the Patients Who Entered the Study Taking a Steroid | 32 Weeks | Ability to taper oral steroids: if dose reduced from start of Part I to end of Part Ic from \> 0.8 mg/kg/day to ≤ 0.5 mg/kg/day, or from ≥ 0.5 mg/kg/day and ≤ 0.8 mg/kg/day by at least 0.3 mg/kg, or from any initial dose to ≤ 0.2 mg/kg/day, while maintaining a minimum adapted ACR 30 pediatric criterion. Patients on oral steroids at study entry who did not enter Part 1c are considered steroid tapering failures. |
| Primary | Part II: Survival Estimate of Time to Flare | Part II was event driven. The study was stopped when the required number of 37 flares had occurred (88 weeks) | Kaplan Meier estimate of the probability to experience a flare. Flare was defined as at least 1 of the following. * Reappearance of fever (\>38°C, lasting for at least 2 consecutive days) not due to infections * Flare according to the JIA pediatric criteria for flare (all criteria must have been met): * ≥ 30% worsening in at least 3 of the first 6 response variables * ≥ 30% improvement in not more than 1 of the first 6 response variables Patients who discontinued the study while in Part II were counted as flared unless they discontinued because of inactive disease for at least 24 weeks in Part II. |
| Secondary | Part I: Percentage of Patients on Steroids at Study Start Who Reached a Steroid Dose ≤0.2 mg/kg at End of Part Ic | 28 Weeks | |
| Secondary | Part I: Percentage of Participants on Steroids at the Start of 1c Who Were Able to Taper Steroids by the End of Part 1c | Start of Part Ic (After Week 8) to End of Part Ic (Week 28) | |
| Secondary | Part I: Percentage of Participants With Minimum American College of Rheumatology (ACR) 30/50/70/90/100 at the End of Part I | Baseline, 32 Weeks | Adapted ACR Pediatric 30/50/70/90/100 criteria are defined as meeting all of the following: * improvement from baseline of ≥ 30%, ≥ 50%, ≥ 70%, ≥ 90%, or 100%, in at least 3 of the first 6 response variables 1. Physician's global assessment of disease activity 2. CHAQ-patient's overall well-being 3. CHAQ-Functional ability 4. \# of joints with active arthritis 5. \# of joints with limitation of motion 6. C-Reactive Protein. * no intermittent fever in the preceding week * no more than one of the first 6 response variables worsening by more than 30% |
| Secondary | Part I: Time to First Minimum American College of Rheumatology (ACR50) and Normal C-Reactive Protein | Baseline, Week 32 | Duration in days in the study to the first minimum adapted ACR Pediatric 50 criteria and a normal (\<10mg/L) C-Reactive Protein |
| Secondary | Part I: Time to First Minimum American College of Rheumatology (ACR70) and Normal C-Reactive Protein | Baseline, Week 32 | Duration in days in the study to the first minimum adapted ACR Pediatric 70 criteria and a normal (\<10mg/L) C-Reactive Protein |
| Secondary | Part I: Percentage of Participants With Body Temperature ≤ 38 Degrees Celsius at Day 3 in Part 1a | Day 3 | |
| Secondary | Part II: Survival Analysis of Time to a Worsening in American College of Rheumatology (ACR) Response | Part II was event driven. The study was stopped when the required number of 37 flares had occurred (88 weeks) | Kaplan Meier estimate of the time in days to the probability of worsening of the ACR response. ACR response is determined by the following items: 1. Physician's global assessment of disease activity 2. CHAQ-patient's overall wellbeing 3. CHAQ-Functional ability 4. Number of joints with active arthritis 5. Number of joints with limitation of motion 6. C-Reactive Protein. 7. No intermittent fever in the preceding week |
| Secondary | Part I: Change in Disability Over Time in the Child Health Assessment Questionnaire-Disability Index (CHAQ-DI) From Baseline to End of Part I | Baseline, End of Part I (Week 32) | The childhood health assessment questionnaire, CHAQ was used to assess physical ability and functional status of patients as well as quality of life. The disability dimension consists of 20 multiple choice items concerning difficulty in performing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and other "activities". Parents choose from four response categories, ranging from 0(without any difficulty) to 3(unable to do). A negative change indicates improvement. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part I: Percentage of Patients Who Were on Steroids at Entry Into Part I and Who Were Able to Taper Steroid as Per Protocol in at Least 25% of the Patients Who Entered the Study Taking a Steroid | 32 Weeks | Participants from the Full Analysis Set who were taking oral steroids at the beginning of Part I. | Percentage of participants | NUMBER |
| PRIMARY | Part II: Survival Estimate of Time to Flare | Part II was event driven. The study was stopped when the required number of 37 flares had occurred (88 weeks) | Full Analysis Set in Part II | Days | MEDIAN |
| SECONDARY | Part I: Percentage of Patients on Steroids at Study Start Who Reached a Steroid Dose ≤0.2 mg/kg at End of Part Ic | 28 Weeks | Participants from the Full Analysis set who were taking oral steroids at the start of the study. | Percentage of participants | NUMBER |
| SECONDARY | Part I: Percentage of Participants on Steroids at the Start of 1c Who Were Able to Taper Steroids by the End of Part 1c | Start of Part Ic (After Week 8) to End of Part Ic (Week 28) | Participants from the Full Analysis set who were taking oral steroids at the start of Part Ic. | Percentage of participants | NUMBER |
| SECONDARY | Part I: Percentage of Participants With Minimum American College of Rheumatology (ACR) 30/50/70/90/100 at the End of Part I | Baseline, 32 Weeks | Participants from the full analysis set with an assessment at the given time-point. | Percentage of participants | NUMBER |
| SECONDARY | Part I: Time to First Minimum American College of Rheumatology (ACR50) and Normal C-Reactive Protein | Baseline, Week 32 | Participants from the Full Analysis Set Part I with ACR 50 and a Normal CRP. | Days | MEAN |
| SECONDARY | Part I: Time to First Minimum American College of Rheumatology (ACR70) and Normal C-Reactive Protein | Baseline, Week 32 | Participants from the Full Analysis Set Part I with ACR 70 and a Normal CRP. | Days | MEAN |
| SECONDARY | Part I: Percentage of Participants With Body Temperature ≤ 38 Degrees Celsius at Day 3 in Part 1a | Day 3 | Participants from the Full Analysis Set Part I with temperature readings at Day 3. | Percentage of participants | NUMBER |
| SECONDARY | Part II: Survival Analysis of Time to a Worsening in American College of Rheumatology (ACR) Response | Part II was event driven. The study was stopped when the required number of 37 flares had occurred (88 weeks) | Full Analysis Set Part II | Days | MEDIAN |
| SECONDARY | Part I: Change in Disability Over Time in the Child Health Assessment Questionnaire-Disability Index (CHAQ-DI) From Baseline to End of Part I | Baseline, End of Part I (Week 32) | Participants from the Full Analysis Set Part I with data at baseline and End of Part I. | Score on a scale | MEDIAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part I: Percentage of Patients Who Were on Steroids at Entry Into Part I and Who Were Able to Taper Steroid as Per Protocol in at Least 25% of the Patients Who Entered the Study Taking a Steroid | Canakinumab | 44.5 | 90% Confidence Interval 37.1 to 52.2 | Percentage of participants | |
| Part II: Survival Estimate of Time to Flare | Canakinumab | NA | 95% Confidence Interval NA to NA | Days | |
| Part II: Survival Estimate of Time to Flare | Placebo | 236.0 | 95% Confidence Interval 141.0 to 449.0 | Days | |
| Part I: Percentage of Patients on Steroids at Study Start Who Reached a Steroid Dose ≤0.2 mg/kg at End of Part Ic | Canakinumab | steroid free | 32.8 | 95% Confidence Interval 24.8 to 41.7 | Percentage of participants |
| Part I: Percentage of Patients on Steroids at Study Start Who Reached a Steroid Dose ≤0.2 mg/kg at End of Part Ic | Canakinumab | >0 and ≤ 0.2 mg/kg/day | 18.8 | 95% Confidence Interval 12.4 to 26.6 | Percentage of participants |
| Part I: Percentage of Participants on Steroids at the Start of 1c Who Were Able to Taper Steroids by the End of Part 1c | Canakinumab | 62.0 | 90% Confidence Interval 52.9 to 70.4 | Percentage of participants | |
| Part I: Percentage of Participants With Minimum American College of Rheumatology (ACR) 30/50/70/90/100 at the End of Part I | Canakinumab | Non-Responders | 22.9 | Percentage of participants | |
| Part I: Percentage of Participants With Minimum American College of Rheumatology (ACR) 30/50/70/90/100 at the End of Part I | Canakinumab | ACR 30 Response | 77.1 | Percentage of participants | |
| Part I: Percentage of Participants With Minimum American College of Rheumatology (ACR) 30/50/70/90/100 at the End of Part I | Canakinumab | ACR 50 Response | 73.1 | Percentage of participants | |
| Part I: Percentage of Participants With Minimum American College of Rheumatology (ACR) 30/50/70/90/100 at the End of Part I | Canakinumab | ACR 70 Response | 64.6 | Percentage of participants |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part I: Open Label | STARTED | Canakinumab | 177 | |
| Part I: Open Label | STARTED | Placebo | 0 | |
| Part I: Open Label | Entered Part Ia | Canakinumab | 145 | |
| Part I: Open Label | Entered Part Ia | Placebo | 0 | |
| Part I: Open Label | Entered Part Ib | Canakinumab | 142 | |
| Part I: Open Label | Entered Part Ib | Placebo | 0 | |
| Part I: Open Label | Entered Part Ic | Canakinumab | 92 | |
| Part I: Open Label | Entered Part Ic | Placebo | 0 | |
| Part I: Open Label | Entered Part 1d | Canakinumab | 103 | |
| Part I: Open Label | Entered Part 1d | Placebo | 0 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events252
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 | Nasopharyngitis | Infections and infestations | Canakinumab: Part I | 27 | 177 | |
| other | Nasopharyngitis | Infections and infestations | Canakinumab: Part II | 7 | 50 | |
| other | Nasopharyngitis | Infections and infestations | Placebo: Part II | 7 | 50 | |
| other | Headache | Nervous system disorders | Canakinumab: Part I | 23 | 177 | |
| other | Headache | Nervous system disorders | Canakinumab: Part II | 3 | 50 | |
| other | Headache | Nervous system disorders | Placebo: Part II | 3 | 50 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Canakinumab: Part I | 20 | 177 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Canakinumab: Part II | 8 | 50 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Placebo: Part II | 6 | 50 | |
| other | Pyrexia | General disorders | Canakinumab: Part I | 18 | 177 |
1 to 10 of 252Source ClinicalTrials.gov
See all 252 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Canakinumab: Part I | ||
| Total, all-cause mortality | Canakinumab: Part II | ||
| Total, all-cause mortality | Placebo: Part II | ||
| Total, other adverse events | Canakinumab: Part I | 138 | 177 |
| Total, other adverse events | Canakinumab: Part II | 40 | 50 |
| Total, other adverse events | Placebo: Part II | 35 | 50 |
| Total, serious adverse events | Canakinumab: Part I | 15 | 177 |
| Total, serious adverse events | Canakinumab: Part II | 6 | 50 |
| Total, serious adverse events | Placebo: Part II | 6 | 50 |
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 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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