Trial · NCT00891046
An Open-label Extension Study of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis and Active Systemic Manifestations Manifestations and Response Characterization Study in Canakinumab Treatment-naïve Patients With Active SJIA With and Without Fever.
NCT00891046, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2017-03-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Open-label Extension Study of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis and Active Systemic Manifestations Manifestations and Response Characterization Study in Canakinumab Treatment-naïve Patients With Active SJIA With and Without Fever. Trials, record NCT00891046. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00891046
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
An Open-label Extension Study of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis and Active Systemic Manifestations Manifestations and Response Characterization Study in Canakinumab Treatment-naïve Patients With Active SJIA With and Without Fever.
- NCT number
- NCT00891046
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 270 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Systemic Juvenile Idiopathic Arthritis
- Interventions
- Canakinumab
- First posted
- 2009-04-30
- Last updated
- 2019-03-26
- Other registries' IDs
- eudract:2008-008008-42
- Results first posted
- 2017-03-10
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs by Severity, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Treatment Related AEs and SAE | From start of study treatment (Day 1) up to end of follow-up period (Week 271 for ACZ885 treated participants and Week 145 for ACZ885 treatment naive participants) | An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the participants or require medical or surgical intervention to prevent one of the aforementioned outcomes. Treatment related AEs or SAEs were defined as AEs or SAEs that were suspected to be related to study treatment as per investigator. |
| Primary | Number of Participants With Anti -ACZ885 Antibodies at Any Visit During the Study | From start of study treatment (Day 1) up to end of follow-up period (Week 271 for ACZ885 treated participants and Week 145 for ACZ885 treatment naive participants) | Immunogenicity assessment included determination of anti-canakinumab (ACZ885) antibodies in serum samples using BIAcore system. |
| Primary | Number of Participants With Clinically Significant Local Injection Site Reactions During the Study | From start of study treatment (Day 1) up to end of follow-up period (Week 271 for ACZ885 treated participants and Week 145 for ACZ885 treatment naive participants) | Local injection site tolerability was assessed on the injection site. Each participant was classified into one of the following four categories: 1. no tolerability reactions at any time during the study, 2. mild reaction observed on at least one occasion but no moderate or severe reactions. 3. moderate reaction observed on at least one occasion but no severe reaction. 4. severe reaction observed on at least one occasion. |
| Primary | Percentage of Participants Previously Treated With Anakinra Who Achieved Minimum Response of American College of Rheumatology (ACR) Pediatric 30/50/70/90/100 at Last Assessment of Study | Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier | Adapted ACR Paediatric 30/50/70/90 or 100 was assessed based on following 7 variables: 1.Physician's Global Assessment on a 1-100 millimeter (mm) visual analog scale (VAS); 2. Participants Global Assessment on a 1-100 mm VAS; 3. Functional ability; 4. Joints count with active arthritis; 5. Joints count with limitation of motion; 6. Laboratory measure of C-reactive protein (CRP) and 7. Absence of intermittent fever due to severe juvenile idiopathic arthritis (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 the response variables 1 to 6, no intermittent fever (i.e. body temperature less than or equal to (≤) 38 °C) in the preceding week (variable 7) and with no more than one variable 1 to 6, worsening by more than 30%. |
| Primary | Percentage of Participants Previously Treated With Tocilizumab Who Achieved Minimum Response of American College of Rheumatology (ACR) Pediatric 30/50/70/90/100 at Last Assessment of Study | Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier | Adapted ACR Paediatric 30/50/70/90 or 100 was assessed based on following 7 variables: 1.Physician's Global Assessment on a 0-100 mm VAS; 2. Participants Global Assessment on a 0-100 mm VAS; 3. Functional ability; 4. Joints count with active arthritis; 5. Joints count with limitation of motion; 6. Laboratory measure of CRP and 7. Absence of intermittent fever due to SJIA during the preceding week. Response was defined as ≥ 30%/50%/70%/90% or 100% improvement in at least 3 of the response variables 1 to 6, no intermittent fever (i.e. body temperature ≤ 38 °C) in the preceding week (variable 7) and with no more than one variable 1 to 6, worsening by more than 30%. |
| Primary | Percentage of Participants Previously Treated With Other Biologics Who Achieved Minimum Response of American College of Rheumatology (ACR) Pediatric 30/50/70/90/100 at Last Assessment of Study | Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier | Adapted ACR Paediatric 30/50/70/90 or 100 was assessed based on following 7 variables: 1.Physician's Global Assessment on a 0-100 mm VAS; 2. Participants Global Assessment on a 0-100 mm VAS; 3. Functional ability; 4. Joints count with active arthritis; 5. Joints count with limitation of motion; 6. Laboratory measure of CRP and 7. Absence of intermittent fever due to SJIA during the preceding week. Response was defined as ≥ 30%/50%/70%/90% or 100% improvement in at least 3 of the response variables 1 to 6, no intermittent fever (i.e. body temperature ≤ 38 °C) in the preceding week (variable 7) and with no more than one variable 1 to 6, worsening by more than 30%. |
| Secondary | Percentage of Non--Responders Who Achieved Minimum Response of American College of Rheumatology (ACR) Pediatric 30/50/70/90/100 | Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier | Adapted ACR Paediatric 30/50/70/90 or 100 was assessed based on following 7 variables: 1.Physician's Global Assessment on a 0-100 mm VAS; 2. Participants Global Assessment on a 0-100 mm VAS; 3. Functional ability; 4. Joints count with active arthritis; 5. Joints count with limitation of motion; 6. Laboratory measure of -CRP and 7. Absence of intermittent fever due to SJIA during the preceding week. Response was defined as ≥ 30%/50%/70%/90% or 100% improvement in at least 3 of the response variables 1 to 6, no intermittent fever (i.e. body temperature ≤ 38°C) in the preceding week (variable 7) and with no more than one variable 1 to 6, worsening by more than 30%. |
| Secondary | Percentage of Participants With Minimum Adapted ACR Pediatric ≥ 30 at Baseline Who Achieved Minimum Response of ACR Pediatric 30/50/70/90/100 at Last Assessment of Study | Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier | Adapted ACR Paediatric 30/50/70/90 or 100 was assessed based on following 7 variables: 1.Physician's Global Assessment on a 0-100 mm VAS; 2. Participants Global Assessment on a 0-100 mm VAS; 3. Functional ability; 4. Joints count with active arthritis; 5. Joints count with limitation of motion; 6. Laboratory measure of CRP and 7. Absence of intermittent fever due to SJIA during the preceding week. Response was defined as ≥ 30%/50%/70%/90% or 100% improvement in at least 3 of the response variables 1 to 6, no intermittent fever in the preceding week (variable 7) and with no more than one variable 1 to 6 worsening by more than 30%. For minimum adapted ACR paediatric scores, the last measurement recorded from the participant's previous study was considered baseline for the current study. |
| Secondary | Percentage of Participants Able to Taper Oral Steroid Use or Reached Steroid Free Regimen | Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier | Steroid tapering with oral steroids was allowed if the participant achieved an adapted ACR Paediatric 50 response and had no fever. A participant was considered to have tapered steroids successfully, if the steroid dose was reduced from baseline and the participant did not flare and maintained a minimum adapted ACR Paediatric 30 at the last measurement. A participant was considered to have unsuccessfully tapered steroids if the steroid dose was reduced during the study but dose at last assessment was equal to or greater than dose at baseline or; if steroid dose was reduced but the participant did not maintain a minimum adapted ACR Paediatric 30 at the last measurement. |
| Secondary | Number of Participants Who Reduced Their Canakinumab Dose to 2 mg/kg | Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier | The canakinumab dose could be reduced from 4 mg/kg to 2 mg/kg in participants who were steroid-free, if requested by the treating physician and agreed by the sponsor. For treatment naive participants , dose reduction was allowed after the participant had received 6 months treatment with canakinumab. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
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 Adverse Events (AEs), Serious Adverse Events (SAEs), AEs by Severity, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Treatment Related AEs and SAE | From start of study treatment (Day 1) up to end of follow-up period (Week 271 for ACZ885 treated participants and Week 145 for ACZ885 treatment naive participants) | The analysis was performed in safety set (SS), defined as all participants who received at least one dose of study drug. | participants | NUMBER |
| PRIMARY | Number of Participants With Anti -ACZ885 Antibodies at Any Visit During the Study | From start of study treatment (Day 1) up to end of follow-up period (Week 271 for ACZ885 treated participants and Week 145 for ACZ885 treatment naive participants) | The analysis was performed on the SS population. | participants | NUMBER |
| PRIMARY | Number of Participants With Clinically Significant Local Injection Site Reactions During the Study | From start of study treatment (Day 1) up to end of follow-up period (Week 271 for ACZ885 treated participants and Week 145 for ACZ885 treatment naive participants) | The analysis was performed in SS population. | participants | NUMBER |
| PRIMARY | Percentage of Participants Previously Treated With Anakinra Who Achieved Minimum Response of American College of Rheumatology (ACR) Pediatric 30/50/70/90/100 at Last Assessment of Study | Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier | The analysis was done in FAS population. Here 'Number of participants analyzed' signifies number of participants with an ACR assessment at the given visit. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Previously Treated With Tocilizumab Who Achieved Minimum Response of American College of Rheumatology (ACR) Pediatric 30/50/70/90/100 at Last Assessment of Study | Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier | The analysis was done in FAS population. Here 'Number of participants analyzed' signifies number of participants with an ACR assessment at the given visit. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Previously Treated With Other Biologics Who Achieved Minimum Response of American College of Rheumatology (ACR) Pediatric 30/50/70/90/100 at Last Assessment of Study | Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier | The analysis was done in FAS population. Here 'Number of participants analyzed' signifies number of participants with an ACR assessment at the given visit. For arm 'ACZ885 treatment naive: Group 2' there were no participants who had discontinued other biologics due to safety/tolerability issues. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Non--Responders Who Achieved Minimum Response of American College of Rheumatology (ACR) Pediatric 30/50/70/90/100 | Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier | The analysis was done in FAS population. Here 'Number of participants analysed' signifies number of participants with an ACR assessment at the given visit. For arm 'ACZ885 treated: Group 2 (Completed core study)' there were no Non-Responders participants available. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Minimum Adapted ACR Pediatric ≥ 30 at Baseline Who Achieved Minimum Response of ACR Pediatric 30/50/70/90/100 at Last Assessment of Study | Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier | The analysis was done in FAS population. Here 'Number of participants analysed' signifies number of participants with an ACR assessment at the given visit. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Able to Taper Oral Steroid Use or Reached Steroid Free Regimen | Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier | The analysis was done in FAS population. Here 'Number of participants analysed' signifies number of participants who were steroid users at baseline. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants Who Reduced Their Canakinumab Dose to 2 mg/kg | Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier | The analysis was done in FAS population. | participants | NUMBER |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group198
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 Adverse Events (AEs), Serious Adverse Events (SAEs), AEs by Severity, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Treatment Related AEs and SAE | ACZ885 Treatment Naive | AEs | 108 | participants | |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs by Severity, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Treatment Related AEs and SAE | ACZ885 Treated | AEs | 137 | participants | |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs by Severity, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Treatment Related AEs and SAE | ACZ885 Treatment Naive | SAEs | 40 | participants | |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs by Severity, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Treatment Related AEs and SAE | ACZ885 Treated | SAEs | 47 | participants | |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs by Severity, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Treatment Related AEs and SAE | ACZ885 Treatment Naive | Discontinuation due to any AE | 14 | participants | |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs by Severity, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Treatment Related AEs and SAE | ACZ885 Treated | Discontinuation due to any AE | 18 | participants | |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs by Severity, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Treatment Related AEs and SAE | ACZ885 Treatment Naive | Discontinuation due to any SAE | 13 | participants | |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs by Severity, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Treatment Related AEs and SAE | ACZ885 Treated | Discontinuation due to any SAE | 14 | participants | |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs by Severity, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Treatment Related AEs and SAE | ACZ885 Treatment Naive | Treatment Related AEs | 44 | participants | |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs by Severity, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Treatment Related AEs and SAE | ACZ885 Treated | Treatment Related AEs | 57 | participants |
1 to 10 of 198Source ClinicalTrials.gov
See all 198 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ACZ885 Treated: Group 1 (Discontinued From Core Study) | 33 | |
| Overall Study | STARTED | ACZ885 Treated: Group 2 (Completed Core Study) | 63 | |
| Overall Study | STARTED | ACZ885 Treated: Group 3 (Steroid Taper Failures in Core Study) | 40 | |
| Overall Study | STARTED | ACZ885 Treated: Group 4 (Other Criteria) | 11 | |
| Overall Study | STARTED | ACZ885 Treatment Naive | 123 | |
| Overall Study | COMPLETED | ACZ885 Treated: Group 1 (Discontinued From Core Study) | 21 | |
| Overall Study | COMPLETED | ACZ885 Treated: Group 2 (Completed Core Study) | 54 | |
| Overall Study | COMPLETED | ACZ885 Treated: Group 3 (Steroid Taper Failures in Core Study) | 17 | |
| Overall Study | COMPLETED | ACZ885 Treated: Group 4 (Other Criteria) | 8 | |
| Overall Study | COMPLETED | ACZ885 Treatment Naive | 84 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events318
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 | Ear pain | Ear and labyrinth disorders | ACZ885 Treated | 10 | 147 | |
| other | Ear pain | Ear and labyrinth disorders | ACZ885 Treatment Naive | 7 | 123 | |
| other | Abdominal pain | Gastrointestinal disorders | ACZ885 Treated | 21 | 147 | |
| other | Abdominal pain | Gastrointestinal disorders | ACZ885 Treatment Naive | 22 | 123 | |
| other | Abdominal pain upper | Gastrointestinal disorders | ACZ885 Treated | 18 | 147 | |
| other | Abdominal pain upper | Gastrointestinal disorders | ACZ885 Treatment Naive | 13 | 123 | |
| other | Diarrhoea | Gastrointestinal disorders | ACZ885 Treated | 30 | 147 | |
| other | Diarrhoea | Gastrointestinal disorders | ACZ885 Treatment Naive | 16 | 123 | |
| other | Nausea | Gastrointestinal disorders | ACZ885 Treated | 17 | 147 | |
| other | Nausea | Gastrointestinal disorders | ACZ885 Treatment Naive | 11 | 123 |
1 to 10 of 318Source ClinicalTrials.gov
See all 318 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ACZ885 Treated | ||
| Total, all-cause mortality | ACZ885 Treatment Naive | ||
| Total, other adverse events | ACZ885 Treated | 124 | 147 |
| Total, other adverse events | ACZ885 Treatment Naive | 91 | 123 |
| Total, serious adverse events | ACZ885 Treated | 47 | 147 |
| Total, serious adverse events | ACZ885 Treatment Naive | 40 | 123 |
Source ClinicalTrials.gov
Papers2
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| ACZ885 Treatment Naive vs ACZ885 Treated: Number of Participants With Anti -ACZ885 Antibodies at Any Visit During the Study | Trial comparisons |
| ACZ885 Treated vs ACZ885 Treatment Naive: 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/NCT00891046
GET https://conductscience.org/api/trials/v1/NCT00891046/results?page=2