Trial · NCT02296424
ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line Use of Canakinumab
NCT02296424, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2019-07-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line Use of Canakinumab. Trials, record NCT02296424. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02296424
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line Use of Canakinumab
- NCT number
- NCT02296424
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 182 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Systemic Juvenile Idiopathic Arthritis (SJIA)
- Interventions
- ACZ885 150 mg (Canakinumab)
- First posted
- 2014-11-20
- Last updated
- 2019-07-09
- Other registries' IDs
- eudract:2013-004867-29
- Results first posted
- 2019-07-09
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants in Clinical Remission on Canakinumab Who Are Able to Remain at an Initial Reduced Canakinumab Dose or Prolonged Canakinumab Dose Interval. | baseline to 24 weeks | The primary efficacy variable for Part II was the proportion of patients in clinical remission on canakinumab 4 mg/kg (+/- concomitant NSAID only) who were able to remain on a reduced dose or on prolonged dose interval for at least 24 consecutive weeks. As the primary objective was to show statistically significance in at least one of canakinumab treatment arms (reduced dose and prolonged dose interval arms) in Part II then the Type I error rate 5% was controlled and split to 2.5%. Clinical remission per protocol is defined as the maintenance of inactive disease for at least 6 months (24consecutive weeks) while on therapy. The primary analysis considered both inactive disease status and the patient dose step duration. In the event the inactive disease status was missing, yet the patient remained at the same dose level through the next visit with the same disease status, it was concluded that inactive disease was maintained during this time period and was carried forward. |
| Secondary | Number and Percentage of Patients With Adverse Events as a Measure of Long-term Safety and Tolerability of Canakinumab - PART 1 | During study parts I and II. The estimated study duration is not more than 216 weeks (with an average expected duration of 108 weeks). | AEs, Deaths, other serious adverse events or discontinuations due to AE, Part I (Safety set) |
| Secondary | Number and Percentage of Patients With Adverse Events as a Measure of Long-term Safety and Tolerability of Canakinumab - PART 2 | During study parts I and II, estimated study duration was not more than 216 weeks (with an average duration of 108 weeks). | AEs, Deaths, other serious adverse events or discontinuations due to AE, Part II (Safety set) |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants in Clinical Remission on Canakinumab Who Are Able to Remain at an Initial Reduced Canakinumab Dose or Prolonged Canakinumab Dose Interval. | baseline to 24 weeks | Full Analysis Set | particiapants | NUMBER |
| SECONDARY | Number and Percentage of Patients With Adverse Events as a Measure of Long-term Safety and Tolerability of Canakinumab - PART 1 | During study parts I and II. The estimated study duration is not more than 216 weeks (with an average expected duration of 108 weeks). | Safety Set | number of participants | NUMBER |
| SECONDARY | Number and Percentage of Patients With Adverse Events as a Measure of Long-term Safety and Tolerability of Canakinumab - PART 2 | During study parts I and II, estimated study duration was not more than 216 weeks (with an average duration of 108 weeks). | Safety Set | number of participants | NUMBER |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants in Clinical Remission on Canakinumab Who Are Able to Remain at an Initial Reduced Canakinumab Dose or Prolonged Canakinumab Dose Interval. | Canakinumab Dose Reduction | Able to remain on dose | 27 | particiapants | |
| Number of Participants in Clinical Remission on Canakinumab Who Are Able to Remain at an Initial Reduced Canakinumab Dose or Prolonged Canakinumab Dose Interval. | Canakinumab Dose Interval Prolongation | Able to remain on dose | 31 | particiapants | |
| Number of Participants in Clinical Remission on Canakinumab Who Are Able to Remain at an Initial Reduced Canakinumab Dose or Prolonged Canakinumab Dose Interval. | Canakinumab Dose Reduction | Not able to remain on dose | 11 | particiapants | |
| Number of Participants in Clinical Remission on Canakinumab Who Are Able to Remain at an Initial Reduced Canakinumab Dose or Prolonged Canakinumab Dose Interval. | Canakinumab Dose Interval Prolongation | Not able to remain on dose | 6 | particiapants | |
| Number and Percentage of Patients With Adverse Events as a Measure of Long-term Safety and Tolerability of Canakinumab - PART 1 | Canakinumab Dose Reduction | Number of patients with at least one AE | 57 | number of participants | |
| Number and Percentage of Patients With Adverse Events as a Measure of Long-term Safety and Tolerability of Canakinumab - PART 1 | Canakinumab Dose Interval Prolongation | Number of patients with at least one AE | 91 | number of participants | |
| Number and Percentage of Patients With Adverse Events as a Measure of Long-term Safety and Tolerability of Canakinumab - PART 1 | Canakinumab Dose Reduction | Number of patients with death | 0 | number of participants | |
| Number and Percentage of Patients With Adverse Events as a Measure of Long-term Safety and Tolerability of Canakinumab - PART 1 | Canakinumab Dose Interval Prolongation | Number of patients with death | 0 | number of participants | |
| Number and Percentage of Patients With Adverse Events as a Measure of Long-term Safety and Tolerability of Canakinumab - PART 1 | Canakinumab Dose Reduction | Number of patients with at least one SAE | 10 | number of participants | |
| Number and Percentage of Patients With Adverse Events as a Measure of Long-term Safety and Tolerability of Canakinumab - PART 1 | Canakinumab Dose Interval Prolongation | Number of patients with at least one SAE | 23 | number of participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part 1 | STARTED | Cohort 1 | 84 | |
| Part 1 | STARTED | PART 1: Cohort 2 | 98 | |
| Part 1 | STARTED | Dose Reduction | 0 | |
| Part 1 | STARTED | Dose Interval Prolongation | 0 | |
| Part 1 | COMPLETED | Cohort 1 | 61 | |
| Part 1 | COMPLETED | PART 1: Cohort 2 | 65 | |
| Part 1 | COMPLETED | Dose Reduction | 0 | |
| Part 1 | COMPLETED | Dose Interval Prolongation | 0 | |
| Part 1 | NOT COMPLETED | Cohort 1 | 23 | |
| Part 1 | NOT COMPLETED | PART 1: Cohort 2 | 33 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events312
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 | Lymphadenopathy | Blood and lymphatic system disorders | Part I | 10 | 166 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Part II@Dose Reduction | 1 | 38 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Part II@Dose Interval@Prolongation | 2 | 37 | |
| other | Abdominal pain | Gastrointestinal disorders | Part I | 13 | 166 | |
| other | Abdominal pain | Gastrointestinal disorders | Part II@Dose Reduction | 5 | 38 | |
| other | Abdominal pain | Gastrointestinal disorders | Part II@Dose Interval@Prolongation | 6 | 37 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Part I | 14 | 166 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Part II@Dose Reduction | 2 | 38 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Part II@Dose Interval@Prolongation | 1 | 37 | |
| other | Diarrhoea | Gastrointestinal disorders | Part I | 18 | 166 |
1 to 10 of 312Source ClinicalTrials.gov
See all 312 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part I | 0 | 166 |
| Total, all-cause mortality | Part II@Dose Reduction | 0 | 38 |
| Total, all-cause mortality | Part II@Dose Interval@Prolongation | 0 | 37 |
| Total, other adverse events | Part I | 140 | 166 |
| Total, other adverse events | Part II@Dose Reduction | 38 | 38 |
| Total, other adverse events | Part II@Dose Interval@Prolongation | 34 | 37 |
| Total, serious adverse events | Part I | 33 | 166 |
| Total, serious adverse events | Part II@Dose Reduction | 4 | 38 |
| Total, serious adverse events | Part II@Dose Interval@Prolongation | 1 | 37 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32783351 | 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
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/NCT02296424
GET https://conductscience.org/api/trials/v1/NCT02296424/flow?page=2