Trial · NCT02334748
A Study of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis or Hereditary Periodic Fevers Who Participated in the CACZ885G2301E1, CACZ885G2306 or CACZ885N2301 Studies
NCT02334748, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2020-05-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis or Hereditary Periodic Fevers Who Participated in the CACZ885G2301E1, CACZ885G2306 or CACZ885N2301 Studies. Trials, record NCT02334748. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02334748
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis or Hereditary Periodic Fevers Who Participated in the CACZ885G2301E1, CACZ885G2306 or CACZ885N2301 Studies
- NCT number
- NCT02334748
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 31 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Systemic Juvenile Idiopathic Arthritis, Hereditary Periodic Fevers
- Interventions
- canakinumab
- First posted
- 2015-01-08
- Last updated
- 2020-05-19
- Other registries' IDs
- eudract:2014-002872-95
- Results first posted
- 2020-05-19
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events | every 4 weeks up to 1 year | The objective of this protocol was to collect additional safety data (serious and non serious AEs) and to provide continuous Ilaris® (canakinumab) treatment to patients in France who completed CACZ885G2301E1, CACZ885N2301 or CACZ885G2306 studies. |
| Primary | All-cause Mortality | uo to 1 year | Number of participants who died for any reason during the study |
Source ClinicalTrials.gov
Outcomes2
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 | every 4 weeks up to 1 year | Safety set: Safety set consisted of all patients who received at least one dose of study drug and had at least one post-treatment safety assessment in the study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | All-cause Mortality | uo to 1 year | Safety set | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group3
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 | Canakinumab | Serious adverse events | 7 | Participants | |
| Number of Participants With Adverse Events | Canakinumab | Treatment emergent adverse events | 29 | Participants | |
| All-cause Mortality | Canakinumab | 0 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Canakinumab | 31 | |
| Overall Study | COMPLETED | Canakinumab | 23 | |
| Overall Study | NOT COMPLETED | Canakinumab | 8 |
Source ClinicalTrials.gov
Adverse events57
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 | Canakinumab (ACZ885) | 3 | 31 | |
| other | Abdominal pain | Gastrointestinal disorders | Canakinumab (ACZ885) | 6 | 31 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Canakinumab (ACZ885) | 2 | 31 | |
| other | Diarrhoea | Gastrointestinal disorders | Canakinumab (ACZ885) | 4 | 31 | |
| other | Mouth ulceration | Gastrointestinal disorders | Canakinumab (ACZ885) | 2 | 31 | |
| other | Nausea | Gastrointestinal disorders | Canakinumab (ACZ885) | 2 | 31 | |
| other | Toothache | Gastrointestinal disorders | Canakinumab (ACZ885) | 2 | 31 | |
| other | Asthenia | General disorders | Canakinumab (ACZ885) | 3 | 31 | |
| other | Pyrexia | General disorders | Canakinumab (ACZ885) | 7 | 31 | |
| other | Bronchitis | Infections and infestations | Canakinumab (ACZ885) | 3 | 31 |
1 to 10 of 57Source ClinicalTrials.gov
See all 57 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Canakinumab (ACZ885) | 0 | 31 |
| Total, other adverse events | Canakinumab (ACZ885) | 28 | 31 |
| Total, serious adverse events | Canakinumab (ACZ885) | 7 | 31 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT02334748
GET https://conductscience.org/api/trials/v1/NCT02334748/events?page=2