Trial · NCT02911857
An Extention Study of Safety of Canakinumab in Japanese Patients With Periodic Fever Syndromes
NCT02911857, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2018-08-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Extention Study of Safety of Canakinumab in Japanese Patients With Periodic Fever Syndromes. Trials, record NCT02911857. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02911857
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Extention Study of Safety of Canakinumab in Japanese Patients With Periodic Fever Syndromes
- NCT number
- NCT02911857
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 4 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Periodic Fevers Syndrome
- Interventions
- Canakinumab (AIN457)
- First posted
- 2016-09-22
- Last updated
- 2018-08-20
- Results first posted
- 2018-08-20
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Non-serious Adverse Events, Serious Adverse Events and Deaths | Participants were followed for the duration until approval, an expected average of 3 months. | Participants were monitored for safety throughout the study. |
Source ClinicalTrials.gov
Outcomes1
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 Non-serious Adverse Events, Serious Adverse Events and Deaths | Participants were followed for the duration until approval, an expected average of 3 months. | Safety set: The safety set included all participants who were treated in this extension study. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group9
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 Non-serious Adverse Events, Serious Adverse Events and Deaths | TRAPS | Non-serious adverse events | 1 | Participants | |
| Number of Participants With Non-serious Adverse Events, Serious Adverse Events and Deaths | HIDS/MKD | Non-serious adverse events | 1 | Participants | |
| Number of Participants With Non-serious Adverse Events, Serious Adverse Events and Deaths | cfFMF | Non-serious adverse events | 0 | Participants | |
| Number of Participants With Non-serious Adverse Events, Serious Adverse Events and Deaths | TRAPS | Serious adverse events | 0 | Participants | |
| Number of Participants With Non-serious Adverse Events, Serious Adverse Events and Deaths | HIDS/MKD | Serious adverse events | 0 | Participants | |
| Number of Participants With Non-serious Adverse Events, Serious Adverse Events and Deaths | cfFMF | Serious adverse events | 0 | Participants | |
| Number of Participants With Non-serious Adverse Events, Serious Adverse Events and Deaths | TRAPS | Deaths | 0 | Participants | |
| Number of Participants With Non-serious Adverse Events, Serious Adverse Events and Deaths | HIDS/MKD | Deaths | 0 | Participants | |
| Number of Participants With Non-serious Adverse Events, Serious Adverse Events and Deaths | cfFMF | Deaths | 0 | Participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TRAPS | 2 | |
| Overall Study | STARTED | HIDS/MKD | 1 | |
| Overall Study | STARTED | cfFMF | 1 | |
| Overall Study | COMPLETED | TRAPS | 2 | |
| Overall Study | COMPLETED | HIDS/MKD | 1 | |
| Overall Study | COMPLETED | cfFMF | 1 | |
| Overall Study | NOT COMPLETED | TRAPS | 0 | |
| Overall Study | NOT COMPLETED | HIDS/MKD | 0 | |
| Overall Study | NOT COMPLETED | cfFMF | 0 |
Source ClinicalTrials.gov
Adverse events3
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 | TRAPS | 1 | 2 | |
| other | NASOPHARYNGITIS | Infections and infestations | HIDS | 1 | 1 | |
| other | NASOPHARYNGITIS | Infections and infestations | cfFMF | 0 | 1 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TRAPS | 0 | 2 |
| Total, all-cause mortality | HIDS | 0 | 1 |
| Total, all-cause mortality | cfFMF | 0 | 1 |
| Total, other adverse events | TRAPS | 1 | 2 |
| Total, other adverse events | HIDS | 1 | 1 |
| Total, other adverse events | cfFMF | 0 | 1 |
| Total, serious adverse events | TRAPS | 0 | 2 |
| Total, serious adverse events | HIDS | 0 | 1 |
| Total, serious adverse events | cfFMF | 0 | 1 |
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/NCT02911857
GET https://conductscience.org/api/trials/v1/NCT02911857/registered