Trial Outcomes & Findings for An Extention Study of Safety of Canakinumab in Japanese Patients With Periodic Fever Syndromes (NCT NCT02911857)
NCT ID: NCT02911857
Last Updated: 2018-08-20
Results Overview
Participants were monitored for safety throughout the study.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
4 participants
Primary outcome timeframe
Participants were followed for the duration until approval, an expected average of 3 months.
Results posted on
2018-08-20
Participant Flow
Participants with Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS), Hyper Immunoglobulin D Syndrome (also known as mevalonate kinase deficiency (HIDS/MKD), or colchicine resistant/intolerant Familial Mediterranean Fever (crFMF) received study drug based on the final dose regimen received in CACZ885N2301 (NCT02059291).
Participant milestones
| Measure |
TRAPS
Participants continued the study drug based on the final dose and regimen administered at the end of the CACZ885N2301 study. All participants received 1 or 2 ACZ885 subcutaneous injections every 4 or 8 weeks.
|
HIDS/MKD
Participants continued the study drug based on the final dose and regimen administered at the end of the CACZ885N2301 study. All participants received 1 or 2 ACZ885 subcutaneous injections every 4 or 8 weeks.
|
cfFMF
Participants continued the study drug based on the final dose and regimen administered at the end of the CACZ885N2301 study. All participants received 1 or 2 ACZ885 subcutaneous injections every 4 or 8 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
1
|
|
Overall Study
COMPLETED
|
2
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Extention Study of Safety of Canakinumab in Japanese Patients With Periodic Fever Syndromes
Baseline characteristics by cohort
| Measure |
TRAPS
n=2 Participants
Participants continued the study drug based on the final dose and regimen administered at the end of the CACZ885N2301 study. All participants received 1 or 2 ACZ885 subcutaneous injections every 4 or 8 weeks.
|
HIDS/MKD
n=1 Participants
Participants continued the study drug based on the final dose and regimen administered at the end of the CACZ885N2301 study. All participants received 1 or 2 ACZ885 subcutaneous injections every 4 or 8 weeks.
|
cfFMF
n=1 Participants
Participants continued the study drug based on the final dose and regimen administered at the end of the CACZ885N2301 study. All participants received 1 or 2 ACZ885 subcutaneous injections every 4 or 8 weeks.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
20.0 Years
STANDARD_DEVIATION 2.83 • n=5 Participants
|
14 Years
STANDARD_DEVIATION NA • n=7 Participants
|
20 Years
STANDARD_DEVIATION NA • n=5 Participants
|
18.5 Years
STANDARD_DEVIATION 3.42 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Participants were followed for the duration until approval, an expected average of 3 months.Population: Safety set: The safety set included all participants who were treated in this extension study.
Participants were monitored for safety throughout the study.
Outcome measures
| Measure |
TRAPS
n=2 Participants
Participants continued the study drug based on the final dose and regimen administered at the end of the CACZ885N2301 study. All participants received 1 or 2 ACZ885 subcutaneous injections every 4 or 8 weeks.
|
HIDS/MKD
n=1 Participants
Participants continued the study drug based on the final dose and regimen administered at the end of the CACZ885N2301 study. All participants received 1 or 2 ACZ885 subcutaneous injections every 4 or 8 weeks.
|
cfFMF
n=1 Participants
Participants continued the study drug based on the final dose and regimen administered at the end of the CACZ885N2301 study. All participants received 1 or 2 ACZ885 subcutaneous injections every 4 or 8 weeks.
|
|---|---|---|---|
|
Number of Participants With Non-serious Adverse Events, Serious Adverse Events and Deaths
Serious adverse events
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Non-serious Adverse Events, Serious Adverse Events and Deaths
Non-serious adverse events
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Non-serious Adverse Events, Serious Adverse Events and Deaths
Deaths
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
TRAPS
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
HIDS
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
cfFMF
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TRAPS
n=2 participants at risk
TRAPS
|
HIDS
n=1 participants at risk
HIDS
|
cfFMF
n=1 participants at risk
Participants continued the study drug based on the final dose and regimen administered at the end of the CACZ885N2301 study. All participants received 1 or 2 ACZ885 subcutaneous injections every 4 or 8 weeks.
|
|---|---|---|---|
|
Infections and infestations
NASOPHARYNGITIS
|
50.0%
1/2 • 3 months
|
100.0%
1/1 • 3 months
|
0.00%
0/1 • 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER