Phase 3
N=4
An Extention Study of Safety of Canakinumab in Japanese Patients With Periodic Fever Syndromes
Periodic Fevers Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT02911857 ↗Enrolled (actual)
4
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcome: Primary: Number of Participants With Non-serious Adverse Events, Serious Adverse Events and Deaths — 1; 1; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Canakinumab (AIN457) (Biological)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Non-serious Adverse Events, Serious Adverse Events and Deaths |
1; 1; 0; 0; 0; 0 | — |
Summary
The primary objective of this study was to evaluate safety and tolerability of ACZ885 in this extension study. This extension study offered the opportunity for participants who completed Epoch 4 of the preceding CACZ885N2301 (NCT02059291) study to continue to be treated with ACZ885 until approval in Japan of the drug in Periodic Fever Syndromes or until development of ACZ885 in Periodic Fever Syndromes was suspended.
Eligibility Criteria
Inclusion Criteria
- Completed Epoch 4 of the CACZ885N2301 study in Japan before the approval of canakinumab in Japan
- Written informed consent. Parent or legal guardian's written informed consent and child's assent, if appropriate, are required before any assessment is performed for patients < 20 years of age
Exclusion Criteria
- Any conditions or significant medical problems in which the investigator judges the patient should not enter this extension study
Data sourced from ClinicalTrials.gov (NCT02911857). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.