CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 31 enrolled
Drug / intervention
canakinumabdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02334748
NCT02334748Phase 3Completed
CompareCT.gov

A French Open-label Extension Study of Canakinumab in Patients Who Participated in International Phase III Studies CACZ885G2301E1 or CACZ885G2306 in Systemic Juvenile Idiopathic Arthritis and CACZ885N2301 in Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF)

Novartis Pharmaceuticals·interventional·Posted Jan 8, 2015·Updated May 19, 2020

In Brief

A Phase 3 clinical trial evaluating canakinumab for Systemic Juvenile Idiopathic Arthritis and Hereditary Periodic Fevers. Completed, enrolled 31 participants across 3 sites.

Detailed Summary

The objective of this extension protocol is to collect safety data (serious and non-serious adverse events) and to provide continuous canakinumab to patients in France who completed study CACZ885G2301E1(NCT00891046), CACZ885G2306 (NCT02296424) or CACZ885N2301 (NCT02059291) until a decision regarding reimbursement in France is effective for canakinumab (Ilaris®) in these indications.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSystemic Juvenile Idiopathic Arthritis, Hereditary Periodic Fevers
CountriesFrance
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 8, 2015
Enrollment StartNov 3, 2014
Primary CompletionAug 31, 2018
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 11.5 years ago

Interventions

canakinumabdrug

canakinumab