Clinical Trials Logo

Clinical Trial Summary

This two-part open-label, multi-arm, non-comparative study will collect long-term safety, efficacy and tolerability data from patients who were responsive to canakinumab from study CACZ885G2301E1 (Cohort 1), and from patients who are treatment naïve to canakinumab (Cohort 2). In addition, the effect of inactivated vaccines in an SJIA patient population will be assessed for the development of adequate (protective) antibody levels following immunization according to respective local vaccination guidelines.

Study Part I:

All patients will be treated with canakinumab 4 mg/kg every 4 weeks (or 2 mg/kg every 4 weeks for Cohort 1 patients who are receiving that dose in CACZ885G2301E1) until study end unless discontinuation occurs, or until they qualify for Part II of the study.

Study Part II:

Patients who are eligible will be randomized to receive canakinumab at a reduced dose or prolonged dose interval (see requirements for dose reduction/dose interval prolongation below).

Patients in Cohort 1 receiving 2 mg/kg q4wk in CACZ885G2301E1 will not be randomized but will be part of the treatment arm canakinumab dose reduction if they are eligible.


Clinical Trial Description

n/a


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01676948
Study type Interventional
Source Novartis
Contact
Status Withdrawn
Phase Phase 3
Start date January 2013
Completion date January 2015

See also
  Status Clinical Trial Phase
Completed NCT00891046 - An Open-label Extension Study of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis and Active Systemic Manifestations Manifestations and Response Characterization Study in Canakinumab Treatment-naïve Patients With Active SJIA With and Without Fever. Phase 3
Completed NCT01304420 - Ultrasonography in Juvenile Idiopathic Arthritis Phase 0
Completed 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 Phase 3
Completed NCT01803321 - Study to Evaluate the Safety and Tolerability of Two Doses of Rilonacept in Pediatric Subjects With Active Systemic Juvenile Idiopathic Arthritis (SJIA) Phase 1
Completed NCT00144664 - Study of MRA for Polyarticular Juvenile Idiopathic Arthritis (pJIA) Phase 3
Completed NCT02396212 - Study of Efficacy and Safety of Canakinumab in Japanese Patients With SJIA Phase 3
Completed NCT00144599 - Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA) Phase 3
Terminated NCT00886769 - Single-dose Study to Assess Efficacy of Canakinumab (ACZ885) in Patients With Active Juvenile Idiopathic Arthritis (SJIA) Phase 3
Completed NCT00144612 - Long-term Treatment Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA) Phase 3
Recruiting NCT04088396 - A Study of Baricitinib (LY3009104) in Participants From 1 Year to Less Than 18 Years Old With sJIA Phase 3
Recruiting NCT05027373 - Safety, Tolerability and Pharmacokinetic of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection Phase 1