Systemic Juvenile Idiopathic Arthritis

• FDA approval · 2024-03-05
  FDA Approved: TYENNE — Original Application (Fresenius Kabi USA, LLC)

  FDA approved TYENNE (tocilizumab-AAZG) from Fresenius Kabi USA, LLC under an Original Application.

• CLINICAL_TRIALS trial_result · 2024-01-30
  Clinical Trial Update: A Study of Tocilizumab in Chinese Participants With Systemic Juvenile Idiopathic Arthritis (sJIA) [Phase 4]

  A Phase 4 clinical trial update evaluating tocilizumab in Chinese participants with systemic juvenile idiopathic arthritis has completed.

• FDA approval · 2021-10-22
  FDA Approved: ACTEMRA — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for Actemra (tocilizumab) from Genentech, expanding its labeling and/or indications. The action conf…

• CLINICAL_TRIALS trial_result · 2021-05-04
  Clinical Trial Update: Open Label, Multicentre Trial to Assess Safety and Efficacy of ITF2357 in Active Systemic Juvenile Idiopathic Arthritis [Phase 2]

  Phase 2 open-label multicenter trial assessing safety and efficacy of ITF2357 in active systemic juvenile idiopathic arthritis has completed…

• CLINICAL_TRIALS trial_result · 2020-05-19
  Clinical Trial Update: 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]

  Phase 3 trial update for canakinumab in systemic juvenile idiopathic arthritis and hereditary periodic fevers; results completed with postin…

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• CLINICAL_TRIALS trial_result · 2020-04-24
  Clinical Trial Update: A Study of Decreased Dose Frequency in Participants With Systemic Juvenile Arthritis Who Experience Laboratory Abnormalities During Treatment With RoActemra/Actemra (Tocilizumab) [Phase 4]

  Phase 4 study evaluating reduced dosing frequency of tocilizumab (RoActemra/Actemra) in pediatric patients with systemic juvenile idiopathic…

• CLINICAL_TRIALS trial_result · 2019-09-25
  Clinical Trial Update: Safety and Efficacy Study of Etanercept (Enbrel®) In Children With Systemic Onset Juvenile Rheumatoid Arthritis [Phase 3]

  Phase 3 trial of etanercept (Enbrel) in children with systemic onset juvenile rheumatoid arthritis was terminated; results posted in 2019.

• CLINICAL_TRIALS trial_result · 2019-09-13
  Clinical Trial Update: Study of Efficacy and Safety of Canakinumab in Japanese Patients With SJIA [Phase 3]

  Phase 3 trial update on canakinumab for systemic juvenile idiopathic arthritis in Japanese patients; results posted after completion.

• CLINICAL_TRIALS trial_result · 2019-07-09
  Clinical Trial Update: ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line Use of Canakinumab [Phase 3]

  Phase 3 trial update for canakinumab in first-line use for systemic juvenile idiopathic arthritis (SJIA) has completed with results posted.

• FDA approval · 2019-06-11
  FDA Approved: ACTEMRA — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for Actemra (tocilizumab) filed by Genentech, Inc., resulting in an approved update to the product's…

• CLINICAL_TRIALS trial_result · 2017-11-20
  Clinical Trial Update: A Study of Subcutaneously Administered Tocilizumab in Participants With Systemic Juvenile Idiopathic Arthritis [Phase 1]

  This is a Phase 1 trial of subcutaneously administered tocilizumab for systemic juvenile idiopathic arthritis; the study has completed.

• FDA approval · 2017-05-22
  FDA Approved: ACTEMRA — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for ACTEMRA (tocilizumab) submitted by Genentech, Inc. The supplementary filing status is AP (approv…

• CLINICAL_TRIALS trial_result · 2017-05-15
  Clinical Trial Update: Single Patient Use of Tocilizumab in Systemic Onset Juvenile Idiopathic Arthritis [NA]

  One-patient trial update describes the use of tocilizumab in systemic juvenile idiopathic arthritis. The trial was terminated and results we…

• CLINICAL_TRIALS trial_result · 2017-03-10
  Clinical Trial Update: 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]

  Phase 3 trial update for canakinumab in systemic juvenile idiopathic arthritis, including an open-label extension and treatment-naïve cohort…

• FDA approval · 2016-09-23
  FDA Approved: ILARIS — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for ILARIS (canakinumab) submitted by Novartis Pharmaceuticals Corporation, resulting in an upda…

• CLINICAL_TRIALS trial_result · 2015-12-11
  Clinical Trial Update: Safety and Effectiveness of Rilonacept for Treating Systemic Juvenile Idiopathic Arthritis in Children and Young Adults [Phase 2]

  Phase 2 trial evaluating the safety and effectiveness of Rilonacept for systemic juvenile idiopathic arthritis in children and young adults;…

• CLINICAL_TRIALS withdrawal · 2015-10-15
  Clinical Trial Update: An Open-label, Multi-arm, Non-comparative Safety and Tolerability Study of Canakinumab (ACZ885) in Patients With Active Systemic Juvenile Idiopathic Arthritis (SJIA) [Phase 3]

  The Phase 3 open-label safety and tolerability study of canakinumab in active systemic Juvenile Idiopathic Arthritis has been withdrawn.

• FDA approval · 2014-11-13
  FDA Approved: ACTEMRA — Supplemental Application (Genentech, Inc.)

  The FDA approved a supplemental application for ACTEMRA (tocilizumab) submitted by Genentech, Inc. This action involves an approved product …

• CLINICAL_TRIALS trial_result · 2013-03-04
  Clinical Trial Update: Study to Evaluate the Safety and Tolerability of Two Doses of Rilonacept in Pediatric Subjects With Active Systemic Juvenile Idiopathic Arthritis (SJIA) [Phase 1]

  A Phase 1 study evaluating the safety and tolerability of two doses of rilonacept in pediatric patients with active systemic juvenile idiopa…

• CLINICAL_TRIALS trial_result · 2012-10-16
  Clinical Trial Update: Flare Prevention Study of Canakinumab in Patients With Active Systemic Juvenile Idiopathic Arthritis (SJIA) [Phase 3]

  This update reports the results of a Phase 3 study evaluating canakinumab for preventing flares in patients with active systemic juvenile id…

• FDA approval · 2012-08-13
  FDA Approved: ACTEMRA — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for Actemra (tocilizumab) submitted by Genentech, broadening its labeling.

• CLINICAL_TRIALS trial_result · 2012-04-09
  Clinical Trial Update: Single-dose Study to Assess Efficacy of Canakinumab (ACZ885) in Patients With Active Juvenile Idiopathic Arthritis (SJIA) [Phase 3]

  A Phase 3 single-dose trial of canakinumab in active systemic juvenile idiopathic arthritis was terminated, with results posted in 2012.

• CLINICAL_TRIALS research · 2012-03-22
  Clinical Trial Update: Ultrasonography in Juvenile Idiopathic Arthritis

  A completed clinical trial update examining the use of ultrasonography in juvenile idiopathic arthritis.

• CLINICAL_TRIALS trial_result · 2011-10-26
  Clinical Trial Update: A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Systemic Juvenile Idiopathic Arthritis (JIA) [Phase 3]

  Phase 3 study of tocilizumab (RoActemra/Actemra) in active systemic juvenile idiopathic arthritis has completed and posted results.

• CLINICAL_TRIALS trial_result · 2011-08-09
  Clinical Trial Update: Safety, Efficacy and Pharmacokinetics of Subcutaneous ACZ885 in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) [Phase 1, Phase 2]

  This completed Phase 1/2 study assessed the safety, efficacy and pharmacokinetics of subcutaneous ACZ885 (canakinumab) in patients with syst…