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ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line Use of Canakinumab

NCT02296424 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2019-07-09

Study results available
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Summary

The purpose of this study was to evaluate the efficacy observed with canakinumab dose reduction in a subgroup of patients in the extension study CACZ885G2301E1.

Conditions

  • Systemic Juvenile Idiopathic Arthritis (SJIA)

Interventions

DRUG

ACZ885 150 mg (Canakinumab)

Active canakinumab in individual 2 mL glass vials, each containing 150 mg canakinumab liquid in vial.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-17
Primary Completion
2016-10-14
Completion
2017-09-25
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Brazil
  • Canada
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Netherlands
  • Poland
  • Russia
  • Spain
  • Sweden
  • Turkey (Türkiye)

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02296424 on ClinicalTrials.gov