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Single-dose Study to Assess Efficacy of Canakinumab (ACZ885) in Patients With Active Juvenile Idiopathic Arthritis (SJIA)

NCT00886769 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2017-03-29

Study results available
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Summary

This study assessed the initial efficacy and safety of canakinumab over a 4 week period in patients with systemic juvenile idiopathic arthritis (SJIA) having a flare. Response to treatment will be according to the adapted American College of Rheumatology(ACR)Pediatric 30 criteria at Day 15.

Conditions

  • Systemic Juvenile Idiopathic Arthritis

Interventions

DRUG

Canakinumab

Canakinumab was supplied in individual 6 mL glass vials each containing 150 mg canakinumab powder as a lyophilized cake. Each reconstituted vial provided 150mg of canakinumab per 1 mL.

DRUG

Placebo

Placebo was provided in individual 6 mL glass vials each containing 150 mg placebo powder matching canakinumab as a lyophilized cake. Each reconstitued vial provided 150mg of placebo per 1 mL.

Sponsors & Collaborators

  • International Maternal Pediatric Adolescent AIDS Clinical Trials Group

    collaborator NETWORK

  • Southwest Pediatric Nephrology Study Group

    collaborator OTHER

  • Novartis Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2010-12-31
Completion
2011-01-31

Countries

  • United States
  • Argentina
  • Belgium
  • Brazil
  • Canada
  • Denmark
  • France
  • Germany
  • Greece
  • Hungary
  • Israel
  • Italy
  • Netherlands
  • Norway
  • Peru
  • Poland
  • South Africa
  • Spain
  • Sweden
  • Switzerland
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT00886769 on ClinicalTrials.gov