Clinical Trial: Effective Dose of Etanercept in Patients Treated for Juvenile Idiopathic Arthritis

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Determination of the Effective Individual Dose of Etanercept in Patients Treated for Juvenile Idiopathic Arthritis

Brief Summary: The purpose of this study is to determine the optimal dosage of etanercept in patients treated for idiopathic juvenile arthritis

Detailed Summary: Etanercept, a fully human soluble tumor necrosis factor (TNF) receptor fusion protein, has been demonstrated to be safe and efficacious for the treatment of patients with polyarticular JIA. However, many patients experience primary or secondary response failure, suggesting that individualization of treatment regimens may be beneficial. It has been shown that the clinical response to two anti-TNFalpha biological agents (infliximab, adalimumab) closely follows the trough drug levels and the presence of antibodies directed against the drugs. This study was undertaken to investigate whether serologic monitoring of etanercept bioavailability and immunogenicity in individual patients with JIA would be useful in optimizing treatment regimens to improve efficacy and tolerability
Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: Etanercept concentration-time courses [ Time Frame: one year ]

estimate etanercept population pharmacokinetic parameters and concentration-effect(s) relationship(s) in patients younger than 18 years treated for juvenile idiopathic arthritis (JIA).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Wallace criteria [ Time Frame: one year ]
    Evaluation of a clinical remission of Juvenile Idiopathic Arthritis (JIA). This measures one the different effects that could be related to the etenercept pharmacokinetics
  • anti-etanercept antibodies levels [ Time Frame: one year ]
    To evaluate their influence on plasma etanercept
  • analogical visual scale [ Time Frame: one year ]
    global activity of JIA, evaluated by the investigator. This measures one the different effects that could be related to the etenercept pharmacokinetics
  • arthritis number [ Time Frame: one year ]
    This measures one the different effects that could be related to the etenercept pharmacokinetics
  • number of limited joints [ Time Frame: one year ]
    This measures one the different effects that could be related to the etenercept pharmacokinetics


Original Secondary Outcome: Same as current

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: August 13, 2013
Date Started: September 2013
Date Completion: March 2018
Last Updated: June 30, 2016
Last Verified: June 2016