Elsevier

The Lancet

Volume 372, Issue 9636, 2–8 August 2008, Pages 348-350
The Lancet

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Are withdrawal trials in paediatric rheumatic disease helpful?

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Cited by (11)

  • Update of evidence- and consensus-based guidelines for the treatment of juvenile idiopathic arthritis (JIA) by the German Society of Pediatric and Juvenile Rheumatic Diseases (GKJR): New perspectives on interdisciplinary care

    2022, Clinical Immunology
    Citation Excerpt :

    Primary outcome parameter is “time to disease flare”. Obvious limitations over other trial designs are: bias towards responders and the risk of carrying over treatment effects into the following placebo phase [27]. The reason for choosing this design lies in ethical considerations in the pediatric context where withholding a potentially effective substance may lead to negative implications for long-term prognosis.

  • Treatment of Juvenile Idiopathic Arthritis in the Biologic Age

    2013, Rheumatic Disease Clinics of North America
    Citation Excerpt :

    The outcome is either the percentage of subjects in both groups who flare over a specific period of time (eg, 24 weeks), or the time to flare. Although this study design avoids long-term exposure to placebo in subjects other than those who maintain a good response to the placebo agent, it is open to criticism on the grounds that the only children who are randomized are those who show an initial response; furthermore, interpretation of the safety data in the control arm is clouded by prior receipt of the study drug.9 Once start of the art, current recommendations give scant emphasis to nonsteroidal anti-inflammatory drug (NSAID) therapy.10

  • Evidence and consensus based GKJR guidelines for the treatment of juvenile idiopathic arthritis

    2012, Clinical Immunology
    Citation Excerpt :

    Third, in 5 of the 13 studies the withdrawal study design has been used [40,45,50,53,54]. Lehmann reviewed the bias of withdrawal design trials in 2008 [72]. After a wash-in phase only responders to treatment are eligible for randomization.

  • Adalimumab in juvenile rheumatoid arthritis [1]

    2008, New England Journal of Medicine
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