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A 26 week randomised, double blind, placebo controlled exploratory study of sulfasalazine in juvenile onset spondyloarthropathies
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  1. R Burgos-Vargas1,
  2. J Vázquez-Mellado2,
  3. C Pacheco-Tena2,
  4. A Hernández-Garduño3,
  5. M V Goycochea-Robles2
  1. 1Research Division, Hospital General de Mexico
  2. 2Rheumatology Service, Hospital General de Mexico
  3. 3Department of Clinical Research, Hospital General de Mexico
  1. Correspondence to:
    Professor R Burgos-Vargas, Dirección de Investigación, Hospital General de Mexico, Dr Balmis 148, México DF 06726;
    burgosv{at}attglobal.net

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Juvenile onset spondyloarthropathies (SpA) comprise a group of conditions, characterised by recurrent episodes of arthritis and enthesitis that may lead to structural changes and functional impairment.1 Except for mild to moderate cases, the efficacy of non-steroidal anti-inflammatory drugs (NSAIDs) appears limited and glucocorticoids may induce severe adverse events. According to open trials,2–6 sulfasalazine (SSZ) appears to be a good alternative for treating juvenile onset SpA. Consequently, we conducted a phase III, exploratory, 26 week prospective, randomised, double blind, placebo controlled trial of SSZ in active juvenile SpA.

PATIENTS AND METHODS

Patients with the seronegative enthesopathy and arthropathy syndrome (SEA)7 or ankylosing spondylitis (AS)8 (onset age 16 years; current age 20 years) fulfilling the three following criteria despite stable NSAID treatment in the previous four weeks were enrolled in the trial: (a) ≥4 active joints; (b) ≥3 tender entheses; and (c) erythrocyte sedimentation rate …

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