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A Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab vers...

Mise à jour : Il y a 4 ans
Référence : EUCTR2009-017443-34

A Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapy

Femme et Homme

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Extrait

To assess the: • Efficacy of treatment with TCZ 4 mg/kg and 8 mg/kg versus placebo in AS patients who are naïve to treatment with TNF antagonist therapy with regard to the proportion of patients who achieve an ASAS20 response at week 12 (confirmation at week 24) • Safety of TCZ 4 mg/kg and 8 mg/kg versus placebo with regard to AEs and laboratory assessments

Critère d'inclusion

  • Ankylosing spondylitis

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