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A Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-Weekly Administration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Mo...

Mise à jour : Il y a 4 ans
Référence : EUCTR2007-000896-41

A Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-Weekly Administration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and methotrexate

Femme et Homme

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Extrait

To compare the efficacy of the combination of etanercept 50 mg once weekly plus MTX with that of MTX monotherapy at week 88 in subjects with moderate RA who have achieved low disease activity or remission after 36-week treatment with open-label etanercept 50 mg once weekly plus MTX. The conditional primary objective will be to compare the efficacy of the combination of etanercept 25 mg once weekly plus MTX with that of MTX monotherapy at week 88 in subjects with moderate RA who have achieved low disease activity or remission after 36-week treatment with open-label etanercept 50 mg once weekly plus MTX. The study hypothesis is that the combination of etanercept 50 mg once weekly plus MTX will be superior to MTX monotherapy, as determined by the proportion of subjects remaining in low disease activity or remission at week 88. The conditional hypothesis is that the combination of etanercept 25 mg once weekly plus MTX will be superior to MTX monotherapy.

Critère d'inclusion

  • Rheumatoid Arthritis

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