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A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept vs. Placebo on a Background of Oral Glucocorticosteroids in the Treatment...

Update Il y a 5 ans
Reference: EUCTR2004-004051-19

A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept vs. Placebo on a Background of Oral Glucocorticosteroids in the Treatment of Subjects with Systemic Lupus Erythematosus and the Prevention of Subsequent Lupus Flares. Revised Protocol Number 02: Incorporates Amendments 2 & 3 - Protocol Amendment 1 - Site Specific

Woman and Man

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Extract

The primary objective for this study will be to assess the proportion of subjects with a new clinical flare of SLE (BILAG “A” or “B”) during the 1 year double-blind treatment period, comparing abatacept with placebo on a background of tapering glucocorticosteroids.

Inclusion criteria

  • Systemic lupus erythematosus NOS

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