Date

2015-11-02

Protocol

Protocol changed

Item Changed

Primary outcome(s)

Previous Version

Proportion of patients achieving an SLE Responder Index [a composite score derived from the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), the British Isles Lupus Assessment Group (BILAG) A and B scores and physicians global assessment]

Next Version

Proportion of patients achieving an SLE Responder Index [a composite score derived from the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), the British Isles Lupus Assessment Group (BILAG) A and B scores and physicians global assessment] The primary endpoint variable is modified from SRI-8 to SRI-6