The purpose of this study is to determine the ability of XmAb5871 to maintain Systemic Lupus Erythematosus (SLE) disease activity improvement achieved by a brief course of disease-suppressing steroid therapy
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
105
UC San Diego
La Jolla, California, United States
Percentage of Patients Without Loss of Systemic Lupus Erythematosus Disease Activity Improvement on Day 225
Landmark proportion of patients without loss of systemic lupus erythematosus disease activity improvement on Day 225
Time frame: Day 225
Percentage of Patients Without Loss of Systemic Lupus Erythematosus Disease Activity Improvement on Day 169
Landmark proportion of patients without loss of systemic lupus erythematosus disease activity improvement on Day 169
Time frame: Day 169
Time to Loss of Systemic Lupus Erythematosus Disease Activity Improvement Achieved by a Short Period of IM Steroid Therapy in SLE Patients
Loss of improvement was defined as worsening of disease activity that in the opinion of the principal investigator requires a change in treatment (exclusive of a decrease in oral steroids) AND one of: 1. SELENA- SLEDAI increase of \>=4 points from maximal improvement OR 2. Worsening of at least 1 BILAG A or B score OR 3. New BILAG A or B score.
Time frame: From the date of randomization until the date of loss of Systemic Lupus Erythematosus Disease Activity Improvement, or the date of the final efficacy assessment, up to 239 days.
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