158
Participants
Start Date
May 31, 2009
Primary Completion Date
December 31, 2012
Study Completion Date
December 31, 2012
Group B SLE one blood donation
Blood drawing, history, physical examination,medical record review, questionnaires, completion of disease activity measures including SLEDAI,BILAG, CLASI,PGA,PROs,LFA investigational systems, BICLA, SRI
Blood drawing only Group C
Blood drawing and Brief medical history to ensure status of healthy control
Group A SLE prospective study
Patients have history and physical exmamination at each visit. Blood is drawn at each visit. At baseline, any background immune suppressant is stopped and patients given depomedrol up to 160 mg IM which can be repeated up to four times in the first two weeks. Patients are seen again at week 2, 4 and monthly until the final flare visit at which time they donate blood, receive appropriate treatments and exit study. Patients may elect to continue in study for up to one year. The following disease activity measures are included: SLEDAI, BILAG, CLASI, PGA, PROs (including lupus PRO and SF-36 ant ptGA), joint counts, exploratory outcome measures,BICLA,SRI
Pfizer Inc, Collegeville
Oklahoma Medical Research Foundation, Oklahoma City
Collaborators (1)
Pfizer
INDUSTRY
Oklahoma Medical Research Foundation
OTHER