Biomarkers of Lupus Disease: Serial Biomarker Sampling in Patients With Active Systemic Lupus Erythematosus (SLE)

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

158

Participants

Timeline

Start Date

May 31, 2009

Primary Completion Date

December 31, 2012

Study Completion Date

December 31, 2012

Conditions
Systemic Lupus Erythematosus
Interventions
OTHER

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

OTHER

Blood drawing only Group C

Blood drawing and Brief medical history to ensure status of healthy control

DRUG

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

Trial Locations (2)

19426

Pfizer Inc, Collegeville

73104

Oklahoma Medical Research Foundation, Oklahoma City

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

lead

Oklahoma Medical Research Foundation

OTHER

NCT00987831 - Biomarkers of Lupus Disease: Serial Biomarker Sampling in Patients With Active Systemic Lupus Erythematosus (SLE) | Biotech Hunter | Biotech Hunter