Status:
COMPLETED
Biomarkers of Lupus Disease: Serial Biomarker Sampling in Patients With Active Systemic Lupus Erythematosus (SLE)
Lead Sponsor:
Oklahoma Medical Research Foundation
Collaborating Sponsors:
Pfizer
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
14-70 years
Phase:
PHASE1
PHASE2
Brief Summary
Hypothesis: A reason for repeated disappointing outcomes of clinical trials testing targeted immune biologics for lupus may be the heterogeneity of the disease, exacerbated by the variable effects on ...
Detailed Description
Original Protocol for Group A: Patients with at least a SLEDAI score of 6 or a BILAG score of B in at least two organ systems or A in at least one organ system were immediately entered into this study...
Eligibility Criteria
Inclusion
- SLE Groups (Group A and B):
- ACR criteria for SLE.
- At least two organ systems moderately active to a minimum of BILAG B or SLEDAI score of 6.
- Control group (Group C):
- Age, ethnicity and gender matched (2:1) with an SLE study participant.
- Free of active or major chronic disease as determined by brief history.
Exclusion
- 1\. Safety or circumstantial reasons why volunteer cannot comply with the protocol.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT00987831
Start Date
May 1 2009
End Date
December 1 2012
Last Update
October 20 2014
Active Locations (2)
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1
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States, 73104
2
Pfizer Inc
Collegeville, Pennsylvania, United States, 19426