Biomarkers of Lupus Disease: Serial Biomarker Sampling in Patients With Active Systemic Lupus Erythematosus (SLE)
Status:
Completed
Trial end date:
2012-12-01
Target enrollment:
Participant gender:
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 immune homeostasis of the background medications that must be continued,
in most study designs, in these flare-prone patients.
Purpose of Study: This study was designed to purposefully study a population equivalent to
the placebo group of typical trials in SLE. In Group A patients entered the trial in
mild-moderate flare, were treated with depomedrol, and any background immune suppressants
withdrawn. Biomarkers at entry on various medications can be compared to biomarkers after
steroid efficacy with background immune suppressants withdrawn. Depomedrol usually wears off
over one to three months. Patients were closely observed, with serial biomarkers drawn at
monthly intervals or immediately at the time of a new flare. Those patients developing new
flares donated blood samples, were immediately treated as deemed appropriate, exiting the
study. Group A was designed for up to 50 patients and recruited a total of 41. An additional
group of 62 SLE patients donated blood once without additional interventions in order to
increase the power of exploratory cross-sectional biomarker analysis on different immune
suppressants (Group B). A control population of matched, healthy individuals donated blood
twice for the same biomarker studies to validate these assays (Group C).