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

Completed · Phase 1/Phase 2

Conditions studied: Systemic Lupus Erythematosus

In brief

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patients entered the trial in mild-moderate flare, were treated with depomedrol, and any background immune suppressants withdrawn.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entry on various medications can be compared to biomarkers after steroid efficacy with background immune suppressants withdrawn.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).

Key facts

Study ID

NCT00987831

Run by

Oklahoma Medical Research Foundation

People needed

158

Starts

2009-05-01

Expected to finish

2012-12-01

Last updated by the study team

2014-10-20

Who can join

Age: 14 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• Safety or circumstantial reasons why volunteer cannot comply with the protocol.

Where it is running

• Oklahoma Medical Research Foundation — Oklahoma City, Oklahoma, United States
• Pfizer Inc — Collegeville, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.