Doxycycline Outcomes in Lupus Erythematosus

Withdrawn before enrolling · Phase 4 · Has a placebo group

Conditions studied: Cardiovascular Disease

In brief

Cardiovascular disease, specifically from atherosclerosis, is the major cause of mortality in SLE in developed countries. In a recent study the investigators have shown that high sensitivity C reactive protein (hs-CRP) is higher in SLE patients with (versus without) coronary calcium, a measure of subclinical atherosclerosis. In an ongoing two year intervention trial of atorvastatin, the investigators will determine if statins retard coronary calcium and reduce hs-CRP. However, 10% of the patients in the trial were intolerant of statins. The investigators want to now investigate whether there are additional, and potentially safer ways, to reduce hs-CRP in SLE. In this study, the investigators will determine if doxycycline reduces hs-CRP and other vascular inflammatory markers including interleukin 6 (IL-6), soluble vascular cell adhesion molecule (sVCAM-1), soluble inter cell adhesion molecule (s-ICAM-1) and matrix metalloproteinase 9 (MMP-9) in SLE.

Key facts

Study ID

NCT01014260

Run by

Johns Hopkins University

People needed

0

Starts

2010-09-01

Expected to finish

2011-03-01

Last updated by the study team

2012-03-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with a clinical diagnosis of SLE, with a hs-CRP above > 3mg/L, (high risk level) for the last 3 months, are eligible.
• Patients must be 18 years of age or older and able to give informed consent.
• Contraception other than OCPs is necessary if a woman is at risk for pregnancy.

You may not qualify if…

• SLE patients who are allergic to doxycycline or other tetracyclines.
• Patients who are pregnant or are planning to become pregnant.
• Patients who are on oral contraceptives (any method of contraception other than OCPs can be used.
• Tetracycline use within the previous 2 weeks of enrollment.
• Patients who are currently on statins will be excluded, because statins might reduce hs- CRP.
• Patients who are on warfarin.
• Patients whose most recent EKG shows significant cardiac dysrhythmias or heart block.

Where it is running

• Johns Hopkins University SOM. 1830 East Monument St, Ste 7500 — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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