Doxycycline Outcomes in Lupus Erythematosus

Johns Hopkins University

Status and phase: Withdrawn; Phase 4

Conditions: Cardiovascular Disease

Treatments: Drug: Doxycycline; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01014260

NA_00001755

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

placebo

Treatment:

Drug: Placebo

Doxycycline

Active Comparator group

Description:

Doxycycline

Treatment:

Drug: Doxycycline