Official Title: “Doxycycline Outcomes in Lupus Erythematosus: (DOLE)”

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.

Study Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment

Study Primary Completion Date: December 2010

Intervention(s) in this Clinical Trial

• Drug: Doxycycline
  • This is a randomized double-blind clinical trial of doxycycline 20 mg bid versus 100mg bid versus placebo, given for 3 months, to be conducted at a single center (JHH).
• Drug: Doxycycline
  • Doxycycline 20 mg bid versus Doxycycline 100 mg bid versus placebo

Arms, Groups and Cohorts in this Clinical Trial

• No Intervention: Placebo
  • Doxycycline will be compared against placebo.
• Active Comparator: Doxycycline
  • Doxycycline will be compared against placebo.

Primary Measures

• Determine whether doxycycline 20 mg bid (periostat) versus 100mg bid versus placebo is more effective in reducing hs-CRP.
  • Time Frame: 3 months
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Johns Hopkins University

Overall Clinical Trial Officials and Contacts

Overall Contact: Michelle Petri, M.D.,M.P.H 410-955-3823 mpetri@jhmi.edu

Information obtained from ClinicalTrials.gov on February 04, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01014260

Study ID Number: NA_00001755

ClinicalTrials.gov Identifier: NCT01014260

Health Authority: United States: Institutional Review Board