Doxycycline Outcomes in Lupus Erythematosus
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo placebo |
Drug: Placebo
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).
|
| Active Comparator: Doxycycline Doxycycline |
Drug: Doxycycline
Doxycycline 20 mg bid versus Doxycycline 100 mg bid versus placebo
|
Outcome Measures
Primary Outcome Measures
- Determine whether doxycycline 20 mg bid (periostat) versus 100mg bid versus placebo is more effective in reducing hs-CRP. [3 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients with a clinical diagnosis of SLE, with a hs-CRP above > 3mg/L, (high risk level) for the last 3 months, are eligible.
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Patients must be 18 years of age or older and able to give informed consent.
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Contraception other than OCPs is necessary if a woman is at risk for pregnancy.
Exclusion Criteria:
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SLE patients who are allergic to doxycycline or other tetracyclines.
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Patients who are pregnant or are planning to become pregnant.
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Patients who are on oral contraceptives (any method of contraception other than OCPs can be used.
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Tetracycline use within the previous 2 weeks of enrollment.
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Patients who are currently on statins will be excluded, because statins might reduce hs- CRP.
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Patients who are on warfarin.
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Patients whose most recent EKG shows significant cardiac dysrhythmias or heart block.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Johns Hopkins University SOM. 1830 East Monument St, Ste 7500 | Baltimore | Maryland | United States | 21205 |
Sponsors and Collaborators
- Johns Hopkins University
Investigators
- Principal Investigator: Michelle Petri, M.D, Johns Hopkins University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NA_00001755