Doxycycline Outcomes in Lupus Erythematosus

Phase 4

Withdrawn

• Conditions: Cardiovascular Disease
• Interventions: Drug: Placebo; Drug: Doxycycline

• Registration Number: NCT01014260
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-11-12
• Study First Submitted QC: 2009-11-13
• Study First Posted: 2009-11-16
• Status Verified: 2010-05
• Study Start: 2010-09
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Last Update Submitted: 2012-03-29
• Last Update Posted: 2012-03-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	placebo
Doxycycline	Doxycycline	Doxycycline

Primary Outcome Measures

Name	Time	Method
Determine whether doxycycline 20 mg bid (periostat) versus 100mg bid versus placebo is more effective in reducing hs-CRP.	3 months

Trial Locations

Locations (1)

Johns Hopkins University SOM. 1830 East Monument St, Ste 7500; 🇺🇸 Baltimore, Maryland, United States