Doxycycline Outcomes in Lupus Erythematosus

Cardiovascular Disease Clinical Trial

Official title:

Doxycycline Outcomes in Lupus Erythematosus: (DOLE)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01014260
• Other study ID #: NA_00001755
• Status: Withdrawn
• Phase: Phase 4
• First received: November 12, 2009
• Last updated: March 29, 2012
• Start date: September 2010
• Est. completion date: March 2011

Study information

• Verified date: May 2010
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

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).
• Doxycycline
Doxycycline 20 mg bid versus Doxycycline 100 mg bid versus placebo

Locations

Country	Name	City	State
United States	Johns Hopkins University SOM. 1830 East Monument St, Ste 7500	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine whether doxycycline 20 mg bid (periostat) versus 100mg bid versus placebo is more effective in reducing hs-CRP.		3 months	No