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Doxycycline Outcomes in Lupus Erythematosus

This study has been withdrawn prior to enrollment.
(We could not get funding for study.)
Information provided by:
Johns Hopkins University Identifier:
First received: November 12, 2009
Last updated: March 29, 2012
Last verified: May 2010
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 Intervention Phase
Cardiovascular Disease Drug: Placebo Drug: Doxycycline Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Doxycycline Outcomes in Lupus Erythematosus: (DOLE)

Resource links provided by NLM:

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Determine whether doxycycline 20 mg bid (periostat) versus 100mg bid versus placebo is more effective in reducing hs-CRP. [ Time Frame: 3 months ]

Enrollment: 0
Study Start Date: September 2010
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 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
Drug: Doxycycline
Doxycycline 20 mg bid versus Doxycycline 100 mg bid versus placebo


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   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.
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Please refer to this study by its identifier: NCT01014260

United States, Maryland
Johns Hopkins University SOM. 1830 East Monument St, Ste 7500
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
Principal Investigator: Michelle Petri, M.D Johns Hopkins University
  More Information

Responsible Party: Michelle Petri, Johns Hopkins University Identifier: NCT01014260     History of Changes
Other Study ID Numbers: NA_00001755
Study First Received: November 12, 2009
Last Updated: March 29, 2012

Keywords provided by Johns Hopkins University:
Inflammatory markers of cardiovascular disease

Additional relevant MeSH terms:
Cardiovascular Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents processed this record on August 23, 2017