Doxycycline Outcomes in Lupus Erythematosus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01014260
Recruitment Status : Withdrawn (We could not get funding for study.)
First Posted : November 16, 2009
Last Update Posted : March 30, 2012
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Drug: Placebo Drug: Doxycycline Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Doxycycline Outcomes in Lupus Erythematosus: (DOLE)
Study Start Date : September 2010
Estimated Primary Completion Date : March 2011
Estimated Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Michelle Petri, Johns Hopkins University Identifier: NCT01014260     History of Changes
Other Study ID Numbers: NA_00001755
First Posted: November 16, 2009    Key Record Dates
Last Update Posted: March 30, 2012
Last Verified: May 2010

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