Doxycycline Outcomes in Lupus Erythematosus: (DOLE) - Full Text View

Sponsor:	Johns Hopkins University
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT01014260

Purpose

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: Doxycycline	Phase IV

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

Resource links provided by NLM:

Drug Information available for: Doxycycline Doxycycline hyclate Doxycycline calcium

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
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
No Intervention: Placebo Doxycycline will be compared against placebo.
Active Comparator: Doxycycline Doxycycline will be compared against placebo.	Drug: Doxycycline 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). Drug: Doxycycline Doxycycline 20 mg bid versus Doxycycline 100 mg bid versus placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.
Patients must be 18 years of age or older and able to give informed consent.
Contraception other than OCPs is necessary if a woman is at risk for pregnancy.

Exclusion Criteria:

SLE patients who are allergic to doxycycline or other tetracyclines.
Patients who are pregnant or are planning to become pregnant.
Patients who are on oral contraceptives (any method of contraception other than OCPs can be used.
Tetracycline use within the previous 2 weeks of enrollment.
Patients who are currently on statins will be excluded, because statins might reduce hs- CRP.
Patients who are on warfarin.
Patients whose most recent EKG shows significant cardiac dysrhythmias or heart block.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01014260

Contacts

Contact: Michelle Petri, M.D.,M.P.H	410-955-3823	mpetri@jhmi.edu
Contact: Adnan N Kiani, M.D.,M.P.H	410-614-1839	akiani2@jhmi.edu

Locations

United States, Maryland
Johns Hopkins University SOM. 1830 East Monument St, Ste 7500	Not yet recruiting
Baltimore, Maryland, United States, 21205
Contact: Michelle Petri, M.D.,M.P.H 410-955-3823 mpetri@jhmi.edu
Contact: Adnan N Kiani, M.D.,M.P.H 410-614-1839 akiani2@jhmi.edu

Sponsors and Collaborators

Johns Hopkins University

Investigators

Principal Investigator:

Michelle Petri, M.D

Johns Hopkins University

More Information

No publications provided

Responsible Party:	Michelle Petri, Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT01014260 History of Changes
Other Study ID Numbers:	NA_00001755
Study First Received:	November 12, 2009
Last Updated:	May 25, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Johns Hopkins University:

Inflammatory markers of cardiovascular disease

Additional relevant MeSH terms:

Cardiovascular Diseases
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Doxycycline
Doxycycline hyclate

Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on February 09, 2012