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Doxycycline Outcomes in Lupus Erythematosus

This study has been withdrawn prior to enrollment.
(We could not get funding for study.)
Sponsor:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01014260
First received: November 12, 2009
Last updated: March 29, 2012
Last verified: May 2010
  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: Placebo
Drug: Doxycycline
Phase 4

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:


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 ]

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
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
Doxycycline
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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Maryland
Johns Hopkins University SOM. 1830 East Monument St, Ste 7500
Baltimore, Maryland, United States, 21205
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: March 29, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Cardiovascular Diseases
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014