Doxycycline Outcomes in Lupus Erythematosus

NCT01014260 | Withdrawn Phase 4 DMC

• 1 other identifier: NA_00001755
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease

Keywords

Inflammatory markers of cardiovascular disease

Outcome Measures

Primary Outcomes (1)

• Determine whether doxycycline 20 mg bid (periostat) versus 100mg bid versus placebo is more effective in reducing hs-CRP.

  3 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

placebo

Drug: Placebo

Doxycycline

ACTIVE COMPARATOR

Doxycycline

Drug: Doxycycline

Interventions

Placebo DRUG

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).

Placebo

Doxycycline DRUG

Doxycycline 20 mg bid versus Doxycycline 100 mg bid versus placebo

Doxycycline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University SOM. 1830 East Monument St, Ste 7500

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Doxycycline

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Michelle Petri, M.D

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 12, 2009
• First Posted: November 16, 2009
• Study Start: September 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: March 30, 2012

Record last verified: 2010-05

Locations

US (1)