NCT01101802

Brief Summary

Systemic lupus erythematosus (SLE) is an independent risk factor for atherosclerosis. Endothelial dysfunction is the earliest marker of atherosclerosis and is measured by flow mediated dilation (FMD) of the brachial artery. The purpose of the study was to measure FMD in mild, stable SLE patients and look for change in FMD with the immunosuppressant drug mycophenolate mofetil (MMF).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2006

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 9, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 12, 2010

Completed
Last Updated

September 28, 2011

Status Verified

May 1, 2005

Enrollment Period

2 years

First QC Date

April 9, 2010

Last Update Submit

September 27, 2011

Conditions

Systemic Lupus ErythematosusAtherosclerosis

Keywords

SLEAtherosclerosisEndothelial functionMycophenolate mofetil

Outcome Measures

Primary Outcomes (1)

  • Flow mediated dilation

    Measure of endothelial function using doppler ultrasound to measure brachial artery dilation in response to increase blood flow.

    8 weeks

Secondary Outcomes (1)

  • BILAG, SLEDAI,

    8 weeks

Study Arms (2)

Mycophenolate mofetil

ACTIVE COMPARATOR

Patients were given 1gm bd mycophenolate mofetil for 8 weeks

Drug: Mycophenolate mofetil

Sugar pill

PLACEBO COMPARATOR
Drug: sugar pill

Interventions

Mycophenolate mofetilDRUG

Arm 1 patients were given 1 gm bd mycophenolate mofetil for 8 weeks, The mycophenolate was dispensed as 500mg tablets.

Also known as: Cellcept
Mycophenolate mofetil
sugar pillDRUG

Arm 2 patients were given 2 sugar pills bd for 8 weeks

Sugar pill

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female SLE patients
  • Age 18-60 years
  • If premenopausal using a reliable method of contraception
  • Clinically stable disease
  • Taking hydroxychloroquine and up to 15mgs of prednisolone daily

You may not qualify if:

  • Smokers
  • Pregnancy or breast feeding
  • Use of other immunosuppressants (hydroxychloroquine and stable dose of prednisolone up to 15 mgs daily will be permitted)
  • Use of any investigational drug within 1 month prior to screening
  • Acute infections 2 weeks prior to Visit 1
  • History of ischaemic heart disease or end stage renal disease
  • Current signs or symptoms of severe, progressive or uncontrolled hepatic, haematological, gastroenterological, endocrine, pulmonary, cardiac or neurological disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lupus Research Unit, St Thomas' Hospital

London, SE1 7EH, United Kingdom

Location

MeSH Terms

Conditions

Lupus Erythematosus, SystemicAtherosclerosis

Interventions

Mycophenolic AcidSugars

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

CaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipidsCarbohydrates

Study Officials

  • David P D'Cruz, MD, FRCP

    Guy's and St Thomas' NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 9, 2010

First Posted

April 12, 2010

Study Start

March 1, 2006

Primary Completion

March 1, 2008

Study Completion

October 1, 2008

Last Updated

September 28, 2011

Record last verified: 2005-05

Locations

GB(1)