NCT00356473

Brief Summary

This research evaluates the effects of a cholesterol-lowering medication, atorvastatin, on both arthritis activity and the ability of high-density lipoprotein cholesterol (HDL-C, sometimes referred to as "good cholesterol") to prevent changes in low-density lipoprotein cholesterol (LDL-C, sometimes referred to as "bad cholesterol"), which lead to atherosclerosis, or "hardening of the arteries." We hypothesize that atorvastatin may improve both joint inflammation and the anti-inflammatory properties of HDL cholesterol.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_4 rheumatoid-arthritis

Timeline
Completed

Started Mar 2003

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, 2003

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 26, 2006

Completed
Last Updated

June 22, 2012

Status Verified

June 1, 2006

Enrollment Period

2.5 years

First QC Date

July 25, 2006

Last Update Submit

June 21, 2012

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritisAtherosclerosisHigh density lipoprotein (HDL) cholesterolStatinsHDL anti-inflammatory propertiesAtorvastatin

Outcome Measures

Primary Outcomes (2)

  • HDL anti-inflammatory properties at 0 and 12 weeks

    at 0 and 12 weeks

  • Highly sensitive C-reactive protein (hs-CRP) at 0 and 12 weeks

    at 0 and 12 weeks

Secondary Outcomes (7)

  • Disease activity score using a 28 joint count (DAS28) at 0,3,6,12, and 18 weeks

    at 0,3,6,12, and 18 weeks

  • Patient and physician global assessments on visual analogue pain scale (VAS; 0-100) at 0,3,6,12, and 18 weeks

    at 0,3,6,12, and 18 weeks

  • Swollen and tender joint counts at 0,3,6,12,and 18 weeks

    at 0,3,6,12, and 18 weeks

  • Patient pain assessment on VAS (0-100)at 0,3,6,12, and 18 weeks

    at 0,3,6,12, and 18 weeks

  • Erythrocyte sedimentation rate(Westergren) at 0,3,6,12, and 18 weeks

    at 0,3,6,12, and 18 weeks

  • +2 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Atorvastatin

Atorvastatin

EXPERIMENTAL

Atorvastatin

Drug: Atorvastatin

Interventions

AtorvastatinDRUG
AtorvastatinPlacebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fulfill American College of Rheumatology (ACR) criteria for RA
  • At least 18 years of age
  • Have RA for at least one year with ongoing active disease (active disease defined as at least two of three: 1) ≥ six tender joints; 2) ≥ three swollen joints; 3) ≥ 45 minutes of morning stiffness)
  • Taking stable doses of disease modifying anti-rheumatic drug (DMARD) therapy for at least 3 months prior to study entry -

You may not qualify if:

  • Unable to give informed consent
  • Pregnant or lactating
  • Eligible for pharmacologic lipid-lowering therapy per National Cholesterol Treatment Program Adult Treatment Panel III guidelines
  • Using any lipid lowering medication
  • Known hepatic disease
  • Elevated liver transaminase levels within the past two months
  • Previous treatment in the last three months with hydroxychloroquine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Charles-Schoeman C, Khanna D, Furst DE, McMahon M, Reddy ST, Fogelman AM, Paulus HE, Park GS, Gong T, Ansell BJ. Effects of high-dose atorvastatin on antiinflammatory properties of high density lipoprotein in patients with rheumatoid arthritis: a pilot study. J Rheumatol. 2007 Jul;34(7):1459-64. Epub 2007 Jun 1.

    PMID: 17552046DERIVED

MeSH Terms

Conditions

Arthritis, RheumatoidAtherosclerosis

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Benjamin J Ansell, MD

    University of California, Los Angeles

    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

July 25, 2006

First Posted

July 26, 2006

Study Start

March 1, 2003

Primary Completion

September 1, 2005

Study Completion

September 1, 2005

Last Updated

June 22, 2012

Record last verified: 2006-06