NCT00037336

Brief Summary

To test the theory that accelerated inflammation-promoted atherosclerosis occurs in patients with rheumatoid arthritis (RA).

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started Sep 2001

Longer than P75 for all trials

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

September 1, 2001

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 17, 2002

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

March 17, 2014

Status Verified

March 1, 2014

Enrollment Period

5.8 years

First QC Date

May 16, 2002

Last Update Submit

March 14, 2014

Conditions

AtherosclerosisCardiovascular DiseasesHeart DiseasesInflammationArthritis, Rheumatoid

Eligibility Criteria

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

people with rheumatoid arthritis

must meet ACR criteria for RA

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (13)

  • Sokka T, Pincus T. Eligibility of patients in routine care for major clinical trials of anti-tumor necrosis factor alpha agents in rheumatoid arthritis. Arthritis Rheum. 2003 Feb;48(2):313-8. doi: 10.1002/art.10817.

    PMID: 12571838BACKGROUND

  • Sokka T, Pincus T. Contemporary disease modifying antirheumatic drugs (DMARD) in patients with recent onset rheumatoid arthritis in a US private practice: methotrexate as the anchor drug in 90% and new DMARD in 30% of patients. J Rheumatol. 2002 Dec;29(12):2521-4.

    PMID: 12465145BACKGROUND

  • Sokka T, Pincus T. Most patients receiving routine care for rheumatoid arthritis in 2001 did not meet inclusion criteria for most recent clinical trials or american college of rheumatology criteria for remission. J Rheumatol. 2003 Jun;30(6):1138-46.

    PMID: 12784382BACKGROUND

  • Olsen NJ, Stein CM. New drugs for rheumatoid arthritis. N Engl J Med. 2004 May 20;350(21):2167-79. doi: 10.1056/NEJMra032906. No abstract available.

    PMID: 15152062BACKGROUND

  • Pincus T, Yazici Y, Sokka T, Aletaha D, Smolen JS. Methotrexate as the "anchor drug" for the treatment of early rheumatoid arthritis. Clin Exp Rheumatol. 2003 Sep-Oct;21(5 Suppl 31):S179-85.

    PMID: 14969073BACKGROUND

  • Sokka T, Willoughby J, Yazici Y, Pincus T. Databases of patients with early rheumatoid arthritis in the USA. Clin Exp Rheumatol. 2003 Sep-Oct;21(5 Suppl 31):S146-53.

    PMID: 14969067BACKGROUND

  • Pincus T, Sokka T. Uniform databases in early arthritis: specific measures to complement classification criteria and indices of clinical change. Clin Exp Rheumatol. 2003 Sep-Oct;21(5 Suppl 31):S79-88.

    PMID: 14969056BACKGROUND

  • Olsen N, Sokka T, Seehorn CL, Kraft B, Maas K, Moore J, Aune TM. A gene expression signature for recent onset rheumatoid arthritis in peripheral blood mononuclear cells. Ann Rheum Dis. 2004 Nov;63(11):1387-92. doi: 10.1136/ard.2003.017194.

    PMID: 15479887BACKGROUND

  • Pincus T, Sokka T, Kautiainen H. Patients seen for standard rheumatoid arthritis care have significantly better articular, radiographic, laboratory, and functional status in 2000 than in 1985. Arthritis Rheum. 2005 Apr;52(4):1009-19. doi: 10.1002/art.20941.

    PMID: 15818706BACKGROUND

  • Yazici Y, Sokka T, Kautiainen H, Swearingen C, Kulman I, Pincus T. Long term safety of methotrexate in routine clinical care: discontinuation is unusual and rarely the result of laboratory abnormalities. Ann Rheum Dis. 2005 Feb;64(2):207-11. doi: 10.1136/ard.2004.023408. Epub 2004 Jun 18.

    PMID: 15208176BACKGROUND

  • Sokka T, Pincus T. An Early Rheumatoid Arthritis Treatment Evaluation Registry (ERATER) in the United States. Clin Exp Rheumatol. 2005 Sep-Oct;23(5 Suppl 39):S178-81.

    PMID: 16273804BACKGROUND

  • Chung CP, Oeser A, Raggi P, Gebretsadik T, Shintani AK, Sokka T, Pincus T, Avalos I, Stein CM. Increased coronary-artery atherosclerosis in rheumatoid arthritis: relationship to disease duration and cardiovascular risk factors. Arthritis Rheum. 2005 Oct;52(10):3045-53. doi: 10.1002/art.21288.

    PMID: 16200609BACKGROUND

  • Asanuma Y, Xie HG, Stein CM. Pharmacogenetics and rheumatology: Molecular mechanisms contributing to variability in drug response. Arthritis Rheum. 2005 May;52(5):1349-59. doi: 10.1002/art.21027. No abstract available.

    PMID: 15880820BACKGROUND

MeSH Terms

Conditions

AtherosclerosisCardiovascular DiseasesHeart DiseasesInflammationArthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Charles Stein

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

May 16, 2002

First Posted

May 17, 2002

Study Start

September 1, 2001

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

March 17, 2014

Record last verified: 2014-03