NCT00815425

Brief Summary

Rheumatoid arthritis (RA) is a long-term autoimmune disease that is characterized by pain, stiffness, inflammation, swelling, and sometimes destruction of joints. RA usually requires lifelong treatment, including medications, physical therapy, exercise, education, and possibly surgery, but the course and severity of the disease can differ significantly from person to person. The purpose of this study is to identify genetic and other factors that determine the severity of RA in African Americans.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,613

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2000

Longer than P75 for all trials

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

September 1, 2000

Completed
8.3 years until next milestone

First Submitted

Initial submission to the registry

December 29, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 30, 2008

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

December 2, 2014

Status Verified

December 1, 2014

Enrollment Period

11.3 years

First QC Date

December 29, 2008

Last Update Submit

December 1, 2014

Conditions

Rheumatoid Arthritis

Keywords

African American

Outcome Measures

Primary Outcomes (1)

  • Radiographic severity of rheumatoid arthritis in African Americans

    Measured at any point during the duration of disease

Study Arms (2)

African Americans with RA

1063 participants with RA

African-Americans without RA

550 participants without RA

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

African Americans with and without RA

You may qualify if:

  • Rheumatoid arthritis
  • Self-declared as African American

You may not qualify if:

  • Lupus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, including DNA and serum, and urine

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • S. Louis Bridges, Jr, MD, PhD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2008

First Posted

December 30, 2008

Study Start

September 1, 2000

Primary Completion

December 1, 2011

Study Completion

March 1, 2012

Last Updated

December 2, 2014

Record last verified: 2014-12

Locations

US(1)