Rheumatoid ArthritisCLEARNCT00074555
Registry for African Americans With Early Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 5 sites in United States.
Trial summary
The purpose of this study is to better understand the causes of rheumatoid arthritis (RA), particularly in African Americans. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 357 participants
- Where
- 5 sitesUnited States
- Study dates
- Jan 2001to Mar 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: African Americans
Who may be able to join
- African American
- Rheumatoid arthritis for less than 2 years
Who cannot join
None listed.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Emory University
Atlanta, Georgia, 30303
University of Alabama at Birmingham
Birmingham, Alabama, 35294
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Medical University of South Carolina
Charleston, South Carolina, 29425
Washington University at St. Louis
St Louis, Missouri, 63130
About this study
Official title: Consortium for the Longitudinal Evaluation of African Americans With Early Rheumatoid Arthritis (CLEAR)
The purpose of this study is to better understand the causes of rheumatoid arthritis (RA), particularly in African Americans.
Read the detailed description
RA is an autoimmune disease in which the body's immune system attacks its own tissues. It occurs in all races and ethnic groups and affects about two to three times as many women as men. Variations in certain genes that play a role in the immune system are associated with a tendency to develop RA. Some individuals without these genetic variations may develop this disease, while others who possess the variations never develop RA. Scientists believe that some environmental factors may play a part in triggering the disease process in people whose genetic makeup makes them susceptible to RA. This registry of African Americans with early RA will provide clinical and x-ray data and DNA to help scientists analyze genetic and nongenetic factors that might predict disease course and outcomes of RA in this population.
Participants in this registry will be enrolled in the study until they reach 5 years in their disease duration. For example, if a participant enters the study after 1 year of having RA, he or she will continue for 4 years. Participants will have three office visits (screening, 3 years' disease duration, and 5 years' disease duration) at which they will complete questionnaires and have blood samples taken, x-rays of their hands and feet, and DEXA scans. Between office visits, the study coordinator will call participants every 6 months to update any changes in medications or health problems.
- Conditions
- Rheumatoid Arthritis
- Keywords
- African American, Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic severity of rheumatoid arthritis in African Americans
Initially seen at 5 yr disease duration. Later, became a cross-sectional (1 time visit).
Measured: 5 yr disease duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2003 (estimated)
- Study startJan 2001
- Primary completionDec 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 357 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- S. Louis Bridges, Jr., MD, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00074555
- Sponsor's protocol ID
- N01 AR02247
- Other IDs
- NIAMS-106
- Acronym
- CLEAR
- Status last verified
- Jan 2016
- First submitted
- 16 Dec 2003
- Last updated
- 6 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consortium for the Longitudinal Evaluation of African Americans With Early Rheumatoid Arthritis (CLEAR)
- ClinicalTrials.gov ID
- NCT00074555
- Acronym / sponsor ID
- CLEAR / N01 AR02247
- Conditions
- Rheumatoid Arthritis
- Keywords
- African American, Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 357 participants (actual)
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)US National Institutes of Health
- Study start
- Jan 2001
- Primary completion
- Dec 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 17 Dec 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to better understand the causes of rheumatoid arthritis (RA), particularly in African Americans.
Detailed description
RA is an autoimmune disease in which the body's immune system attacks its own tissues. It occurs in all races and ethnic groups and affects about two to three times as many women as men. Variations in certain genes that play a role in the immune system are associated with a tendency to develop RA. Some individuals without these genetic variations may develop this disease, while others who possess the variations never develop RA. Scientists believe that some environmental factors may play a part in triggering the disease process in people whose genetic makeup makes them susceptible to RA. This registry of African Americans with early RA will provide clinical and x-ray data and DNA to help scientists analyze genetic and nongenetic factors that might predict disease course and outcomes of RA in this population.
Participants in this registry will be enrolled in the study until they reach 5 years in their disease duration. For example, if a participant enters the study after 1 year of having RA, he or she will continue for 4 years. Participants will have three office visits (screening, 3 years' disease duration, and 5 years' disease duration) at which they will complete questionnaires and have blood samples taken, x-rays of their hands and feet, and DEXA scans. Between office visits, the study coordinator will call participants every 6 months to update any changes in medications or health problems.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- African Americans
Key inclusion criteria (2 listed)
- African American
- Rheumatoid arthritis for less than 2 years
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Radiographic severity of rheumatoid arthritis in African Americans
Time frame: 5 yr disease duration
Initially seen at 5 yr disease duration. Later, became a cross-sectional (1 time visit).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
S. Louis Bridges, Jr., MD, PhD principal investigator
University of Alabama at Birmingham
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic severity of rheumatoid arthritis in African Americans (time frame: 5 yr disease duration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2016.