Denne side blev automatisk oversat, og nøjagtigheden af oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Registry for African Americans With Early Rheumatoid Arthritis (CLEAR)

5. januar 2016 opdateret af: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

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.

Studieoversigt

Status

Afsluttet

Betingelser

Rheumatoid arthritis

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

357

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Forenede Stater
- Alabama
  - Birmingham, Alabama, Forenede Stater, 35294
    - University of Alabama at Birmingham
- Georgia
  - Atlanta, Georgia, Forenede Stater, 30303
    - Emory University
- Missouri
  - St. Louis, Missouri, Forenede Stater, 63130
    - Washington University at St. Louis
- North Carolina
  - Chapel Hill, North Carolina, Forenede Stater, 27599
    - University of North Carolina at Chapel Hill
- South Carolina
  - Charleston, South Carolina, Forenede Stater, 29425
    - Medical University of South Carolina

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

African Americans

Beskrivelse

Inclusion Criteria

African American
Rheumatoid arthritis for less than 2 years

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Radiographic severity of rheumatoid arthritis in African Americans Tidsramme: 5 yr disease duration	Initially seen at 5 yr disease duration. Later, became a cross-sectional (1 time visit).	5 yr disease duration

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Efterforskere

Ledende efterforsker: S. Louis Bridges, Jr., MD, PhD, University of Alabama at Birmingham

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2001

Primær færdiggørelse (Faktiske)

1. december 2011

Studieafslutning (Faktiske)

1. marts 2012

Datoer for studieregistrering

Først indsendt

16. december 2003

Først indsendt, der opfyldte QC-kriterier