- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00418405
Hanyang University Medical Center Arthritis Network
Rheumatoid arthritis is a relatively common autoimmune disease that affects about 1% of the population. Its impact on health-related quality of life of the affected patients and the national medical cost are enormous. However, a systemic prospective cohort study of rheumatoid arthritis has not yet been established in Korea, so data on characteristics and prognosis of Korean rheumatoid arthritis and their response to therapy and adverse events are limited. Therefore establishment of large prospective cohort of Korean rheumatoid arthritis is imperative.
With inauguration of a steadfast prospective cohort of Korean rheumatoid arthritis patients in The Hospital for Rheumatic Diseases at Hanyang University, where patients gather from all over Korea forming the largest and most diverse patient pool in Korea, we will be able to define the characteristics and prognosis of Korean rheumatoid arthritis patients and gather information on treatment response and adverse events. This will eventually lead to improvement of health-related quality of life in Korean rheumatoid arthritis patients and provide opportunity for reliable comparison study with research institutes from other countries. The data gathered through the cohort will provide valuable foundational information for the genetic studies, pharmacological economic analyses, and standard treatment guidelines of Korean rheumatoid arthritis patients.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
This study is a longitudinal prospective cohort of Korean rheumatoid arthritis patients comprising of all Korean adult rheumatoid arthritis patients satisfying the 1987 revised American College of Rheumatology (ACR) criteria and voluntarily agreeing to participate in the study with following objectives;
Primary Objectives:
- Gather information on treatment response and adverse events of various pharmacological therapies for treatment of Korean rheumatoid arthritis patients
- Identify the incidence and mortality rates of concurrent diseases including the cardiovascular & gastrointestinal diseases and assess the contributing factors involved
Secondary Objectives:
Enrich understanding of disease characteristics, treatment response and adverse events in Korean rheumatoid arthritis to promote health and increase the health-related quality of life in Korean rheumatoid arthritis patients
Undersøgelsestype
Tilmelding
Kontakter og lokationer
Studiesteder
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Seoul, Korea, Republikken, 133-792
- The Hospital for Rheumatic Diseases, Hanyang University
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Korean adult rheumatoid arthritis patients satisfying the 1987 revised American College of Rheumatology (ACR) criteria
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Defineret befolkning
- Tidsperspektiver: Fremadrettet
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Sang-Cheol Bae, MD, PhD, MPH, Hanyang University
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- HUMAN
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