Hanyang University Medical Center Arthritis Network

Arthritis, Rheumatoid Clinical Trial

Official title:

Hanyang University Medical Center Arthritis Network

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00418405
• Other study ID #: HUMAN
• Status: Not yet recruiting
• Phase: Phase 4
• First received: January 3, 2007
• Last updated: January 3, 2007
• Start date: January 2007
• Est. completion date: January 2012

Study information

• Verified date: January 2007
• Source: Hanyang University
• Contact: Sang-Cheol Bae, MD, PhD, MPH
• Phone: +82-2-2290-9237
• Email: scbae[@]hanyang.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

Description:

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:

1. Gather information on treatment response and adverse events of various pharmacological therapies for treatment of Korean rheumatoid arthritis patients

2. 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1500
• Est. completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Korean adult rheumatoid arthritis patients satisfying the 1987 revised American College of Rheumatology (ACR) criteria

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Locations

Country	Name	City	State
Korea, Republic of	The Hospital for Rheumatic Diseases, Hanyang University	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Hanyang University	Merck Sharp & Dohme Corp., Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Korea, Republic of,