Hanyang University Medical Center Arthritis Network

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by Hanyang University.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Hanyang University
ClinicalTrials.gov Identifier:
NCT00418405
First received: January 3, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted
  Purpose

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.


Condition Phase
Arthritis, Rheumatoid
Phase 4

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Official Title: Hanyang University Medical Center Arthritis Network

Resource links provided by NLM:


Further study details as provided by Hanyang University:

Estimated Enrollment: 1500
Study Start Date: January 2007
Estimated Study Completion Date: January 2012
Detailed 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Korean adult rheumatoid arthritis patients satisfying the 1987 revised American College of Rheumatology (ACR) criteria
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00418405

Contacts
Contact: Sang-Cheol Bae, MD, PhD, MPH +82-2-2290-9237 scbae@hanyang.ac.kr
Contact: Eun-Kyung Joo, BS, RN +82-2-2290-9240 siverk@empal.com

Locations
Korea, Republic of
The Hospital for Rheumatic Diseases, Hanyang University Not yet recruiting
Seoul, Korea, Republic of, 133-792
Principal Investigator: Sang-Cheol Bae, MD, PhD, MPH         
Sponsors and Collaborators
Hanyang University
Merck Sharp & Dohme Corp.
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Principal Investigator: Sang-Cheol Bae, MD, PhD, MPH Hanyang University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00418405     History of Changes
Other Study ID Numbers: HUMAN
Study First Received: January 3, 2007
Last Updated: January 3, 2007
Health Authority: Korea: Food and Drug Administration

Keywords provided by Hanyang University:
Arthritis, Rheumatoid
Cohort Studies

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014