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Trial record 1 of 1 for:    NCT00418405
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Hanyang University Medical Center Arthritis Network

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ClinicalTrials.gov Identifier: NCT00418405
Recruitment Status : Unknown
Verified January 2007 by Hanyang University.
Recruitment status was:  Not yet recruiting
First Posted : January 4, 2007
Last Update Posted : January 4, 2007
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Hanyang University

Tracking Information
First Submitted Date January 3, 2007
First Posted Date January 4, 2007
Last Update Posted Date January 4, 2007
Study Start Date January 2007
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Hanyang University Medical Center Arthritis Network
Official Title Hanyang University Medical Center Arthritis Network
Brief 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.

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

Study Type Observational
Study Design Observational Model: Defined Population
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Arthritis, Rheumatoid
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Enrollment
 (submitted: January¬†3,¬†2007)
1500
Original Enrollment Same as current
Study Completion Date January 2012
Primary Completion Date Not Provided
Eligibility Criteria

Inclusion Criteria:

  • Korean adult rheumatoid arthritis patients satisfying the 1987 revised American College of Rheumatology (ACR) criteria
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT00418405
Other Study ID Numbers HUMAN
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor Hanyang University
Collaborators
  • Merck Sharp & Dohme Corp.
  • Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Principal Investigator: Sang-Cheol Bae, MD, PhD, MPH Hanyang University
PRS Account Hanyang University
Verification Date January 2007