A Study to Determine the Number of Participants With Rheumatoid Arthritis (RA) Who Meet the Requirements for Treatment With Anti‐Tumor Necrosis Factor α (TNFα) in a General Hospital Setting in Korea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:
NCT01294722
First received: February 10, 2011
Last updated: March 18, 2013
Last verified: March 2013
  Purpose

This is an observational study to estimate the proportion of patients diagnosed with RA visiting a medical internist in a general hospital in Korea who are candidates for anti‐TNF α therapy.


Condition Phase
Rheumatoid Arthritis
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: The Prevalence of Out-patients With Rheumatoid Arthritis Fulfilling the Indication for Anti-tumor Necrosis Factor(TNFa) Therapy in General Hospital Setting in Korea: a Multi-center, Non-interventional, Observational Study

Resource links provided by NLM:


Further study details as provided by Janssen Korea, Ltd., Korea:

Primary Outcome Measures:
  • Number of anti-TNF α agent candidates fulfilling the reimbursement guideline of Korea government in total out-patients with RA [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Number of anti‐TNF α agent candidates based on the clinical judgement in total out‐ patients with RA [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Enrollment: 1700
Study Start Date: December 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants with diagnosis of RA visiting an internist as an outpatient

Criteria

Inclusion Criteria:

  • Diagnosed with RA
  • Visiting a medical internist in a study site during the study period on out patient basis
  • Able to give written informed consent voluntarily Exclusion Criteria: None
  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: NCT01294722

Locations
Korea, Republic of
Seoul, Korea, Republic of
Sponsors and Collaborators
Janssen Korea, Ltd., Korea
Investigators
Study Director: Janssen Korea, Ltd., Korea Clinical Trial Janssen Korea, Ltd., Korea
  More Information

No publications provided

Responsible Party: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT01294722     History of Changes
Other Study ID Numbers: CR100769, REMICADEARA4015
Study First Received: February 10, 2011
Last Updated: March 18, 2013
Health Authority: Korea: Institutional Review Board
Republic of Korea: Food and Drug Administration

Keywords provided by Janssen Korea, Ltd., Korea:
Rheumatoid Arthritis
anti-TNF α

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 October 20, 2014