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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:
ClinicalTrials.gov Identifier:
NCT01294722
First Posted: February 11, 2011
Last Update Posted: March 19, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea
  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 ]
  • Number of anti‐TNF α agent candidates based on the clinical judgement in total out‐ patients with RA [ Time Frame: Baseline ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT01294722     History of Changes
Other Study ID Numbers: CR100769
REMICADEARA4015 ( Other Identifier: Janssen Korea, Ltd., Korea )
First Submitted: February 10, 2011
First Posted: February 11, 2011
Last Update Posted: March 19, 2013
Last Verified: March 2013

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

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