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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

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ClinicalTrials.gov Identifier: NCT01294722
Recruitment Status : Completed
First Posted : February 11, 2011
Last Update Posted : March 19, 2013
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea

Brief Summary:
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 or disease
Rheumatoid Arthritis

Study Type : Observational
Actual Enrollment : 1700 participants
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
Study Start Date : December 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Number of anti-TNF α agent candidates fulfilling the reimbursement guideline of Korea government in total out-patients with RA [ Time Frame: Baseline ]
  2. Number of anti‐TNF α agent candidates based on the clinical judgement in total out‐ patients with RA [ Time Frame: Baseline ]


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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

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

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 Posted: February 11, 2011    Key Record Dates
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