Text Size

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
History of Changes
  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:

U.S. FDA Resources

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
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 May 16, 2013