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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01294722
• Other study ID #: CR100769
• Secondary ID: REMICADEARA4015
• Status: Completed
• Phase: Phase 4
• First received: February 10, 2011
• Last updated: March 18, 2013
• Start date: December 2011
• Est. completion date: August 2012

Study information

• Verified date: March 2013
• Source: Janssen Korea, Ltd., Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review BoardRepublic of Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1700
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Korea, Ltd., Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of anti-TNF a agent candidates fulfilling the reimbursement guideline of Korea government in total out-patients with RA		Baseline	No
Primary	Number of anti-TNF a agent candidates based on the clinical judgement in total out- patients with RA		Baseline	No