NCT01294722

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2011

Completed
10 months until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

March 19, 2013

Status Verified

March 1, 2013

Enrollment Period

8 months

First QC Date

February 10, 2011

Last Update Submit

March 18, 2013

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritisanti-TNF α

Outcome Measures

Primary Outcomes (2)

  • Number of anti-TNF α agent candidates fulfilling the reimbursement guideline of Korea government in total out-patients with RA

    Baseline

  • Number of anti-TNF α agent candidates based on the clinical judgement in total out- patients with RA

    Baseline

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants with diagnosis of RA visiting an internist as an outpatient

You may qualify if:

  • Diagnosed with RA
  • Visiting a medical internist in a study site during the study period on out patient basis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Seoul, South Korea

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Janssen Korea, Ltd., Korea Clinical Trial

    Janssen Korea, Ltd., Korea

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2011

First Posted

February 11, 2011

Study Start

December 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

March 19, 2013

Record last verified: 2013-03

Locations

KR(1)