Rheumatoid ArthritisNCT01294722
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
An observational study of Rheumatoid Arthritis, run by Janssen Korea, Ltd., Korea at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 1,700 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2011to Aug 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with diagnosis of RA visiting an internist as an outpatient
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, anti-TNF α
- Medical subject headings
- Arthritis, Rheumatoid
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of anti-TNF α agent candidates fulfilling the reimbursement guideline of Korea government in total out-patients with RA
Measured: Baseline
Number of anti-TNF α agent candidates based on the clinical judgement in total out- patients with RA
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2011 (estimated)
- Study startDec 2011
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Korea, Ltd., Korea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Korea, Ltd., Korea Clinical Trial, Study director, Janssen Korea, Ltd., Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01294722
- Sponsor's protocol ID
- CR100769
- Other IDs
- REMICADEARA4015
- Status last verified
- Mar 2013
- First submitted
- 10 Feb 2011
- Last updated
- 19 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01294722
- Acronym / sponsor ID
- CR100769
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, anti-TNF α
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,700 participants (actual)
- Lead sponsor
- Janssen Korea, Ltd., KoreaIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 11 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with diagnosis of RA visiting an internist as an outpatient
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Korea, Ltd., Korea Clinical Trial study director
Janssen Korea, Ltd., Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Janssen Korea, Ltd., Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of anti-TNF α agent candidates fulfilling the reimbursement guideline of Korea government in total out-patients with RA (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2013.