Rheumatoid ArthritisNCT01583244
Korean Post-marketing Surveillance for Orencia®
An observational study of Rheumatoid Arthritis, run by Bristol-Myers Squibb at 1 site in South Korea.
Trial summary
The purpose of this post-marketing surveillance is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and efficacy of Orencia® so that the regulatory authority can manage the marketing approval properly. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 701 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2010to Feb 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients aged 6 years and over who have moderate-to-severe active rheumatoid arthritis
Who may be able to join
- Patients must be diagnosed with: Adult Rheumatoid arthritis (RA): adult patients with moderate-to-severe active RA
- Or
- Juvenile idiopathic RA: juvenile patients aged 6 years and older with moderate-to-severe active RA
Who cannot join
- Children aged <6 years
- Pregnant or lactating women
- Patients who are participating in another study
- Patients known to be hypersensitive to the active component of the surveillance drug or any other component of the surveillance drug
- Patients who had a positive tuberculosis screening test but were not treated with standard therapy before participating in the study
- Patients who have a positive hepatitis virus test
- Patients who were given a live vaccine concurrently with the surveillance drug or are expected to be given a live vaccine again within 3 months after discontinuation of the surveillance drug
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this post-marketing surveillance is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and efficacy of Orencia® so that the regulatory authority can manage the marketing approval properly.
Read the detailed description
Time Perspective: Prospective / Retrospective(On-treatment)
- Conditions
- Rheumatoid Arthritis
- Being tested
- No Intervention (subjects were previously treated with Orencia®)
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention (subjects were previously treated with Orencia®)Drug
Also called Abatacept
No Intervention
| Study group | Role | What they receive |
|---|---|---|
| Patients with active rheumatoid arthritis | Patients aged 6 years and over who have moderate-to-severe active rheumatoid arthritis Receives: Drug: No Intervention (subjects were previously treated with Orencia®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events occurrence
Measured: 30 days after last dose of study drug
Secondary outcomes (2)
Number of Adverse Events and Serious Adverse Events
Measured: 30 days after last dose of study drug
Efficacy of Orencia® measured by swollen joint counts and tender joint counts in the subject treated with the surveillance drug, patient-assessed pain, APR, patient-assessed global health, physician-assessed global disease activity
- APR = acute phase reactants
Measured: 24 weeks of registration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2012 (estimated)
- Study startMar 2010
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 701 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01583244
- Sponsor's protocol ID
- IM101-300
- Status last verified
- Mar 2016
- First submitted
- 20 Apr 2012
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee JS, Ahmad H, Shim SC, Bae SC, Song YW, Lee EY. High Proportion of Subjective Component to the Disease Activity Score is Associated with Favorable Response to Abatacept in Rheumatoid Arthritis. Patient. 2019 Jun;12(3):319-326. doi: 10.1007/s40271-018-0347-z.
PubMed 30484084
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Korean Post-marketing Surveillance for Orencia®
- ClinicalTrials.gov ID
- NCT01583244
- Acronym / sponsor ID
- IM101-300
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 701 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 23 Apr 2012 (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.
The purpose of this post-marketing surveillance is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and efficacy of Orencia® so that the regulatory authority can manage the marketing approval properly.
Detailed description
Time Perspective: Prospective / Retrospective(On-treatment)
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with active rheumatoid arthritis | – | Drug: No Intervention (subjects were previously treated with Orencia®)Patients aged 6 years and over who have moderate-to-severe active rheumatoid arthritis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients aged 6 years and over who have moderate-to-severe active rheumatoid arthritis
Key inclusion criteria (3 listed)
- Patients must be diagnosed with: Adult Rheumatoid arthritis (RA): adult patients with moderate-to-severe active RA
- Or
- Juvenile idiopathic RA: juvenile patients aged 6 years and older with moderate-to-severe active RA
Key exclusion criteria (7 listed)
- Children aged <6 years
- Pregnant or lactating women
- Patients who are participating in another study
- Patients known to be hypersensitive to the active component of the surveillance drug or any other component of the surveillance drug
- Patients who had a positive tuberculosis screening test but were not treated with standard therapy before participating in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention (subjects were previously treated with Orencia®)Also: AbataceptNo Intervention | Drug | Patients with active rheumatoid arthritis |
Primary outcome
Adverse events occurrence
Time frame: 30 days after last dose of study drug
2 secondary outcomes
Number of Adverse Events and Serious Adverse Events
Time frame: 30 days after last dose of study drug
Efficacy of Orencia® measured by swollen joint counts and tender joint counts in the subject treated with the surveillance drug, patient-assessed pain, APR, patient-assessed global health, physician-assessed global disease activity
Time frame: 24 weeks of registration
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 12 May 2016.
- Derived from this study: PubMed 30484084Lee JS, Ahmad H, Shim SC, Bae SC, Song YW, Lee EY. High Proportion of Subjective Component to the Disease Activity Score is Associated with Favorable Response to Abatacept in Rheumatoid Arthritis. Patient. 2019 Jun;12(3):319-326. doi: 10.1007/s40271-018-0347-z.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
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 Bristol-Myers Squibb 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 7 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 12 May 2016. 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?
Adverse events occurrence (time frame: 30 days after last dose of study drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01583244, which also lists 1 linked publication.
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 12 May 2016.