Rheumatoid ArthritisNCT02758769
Long-Term Outcomes With Abatacept In Biologic Treatment-Naive Rheumatoid Arthritis Patients In Japanese Clinical Practice Settings
An observational study of Rheumatoid Arthritis, run by Bristol-Myers Squibb at 2 sites in Japan.
Trial summary
The purpose of this study is to examine the effectiveness and safety of the abatacept administration in biologic-naïve rheumatoid arthritis patients who have moderate disease activity despite treatments with conventional synthetic disease modified anti-rheumatic drugs. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- ORENCIA Subcutaneous Injection
- Type of treatment
- Injection or infusion
- How many people
- 303 participants
- Where
- 2 sitesJapan
- Study dates
- 7 Jun 2016to 15 Nov 2023
- 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: Primary Care Clinic
Who may be able to join
- Patients with RA who meet the 2010 American College of Rheumatology / European League against Rheumatisms (ACR/EULAR) RA Classification Criteria
- Patients with RA with a moderate disease activity (SDAI: > 11 and 26)
- Biologic-naive patients with treatment history csDMARDs
- Patients who meet the following criteria by hematological examination:
- Peripheral white blood cell count: 4,000/mm3
- Peripheral lymphocyte count: 1,000/mm3
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- Blood β-D-glucan negative
- Patients who understand the investigator's explanation of study procedures and have given voluntary written consent to participate in this study
- Patients initiated with abatacept at per their physician's therapeutic decision
Who cannot join
- Past history of hypersensitivity to the components of the abatacept preparation
- Disease complications from a comorbidity
- Active infectious disease
- Been judged by the investigator or the co-investigator as being inappropriate
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
Local Institution - 0001
Minato-ku, Tokyo, 1070052
Local Institution
Minato-ku, Tokyo, 1070052
About this study
The purpose of this study is to examine the effectiveness and safety of the abatacept administration in biologic-naïve rheumatoid arthritis patients who have moderate disease activity despite treatments with conventional synthetic disease modified anti-rheumatic drugs.
- Conditions
- Rheumatoid Arthritis
- Being tested
- ORENCIA Subcutaneous Injection
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORENCIA Subcutaneous InjectionBiological
Also called Abatacept
| Study group | Role | What they receive |
|---|---|---|
| ORENCIA with Exposure | ORENCIA with Exposure Receives: Biological: ORENCIA Subcutaneous Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of achievement in simplified disease activity index (SDAI) remission after administration of abatacept
Measured: 52 Weeks
Secondary outcomes (21)
Percentage of achievement in low disease activity by simplified disease activity index (SDAI).
Measured: 52 Weeks
Change in the percentage of disease activity category by simplified disease activity index(SDAI)
Measured: 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Change in the percentage of disease activity category by clinical disease activity index(CDAI)
Measured: 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Change in the percentage of disease activity category by disease activity score with 28 joint counts - erythrocyte sedimentation rate (DAS28-ESR)
Measured: 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Change in the percentage of disease activity category by disease activity score with 28 joint counts creactive protein (DAS28-CRP)
Measured: 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Change in simplified disease activity index(SDAI)
Measured: 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Change in clinical disease activity index(CDAI)
Measured: 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Change in disease activity score with 28 joint counts - erythrocyte sedimentation rate (DAS28-ESR)
Measured: 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Change in disease activity score with 28 joint counts Creactive protein (DAS28-CRP)
Measured: 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Change in Anti-citrullinated protein antibodies (ACPA)
Measured: 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Change in Rheumatoid factors (RF)
Measured: 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Survival rate
Measured: 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Hospitalization rate
Measured: 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Number of occurrences of rheumatoid arthritis related surgery
Measured: 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Persistence rate of Abatacept treatment
Measured: 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Reasons for discontinuation of Abatacept treatment
Measured: 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Change in Japanese Health Assessment Questionnaire
Measured: 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Change in European Quality of Life 5 Dimension Questionnaire
Measured: 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Change in Pain visual analog scale
Measured: 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Change in General visual analog scale
Measured: 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Change in PRO parameters defined in IORRA registry (JMAJ 2009 52 (1) 54-56)
Measured: 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study start7 Jun 2016
- Primary completion15 Nov 2023
- Study completion15 Nov 2023
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.
- 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
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ono Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02758769
- Sponsor's protocol ID
- IM101-574
- Status last verified
- Jun 2025
- First submitted
- 14 Apr 2016
- Last updated
- 22 Jun 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Outcomes With Abatacept In Biologic Treatment-Naive Rheumatoid Arthritis Patients In Japanese Clinical Practice Settings
- ClinicalTrials.gov ID
- NCT02758769
- Acronym / sponsor ID
- IM101-574
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Ono Pharmaceutical Co., Ltd.
- Study start
- 7 Jun 2016 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 2 May 2016 (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 study is to examine the effectiveness and safety of the abatacept administration in biologic-naïve rheumatoid arthritis patients who have moderate disease activity despite treatments with conventional synthetic disease modified anti-rheumatic drugs.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ORENCIA with Exposure | – | Biological: ORENCIA Subcutaneous InjectionORENCIA with Exposure |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Care Clinic
Key inclusion criteria (9 listed)
- Patients with RA who meet the 2010 American College of Rheumatology / European League against Rheumatisms (ACR/EULAR) RA Classification Criteria
- Patients with RA with a moderate disease activity (SDAI: > 11 and 26)
- Biologic-naive patients with treatment history csDMARDs
- Patients who meet the following criteria by hematological examination:
- Patients who understand the investigator's explanation of study procedures and have given voluntary written consent to participate in this study
Key exclusion criteria (5 listed)
- Past history of hypersensitivity to the components of the abatacept preparation
- Disease complications from a comorbidity
- Active infectious disease
- Been judged by the investigator or the co-investigator as being inappropriate
- Other protocol defined inclusion/exclusion criteria could apply
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 |
|---|---|---|
| ORENCIA Subcutaneous InjectionAlso: Abatacept | Biological | ORENCIA with Exposure |
Primary outcome
Percentage of achievement in simplified disease activity index (SDAI) remission after administration of abatacept
Time frame: 52 Weeks
21 secondary outcomes
Percentage of achievement in low disease activity by simplified disease activity index (SDAI).
Time frame: 52 Weeks
Change in the percentage of disease activity category by simplified disease activity index(SDAI)
Time frame: 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Change in the percentage of disease activity category by clinical disease activity index(CDAI)
Time frame: 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Change in the percentage of disease activity category by disease activity score with 28 joint counts - erythrocyte sedimentation rate (DAS28-ESR)
Time frame: 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Change in the percentage of disease activity category by disease activity score with 28 joint counts creactive protein (DAS28-CRP)
Time frame: 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Change in simplified disease activity index(SDAI)
Time frame: 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Change in clinical disease activity index(CDAI)
Time frame: 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Change in disease activity score with 28 joint counts - erythrocyte sedimentation rate (DAS28-ESR)
Time frame: 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Change in disease activity score with 28 joint counts Creactive protein (DAS28-CRP)
Time frame: 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Change in Anti-citrullinated protein antibodies (ACPA)
Time frame: 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Change in Rheumatoid factors (RF)
Time frame: 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Survival rate
Time frame: 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Hospitalization rate
Time frame: 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Number of occurrences of rheumatoid arthritis related surgery
Time frame: 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Persistence rate of Abatacept treatment
Time frame: 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Reasons for discontinuation of Abatacept treatment
Time frame: 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Change in Japanese Health Assessment Questionnaire
Time frame: 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Change in European Quality of Life 5 Dimension Questionnaire
Time frame: 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Change in Pain visual analog scale
Time frame: 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Change in General visual analog scale
Time frame: 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Change in PRO parameters defined in IORRA registry (JMAJ 2009 52 (1) 54-56)
Time frame: 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
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 22 Jun 2025.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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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
2 sites 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 2 sites in Japan.
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 9 inclusion and 5 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 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. 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?
Percentage of achievement in simplified disease activity index (SDAI) remission after administration of abatacept (time frame: 52 Weeks). 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 22 Jun 2025.