Rheumatoid ArthritisABCNCT03274141
Comparing the Effectiveness of a Treat-to-target (T2T) Disease Management Strategy vs. Routine Care (RC) in Adult Patients With Moderate to Severe Rheumatoid Arthritis (RA) Treated With Subcutaneous Abatacept (Orencia - SC)
An observational study of Rheumatoid Arthritis, run by Bristol-Myers Squibb at 1 site in Canada.
Trial summary
This is a 12 month prospective, multicenter, post-marketing, observational study to compare the effectiveness of a treat-to-target (T2T) disease management strategy vs. routine care (RC) in adult patients with moderate to severe rheumatoid arthritis (RA) treated with subcutaneous abatacept (Orencia - SC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Non-Interventional
- How many people
- 281 participants
- Where
- 1 siteCanada
- Study dates
- 31 Oct 2011to 31 Oct 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with active RA defined as a CDAI > 10 for whom the treating physician has made the decision to initiate treatment with SC abatacept according to the approved Canadian product monograph and regional reimbursement criteria will be potentially eligible for inclusion in the study. The decision to treat the patient with SC abatacept must have been reached prior to and independently of considering the patient for study enrollment.
Who may be able to join
- 18 years of age or older.
- Active moderate to severe RA, defined as CDAI > 10.
- The treating physician has made the decision to initiate treatment with SC abatacept in accordance with the Canadian product monograph.
- Patient has provided a written informed consent and is able to complete the survey requirements.
- Patient fulfills the reimbursement criteria for treatment with SC abatacept under provincial or private health insurance reimbursement coverage.
Who cannot join
- Has received abatacept (SC or IV) prior to the enrolment visit.
- Has failed more than one prior biologic DMARD therapy
- Has a history of autoimmune disease or of any joint inflammatory disease other than RA with the exception of concomitant secondary Sjogren's syndrome.
- Is participating in an ongoing clinical trial and/or has received treatment with an investigational agent within 4 weeks before starting treatment with SC abatacept.
- Is participating in another industry-sponsored observational study.
- Patients participating to non-industry related registries or other data collection studies can be included
- Presence of any condition that, in the opinion of the treating physician, prohibits the patient from participating in the study or obscures the assessment of RA treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Abatacept Best Care (ABC) Trial
This is a 12 month prospective, multicenter, post-marketing, observational study to compare the effectiveness of a treat-to-target (T2T) disease management strategy vs. routine care (RC) in adult patients with moderate to severe rheumatoid arthritis (RA) treated with subcutaneous abatacept (Orencia - SC). Patients completing the study will be offered to participate in a 12-month extension of their follow-up provided that this is in agreement with the judgment of the treating physician.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Non-Interventional
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-InterventionalOther
Non-Interventional
| Study group | Role | What they receive |
|---|---|---|
| T2T Patients | RA patients managed with a treat-to-target (T2T) strategy Receives: Other: Non-Interventional | |
| RC Patients | RA patients managed with routine care(RC) Receives: Other: Non-Interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of T2T patients achieving sustained CDAI LDA
Low Disease Activity (LDA) as determined by the Clinical Disease Activity Index (CDAI) is defined as a CDAI score of less than or equal to 10.
Measured: Approximately 1 year
Number of RC patients achieving sustained CDAI LDA
Low Disease Activity (LDA) as determined by the Clinical Disease Activity Index (CDAI) is defined as a CDAI score of less than or equal to 10.
Measured: Approximately 1 year
Secondary outcomes (35)
Number of patients achieving SDAI remission
Simplified Disease Activity Index (SDAI) remission is achieved when SDAI score is less than or equal to 3.3
Measured: Up to 24 months
Mean time for patients to achieve SDAI remission
Length of time from treatment initiation SDAI remission
Measured: Up to 24 months
Number of patients achieving CDAI remission
Clinical Disease Activity Index (CDAI) remission is achieved when CDAI score is less than or equal to 2.8
Measured: Up to 24 months
Mean time for patients to achieve CDAI remission
Length of time from treatment initiation CDAI remission
Measured: Up to 24 months
Number of patients achieving DAS28-CRP LDA
Disease Activity Score (DAS) Low Disease Activity (LDA) is achieved when DAS28-CRP score is less than 3.2
Measured: Up to 24 months
Mean time for patients to achieve DAS28-CRP LDA
Length of time from treatment initiation to a DAS28-CRP score of less than 3.2
Measured: Up to 24 months
Number of patients achieving DAS28-CRP remission
Disease Activity Score (DAS) remission is achieved when DAS28-CRP score is less than 2.6
Measured: Up to 24 months
Mean time for patients to achieve DAS28-CRP remission
Length of time from treatment initiation to a DAS28-CRP score of less than 2.6
Measured: Up to 24 months
Number of patients achieving Boolean remission
Boolean remission is defined as TJC28 ≤1 and SJC28 ≤1 and CRP ≤1 mg/dl and PtGA ≤1 (on a 0-10 scale)
Measured: Up to 24 months
Mean time for patients to achieve Boolean remission
Length of time from treatment initiation to Boolean remission.
Measured: Up to 24 months
Number of patients achieving RAPID3 LDA
Routine Assessment of Patient Index Data 3 (RAPID3) Low Disease Activity (LDA) is achieved when RAPID3 score is less than or equal to 6.
Measured: Up to 24 months
Mean time for patients to achieve RAPID3 LDA
Length of time from treatment initiation to a RAPID3 score of less than or equal to 6
Measured: Up to 24 months
Number of patients achieving RAPID3 remission
Routine Assessment of Patient Index Data 3 (RAPID3) remission is achieved when RAPID3 score is less than or equal to 3.
Measured: Up to 24 months
Mean time for patients to achieve RAPID3 remission
Length of time from treatment initiation to a RAPID3 score of less than or equal to 3
Measured: Up to 24 months
Number of patients achieving MCID in HAQ-DI
minimal clinically important difference (MCID; Δ ≥ 0.22, ≥0.25, and ≥0.5) in Health Assessment Questionnaire Disability Index (HAQ-DI)
Measured: Up to 24 months
Mean time for patients to achieve MCID in HAQ-DI
Length of time from treatment initiation to a Δ ≥ 0.22, ≥0.25, and ≥0.5 in HAQ-DI
Measured: Up to 24 months
Number of patients achieving clinically meaningful improvement
Number of patients achieving clinically meaningful improvement as measured by a decrease in CDAI of ≥ 20 or DAS28-CRP ≥ 1.2
Measured: Up to 24 months
Mean time for patients to achieve clinically meaningful improvement
Length of time from treatment initiation to a decrease in CDAI of ≥ 20 or DAS28-CRP ≥ 1.2
Measured: Up to 24 months
Number of patients achieving patient expectations for treatment of their RA
Assessed using simple Visual Analogue Scales (VAS)
Measured: Up to 24 months
Change from baseline in DAS28-CRP score
Measured by investigator assessment
Measured: Baseline up to 24 months
Change from baseline in CDAI score
Measured by investigator assessment
Measured: Baseline up to 24 months
Change from baseline in SDAI score
Measured by investigator assessment
Measured: Baseline up to 24 months
Change from baseline in RAPID3 score
Measured by investigator assessment
Measured: Baseline up to 24 months
Change from baseline in Tender Joint Count of 28 joints (TJC28) score
Measured by patient assessment
Measured: Baseline up to 24 months
Change from baseline in Swollen Joint Count of 28 joints (SJC28) score
Measured by patient assessment
Measured: Baseline up to 24 months
Change from baseline in HAQ-DI score
Measured by patient assessment
Measured: Baseline up to 24 months
Change from baseline in Work Productivity and Activity Impairment (WPAI) score
Measured by patient assessment
Measured: Baseline up to 24 months
Change from baseline in Patient Pain
Measured by patient assessment
Measured: Baseline up to 24 months
Change from baseline in Patient Fatigue
Measured by patient assessment
Measured: Baseline up to 24 months
Number of patients continuing treatment
Measured by investigator assessment
Measured: At 12 months
Number of patients continuing treatment
Measured by investigator assessment
Measured: At 24 months
Number of changes to Rheumatoid Arthritis (RA) treatment
Measured by investigator assessment
Measured: Up to 24 months
Distribution of reasons for changes to Rheumatoid Arthritis (RA) treatment
Measured by questionnaire
Measured: Up to 12 months
Incidence of treatment-emergent Adverse Events
Measured by investigator assessment
Measured: Up to 24 months
Time to achieve sustained CDAI LDA
Time to achieve sustained Clinical Disease Activity Index (CDAI) Low Disease Activity (LDA)
Measured: Up to 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study start31 Oct 2011
- Primary completion31 Oct 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 281 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
- NCT03274141
- Sponsor's protocol ID
- IM101-331
- Acronym
- ABC
- Status last verified
- Jan 2019
- First submitted
- 5 Sep 2017
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Pope JE, Sampalis JS, Haraoui B, Rampakakis E, Keating D, Allum F, Trepanier MO, Bessette L. CDAI trajectories in patients with rheumatoid arthritis treated with abatacept in real-world. Adv Rheumatol. 2026 Jun 23. doi: 10.1186/s42358-026-00554-y. Online ahead of print.
PubMed 42337779Bessette L, Haraoui B, Rampakakis E, Dembowy J, Trepanier MO, Pope J. Effectiveness of a treat-to-target strategy in patients with moderate to severely active rheumatoid arthritis treated with abatacept. Arthritis Res Ther. 2023 Sep 28;25(1):183. doi: 10.1186/s13075-023-03151-2.
PubMed 37759330
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Abatacept Best Care (ABC) Trial
- ClinicalTrials.gov ID
- NCT03274141
- Acronym / sponsor ID
- ABC / IM101-331
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 281 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2011 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 6 Sep 2017 (actual)
- 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 a 12 month prospective, multicenter, post-marketing, observational study to compare the effectiveness of a treat-to-target (T2T) disease management strategy vs. routine care (RC) in adult patients with moderate to severe rheumatoid arthritis (RA) treated with subcutaneous abatacept (Orencia - SC). Patients completing the study will be offered to participate in a 12-month extension of their follow-up provided that this is in agreement with the judgment of the treating physician.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T2T Patients | – | Other: Non-InterventionalRA patients managed with a treat-to-target (T2T) strategy |
| RC Patients | – | Other: Non-InterventionalRA patients managed with routine care(RC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with active RA defined as a CDAI > 10 for whom the treating physician has made the decision to initiate treatment with SC abatacept according to the approved Canadian product monograph and regional reimbursement criteria will be potentially eligible for inclusion in the study. The decision to treat the patient with SC abatacept must have been reached prior to and independently of considering the patient for study enrollment.
Key inclusion criteria (5 listed)
- 18 years of age or older.
- Active moderate to severe RA, defined as CDAI > 10.
- The treating physician has made the decision to initiate treatment with SC abatacept in accordance with the Canadian product monograph.
- Patient has provided a written informed consent and is able to complete the survey requirements.
- Patient fulfills the reimbursement criteria for treatment with SC abatacept under provincial or private health insurance reimbursement coverage.
Key exclusion criteria (7 listed)
- Has received abatacept (SC or IV) prior to the enrolment visit.
- Has failed more than one prior biologic DMARD therapy
- Has a history of autoimmune disease or of any joint inflammatory disease other than RA with the exception of concomitant secondary Sjogren's syndrome.
- Is participating in an ongoing clinical trial and/or has received treatment with an investigational agent within 4 weeks before starting treatment with SC abatacept.
- Is participating in another industry-sponsored observational 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 |
|---|---|---|
| Non-InterventionalNon-Interventional | Other | RC Patients, T2T Patients |
Primary outcome
Number of T2T patients achieving sustained CDAI LDA
Time frame: Approximately 1 year
Low Disease Activity (LDA) as determined by the Clinical Disease Activity Index (CDAI) is defined as a CDAI score of less than or equal to 10.
Number of RC patients achieving sustained CDAI LDA
Time frame: Approximately 1 year
Low Disease Activity (LDA) as determined by the Clinical Disease Activity Index (CDAI) is defined as a CDAI score of less than or equal to 10.
35 secondary outcomes
Number of patients achieving SDAI remission
Time frame: Up to 24 months
Mean time for patients to achieve SDAI remission
Time frame: Up to 24 months
Number of patients achieving CDAI remission
Time frame: Up to 24 months
Mean time for patients to achieve CDAI remission
Time frame: Up to 24 months
Number of patients achieving DAS28-CRP LDA
Time frame: Up to 24 months
Mean time for patients to achieve DAS28-CRP LDA
Time frame: Up to 24 months
Number of patients achieving DAS28-CRP remission
Time frame: Up to 24 months
Mean time for patients to achieve DAS28-CRP remission
Time frame: Up to 24 months
Number of patients achieving Boolean remission
Time frame: Up to 24 months
Mean time for patients to achieve Boolean remission
Time frame: Up to 24 months
Number of patients achieving RAPID3 LDA
Time frame: Up to 24 months
Mean time for patients to achieve RAPID3 LDA
Time frame: Up to 24 months
Number of patients achieving RAPID3 remission
Time frame: Up to 24 months
Mean time for patients to achieve RAPID3 remission
Time frame: Up to 24 months
Number of patients achieving MCID in HAQ-DI
Time frame: Up to 24 months
Mean time for patients to achieve MCID in HAQ-DI
Time frame: Up to 24 months
Number of patients achieving clinically meaningful improvement
Time frame: Up to 24 months
Mean time for patients to achieve clinically meaningful improvement
Time frame: Up to 24 months
Number of patients achieving patient expectations for treatment of their RA
Time frame: Up to 24 months
Change from baseline in DAS28-CRP score
Time frame: Baseline up to 24 months
Change from baseline in CDAI score
Time frame: Baseline up to 24 months
Change from baseline in SDAI score
Time frame: Baseline up to 24 months
Change from baseline in RAPID3 score
Time frame: Baseline up to 24 months
Change from baseline in Tender Joint Count of 28 joints (TJC28) score
Time frame: Baseline up to 24 months
Change from baseline in Swollen Joint Count of 28 joints (SJC28) score
Time frame: Baseline up to 24 months
Change from baseline in HAQ-DI score
Time frame: Baseline up to 24 months
Change from baseline in Work Productivity and Activity Impairment (WPAI) score
Time frame: Baseline up to 24 months
Change from baseline in Patient Pain
Time frame: Baseline up to 24 months
Change from baseline in Patient Fatigue
Time frame: Baseline up to 24 months
Number of patients continuing treatment
Time frame: At 12 months
Number of patients continuing treatment
Time frame: At 24 months
Number of changes to Rheumatoid Arthritis (RA) treatment
Time frame: Up to 24 months
Distribution of reasons for changes to Rheumatoid Arthritis (RA) treatment
Time frame: Up to 12 months
Incidence of treatment-emergent Adverse Events
Time frame: Up to 24 months
Time to achieve sustained CDAI LDA
Time frame: Up to 12 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 30 Jan 2019.
- Derived from this study: PubMed 42337779Pope JE, Sampalis JS, Haraoui B, Rampakakis E, Keating D, Allum F, Trepanier MO, Bessette L. CDAI trajectories in patients with rheumatoid arthritis treated with abatacept in real-world. Adv Rheumatol. 2026 Jun 23. doi: 10.1186/s42358-026-00554-y. Online ahead of print.
- Derived from this study: PubMed 37759330Bessette L, Haraoui B, Rampakakis E, Dembowy J, Trepanier MO, Pope J. Effectiveness of a treat-to-target strategy in patients with moderate to severely active rheumatoid arthritis treated with abatacept. Arthritis Res Ther. 2023 Sep 28;25(1):183. doi: 10.1186/s13075-023-03151-2.
- 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
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 Canada.
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 5 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 30 Jan 2019. 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 Canada. 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 T2T patients achieving sustained CDAI LDA (time frame: Approximately 1 year). 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?
On the ClinicalTrials.gov record for NCT03274141, which also lists 2 linked publications.
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 30 Jan 2019.