Rheumatoid ArthritisReACTIONNCT02037737
Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting
An observational study of Rheumatoid Arthritis, run by Bristol-Myers Squibb.
Trial summary
The purpose of this study is to assess Abatacept Intravenous (IV) effectiveness in patients with inadequate response to one or more conventional Disease Modifying Against Rheumatism (DMARDs) including Methotrexate in France, through the estimation of Abatacept retention rate over 2 years and reasons of discontinuation 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?
- Abatacept
- Type of treatment
- Injection or infusion
- How many people
- 153 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2016to 31 Jan 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: RA patients with inadequate response to one or more conventional DMARDs including Methotrexate and treated with Abatacept IV according to routine clinical practice in France
Who may be able to join
- All patients enrolled in ACTION with inadequate response to one or more conventional DMARDs including Methotrexate and treated with Abatacept IV will be included in ReACTION
- ACTION inclusion criteria for France were:
- Male or female subjects of more than 18 years old
- Patients with a diagnosis of established moderate to severe active RA
- Patients who at their physician's discretion are treated with Abatacept (initiated or already on treatment within 3 months) according to routine clinical practice
- Patients for whom baseline characteristics are available
- Patients consent for usage of their data in ACTION study
- Patients who were not included in any interventional clinical trial in RA
Who cannot join
None listed.
About this study
Official title: Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting in Patients With Inadequate Response to One or Several Conventional DMARDs Including Methotrexate in France. A Database Analysis Based on the ACTION Study
The purpose of this study is to assess Abatacept Intravenous (IV) effectiveness in patients with inadequate response to one or more conventional Disease Modifying Against Rheumatism (DMARDs) including Methotrexate in France, through the estimation of Abatacept retention rate over 2 years and reasons of discontinuation
Read the detailed description
Observational Model:
Other: ReACTION is a study using secondary data originally collected in ACTION study. In ACTION, data were collected prospectively from October 2010 up to 2015 at each clinical visit. In France, data collection started in June 2011
- Conditions
- Rheumatoid Arthritis
- Being tested
- Abatacept
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbataceptDrug
| Study group | Role | What they receive |
|---|---|---|
| RA patients on Abatacept IV | Rheumatoid Arthritis (RA) patients with inadequate response to one or more conventional DMARDs including Methotrexate and treated with Abatacept IV according to routine clinical practice in France Receives: Drug: Abatacept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abatacept IV effectiveness in patients with inadequate response to one or more conventional DMARDs including Methotrexate in France, through the estimation of Abatacept retention rate over 2 years and reasons of discontinuation
Measured: Up to 2 years of followup
Secondary outcomes (7)
Abatacept effectiveness in the treated population
Based on simplified disease activity score - 28 joints (DAS28), clinical disease activity index (CDAI), health assessment questionnaire (HAQ), and occurrence of serious adverse events
Measured: 3, 6, and 12 months and every 3 months up to 2 years of followup
Impact of patient and disease characteristics on treatment outcomes
Measured: Every 3 months up to 2 years of followup
Joint population of French patients with inadequate response to one or more conventional DMARDs including Methotrexate treated with Abatacept IV (demographics, medical history, disease characteristics, previous treatments)
Measured: Every 3 months up to 2 years of followup
Conditions of Abatacept IV utilization in first line of biologic agents (indication, dosage, administration schedule, treatment duration, concomitant treatments)
Measured: Every 3 months up to 2 years of followup
Therapeutic strategies over time including change in concomitants treatments
Measured: Every 3 months up to 2 years of followup
The healthcare resource use as assessed by number of visits to any rheumatologists, hospitalizations
Measured: Every 3 months up to 2 years of followup
Abatacept effectiveness in patients with inadequate response to one or more conventional DMARDs including Methotrexate of the patients treated with Abatacept IV according to Summary Product Characteristics (SmPC)
Measured: Every 3 months up to 2 years of followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2014 (estimated)
- Study start30 Sep 2016
- Primary completion31 Jan 2018
- Study completion31 Jan 2018
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
- Other
- Time perspective
- Retrospective
- Enrolment
- 153 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
- NCT02037737
- Sponsor's protocol ID
- IM101-409
- Acronym
- ReACTION
- Status last verified
- Feb 2018
- First submitted
- 21 Nov 2013
- Last updated
- 7 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting in Patients With Inadequate Response to One or Several Conventional DMARDs Including Methotrexate in France. A Database Analysis Based on the ACTION Study
- ClinicalTrials.gov ID
- NCT02037737
- Acronym / sponsor ID
- ReACTION / IM101-409
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2016 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 16 Jan 2014 (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 assess Abatacept Intravenous (IV) effectiveness in patients with inadequate response to one or more conventional Disease Modifying Against Rheumatism (DMARDs) including Methotrexate in France, through the estimation of Abatacept retention rate over 2 years and reasons of discontinuation
Detailed description
Observational Model:
Other: ReACTION is a study using secondary data originally collected in ACTION study. In ACTION, data were collected prospectively from October 2010 up to 2015 at each clinical visit. In France, data collection started in June 2011
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RA patients on Abatacept IV | – | Drug: AbataceptRheumatoid Arthritis (RA) patients with inadequate response to one or more conventional DMARDs including Methotrexate and treated with Abatacept IV according to routine clinical practice in France |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- RA patients with inadequate response to one or more conventional DMARDs including Methotrexate and treated with Abatacept IV according to routine clinical practice in France
Key inclusion criteria (8 listed)
- All patients enrolled in ACTION with inadequate response to one or more conventional DMARDs including Methotrexate and treated with Abatacept IV will be included in ReACTION
- Male or female subjects of more than 18 years old
- Patients with a diagnosis of established moderate to severe active RA
- Patients who at their physician's discretion are treated with Abatacept (initiated or already on treatment within 3 months) according to routine clinical practice
- Patients for whom baseline characteristics are available
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abatacept | Drug | RA patients on Abatacept IV |
Primary outcome
Abatacept IV effectiveness in patients with inadequate response to one or more conventional DMARDs including Methotrexate in France, through the estimation of Abatacept retention rate over 2 years and reasons of discontinuation
Time frame: Up to 2 years of followup
7 secondary outcomes
Abatacept effectiveness in the treated population
Time frame: 3, 6, and 12 months and every 3 months up to 2 years of followup
Impact of patient and disease characteristics on treatment outcomes
Time frame: Every 3 months up to 2 years of followup
Joint population of French patients with inadequate response to one or more conventional DMARDs including Methotrexate treated with Abatacept IV (demographics, medical history, disease characteristics, previous treatments)
Time frame: Every 3 months up to 2 years of followup
Conditions of Abatacept IV utilization in first line of biologic agents (indication, dosage, administration schedule, treatment duration, concomitant treatments)
Time frame: Every 3 months up to 2 years of followup
Therapeutic strategies over time including change in concomitants treatments
Time frame: Every 3 months up to 2 years of followup
The healthcare resource use as assessed by number of visits to any rheumatologists, hospitalizations
Time frame: Every 3 months up to 2 years of followup
Abatacept effectiveness in patients with inadequate response to one or more conventional DMARDs including Methotrexate of the patients treated with Abatacept IV according to Summary Product Characteristics (SmPC)
Time frame: Every 3 months up to 2 years of followup
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 7 Feb 2018.
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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
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Bristol-Myers Squibb.
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 8 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 7 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Abatacept IV effectiveness in patients with inadequate response to one or more conventional DMARDs including Methotrexate in France, through the estimation of Abatacept retention rate over 2 years and reasons of discontinuation (time frame: Up to 2 years of followup). 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 7 Feb 2018.