Rheumatoid ArthritisNCT01088360
Safety Study of Abatacept to Treat Rheumatoid Arthritis (B)
An observational study of Rheumatoid Arthritis, run by Bristol-Myers Squibb.
Trial summary
The purpose of this study is to compare the incidence rates of targeted infections, malignancies and mortality among patients with rheumatoid arthritis who are treated with abatacept and those who are treated with other anti-rheumatic medications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 20,000 participants
- Where
- No sites listed yet
- Study dates
- 31 Mar 2005to 30 Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients being treated for rheumatoid arthritis in the US
Who may be able to join
- Signed informed consent
- Diagnosis of rheumatoid arthritis
- > 18 years at index treatment initiation or switch
- Starting treatment with abatacept or new disease-modifying anti-rheumatic drug (including switching or adding) or biologic disease modifying drug.
- Read/write English
Who cannot join
- None
About this study
Official title: An Observational Cohort to Assess Safety and Outcomes in Patients Treated With Abatacept and Other Anti-Rheumatic Therapies
The purpose of this study is to compare the incidence rates of targeted infections, malignancies and mortality among patients with rheumatoid arthritis who are treated with abatacept and those who are treated with other anti-rheumatic medications.
- Conditions
- Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with rheumatoid arthritis initiating abatacept | Not described | |
| Pts with RA initiating other biologic disease-modifying drugs | Not described | |
| Pts w/ RA non-biologic disease-modifying anti-rheumatic drugs | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Key safety outcomes (targeted infections, malignancies, mortality)
Measured: Every 6 months throughout the study
Secondary outcomes (4)
Patient-reported infusion reactions
Measured: Every 6 months throughout the study
Multiple sclerosis, lupus, and psoriasis
Measured: Every 6 months throughout the study
Adverse events in pregnant women who receive abatacept
Measured: Every 6 months throughout the study
Adverse events in subjects on abatacept who receive concomitant biologics
Measured: Every 6 months throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2010 (estimated)
- Study start31 Mar 2005
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Data Bank for Rheumatic Diseases (NDB)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01088360
- Sponsor's protocol ID
- IM101-045B
- Status last verified
- Jan 2019
- First submitted
- 12 Mar 2010
- Last updated
- 18 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Cohort to Assess Safety and Outcomes in Patients Treated With Abatacept and Other Anti-Rheumatic Therapies
- ClinicalTrials.gov ID
- NCT01088360
- Acronym / sponsor ID
- IM101-045B
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- National Data Bank for Rheumatic Diseases (NDB)
- Study start
- 31 Mar 2005 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 17 Mar 2010 (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 compare the incidence rates of targeted infections, malignancies and mortality among patients with rheumatoid arthritis who are treated with abatacept and those who are treated with other anti-rheumatic medications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with rheumatoid arthritis initiating abatacept | – | – |
| Pts with RA initiating other biologic disease-modifying drugs | – | – |
| Pts w/ RA non-biologic disease-modifying anti-rheumatic drugs | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients being treated for rheumatoid arthritis in the US
Key inclusion criteria (5 listed)
- Signed informed consent
- Diagnosis of rheumatoid arthritis
- > 18 years at index treatment initiation or switch
- Starting treatment with abatacept or new disease-modifying anti-rheumatic drug (including switching or adding) or biologic disease modifying drug.
- Read/write English
Key exclusion criteria (1 listed)
- None
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
Key safety outcomes (targeted infections, malignancies, mortality)
Time frame: Every 6 months throughout the study
4 secondary outcomes
Patient-reported infusion reactions
Time frame: Every 6 months throughout the study
Multiple sclerosis, lupus, and psoriasis
Time frame: Every 6 months throughout the study
Adverse events in pregnant women who receive abatacept
Time frame: Every 6 months throughout the study
Adverse events in subjects on abatacept who receive concomitant biologics
Time frame: Every 6 months throughout the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2019.
- BMS Clinical Trial InformationLink 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
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 5 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 18 Jan 2019. 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?
This study is still under way. Results are not available in the source record yet.
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?
Key safety outcomes (targeted infections, malignancies, mortality) (time frame: Every 6 months throughout the study). 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 18 Jan 2019.