Rheumatoid ArthritisNCT01088321
Safety Study of Abatacept to Treat Rheumatoid Arthritis (A)
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 infection 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?
- Any age
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 81,332 participants
- Where
- No sites listed yet
- Study dates
- Mar 2005to Nov 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: United Healthcare
Who may be able to join
- Diagnosis of rheumatoid arthritis
- Claims indicating infusion, injection, or dispensing of abatacept, a DMARD, or a BDM
- Age 18 years or older at the time of drug initiation
- Enrollment in the health plan at least 6 continuous months leading up to the time of study drug initiation
Who cannot join
- Below 18 years of age at the time of BDM or DMARD initiation
- Lacking six months of continuous enrollment prior to the initiation of one of the study drugs
About this study
Official title: Safety of Disease Modifying Antirheumatic Drug (DMARD) and Biologic Treatment of Rheumatoid Arthritis
The purpose of this study is to compare the incidence rates of infection 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 initiating abatacept | Not described | |
| Patients initiating other biologic disease-modifying drugs | Not described | |
| Pts initiate non-biologic disease-modify anti-rheumatic drugs | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infections, specifically hospitalized infection, hospitalized pneumonia, hospitalized and/or IV treated pneumonia, tuberculosis, herpes zoster, and opportunistic infection
Measured: Every four months throughout the study
Secondary outcomes (3)
Anaphylactic reactions
Measured: Every four months throughout the study
Multiple sclerosis, lupus, and psoriasis
Measured: Every four months throughout the study
Concomitant biologic use
Measured: Every four 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 startMar 2005
- Primary completionNov 2016
- Study completionNov 2016
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
- 81,332 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
- NCT01088321
- Sponsor's protocol ID
- IM101-045A
- Status last verified
- Dec 2016
- First submitted
- 12 Mar 2010
- Last updated
- 8 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Disease Modifying Antirheumatic Drug (DMARD) and Biologic Treatment of Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT01088321
- Acronym / sponsor ID
- IM101-045A
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81,332 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- 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 infection 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 initiating abatacept | – | – |
| Patients initiating other biologic disease-modifying drugs | – | – |
| Pts initiate non-biologic disease-modify anti-rheumatic drugs | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- United Healthcare
Key inclusion criteria (4 listed)
- Diagnosis of rheumatoid arthritis
- Claims indicating infusion, injection, or dispensing of abatacept, a DMARD, or a BDM
- Age 18 years or older at the time of drug initiation
- Enrollment in the health plan at least 6 continuous months leading up to the time of study drug initiation
Key exclusion criteria (2 listed)
- Below 18 years of age at the time of BDM or DMARD initiation
- Lacking six months of continuous enrollment prior to the initiation of one of the study drugs
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
Infections, specifically hospitalized infection, hospitalized pneumonia, hospitalized and/or IV treated pneumonia, tuberculosis, herpes zoster, and opportunistic infection
Time frame: Every four months throughout the study
3 secondary outcomes
Anaphylactic reactions
Time frame: Every four months throughout the study
Multiple sclerosis, lupus, and psoriasis
Time frame: Every four months throughout the study
Concomitant biologic use
Time frame: Every four months throughout the study
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 8 Dec 2016.
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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 4 inclusion and 2 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 8 Dec 2016. 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?
Infections, specifically hospitalized infection, hospitalized pneumonia, hospitalized and/or IV treated pneumonia, tuberculosis, herpes zoster, and opportunistic infection (time frame: Every four 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 8 Dec 2016.