Rheumatoid ArthritisNCT01136707
Predictors of Adherence to Orencia
An observational study of Rheumatoid Arthritis, run by Bristol-Myers Squibb.
Trial summary
The purpose of this study is to examine the relationship between loading dose and adherence to Orencia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 422 participants
- Where
- No sites listed yet
- Study dates
- Dec 2009to Jul 2010
- 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: Commercial health plan members
Who may be able to join
- Patients will be identified based on the presence of first infusion claim during study period for Orencia
- At least 1 medical or facility claim for rheumatoid arthritis at the time of or 6 months prior to index date
- Patients are required to be continuously enrolled for a minimum pre-index and follow-up period as detailed below
- Patients with a minimum of 3 infusion claims for Orencia
- Only those patients will be included whose first 3 infusion claims occur within 84 days
Who cannot join
- Patients less than 18 years of age at index date.
- One or more diagnoses of regional enteritis (including Crohn's disease), ulcerative colitis, anal or intestinal fistula, ankylosing spondylitis or other inflammatory spondylopathy, psoriatic arthropathy, or psoriasis any time during the 6-month pre-index period
- Patients who switch between biologics within their first three infusion claims
- Restarts, defined as those patients who go back on Orencia after a gap of 42 days
- Patients who are on other biologics at the same time as Orencia
About this study
The purpose of this study is to examine the relationship between loading dose and adherence to Orencia.
- 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 new to Orencia | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of days on Orencia therapy
Measured: 6 months
Secondary outcomes (1)
Rheumatoid arthritis-related and total healthcare costs
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2010 (estimated)
- Study startDec 2009
- Primary completionJul 2010
- Study completionJul 2010
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
- Retrospective
- Enrolment
- 422 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01136707
- Sponsor's protocol ID
- IM101-266
- Status last verified
- Sep 2016
- First submitted
- 2 Jun 2010
- Last updated
- 16 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Adherence to Orencia
- ClinicalTrials.gov ID
- NCT01136707
- Acronym / sponsor ID
- IM101-266
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 422 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 3 Jun 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 examine the relationship between loading dose and adherence to Orencia.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with rheumatoid arthritis new to Orencia | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Commercial health plan members
Key inclusion criteria (5 listed)
- Patients will be identified based on the presence of first infusion claim during study period for Orencia
- At least 1 medical or facility claim for rheumatoid arthritis at the time of or 6 months prior to index date
- Patients are required to be continuously enrolled for a minimum pre-index and follow-up period as detailed below
- Patients with a minimum of 3 infusion claims for Orencia
- Only those patients will be included whose first 3 infusion claims occur within 84 days
Key exclusion criteria (5 listed)
- Patients less than 18 years of age at index date.
- One or more diagnoses of regional enteritis (including Crohn's disease), ulcerative colitis, anal or intestinal fistula, ankylosing spondylitis or other inflammatory spondylopathy, psoriatic arthropathy, or psoriasis any time during the 6-month pre-index period
- Patients who switch between biologics within their first three infusion claims
- Restarts, defined as those patients who go back on Orencia after a gap of 42 days
- Patients who are on other biologics at the same time as Orencia
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
Total number of days on Orencia therapy
Time frame: 6 months
1 secondary outcome
Rheumatoid arthritis-related and total healthcare costs
Time frame: 6 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 16 Sep 2016.
- For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htmLink 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 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 16 Sep 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?
Total number of days on Orencia therapy (time frame: 6 months). 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 16 Sep 2016.