Arthritis, RheumatoidNCT01555879
Real-world Clinical Efficacy of Abatacept in the T3 Data Registry
An observational study of Arthritis, Rheumatoid, run by Arthritis Northwest PLLC at 1 site in United States.
Trial summary
The purpose of this study is to assess the effectiveness of Abatacept in real-world clinical practice. The main hypothesis to be examined in this study is, "Abatacept's effectiveness results in a single real-world clinic (n = 100) are reproducible at another site (n ~= 200)". Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- Abatacept
- Type of treatment
- Injection or infusion
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to 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: All rheumatoid arthritis patients from a single site who have been on Abatacept for greater than 3 months.
Who may be able to join
- Diagnosed with rheumatoid arthritis
- Have used Abatacept for 3 or more months
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Abatacept in T3: A Characterization of Abatacept's Efficacy and Outcomes From a Real-Word Clinical Practice Information Hub on Novel Patient Sub-Groups
The purpose of this study is to assess the effectiveness of Abatacept in real-world clinical practice. The main hypothesis to be examined in this study is, "Abatacept's effectiveness results in a single real-world clinic (n = 100) are reproducible at another site (n ~= 200)".
Read the detailed description
Two secondary hypotheses that will be tested are:
- Abatacept aids in achieving low disease activity or clinical remission in patients of the following Rheumatoid Arthritis (RA) sub-groups: RF+/CCP+, RF+/CCP- RF-/CCP+ RF-/CCP-; first time on a bio-tech drug; having previously failed a biological drug; having interstitial lung disease; identified as disabled; twenty-eight individual joints identified as {swollen, painful, tender, deformed or having decreased range of motion}; on or not on oral DMARD; age; or gender.
- A database with sufficient attributes exists from which a patient's efficacy on abatacept is accurately predictable.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- Abatacept
- Keywords
- Retrospective, Database, Data warehouse, Data mining, Collaborative effectiveness, Comparative effectiveness, Outcome based medicine, Evidence based medicine
- 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
Also called Orencia Intravenous
As prescribed by a doctor for patient medical care.
| Study group | Role | What they receive |
|---|---|---|
| All patients | All patients in T3 who have used Abatacept for at least 3 months between 2009-03-17 and 2011-11-30. Receives: Drug: Abatacept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the efficacy of abatacept by analyzing the change in CDAI, DAS28, and RAPID3 scores.
Measured: Change from baseline in CDAI, DAS28, and RAPID3 scores at approximately 6 months.
Secondary outcomes (2)
Determine the efficacy of abatacept by analyzing the change in CDAI, DAS28, and RAPID3 scores.
Measured: Change from baseline in CDAI, DAS28, and RAPID3 scores at approximately 3 months.
Determine the efficacy of abatacept by analyzing the change in CDAI, DAS28, and RAPID3 scores.
Measured: Change from baseline in CDAI, DAS28, and RAPID3 scores at approximately 9 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionNov 2016
- Study completionNov 2016
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 Arthritis, RheumatoidStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arthritis Northwest PLLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Keith Knapp, Ph.D., Study director, Arthritis Northwest PLLCGary Craig, M.D., Principal investigator, Arthritis Northwest PLLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01555879
- Sponsor's protocol ID
- IM101-322
- Other IDs
- ANW_20110816
- Status last verified
- Nov 2017
- First submitted
- 29 Feb 2012
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Michael Schiff, Coralie Poncet, and Manuela Le Bars International Journal of Clinical Rheumatology 2010 5:5, 581-591
Pincus T, Swearingen CJ, Bergman M, Yazici Y. RAPID3 (Routine Assessment of Patient Index Data 3), a rheumatoid arthritis index without formal joint counts for routine care: proposed severity categories compared to disease activity score and clinical disease activity index categories. J Rheumatol. 2008 Nov;35(11):2136-47. doi: 10.3899/jrheum.080182. Epub 2008 Sep 15.
PubMed 18793006
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abatacept in T3: A Characterization of Abatacept's Efficacy and Outcomes From a Real-Word Clinical Practice Information Hub on Novel Patient Sub-Groups
- ClinicalTrials.gov ID
- NCT01555879
- Acronym / sponsor ID
- IM101-322
- Conditions
- Arthritis, Rheumatoid
- Keywords
- Retrospective, Database, Data warehouse, Data mining, Collaborative effectiveness, Comparative effectiveness, Outcome based medicine, Evidence based medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Arthritis Northwest PLLCIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- Mar 2012
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 16 Mar 2012 (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 the effectiveness of Abatacept in real-world clinical practice. The main hypothesis to be examined in this study is, "Abatacept's effectiveness results in a single real-world clinic (n = 100) are reproducible at another site (n ~= 200)".
Detailed description
Two secondary hypotheses that will be tested are:
- Abatacept aids in achieving low disease activity or clinical remission in patients of the following Rheumatoid Arthritis (RA) sub-groups: RF+/CCP+, RF+/CCP- RF-/CCP+ RF-/CCP-; first time on a bio-tech drug; having previously failed a biological drug; having interstitial lung disease; identified as disabled; twenty-eight individual joints identified as {swollen, painful, tender, deformed or having decreased range of motion}; on or not on oral DMARD; age; or gender.
- A database with sufficient attributes exists from which a patient's efficacy on abatacept is accurately predictable.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | – | Drug: AbataceptAll patients in T3 who have used Abatacept for at least 3 months between 2009-03-17 and 2011-11-30. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All rheumatoid arthritis patients from a single site who have been on Abatacept for greater than 3 months.
Key inclusion criteria (2 listed)
- Diagnosed with rheumatoid arthritis
- Have used Abatacept for 3 or more months
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AbataceptAlso: Orencia IntravenousAs prescribed by a doctor for patient medical care. | Drug | All patients |
Primary outcome
Determine the efficacy of abatacept by analyzing the change in CDAI, DAS28, and RAPID3 scores.
Time frame: Change from baseline in CDAI, DAS28, and RAPID3 scores at approximately 6 months.
2 secondary outcomes
Determine the efficacy of abatacept by analyzing the change in CDAI, DAS28, and RAPID3 scores.
Time frame: Change from baseline in CDAI, DAS28, and RAPID3 scores at approximately 3 months.
Determine the efficacy of abatacept by analyzing the change in CDAI, DAS28, and RAPID3 scores.
Time frame: Change from baseline in CDAI, DAS28, and RAPID3 scores at approximately 9 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 6 Nov 2017.
- BackgroundMichael Schiff, Coralie Poncet, and Manuela Le Bars International Journal of Clinical Rheumatology 2010 5:5, 581-591
- Background: PubMed 18793006Pincus T, Swearingen CJ, Bergman M, Yazici Y. RAPID3 (Routine Assessment of Patient Index Data 3), a rheumatoid arthritis index without formal joint counts for routine care: proposed severity categories compared to disease activity score and clinical disease activity index categories. J Rheumatol. 2008 Nov;35(11):2136-47. doi: 10.3899/jrheum.080182. Epub 2008 Sep 15.
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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.
Keith Knapp, Ph.D. study director
Arthritis Northwest PLLC
Gary Craig, M.D. principal investigator
Arthritis Northwest PLLC
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 Arthritis, Rheumatoid, run by Arthritis Northwest PLLC at 1 site in United States.
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 2 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: finished, as of the sponsor's last update on 6 Nov 2017. 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 United States. 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?
Determine the efficacy of abatacept by analyzing the change in CDAI, DAS28, and RAPID3 scores. (time frame: Change from baseline in CDAI, DAS28, and RAPID3 scores at approximately 6 months.). 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 NCT01555879, 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 6 Nov 2017.