Rheumatoid ArthritisNCT03331393
The Value of Orencia in Rapidly Progressing Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis, run by Bristol-Myers Squibb at 7 sites in United States.
Trial summary
The purpose of this study is to investigate the value of Orencia in rapidly progressing Rheumatoid Arthritis (RA). 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?
- Non-interventional
- How many people
- 265 participants
- Where
- 7 sitesUnited States
- Study dates
- 16 Mar 2017to 17 Jan 2019
- 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: Rapidly-progressing RA patients initiating treatment with abatacept or TNFi at approximately 10 rheumatology practices across the US.
Who may be able to join
- 18 years of age at enrollment
- Confirmed diagnosed with RA
- Initiated first-line treatment with abatacept, adalimumab, etanercept, or infliximab with a record of the start date at the practice site
Who cannot join
- Does not have at least 1 or more poor RA prognostic factor: Evidence of joint erosions, Positive anti-CCP autoantibodies, Positive RF autoantibodies, Increased CRP levels, Increased ESR levels
- Was followed at the site for less than 1 year since biologic treatment initiation
- Patients with autoimmune diseases: Crohn's, ankylosing spondylitis, ulcerative colitis, psoriatic arthritis, anal fistula
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Local Institution
Beverly Hills, California, 90212
Local Institution
Coeur d'Alene, Idaho, 83814-2644
Local Institution - 0007
Eagan, Minnesota, 55121
Local Institution - 0005
Gainesville, Georgia, 30501
Medication Management, LLC
Greensboro, North Carolina, 27408
Local Institution
Myrtle Beach, South Carolina, 29572
Local Institution
Richland, Washington, 99352
About this study
Official title: The Value of Orencia in Rapidly Progressing Rheumatoid Arthritis: A Chart Review Study
The purpose of this study is to investigate the value of Orencia in rapidly progressing Rheumatoid Arthritis (RA).
- Conditions
- Rheumatoid Arthritis
- Being tested
- Non-interventional
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventionalOther
Non-interventional
| Study group | Role | What they receive |
|---|---|---|
| RA patients treated with Abatacept | Treated with Abatacept as a first-line biologic Receives: Other: Non-interventional | |
| RA patients treated with TNFi | Treated with Tumor necrosis factor inhibitor (TNFi) as a first-line biologic Receives: Other: Non-interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients discontinuing treatment before completing 12 months of therapy
Measured: approximately 1 year
time from treatment initiation to discontinuation
Measured: approximately 1 year
Secondary outcomes (6)
Distribution of Healthcare Resource Utilization (HCRU)
Measured: approximately 1 year
Disease Activity Score
Disease Activity Score (DAS)
Measured: approximately 1 year
Health Assessment Questionnaire
Health Assessment Questionnaire (HAQ)
Measured: approximately 1 year
C-reactive Protein Levels
C-reactive protein (CRP) levels
Measured: approximately 1 year
Erythrocyte Sedimentation Rate
Erythrocyte sedimentation rate (ESR) levels
Measured: approximately 1 year
Joint Erosions
Measured by radiographic reports
Measured: approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start16 Mar 2017
- Primary completion17 Jan 2019
- Study completion17 Jan 2019
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
- 265 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
- NCT03331393
- Sponsor's protocol ID
- IM101-686
- Status last verified
- Jul 2022
- First submitted
- 17 Oct 2017
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Orencia in Rapidly Progressing Rheumatoid Arthritis: A Chart Review Study
- ClinicalTrials.gov ID
- NCT03331393
- Acronym / sponsor ID
- IM101-686
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 16 Mar 2017 (actual)
- Primary completion
- 17 Jan 2019 (actual)
- Study completion
- 17 Jan 2019 (actual)
- First posted
- 6 Nov 2017 (actual)
- 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 investigate the value of Orencia in rapidly progressing Rheumatoid Arthritis (RA).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RA patients treated with Abatacept | – | Other: Non-interventionalTreated with Abatacept as a first-line biologic |
| RA patients treated with TNFi | – | Other: Non-interventionalTreated with Tumor necrosis factor inhibitor (TNFi) as a first-line biologic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Rapidly-progressing RA patients initiating treatment with abatacept or TNFi at approximately 10 rheumatology practices across the US.
Key inclusion criteria (3 listed)
- 18 years of age at enrollment
- Confirmed diagnosed with RA
- Initiated first-line treatment with abatacept, adalimumab, etanercept, or infliximab with a record of the start date at the practice site
Key exclusion criteria (4 listed)
- Does not have at least 1 or more poor RA prognostic factor: Evidence of joint erosions, Positive anti-CCP autoantibodies, Positive RF autoantibodies, Increased CRP levels, Increased ESR levels
- Was followed at the site for less than 1 year since biologic treatment initiation
- Patients with autoimmune diseases: Crohn's, ankylosing spondylitis, ulcerative colitis, psoriatic arthritis, anal fistula
- Other protocol defined inclusion/exclusion criteria could apply
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 |
|---|---|---|
| Non-interventionalNon-interventional | Other | RA patients treated with Abatacept, RA patients treated with TNFi |
Primary outcome
number of patients discontinuing treatment before completing 12 months of therapy
Time frame: approximately 1 year
time from treatment initiation to discontinuation
Time frame: approximately 1 year
6 secondary outcomes
Distribution of Healthcare Resource Utilization (HCRU)
Time frame: approximately 1 year
Disease Activity Score
Time frame: approximately 1 year
Health Assessment Questionnaire
Time frame: approximately 1 year
C-reactive Protein Levels
Time frame: approximately 1 year
Erythrocyte Sedimentation Rate
Time frame: approximately 1 year
Joint Erosions
Time frame: approximately 1 year
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 Jul 2022.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink 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
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Bristol-Myers Squibb at 7 sites 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 3 inclusion and 4 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 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
number of patients discontinuing treatment before completing 12 months of therapy (time frame: approximately 1 year). The study lists 2 primary outcomes in all. 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 6 Jul 2022.