Rheumatoid ArthritisNCT01694693
Description of Joint Population and Assessment of Impact on Health Status of Orencia in Patients With Rheumatoid Arthritis in France. A Database Analysis Based on SFR's ORA Long-term Cohort Study
An observational study of Rheumatoid Arthritis, run by Bristol-Myers Squibb.
Trial summary
Database analysis: To describe how Orencia is prescribed in France in Rheumatoid Arthritis (RA) To describe joint population of Orencia To assess the impact of the treatment on health status of the treated population as assessed by morbid-mortality criteria To describe therapeutic strategies and use of health services 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?
- Orencia
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 31 Jan 2018to 31 Dec 2018
- 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: Patients included in SFR's ORA Registry
Who may be able to join
- Adult outpatients, male or female aged ≥ 18 years old
- Diagnosed with a rheumatoid arthritis according to ACR criteria
- Treated with Orencia according to usual practice conditions from June 1st 2007
- Agreeing to participate
Who cannot join
- Patients treated by Orencia in the context of clinical trials
About this study
Database analysis:
- To describe how Orencia is prescribed in France in Rheumatoid Arthritis (RA)
- To describe joint population of Orencia
- To assess the impact of the treatment on health status of the treated population as assessed by morbid-mortality criteria
- To describe therapeutic strategies and use of health services
Read the detailed description
- Observational Model: Historic cohort generated from Société Française de Rhumatologie's (SFR) Orencia and Rheumatoid Arthritis (ORA) registry
- Sampling Method: all physicians and sites taking in charge RA patients received an invitation mailing to participate to ORA
- Minimum Age: 18 years old at Orencia initiation
- Conditions
- Rheumatoid Arthritis
- Being tested
- Orencia
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrenciaDrug
No Intervention
| Study group | Role | What they receive |
|---|---|---|
| RA patients treated by Orencia | RA patients treated by Orencia according to usual practice from June 1st 2007 Receives: Drug: Orencia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with first clinically significant Disease Activity Score (DAS) change
Change from DAS28 [C - reactive protein (CRP) and erythrocyte sedimentation rate (ESR)] measured at treatment initiation ≥ 1.2
DAS28 will be measured every 6 months during 5 years
Measured: Up to 5 Years
Number of patients with first response to treatment [according to definition of European League Against Rheumatism (EULAR) response criteria]
EULAR response will be measured every 6 months during 5 years
Measured: Up to 5 Years
Number of patients with first Low Disease Activity State (LDAS)
Change from DAS28 [C - reactive protein (CRP) and erythrocyte sedimentation rate (ESR)] measured at treatment initiation ≤ 3.2
DAS28 will be measured every 6 months during 5 years
Measured: Up to 5 Years
Number of patients with first Remission state
Change from DAS28 [C - reactive protein (CRP) and erythrocyte sedimentation rate (ESR)] measured at treatment initiation <2.6
DAS28 will be measured every 6 months during 5 years
Measured: Up to 5 Years
Number of patients disease progression with prior improvement
Measured: Up to 5 Years
Number of patients disease progression with no prior improvement
Measured: Up to 5 Years
Number of patients with modification of Orencia administration condition
Measured: Up to 5 Years
Number of patients discontinued and switched from Orencia
Measured: Up to 5 Years
Incidence rate of any type of Adverse events related to Orencia
Measured: Up to 5 Years
Number of patients with specific predefined events
Predefined events are severe infection, thromboembolic events, cancer, lymphoma, other autoimmune disease, cutaneous disorder, significant or persistent disability, death
Measured: Up to 5 Years
Response over the time will be assessed over 5 years on EULAR response, LDAS
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2012 (estimated)
- Study start31 Jan 2018 (estimated)
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Why it stopped: Business objectives have changed
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
- Other
- Time perspective
- Retrospective
- Enrolment
- 0 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
- NCT01694693
- Sponsor's protocol ID
- IM101-364
- Status last verified
- May 2017
- First submitted
- 24 Sep 2012
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Description of Joint Population and Assessment of Impact on Health Status of Orencia in Patients With Rheumatoid Arthritis in France. A Database Analysis Based on SFR's ORA Long-term Cohort Study
- ClinicalTrials.gov ID
- NCT01694693
- Acronym / sponsor ID
- IM101-364
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Business objectives have changed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2018 (estimated)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 27 Sep 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.
Database analysis:
- To describe how Orencia is prescribed in France in Rheumatoid Arthritis (RA)
- To describe joint population of Orencia
- To assess the impact of the treatment on health status of the treated population as assessed by morbid-mortality criteria
- To describe therapeutic strategies and use of health services
Detailed description
- Observational Model: Historic cohort generated from Société Française de Rhumatologie's (SFR) Orencia and Rheumatoid Arthritis (ORA) registry
- Sampling Method: all physicians and sites taking in charge RA patients received an invitation mailing to participate to ORA
- Minimum Age: 18 years old at Orencia initiation
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RA patients treated by Orencia | – | Drug: OrenciaRA patients treated by Orencia according to usual practice from June 1st 2007 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients included in SFR's ORA Registry
Key inclusion criteria (4 listed)
- Adult outpatients, male or female aged ≥ 18 years old
- Diagnosed with a rheumatoid arthritis according to ACR criteria
- Treated with Orencia according to usual practice conditions from June 1st 2007
- Agreeing to participate
Key exclusion criteria (1 listed)
- Patients treated by Orencia in the context of clinical trials
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 |
|---|---|---|
| OrenciaNo Intervention | Drug | RA patients treated by Orencia |
Primary outcome
Number of patients with first clinically significant Disease Activity Score (DAS) change
Time frame: Up to 5 Years
Change from DAS28 [C - reactive protein (CRP) and erythrocyte sedimentation rate (ESR)] measured at treatment initiation ≥ 1.2 DAS28 will be measured every 6 months during 5 years
Number of patients with first response to treatment [according to definition of European League Against Rheumatism (EULAR) response criteria]
Time frame: Up to 5 Years
EULAR response will be measured every 6 months during 5 years
Number of patients with first Low Disease Activity State (LDAS)
Time frame: Up to 5 Years
Change from DAS28 [C - reactive protein (CRP) and erythrocyte sedimentation rate (ESR)] measured at treatment initiation ≤ 3.2 DAS28 will be measured every 6 months during 5 years
Number of patients with first Remission state
Time frame: Up to 5 Years
Change from DAS28 [C - reactive protein (CRP) and erythrocyte sedimentation rate (ESR)] measured at treatment initiation <2.6 DAS28 will be measured every 6 months during 5 years
Number of patients disease progression with prior improvement
Time frame: Up to 5 Years
Number of patients disease progression with no prior improvement
Time frame: Up to 5 Years
Number of patients with modification of Orencia administration condition
Time frame: Up to 5 Years
Number of patients discontinued and switched from Orencia
Time frame: Up to 5 Years
Incidence rate of any type of Adverse events related to Orencia
Time frame: Up to 5 Years
Number of patients with specific predefined events
Time frame: Up to 5 Years
Predefined events are severe infection, thromboembolic events, cancer, lymphoma, other autoimmune disease, cutaneous disorder, significant or persistent disability, death
Response over the time will be assessed over 5 years on EULAR response, LDAS
Time frame: Up to 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
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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 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: withdrawn, as of the sponsor's last update on 10 May 2017. 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 was withdrawn before enrolling participants, so there are no results.
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 with first clinically significant Disease Activity Score (DAS) change (time frame: Up to 5 Years). The study lists 11 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 10 May 2017.