Arthritis, RheumatoidNCT02886689
C.O.R.P.U.S.: Observational Cohort of Adult and Child Inflammatory Arthritis in France
An observational study of Arthritis, Rheumatoid and Spondylitis, Ankylosing, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
C.O.R.P.U.S. is the first French observatory of care practices in active inflammatory rheumatism of children and adults: rheumatoid arthritis, spondylarthropathy, and idiopathic juvenile arthritis, established under the auspices of national health authorities. Read more about this study
- Who is it for?
- Ages 3 to 75 years
- Conditions the study is for
- Arthritis, Rheumatoid, Spondylitis, Ankylosing, Arthritis, Psoriatic
- What is being tested?
- TNF-alpha antagonist and other biotherapy
- How many people
- 5,400 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2007to Dec 2011
- 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 3 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients suffering rheumatoid arthritis, spondyloarthropathy or idiopathic juvenile arthritis, recruited with rheumatologist in public and private practice
Who may be able to join
- Diagnosis by rheumatologist of rheumatoid arthritis
- DAS score > 3.2,
- any age of onset
- hand and feet x-ray within the past 3 months
- never received any biotherapy Diagnosis by rheumatologist of spondylarthropathy (ankylosing spondylitis, psoriasic arthritis)
- active disease
Show all 9Show fewer
- hand and feet (peripheral) or spine (axial) x-ray within the past 3 months Diagnosis by rheumatologist of idiopathic juvenile arthritis
- failure or intolerance to methotrexate
- x-ray within the past 3 months
Who cannot join
- received previous biotherapy
- other spondylarthropathy than ankylosing spondylitis, psoriasic arthritis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: C.O.R.P.U.S. : Observational Cohort of Active Rheumatoid Arthritis, Spondylarthropathy and Idiopathic Juvenile Arthritis in France
C.O.R.P.U.S. is the first French observatory of care practices in active inflammatory rheumatism of children and adults: rheumatoid arthritis, spondylarthropathy, and idiopathic juvenile arthritis, established under the auspices of national health authorities.
Its goal is to document safety, effectiveness in routine practice of various therapy, including biotherapy, of prescription or non-prescription over 5 years.
A cohort will be constituted including any new case of active disease (DAS 28 > 3,2, BASDAI > 4, failure of methotrexate), without previous prescription of biotherapy. Therefore, it will be possible to have patients non exposed to biotherapy (non indication, refusal, contraindication) compared to patients exposed to biotherapy, and to monitor adverse events occurrence as well as effectiveness in routine practice over time, according to prescription, maintenance or switch of various therapies.
Read the detailed description
Rational:
Biotherapies, including anti-TNF alpha have demonstrated effectiveness by several randomized clinical trials. The long-term use in clinical practice raise several questions regarding their safety, the risk-benefit ratio, and the actual advantage of such treatment in real life routine practice. Moreover such practice may considerably change, as far as increasing number of therapies are made available on the market.
On request form national health authorities in France, this phase 4 study will help monitor the changing strategies of prescription, the effectiveness and safety of these drugs.
Objectives :
- to determine the impact of biotherapy prescription in 3 category of diseases assessed on articular, functional and quality of life outcomes, as well as other drug consumption, and to monitor adverse events
- to determine the place of biotherapy in the sequence of treatments of patients
Study design:
an open cohort study to include patients over 3 years continuously, and to last at least 5 years form study start, with annual prospective follow-up. C.O.R.P.U.S. will be the first French observatory of prescription (or non-prescription) practices of biotherapy in first or switch treatment.
Sample:
Patients will be recruited by French network of private rheumatologist, and 40 university hospital rheumatology ward.
Data collected:
Socio-demographic, clinical parameters, function and quality of life know to have prognostic value
- Exposed patients will be those receiving any biotherapy
- Non-exposed patients will be those not receiving biotherapy : non indication, refusal, contraindication.
Outcomes:
radiographic joint lesions, function, adverse events, maintenance rate, drug consumption.
Sample size:
a sample of 1200 RA, 350 SPA and 300 IJA will be recruited every year for the first 3 years.
Adverse events:
Any adverse events will be reported to the national centre for pharmacovigilance.
IRB:
this protocol has been accepted by the CCTIRS and the CNIL.
Study monitoring:
A scientific committee has been constituted and is in charge of respect of any aspects of the protocol, particularly regarding safety A steering committee has been constituted and includes any drug company representative marketing such therapy, as well as representative of Inserm.
- Conditions
- Arthritis, Rheumatoid, Spondylitis, Ankylosing, Arthritis, Psoriatic, Arthitis, Juvenile Idiopathic
- Being tested
- TNF-alpha antagonist and other biotherapy
- Medical subject headings
- Arthritis, Rheumatoid, Spondylitis, Ankylosing, Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNF-alpha antagonist and other biotherapyDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | patients will be those receiving any biotherapy Receives: Drug: TNF-alpha antagonist and other biotherapy | |
| 2 | patients will be those not receiving biotherapy : non indication, refusal, contraindication. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug consumption
Measured: first year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2016 (estimated)
- Study startJan 2007
- Primary completionDec 2010
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- 5,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GUILLEMIN Francis, MD, Central Hospital, Nancy, France
- Investigators
- Francis Guillemin, MD, PhD, Study chair, Central Hospital, Nancy, FranceJacques Benichou, MD, PhD, Principal investigator, CHU, Rouen, FranceAlain Sasraux, MD, PhD, Principal investigator, CHU de la Cavale Blanche, Brest, FranceLoic Guillevin, MD, PhD, Principal investigator, Hopital Cochin, Paris, FranceJean Sibilia, MD, PhD, Principal investigator, CHU Hautepierre, Strasbourg, FranceAnne Marie Prieur, MD, PhD, Principal investigator, Hopital Necker, Paris , FranceDaniel Wendling, MD, PhD, Principal investigator, CHU Minioz, Besançon, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02886689
- Sponsor's protocol ID
- PCv1.6-12-11-05
- Status last verified
- Aug 2016
- First submitted
- 29 Aug 2016
- Last updated
- 1 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: open to partnership
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- C.O.R.P.U.S. : Observational Cohort of Active Rheumatoid Arthritis, Spondylarthropathy and Idiopathic Juvenile Arthritis in France
- ClinicalTrials.gov ID
- NCT02886689
- Acronym / sponsor ID
- PCv1.6-12-11-05
- Conditions
- Arthritis, Rheumatoid, Spondylitis, Ankylosing, Arthritis, Psoriatic, Arthitis, Juvenile Idiopathic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,400 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 1 Sep 2016 (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.
C.O.R.P.U.S. is the first French observatory of care practices in active inflammatory rheumatism of children and adults: rheumatoid arthritis, spondylarthropathy, and idiopathic juvenile arthritis, established under the auspices of national health authorities.
Its goal is to document safety, effectiveness in routine practice of various therapy, including biotherapy, of prescription or non-prescription over 5 years.
A cohort will be constituted including any new case of active disease (DAS 28 > 3,2, BASDAI > 4, failure of methotrexate), without previous prescription of biotherapy. Therefore, it will be possible to have patients non exposed to biotherapy (non indication, refusal, contraindication) compared to patients exposed to biotherapy, and to monitor adverse events occurrence as well as effectiveness in routine practice over time, according to prescription, maintenance or switch of various therapies.
Detailed description
Rational:
Biotherapies, including anti-TNF alpha have demonstrated effectiveness by several randomized clinical trials. The long-term use in clinical practice raise several questions regarding their safety, the risk-benefit ratio, and the actual advantage of such treatment in real life routine practice. Moreover such practice may considerably change, as far as increasing number of therapies are made available on the market.
On request form national health authorities in France, this phase 4 study will help monitor the changing strategies of prescription, the effectiveness and safety of these drugs.
Objectives :
- to determine the impact of biotherapy prescription in 3 category of diseases assessed on articular, functional and quality of life outcomes, as well as other drug consumption, and to monitor adverse events
- to determine the place of biotherapy in the sequence of treatments of patients
Study design:
an open cohort study to include patients over 3 years continuously, and to last at least 5 years form study start, with annual prospective follow-up. C.O.R.P.U.S. will be the first French observatory of prescription (or non-prescription) practices of biotherapy in first or switch treatment.
Sample:
Patients will be recruited by French network of private rheumatologist, and 40 university hospital rheumatology ward.
Data collected:
Socio-demographic, clinical parameters, function and quality of life know to have prognostic value
- Exposed patients will be those receiving any biotherapy
- Non-exposed patients will be those not receiving biotherapy : non indication, refusal, contraindication.
Outcomes:
radiographic joint lesions, function, adverse events, maintenance rate, drug consumption.
Sample size:
a sample of 1200 RA, 350 SPA and 300 IJA will be recruited every year for the first 3 years.
Adverse events:
Any adverse events will be reported to the national centre for pharmacovigilance.
IRB:
this protocol has been accepted by the CCTIRS and the CNIL.
Study monitoring:
A scientific committee has been constituted and is in charge of respect of any aspects of the protocol, particularly regarding safety A steering committee has been constituted and includes any drug company representative marketing such therapy, as well as representative of Inserm.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: TNF-alpha antagonist and other biotherapypatients will be those receiving any biotherapy |
| 2 | – | –patients will be those not receiving biotherapy : non indication, refusal, contraindication. |
Who may qualify
- Ages
- 3 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients suffering rheumatoid arthritis, spondyloarthropathy or idiopathic juvenile arthritis, recruited with rheumatologist in public and private practice
Key inclusion criteria (9 listed)
- Diagnosis by rheumatologist of rheumatoid arthritis
- DAS score > 3.2,
- any age of onset
- hand and feet x-ray within the past 3 months
- never received any biotherapy Diagnosis by rheumatologist of spondylarthropathy (ankylosing spondylitis, psoriasic arthritis)
Key exclusion criteria (2 listed)
- received previous biotherapy
- other spondylarthropathy than ankylosing spondylitis, psoriasic arthritis
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 |
|---|---|---|
| TNF-alpha antagonist and other biotherapy | Drug | 1 |
Primary outcome
Drug consumption
Time frame: first 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 1 Sep 2016.
- Individual participant dataSharing planned: Yes. open to partnership
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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.
Francis Guillemin, MD, PhD study chair
Central Hospital, Nancy, France
Jacques Benichou, MD, PhD principal investigator
CHU, Rouen, France
Alain Sasraux, MD, PhD principal investigator
CHU de la Cavale Blanche, Brest, France
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 and Spondylitis, Ankylosing, run by Central Hospital, Nancy, France at 1 site in France.
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 9 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 1 Sep 2016. 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 France. 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?
Drug consumption (time frame: first year). 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 1 Sep 2016.