Rheumatoid ArthritisSMAPNCT06059430
Cohort Project of Patients With Inflammatory Rheumatism
An observational study of Rheumatoid Arthritis and Spondyloarthritis, Axial, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Chronic inflammatory rheumatism (CIR) is a group of inflammatory diseases that affect the joints and spine and are related to an abnormal immune response. CIR includes many different forms of arthritis that manifest as painful and swollen joints, stiffness, especially in the morning and persisting even after exercise… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Spondyloarthritis, Axial, Psoriatic Arthritis
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 20 Sep 2023to 20 Dec 2043
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 over 18 years old with rheumatoid arthritis or axial and/or peripheral spondyloarthritis
Who may be able to join
- Patient over 18 years of age.
- Patients with rheumatoid arthritis meeting ACR/EULAR criteria or axial and/or peripheral spondyloarthritis meeting ASAS criteria.
- Patients who have failed or are intolerant of DMARDs (methotrexate or arava) for rheumatoid arthritis.
- Patients who have failed treatment with at least two NSAIDs for spondyloarthritis.
- Patients who require biologic/synthetic therapy or patients already receiving biologic or synthetic therapy.
Who cannot join
- Patient under curatorship.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Nice University Hospital
Nice, 06000
Christian Roux, PUPH, 0492034591, roux.c2@chu-nice.fr
Christian Roux, PUPH
About this study
Official title: Cohort Project of Patients With Inflammatory Rheumatism (Rheumatoid Arthritis, Axial and Peripheral Spondyloarthritis Including Psoriatic Arthritis)
Chronic inflammatory rheumatism (CIR) is a group of inflammatory diseases that affect the joints and spine and are related to an abnormal immune response. CIR includes many different forms of arthritis that manifest as painful and swollen joints, stiffness, especially in the morning and persisting even after exercise, and limited joint mobility. CIR can also affect bones, cartilage, ligaments, tendons and muscles. Some may affect other organs. These symptoms can lead to a reduced quality of life, limited physical activity and progressive structural and functional deterioration of the joints.
Current treatment for CIR is aimed at reducing inflammation and relieving pain. Anti-inflammatory medications such as corticosteroids and non-steroidal anti-inflammatory drugs can be used to relieve pain and inflammation. Biotherapies can also be used to modify the progression of the disease. On the other hand, regular exercise can help strengthen the muscles that support the affected joints and improve mobility. Physical therapies, such as physical and occupational therapy, can also help improve mobility and relieve pain.
Read more
Although there is no definitive cure for CIR early and appropriate treatment can help reduce symptoms and improve quality of life, as well as avoid the risk of developing complications such as lung, cardiovascular, kidney, ophthalmic, liver and other diseases.
It is in this context, in order to better understand CIR to improve the global management of patients, and to analyze the evolution of CIR over time in relation to the different treatments proposed, that the interest in creating a database of patients with CIR arises.
- Being tested
- no intervention
- Medical subject headings
- Arthritis, Rheumatoid, Axial Spondyloarthritis, Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| patient already on treatment | Patients already on biologic or synthetic TRT will be followed for 10 years Receives: Other: no intervention | |
| Naive patients | Patients who are naive to biological or synthetic treatments Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare rheumatoid arthritis activity
Measurement of disease activity for rheumatoid arthritis using the "Disease Activity Score 28" (DAS28) score ranging from 1 to 6.
Measured: evrey year during 10 years
compare psoriatic arthritis activity
Measurement of disease activity for psoriatic arthritis using the "Disease Activity Score 44" (DAS44) score ranging from 1 to 6.
Measured: every year during 10 years
compare spondylitis activity
Measurement of disease activity for spondylitis using the "Bath Ankylosing Spondylitis Activity Index" (BASDAI) score ranging from 1 to 10.
Measured: every year during 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start20 Sep 2023 (estimated)
- Primary completion20 Sep 2043 (estimated)
- Study completion20 Dec 2043 (estimated)
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 Centre Hospitalier Universitaire de NiceThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06059430
- Sponsor's protocol ID
- 23Rhumato03
- Acronym
- SMAP
- Status last verified
- Sep 2023
- First submitted
- 22 Sep 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Project of Patients With Inflammatory Rheumatism (Rheumatoid Arthritis, Axial and Peripheral Spondyloarthritis Including Psoriatic Arthritis)
- ClinicalTrials.gov ID
- NCT06059430
- Acronym / sponsor ID
- SMAP / 23Rhumato03
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 20 Sep 2023 (estimated)
- Primary completion
- 20 Sep 2043 (estimated)
- Study completion
- 20 Dec 2043 (estimated)
- First posted
- 28 Sep 2023 (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.
Chronic inflammatory rheumatism (CIR) is a group of inflammatory diseases that affect the joints and spine and are related to an abnormal immune response. CIR includes many different forms of arthritis that manifest as painful and swollen joints, stiffness, especially in the morning and persisting even after exercise, and limited joint mobility. CIR can also affect bones, cartilage, ligaments, tendons and muscles. Some may affect other organs. These symptoms can lead to a reduced quality of life, limited physical activity and progressive structural and functional deterioration of the joints.
Current treatment for CIR is aimed at reducing inflammation and relieving pain. Anti-inflammatory medications such as corticosteroids and non-steroidal anti-inflammatory drugs can be used to relieve pain and inflammation. Biotherapies can also be used to modify the progression of the disease. On the other hand, regular exercise can help strengthen the muscles that support the affected joints and improve mobility. Physical therapies, such as physical and occupational therapy, can also help improve mobility and relieve pain.
Although there is no definitive cure for CIR early and appropriate treatment can help reduce symptoms and improve quality of life, as well as avoid the risk of developing complications such as lung, cardiovascular, kidney, ophthalmic, liver and other diseases.
It is in this context, in order to better understand CIR to improve the global management of patients, and to analyze the evolution of CIR over time in relation to the different treatments proposed, that the interest in creating a database of patients with CIR arises.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient already on treatment | – | Other: no interventionPatients already on biologic or synthetic TRT will be followed for 10 years |
| Naive patients | – | Other: no interventionPatients who are naive to biological or synthetic treatments |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 18 years old with rheumatoid arthritis or axial and/or peripheral spondyloarthritis
Key inclusion criteria (5 listed)
- Patient over 18 years of age.
- Patients with rheumatoid arthritis meeting ACR/EULAR criteria or axial and/or peripheral spondyloarthritis meeting ASAS criteria.
- Patients who have failed or are intolerant of DMARDs (methotrexate or arava) for rheumatoid arthritis.
- Patients who have failed treatment with at least two NSAIDs for spondyloarthritis.
- Patients who require biologic/synthetic therapy or patients already receiving biologic or synthetic therapy.
Key exclusion criteria (1 listed)
- Patient under curatorship.
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 |
|---|---|---|
| no interventionno intervention | Other | Naive patients, patient already on treatment |
Primary outcome
compare rheumatoid arthritis activity
Time frame: evrey year during 10 years
Measurement of disease activity for rheumatoid arthritis using the "Disease Activity Score 28" (DAS28) score ranging from 1 to 6.
compare psoriatic arthritis activity
Time frame: every year during 10 years
Measurement of disease activity for psoriatic arthritis using the "Disease Activity Score 44" (DAS44) score ranging from 1 to 6.
compare spondylitis activity
Time frame: every year during 10 years
Measurement of disease activity for spondylitis using the "Bath Ankylosing Spondylitis Activity Index" (BASDAI) score ranging from 1 to 10.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: No
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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.
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 Rheumatoid Arthritis and Spondyloarthritis, Axial, run by Centre Hospitalier Universitaire de Nice 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 5 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: opening soon, as of the sponsor's last update on 28 Sep 2023. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact christian Roux, PUPH (0492034591, roux.c2@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compare rheumatoid arthritis activity (time frame: evrey year during 10 years). The study lists 3 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 28 Sep 2023.