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
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.
- 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