Cohort Project of Patients With Inflammatory Rheumatism

Rheumatoid Arthritis Clinical Trial

— SMAP  

Official title:

Cohort Project of Patients With Inflammatory Rheumatism (Rheumatoid Arthritis, Axial and Peripheral Spondyloarthritis Including Psoriatic Arthritis)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06059430
• Other study ID #: 23Rhumato03
• Status: Not yet recruiting
• Start date: September 20, 2023
• Est. completion date: December 20, 2043

Study information

• Verified date: September 2023
• Source: Centre Hospitalier Universitaire de Nice
• Contact: christian Roux, PUPH
• Phone: 0492034591
• Email: roux.c2[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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, 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: December 20, 2043
• Est. primary completion date: September 20, 2043
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Patient under curatorship.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Arthritis, Rheumatoid
• Axial Spondyloarthritis
• Psoriatic Arthritis
• Rheumatic Diseases
• Rheumatic Fever
• Rheumatoid Arthritis
• Spondylarthritis
• Spondylitis
• Spondyloarthritis, Axial

Intervention

Other:
• no intervention
no intervention

Locations

Country	Name	City	State
France	Nice University Hospital	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	compare rheumatoid arthritis activity	Measurement of disease activity for rheumatoid arthritis using the "Disease Activity Score 28" (DAS28) score ranging from 1 to 6.	evrey year during 10 years
Primary	compare psoriatic arthritis activity	Measurement of disease activity for psoriatic arthritis using the "Disease Activity Score 44" (DAS44) score ranging from 1 to 6.	every year during 10 years
Primary	compare spondylitis activity	Measurement of disease activity for spondylitis using the "Bath Ankylosing Spondylitis Activity Index" (BASDAI) score ranging from 1 to 10.	every year during 10 years