Cohort Project of Patients With Inflammatory Rheumatism

Not yet recruiting

• Conditions: Spondyloarthritis, Axial; Psoriatic Arthritis; Rheumatoid Arthritis
• Interventions: Other: no intervention

• Registration Number: NCT06059430
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-09
• Study Start: 2023-09-20
• Study First Submitted: 2023-09-22
• Study First Submitted QC: 2023-09-22
• Last Update Submitted: 2023-09-22
• Study First Posted: 2023-09-28
• Last Update Posted: 2023-09-28
• Primary Completion: 2043-09-20
• Study Completion: 2043-12-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patient already on treatment	no intervention	Patients already on biologic or synthetic TRT will be followed for 10 years
Naive patients	no intervention	Patients who are naive to biological or synthetic treatments

Primary Outcome Measures

Name	Time	Method
compare rheumatoid arthritis activity	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	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	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.

Trial Locations

Locations (1)

Nice University Hospital; 🇫🇷 Nice, France