Cohort Project of Patients With Inflammatory Rheumatism

NCT06059430 | Not Yet Recruiting

• 1 other identifier: 23Rhumato03
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis; Spondyloarthritis, Axial; Psoriatic Arthritis

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

patient already on treatment

Patients already on biologic or synthetic TRT will be followed for 10 years

Other: no intervention

Naive patients

Patients who are naive to biological or synthetic treatments

Other: no intervention

Interventions

no intervention OTHER

no intervention

Naive patients; patient already on treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients over 18 years old with rheumatoid arthritis or axial and/or peripheral spondyloarthritis

You may qualify if:

• 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.

You may not qualify if:

• \- Patient under curatorship.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Nice University Hospital

Nice, 06000, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma and serum collection

MeSH Terms

Conditions

Arthritis, Rheumatoid; Axial Spondyloarthritis; Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Ankylosis; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases

Central Study Contacts

christian Roux, PUPH

CONTACT

0492034591; roux.c2@chu-nice.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: September 28, 2023
• Study Start: September 20, 2023
• Primary Completion (Estimated): September 20, 2043
• Study Completion (Estimated): December 20, 2043
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)