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NCT Number: NCT06059430

Cohort Project of Patients With Inflammatory Rheumatism

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

no intervention

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

christian Roux, PUPH

CONTACT

[email protected]

0492034591

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Acronym: SMAP

Important dates

Study start
2023
Primary completion
2043
Study completion
2043
First posted
Sep 28, 2023
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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