SMAP: Cohort Project of Patients With Inflammatory Rheumatism

Sponsor
Centre Hospitalier Universitaire de Nice (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06059430
Collaborator
(none)
1,000
1
243
4.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: no intervention

Study Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Cohort Project of Patients With Inflammatory Rheumatism (Rheumatoid Arthritis, Axial and Peripheral Spondyloarthritis Including Psoriatic Arthritis)
Anticipated Study Start Date :
Sep 20, 2023
Anticipated Primary Completion Date :
Sep 20, 2043
Anticipated Study Completion Date :
Dec 20, 2043

Arms and Interventions

Arm Intervention/Treatment
patient already on treatment

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

Other: no intervention
no intervention

Naive patients

Patients who are naive to biological or synthetic treatments

Other: no intervention
no intervention

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nice University Hospital Nice France 06000

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Nice

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT06059430
Other Study ID Numbers:
  • 23Rhumato03
First Posted:
Sep 28, 2023
Last Update Posted:
Sep 28, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 28, 2023