Cohort Project of Patients With Inflammatory Rheumatism (SMAP)

September 22, 2023 updated by: Centre Hospitalier Universitaire de Nice

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Nice, France, 06000
        • Nice University Hospital
        • Principal Investigator:
          • Christian ROUX, PUPH
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
evrey year during 10 years
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.
every year during 10 years
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.
every year during 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 20, 2023

Primary Completion (Estimated)

September 20, 2043

Study Completion (Estimated)

December 20, 2043

Study Registration Dates

First Submitted

September 22, 2023

First Submitted That Met QC Criteria

September 22, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 22, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23Rhumato03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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