Prospective Follow-up of Patients With Chronic Inflammatory Rheumatism (PPCRNice)

March 13, 2017 updated by: Service de Rhumatologie, Centre Hospitalier Universitaire de Nice

Suivi Prospectif Des Patients Presentant un Rhumatisme Inflammatoire Chronique

It is a prospective follow-up. The aim is to study the maintenance of therapeutic at 10 years and 20 years of inflammatory rheumatism (rheumatoid arthritis and spondyloarthritis)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

All subjects were followed up on a yearly basis collection with clinical data (weight, sex, age, comorbidities, treatment), biological (VS, CRP, ACPA, lipid balance, cross laps), radiology (hand and foot radiographs and ultrasonography ), BMO Measure

Study Type

Observational

Enrollment (Anticipated)

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 Locations

  • France
      • Nice, France, 06000
        • Recruiting
        • rheumatology department CHU nice
        • 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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

all patients with a inflammatory disease (rheumatoid arthritis and spondyloarthritis) follow-up in the rheumatologic department

Description

Inclusion Criteria:

  • More than 18 years
  • Rheumatoid arthritis meeting ACR criteria Spondyloarthritis meeting ASAS criteria

Exclusion Criteria:

  • Patient under guardianship

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
therapeutic maintenance at 20 years of follow-up
Time Frame: 20 years
All subjects benefit from an annual follow-up including a collection of clinical data (age, sex, weight, comorbidities, swelling and painful joints), biological (CRP, ACPA, cross laps, lipids), radiological, BMO measures (Hologic), and treatments (biological and synthetic DMARDS). Each rheumatologic modification or stop of treatment is transcribed. Therapeutic maintenance definition: modification in rheumatologic treatment (number of DMARDS at 20 years)
20 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
evolution of lipidics parameters at 20 years of follow-up
Time Frame: 20 years
lipidics parameters ( total, HDL, LDL cholesterol and tryglicerides) are collected each years and modifications/evolution of these parameters will be studied
20 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
evolution of BMD at 20 years of follow-up
Time Frame: 20 years
each 2 years during visit of follow up, BMD parameters (Hologic QDR 4500A measurements performed in pasteur 2 hospital: tscore, Zscore and BMD in in g/cm2) are collected. Osteopenia was defined by a T-score between -1 and -2.5 SD and osteoporosis by a T-score below -2.5 SD, in accordance with the World Health Organization guidelines. evolution of BMD will be studied in relation with rheumatologics treatments
20 years

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Nice

Investigators

  • Principal Investigator: christian roux, PhD, 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 (Actual)

January 1, 2001

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

February 23, 2017

First Submitted That Met QC Criteria

March 6, 2017

First Posted (Actual)

March 10, 2017

Study Record Updates

Last Update Posted (Actual)

March 15, 2017

Last Update Submitted That Met QC Criteria

March 13, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 260

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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