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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03076866
Recruitment Status : Recruiting
First Posted : March 10, 2017
Last Update Posted : March 15, 2017
Information provided by (Responsible Party):
Service de Rhumatologie, Centre Hospitalier Universitaire de Nice

Brief Summary:
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)

Condition or disease Intervention/treatment
Inflammatory Disease Rheumatoid Arthritis Spondyloarthritis Other: observational follow-up:clinical, radiological et biological

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

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 20 Years
Official Title: Suivi Prospectif Des Patients Presentant un Rhumatisme Inflammatoire Chronique
Actual Study Start Date : January 1, 2001
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2020

Primary Outcome Measures :
  1. 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)

Secondary Outcome Measures :
  1. 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

Other Outcome Measures:
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
all patients with a inflammatory disease (rheumatoid arthritis and spondyloarthritis) follow-up in the rheumatologic department

Inclusion Criteria:

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

Exclusion Criteria:

  • Patient under guardianship

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03076866

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Contact: christian H roux, PhD 492035512

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rheumatology department CHU nice Recruiting
Nice, France, 06000
Contact: christian H ROUX, PhD    492035512   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
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Principal Investigator: christian roux, PhD Centre Hospitalier Universitaire de Nice

Additional Information:

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Responsible Party: Service de Rhumatologie, Professor, Centre Hospitalier Universitaire de Nice Identifier: NCT03076866     History of Changes
Other Study ID Numbers: 260
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: March 15, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Spinal Diseases
Bone Diseases