Prospective Follow-up of Patients With Chronic Inflammatory Rheumatism

Rheumatoid Arthritis Clinical Trial

— PPCRNice  

Official title:

Suivi Prospectif Des Patients Presentant un Rhumatisme Inflammatoire Chronique

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03076866
• Other study ID #: 260
• Status: Recruiting
• Phase: N/A
• First received: February 23, 2017
• Last updated: March 13, 2017
• Start date: January 1, 2001
• Est. completion date: January 1, 2020

Study information

• Verified date: March 2017
• Source: Centre Hospitalier Universitaire de Nice
• Contact: christian H roux, PhD
• Phone: 492035512
• Email: roux.c2[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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)

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• More than 18 years

• Rheumatoid arthritis meeting ACR criteria Spondyloarthritis meeting ASAS criteria

Exclusion Criteria:

• Patient under guardianship

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Inflammatory Disease
• Rheumatoid Arthritis
• Spondylarthritis
• Spondyloarthritis

Intervention

Other:
• observational follow-up:clinical, radiological et biological

Locations

Country	Name	City	State
France	rheumatology department CHU nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	evolution of BMD at 20 years of follow-up	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
Primary	therapeutic maintenance at 20 years of follow-up	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	evolution of lipidics parameters at 20 years of follow-up	lipidics parameters ( total, HDL, LDL cholesterol and tryglicerides) are collected each years and modifications/evolution of these parameters will be studied	20 years