Confinement and Spondyloarthritis Treatment

May 12, 2020 updated by: Centre Hospitalier Universitaire de Nice

Impact of Confinement on the Treatment of Spondyloarthritis.

Evaluate the impact of confinement on treatment use in spondyloarthritis. Study hypothesis that with the confinement, subjects will stop their treatment. The main objective is to study the impact of confinement on treatment. And secondly to look for for specific psychological profile linked to the interruption of the treatment. the study population consists of patients with spondyloarthritis and belonging to a patient association (ACS). All patients over 18 are included. A mailing questionnaire will be send to all patients. data on diseases activity and treatment will be collected

Study Overview

Status

Unknown

Conditions

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 Contact

Study Contact Backup

Study Locations

  • France
      • Nice, France, 06300
        • Recruiting
        • CHU de Nice

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

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with spondyloarthritis and member of ACS patient association group

Description

Inclusion Criteria:

  • spondyloarthritis,
  • age over 18 ans
  • treatment by NSAID or biological treatment to be part of the patient association "ACS" (action contre les spondylarthropathies).

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
treatment use
Time Frame: 1 month
treatment continuation
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
activity of disease
Time Frame: 1 week
number of crisis
1 week
psychological aspects
Time Frame: 1 month
Ten Item Personality Inventory rated on a scale from 1, disagree strongly, to 7, agree strongly)
1 month
psychological aspects
Time Frame: 1 month
quality of life questionnaire (EQ-5D) evaluating mobility, self care, usual activity, pain and anxiety
1 month

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 (ACTUAL)

April 20, 2020

Primary Completion (ANTICIPATED)

May 15, 2020

Study Completion (ANTICIPATED)

May 15, 2020

Study Registration Dates

First Submitted

April 16, 2020

First Submitted That Met QC Criteria

April 20, 2020

First Posted (ACTUAL)

April 21, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 13, 2020

Last Update Submitted That Met QC Criteria

May 12, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20rhumatocovid01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

no data sharing plan has been established

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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