Biotherapy Treatment on Features of Microcrystalline Polyarthritis (FUMBLE)

September 11, 2020 updated by: University Hospital, Brest

Features of Microcrystalline Polyarthritis Treated by Biologics and Evolution - FUMBLE Study

The study will involve adult patient who had received any biologic agent for microcrystalline disease in western France (Tours, Le Mans, Orléans, Angers, Rennes, Poitiers et Brest) between 01/01/2010 and 31/12/2018.

Investigators will answer retrospectively a questionnaire that covers patient and disease data, biologic agent use, efficacy and adverse events.

Study Overview

Status

Completed

Conditions

Detailed Description

This is a retrospective multicentric study of all patients treated by biologic for microcrystalline disease in France in western France (Tours, Le Mans, Nantes, La Roche sur Yon, Orléans, Angers, Rennes, Poitiers et Brest) between 01/01/2010 and 31/12/2018.

The investigators will collect all clinical (diagnosis of gout CCPD or hydroxyapatitis, tender and swollen joint count), biological (blood results: ESR, CRP, uric acid, synovial analysis), radiological data (X-rays performed and their description) .

Study Type

Observational

Enrollment (Actual)

46

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
      • Brest, France
        • CHRU de Brest

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Crystal- induced arthritis Treated by biologic

Description

Inclusion Criteria:

  • Crystal- induced arthritis
  • Treatment by biologic
  • In western France

Exclusion Criteria:

  • None

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 duration
Time Frame: one year
Duration of treatment by biologic in days
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of synovitis
Time Frame: inclusion
number of synovitis on 44
inclusion

Collaborators and Investigators

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

Sponsor

University Hospital, Brest

Investigators

  • Principal Investigator: Alain SARAUX, MD, PhD, CHU Brest

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)

May 1, 2019

Primary Completion (Actual)

June 1, 2020

Study Completion (Actual)

June 1, 2020

Study Registration Dates

First Submitted

March 29, 2019

First Submitted That Met QC Criteria

July 1, 2019

First Posted (Actual)

July 2, 2019

Study Record Updates

Last Update Posted (Actual)

September 14, 2020

Last Update Submitted That Met QC Criteria

September 11, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29BRC19.0056

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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