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Biotherapy Treatment on Features of Microcrystalline Polyarthritis (FUMBLE)

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.
 
ClinicalTrials.gov Identifier: NCT04005625
Recruitment Status : Recruiting
First Posted : July 2, 2019
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Brief Summary:

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.


Condition or disease
Crystal-Induced Arthritis

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) .

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Features of Microcrystalline Polyarthritis Treated by Biologics and Evolution - FUMBLE Study
Actual Study Start Date : March 28, 2019
Estimated Primary Completion Date : March 28, 2021
Estimated Study Completion Date : June 20, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis




Primary Outcome Measures :
  1. Treatment duration [ Time Frame: one year ]
    Duration of treatment by biologic in days


Secondary Outcome Measures :
  1. number of synovitis [ Time Frame: inclusion ]
    number of synovitis on 44



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Crystal- induced arthritis Treated by biologic
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None

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 ClinicalTrials.gov identifier (NCT number): NCT04005625


Contacts
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Contact: Alain SARAUX, MD, PhD 2 98347267 ext 33 alain.saraux@chu-brest.fr

Locations
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France
CHRU de Brest Recruiting
Brest, France
Contact: Alain Saraux       alain.saraux@chu-brest.fr   
Sponsors and Collaborators
University Hospital, Brest
Investigators
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Principal Investigator: Alain SARAUX, MD, PhD CHU Brest
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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT04005625    
Other Study ID Numbers: 29BRC19.0056
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
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
Keywords provided by University Hospital, Brest:
Crystal-Induced Arthritis
Additional relevant MeSH terms:
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Arthritis
Joint Diseases
Musculoskeletal Diseases