Crystal-Induced ArthritisFUMBLENCT04005625
Biotherapy Treatment on Features of Microcrystalline Polyarthritis
An observational study of Crystal-Induced Arthritis, run by University Hospital, Brest at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Crystal-Induced Arthritis
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2019to 1 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Crystal- induced arthritis Treated by biologic
Who may be able to join
- Crystal- induced arthritis
- Treatment by biologic
- In western France
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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) .
- Conditions
- Crystal-Induced Arthritis
- Keywords
- Crystal-Induced Arthritis
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment duration
Duration of treatment by biologic in days
Measured: one year
Secondary outcomes (1)
number of synovitis
number of synovitis on 44
Measured: inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start1 May 2019
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crystal-Induced ArthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alain SARAUX, MD, PhD, Principal investigator, CHU Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04005625
- Sponsor's protocol ID
- 29BRC19.0056
- Acronym
- FUMBLE
- Status last verified
- Sep 2020
- First submitted
- 29 Mar 2019
- Last updated
- 14 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Features of Microcrystalline Polyarthritis Treated by Biologics and Evolution - FUMBLE Study
- ClinicalTrials.gov ID
- NCT04005625
- Acronym / sponsor ID
- FUMBLE / 29BRC19.0056
- Conditions
- Crystal-Induced Arthritis
- Keywords
- Crystal-Induced Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 2 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Crystal- induced arthritis Treated by biologic
Key inclusion criteria (3 listed)
- Crystal- induced arthritis
- Treatment by biologic
- In western France
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Treatment duration
Time frame: one year
Duration of treatment by biologic in days
1 secondary outcome
number of synovitis
Time frame: inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Crystal-Induced Arthritis
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Gout Initiating Urate-loweringUrate-lowering Therapy, Gout Arthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alain SARAUX, MD, PhD principal investigator
CHU Brest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crystal-Induced Arthritis, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment duration (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2020.