ArthritisNCT03926429
Features and Outcomes of Patients With Reactive Arthritis
An observational study of Arthritis, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
The aim of this study is to assess the incidence and the clinical and therapeutic characteristics of reactive arthritis and to compare them with those of a historical cohort. We hypothesised that improved hygiene together with prevention and treatment of sexually transmitted infections may have decreased the incidence… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis
- What is being tested?
- Standardised data collection
- How many people
- 58 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Feb 2013to 31 Dec 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with active reactive arthritis
Who may be able to join
- reactive arthritis diagnosed in one of the two rheumatology departments from Centre Hospitalier Lyon Sud or Besançon
Who cannot join
- presence of other known causes of arthritis, such as other defined spondyloarthritides, septic arthritis, Lyme disease, microcrystalline arthritis or rheumatoid arthritis
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU de Besançon
Besançon
Centre Hospitalier Lyon Sud
Pierre-Bénite
About this study
Official title: A Bicentre Retrospective Study of Features and Outcomes of Patients With Reactive Arthritis
The aim of this study is to assess the incidence and the clinical and therapeutic characteristics of reactive arthritis and to compare them with those of a historical cohort. We hypothesised that improved hygiene together with prevention and treatment of sexually transmitted infections may have decreased the incidence of reactive arthritis.
- Conditions
- Arthritis
- Being tested
- Standardised data collection
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardised data collectionOther
The following variables will be retrospectively assessed by medical record review using a standardised data collection form:demographics; gender, age; family or personal history of spondyloarthritis, psoriasis, uveitis, inflammatory bowel disease; clinical presentation; mono, oligo or polyarthritis, dactylitis, inflammatory joint pain, enthesopathy, axial symptoms, fever, extra-articular manifestations (conjunctivitis, anterior uveitis, circinate balanitis, skin rash); time interval between infection and musculoskeletal manifestations; causal microorganism if known, or triggering event; HLA-B27; radiographic sacroiliitis; treatments and outcomes (complete recovery at one year follow-up, relapse within 6 months after onset, or spondyloarthritis according to the ASAS criteria).
| Study group | Role | What they receive |
|---|---|---|
| Patient with reactive arthritis | Not described Receives: Other: Standardised data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the incidence of reactive arthritis in patients hospitalised in the rheumatology department
Incidence of reactive arthritis in patients hospitalised in the rheumatology department
Measured: December 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start1 Feb 2013
- Primary completion31 Dec 2014
- Study completion31 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabienne COURY-LUCAS, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03926429
- Sponsor's protocol ID
- FOPRA
- Status last verified
- Apr 2019
- First submitted
- 19 Apr 2019
- Last updated
- 24 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Bicentre Retrospective Study of Features and Outcomes of Patients With Reactive Arthritis
- ClinicalTrials.gov ID
- NCT03926429
- Acronym / sponsor ID
- FOPRA
- Conditions
- Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Feb 2013 (actual)
- Primary completion
- 31 Dec 2014 (actual)
- Study completion
- 31 Dec 2014 (actual)
- First posted
- 24 Apr 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 aim of this study is to assess the incidence and the clinical and therapeutic characteristics of reactive arthritis and to compare them with those of a historical cohort. We hypothesised that improved hygiene together with prevention and treatment of sexually transmitted infections may have decreased the incidence of reactive arthritis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with reactive arthritis | – | Other: Standardised data collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with active reactive arthritis
Key inclusion criteria (1 listed)
- reactive arthritis diagnosed in one of the two rheumatology departments from Centre Hospitalier Lyon Sud or Besançon
Key exclusion criteria (1 listed)
- presence of other known causes of arthritis, such as other defined spondyloarthritides, septic arthritis, Lyme disease, microcrystalline arthritis or rheumatoid arthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardised data collectionThe following variables will be retrospectively assessed by medical record review using a standardised data collection form:demographics; gender, age; family or personal history of spondyloarthritis, psoriasis, uveitis, inflammatory bowel disease; clinical presentation; mono, oligo or polyarthritis, dactylitis, inflammatory joint pain, enthesopathy, axial symptoms, fever, extra-articular manifestations (conjunctivitis, anterior uveitis, circinate balanitis, skin rash); time interval between infection and musculoskeletal manifestations; causal microorganism if known, or triggering event; HLA-B27; radiographic sacroiliitis; treatments and outcomes (complete recovery at one year follow-up, relapse within 6 months after onset, or spondyloarthritis according to the ASAS criteria). | Other | Patient with reactive arthritis |
Primary outcome
To determine the incidence of reactive arthritis in patients hospitalised in the rheumatology department
Time frame: December 2014
Incidence of reactive arthritis in patients hospitalised in the rheumatology department
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 24 Apr 2019.
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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.
Fabienne COURY-LUCAS, MD principal investigator
Hospices Civils de Lyon
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, run by Hospices Civils de Lyon at 2 sites 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 1 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 24 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
To determine the incidence of reactive arthritis in patients hospitalised in the rheumatology department (time frame: December 2014). 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 24 Apr 2019.