SpondylarthritisCoEnvNCT01314547
Impact of Environmental Factors on Disease Activity in Spondyloarthritis (SPA): Results of the Prospective Co-Env Cohort
An observational study of Spondylarthritis and Primary Systemic Vasculitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Susceptibility to SPA has been shown to be largely genetically determined. The objective of this study was to prospectively investigate the impact of several environmental factors on disease activity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spondylarthritis, Primary Systemic Vasculitis
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2005to Dec 2011
- 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 SPA disease
Who may be able to join
- 18 years SPONDILARTHRITIS: modified New York criteria Systemic vasculitis: ACR criteria
Who cannot join
- no internet access
Trial locations and contacts
1 site in 1 country.
About this study
Susceptibility to SPA has been shown to be largely genetically determined. The objective of this study was to prospectively investigate the impact of several environmental factors on disease activity.
Read the detailed description
Susceptibility to SPA has been shown to be largely genetically determined but the contribution of environmental factors to disease evolution has not yet been elucidated. The objective of this study was to prospectively investigate the impact of several environmental factors on disease activity.
- Conditions
- Spondylarthritis, Primary Systemic Vasculitis
- Keywords
- Environment, spondylarthritis, vasculitis, stress, life event, vaccine
- Medical subject headings
- Spondylarthritis, Vasculitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on a disease activity rating scale
Score on a disease activity rating scale (quaterly,than monthly basis)
Measured: Six years
Secondary outcomes (1)
Ancillary studies will be possible with the available database
Ancillary studies will be possible with the available database
Measured: six years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2011 (estimated)
- Study startMar 2005
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondylarthritisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- THOMAS HANSLIK, PU-PH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01314547
- Sponsor's protocol ID
- AOM02020
- Acronym
- CoEnv
- Status last verified
- Nov 2010
- First submitted
- 11 Mar 2011
- Last updated
- 15 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Environmental Factors on Disease Activity in Spondyloarthritis (SPA): Results of the Prospective Co-Env Cohort
- ClinicalTrials.gov ID
- NCT01314547
- Acronym / sponsor ID
- CoEnv / AOM02020
- Conditions
- Spondylarthritis, Primary Systemic Vasculitis
- Keywords
- Environment, spondylarthritis, vasculitis, stress, life event, vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 14 Mar 2011 (estimated)
- 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.
Susceptibility to SPA has been shown to be largely genetically determined. The objective of this study was to prospectively investigate the impact of several environmental factors on disease activity.
Detailed description
Susceptibility to SPA has been shown to be largely genetically determined but the contribution of environmental factors to disease evolution has not yet been elucidated. The objective of this study was to prospectively investigate the impact of several environmental factors on disease activity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with SPA disease
Key inclusion criteria (1 listed)
- 18 years SPONDILARTHRITIS: modified New York criteria Systemic vasculitis: ACR criteria
Key exclusion criteria (1 listed)
- no internet access
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
Score on a disease activity rating scale
Time frame: Six years
Score on a disease activity rating scale (quaterly,than monthly basis)
1 secondary outcome
Ancillary studies will be possible with the available database
Time frame: six years
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 15 Oct 2012.
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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.
THOMAS HANSLIK, PU-PH principal investigator
Assistance Publique - Hôpitaux de Paris
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 Spondylarthritis and Primary Systemic Vasculitis, run by Assistance Publique - Hôpitaux de Paris 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 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 15 Oct 2012. 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?
Score on a disease activity rating scale (time frame: Six years). 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 15 Oct 2012.