Impact of Environmental Factors on Disease Activity in Spondyloarthritis (SPA): Results of the Prospective Co-Env Cohort (CoEnv)
This study has been completed.
Sponsor:
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01314547
First received: March 11, 2011
Last updated: October 12, 2012
Last verified: November 2010
| Tracking Information | |||||
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| First Received Date ICMJE | March 11, 2011 | ||||
| Last Updated Date | October 12, 2012 | ||||
| Start Date ICMJE | March 2005 | ||||
| Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Score on a disease activity rating scale [ Time Frame: Six years ] [ Designated as safety issue: No ] Score on a disease activity rating scale (quaterly,than monthly basis) |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01314547 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Ancillary studies will be possible with the available database [ Time Frame: six years ] [ Designated as safety issue: No ] Ancillary studies will be possible with the available database |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Impact of Environmental Factors on Disease Activity in Spondyloarthritis (SPA): Results of the Prospective Co-Env Cohort | ||||
| Official Title ICMJE | Impact of Environmental Factors on Disease Activity in Spondyloarthritis (SPA): Results of the Prospective Co-Env Cohort | ||||
| Brief 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | patients with SPA disease |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 300 | ||||
| Completion Date | December 2011 | ||||
| Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: no internet access |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01314547 | ||||
| Other Study ID Numbers ICMJE | AOM02020 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Assistance Publique - Hôpitaux de Paris | ||||
| Study Sponsor ICMJE | Assistance Publique - Hôpitaux de Paris | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Assistance Publique - Hôpitaux de Paris | ||||
| Verification Date | November 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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