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Impact of Environmental Factors on Disease Activity in Spondyloarthritis (SPA): Results of the Prospective Co-Env Cohort (CoEnv)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01314547
First Posted: March 14, 2011
Last Update Posted: October 15, 2012
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. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  Purpose
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.

Condition
Spondylarthritis Primary Systemic Vasculitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Environmental Factors on Disease Activity in Spondyloarthritis (SPA): Results of the Prospective Co-Env Cohort

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Score on a disease activity rating scale [ Time Frame: Six years ]
    Score on a disease activity rating scale (quaterly,than monthly basis)


Secondary Outcome Measures:
  • Ancillary studies will be possible with the available database [ Time Frame: six years ]
    Ancillary studies will be possible with the available database


Enrollment: 300
Study Start Date: March 2005
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
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.
  Eligibility

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with SPA disease
Criteria

Inclusion Criteria:

  • 18 years SPONDILARTHRITIS: modified New York criteria Systemic vasculitis: ACR criteria

Exclusion Criteria:

no internet access

  Contacts and Locations
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): NCT01314547


Locations
France
hopital ambroise Pare
Boulogne, France, 92100
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: THOMAS HANSLIK, PU-PH Assistance Publique - Hôpitaux de Paris
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01314547     History of Changes
Other Study ID Numbers: AOM02020
First Submitted: March 11, 2011
First Posted: March 14, 2011
Last Update Posted: October 15, 2012
Last Verified: November 2010

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Environment
spondylarthritis
vasculitis
stress
life event
vaccine

Additional relevant MeSH terms:
Vasculitis
Spondylarthritis
Systemic Vasculitis
Vascular Diseases
Cardiovascular Diseases
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases