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

This study has been completed.
Sponsor:
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
  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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01314547     History of Changes
Other Study ID Numbers: AOM02020
Study First Received: March 11, 2011
Last Updated: October 12, 2012
Health Authority: France: Ministry of Health

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

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

ClinicalTrials.gov processed this record on July 20, 2014