NCT01314547

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 14, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

October 15, 2012

Status Verified

November 1, 2010

Enrollment Period

6.8 years

First QC Date

March 11, 2011

Last Update Submit

October 12, 2012

Conditions

SpondylarthritisPrimary Systemic Vasculitis

Keywords

Environmentspondylarthritisvasculitisstresslife eventvaccine

Outcome Measures

Primary Outcomes (1)

  • Score on a disease activity rating scale

    Score on a disease activity rating scale (quaterly,than monthly basis)

    Six years

Secondary Outcomes (1)

  • Ancillary studies will be possible with the available database

    six years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with SPA disease

You may qualify if:

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

You may not qualify if:

  • no internet access

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

hopital ambroise Pare

Boulogne, 92100, France

Location

MeSH Terms

Conditions

SpondylarthritisVasculitis

Condition Hierarchy (Ancestors)

SpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • THOMAS HANSLIK, PU-PH

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2011

First Posted

March 14, 2011

Study Start

March 1, 2005

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

October 15, 2012

Record last verified: 2010-11

Locations

FR(1)