NCT00383617

Brief Summary

The purpose of this study is to determine which of the proposed screening parameters or which combination of screening parameters perform best in daily clinical practice for making the diagnosis of axial Spondyloarthritis (SpA)in patients with chronic low back pain.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at 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

July 1, 2004

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

October 2, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 3, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Last Updated

February 13, 2013

Status Verified

February 1, 2013

Enrollment Period

2.8 years

First QC Date

October 2, 2006

Last Update Submit

February 12, 2013

Conditions

SpondyloarthropathyAnkylosing SpondylitisSpondyloarthritis

Keywords

pre-radiographicscreeningearly diagnosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • chronic back pain with a duration of more than 3 months
  • onset of back pain before age of 45 years

You may not qualify if:

  • age younger than 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Rheumatology, Medical Clinic I, Charite Campus Benjamin Franklin, Hindenburgdamm 30

Berlin, State of Berlin, 12200, Germany

Location

Related Publications (2)

  • Rudwaleit M, Khan MA, Sieper J. The challenge of diagnosis and classification in early ankylosing spondylitis: do we need new criteria? Arthritis Rheum. 2005 Apr;52(4):1000-8. doi: 10.1002/art.20990. No abstract available.

    PMID: 15818678BACKGROUND

  • Sieper J, Rudwaleit M. Early referral recommendations for ankylosing spondylitis (including pre-radiographic and radiographic forms) in primary care. Ann Rheum Dis. 2005 May;64(5):659-63. doi: 10.1136/ard.2004.028753. Epub 2004 Nov 4.

    PMID: 15528281BACKGROUND

MeSH Terms

Conditions

SpondylarthropathiesSpondylitis, AnkylosingSpondylarthritisDisease

Condition Hierarchy (Ancestors)

SpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesAxial SpondyloarthritisAnkylosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Joachim Sieper, MD

    Department of Rheumatology, Medical Clinic I, Charité University Medicine Berlin, Campus Benjamin Franklin, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

October 2, 2006

First Posted

October 3, 2006

Study Start

July 1, 2004

Primary Completion

April 1, 2007

Last Updated

February 13, 2013

Record last verified: 2013-02

Locations

DE(1)