GESPIC: German Spondyloarthritis Inception Cohort

Sponsor

Charite University, Berlin, Germany (Other)

Overall Status

Recruiting

CT.gov ID

NCT01277419

Collaborator

German Federal Ministry of Education and Research (Other), AbbVie (Industry), Amgen (Industry), Centocor, Inc. (Industry), Schering-Plough (Industry), Wyeth is now a wholly owned subsidiary of Pfizer (Industry), Berlin Institute of Health (Other), Novartis (Industry), UCB Pharma (Industry)

1,000

Enrollment

Location

360

Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The German Spondyloarthritis Inception cohort (GESPIC) was started 2000 as a prospective, longitudinal, multicentre, nationwide study in Germany on patients with early SpA including ankylosing spondylitis (AS, also known as radiographic axial spondyloarthritis) and non-radiographic axial SpA. The objectives of GESPIC are to learn about the course of SpA during the very early stage of the disease, to appropriately assess the outcome including radiographic progression of patients after several years of follow-up, to identify outcome predictors, to assess quality of life, function, and costs (direct and indirect costs). GESPIC has been recently expanded to recruit patients with other forms of SpA / conditions associated with SpA: acute anterior uveitis, Crohn's disease as well as with psoriasis / axial psoriatic arthritis.

Condition or Disease	Intervention/Treatment	Phase
Ankylosing Spondylitis (AS) / Radiographic Axial SpA (r-axSpA) Non-radiographic Axial Spondyloarthritis (Nr-axSpA) Axial Psoriatic Arthritis (axPsA) Acute Anterior Uveitis (AAU) Crohn Disease (CD) Ulcerative Colitis (UC)

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

German Spondyloarthritis Inception Cohort

Study Start Date :

Jul 1, 2000

Anticipated Primary Completion Date :

Jul 1, 2030

Anticipated Study Completion Date :

Jul 1, 2030

Arms and Interventions

Arm	Intervention/Treatment
Ankylosing spondylitis Ankylosing spondylitis according to the modified New York criteria or with the clinical diagnosis of AS/r-axSpA fulfilling the ASAS Classification Criteria AND the mNY criteria plus having the indiaction for starting a bDMARD therapy according to the treating rheumatologist
Non-radiographic axial spondyloarthritis Patients with clinical characteristics of axial SpA but not fulfilling the modified New York criteria for which radiographic sacroiliitis is essential or with the clinical diagnosis of nr-axSpA fulfilling the ASAS Classification Criteria not fulfilling the mNY criteria and the indiaction for starting a bDMARD therapy according to the treating rheumatologist
Juvenile spondyloarthritis Patients with juvenile spondyloarthritis (juvenile ankylosing spondylitis, juvenile non-AS-spondyloarthritis).
Crohn's disease Patients with Crohn's disease
Acute anterior uveitis Patients with acute anterior uveitis
Axial psoriatic arthritis Patients with the clinical diagnosis of psoriatic arthritis with axial involvement (sacroiliac joints and/or spine) (axPsA)

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Main inclusion Criteria:

Patients with definite diagnosis of axial spondyloarthritis or juvenile spondyloarthritis.
Patients with definite diagnosis of Crohn's disease.
Patients with definite diagnosis of acute anterior uveitis.
Patients with definite diagnosis of psoriatic arthritis with axial involvement.