Overview

Conditions ankylosing spondylitis, non-radiographic axial spondyloarthritis
Sponsor Charite University, Berlin, Germany
Collaborator German Federal Ministry of Education and Research (BMBF): 2000-2007 and 2010-current
Start date July 2000
End date July 2020
Trial size 1000 participants
Trial identifier NCT01277419, GESPIC

Summary

The German Spondyloarthritis Inception cohort (GESPIC) was started as a prospective, longitudinal, multicentre, nationwide study in Germany on patients with early SpA including ankylosing spondylitis and non-radiographic axial SpA. The objectives of GESPIC are to learn about the course of AS and other 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).

Recruiting in the following locations…

United States No locations recruiting
Other countries Germany

Study Design

Observational model cohort
Time perspective prospective
Arm
Ankylosing spondylitis according to the modified New York criteria and duration of symptoms ≤10 years
Patients with clinical characteristics of axial SpA but not fulfilling the modified New York criteria for which radiographic sacroiliitis is essential. Maximal duration of symptoms: 5 years.
Patients with juvenile spondyloarthritis (juvenile ankylosing spondylitis, juvenile non-AS-spondyloarthritis).
Crohn's disease with duration of symptoms ≤5 years

Eligibility Criteria

All participants of any age.

Main inclusion Criteria: - AS fulfilling the modified New York criteria, and the duration of AS symptoms (usually back pain) ≤10 years at the time of inclusion. - Patients with Crohn's disease and symptom duration ≤5 years at the time of inclusion.

Additional Information

Official title German Spondyloarthritis Inception Cohort
Principal investigator Denis Poddubnyy, Prof. Dr.
Trial information was received from ClinicalTrials.gov and was last updated in March 2017.
Information provided to ClinicalTrials.gov by Charite University, Berlin, Germany.