Overview

This trial is active, not recruiting.

Conditions ankylosing spondylitis, non-radiographic axial spondyloarthritis
Sponsor Charite University, Berlin, Germany
Collaborator German Federal Ministry of Education and Research (BMBF): 2000-2007 and since 2010
Start date July 2000
End date July 2018
Trial size 803 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. 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).

United States No locations recruiting
Other Countries No locations recruiting

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).

Eligibility Criteria

Male or female participants of any age.

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. - Non-radiographic axial SpA fulfilling the European Spondylarthropathy Study Group (ESSG) criteria with the maximum duration of symptoms ≤5 years and no radiographic changes in the SI joints of at least grade II bilaterally or grade III or IV unilaterally - Juvenile SpA - fulfilment of the modified NY/ESSG criteria and age of symptoms onset ≤16 years

Additional Information

Official title German Spondyloarthritis Inception Cohort
Principal investigator Joachim Sieper, Prof. Dr.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Charite University, Berlin, Germany.