German Spondyloarthritis Inception Cohort (GESPIC)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
German Federal Ministry of Education and Research (BMBF): 2000-2007 and 2010-2014 through ANCYLOSS and ArthrotMark projects
AbbVie
Amgen
Centocor: 2008-2009
Schering-Plough (MSD): 2008-2009
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
J. Sieper, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01277419
First received: January 14, 2011
Last updated: November 29, 2013
Last verified: November 2013
  Purpose

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).


Condition
Ankylosing Spondylitis
Non-radiographic Axial Spondyloarthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: German Spondyloarthritis Inception Cohort

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Enrollment: 803
Study Start Date: July 2000
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Ankylosing spondylitis
Ankylosing spondylitis according to the modified New York criteria and duration of symptoms <10 years
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. Maximal duration of symptoms: 5 years.
Juvenile spondyloarthritis
Patients with juvenile spondyloarthritis (juvenile ankylosing spondylitis, juvenile non-AS-spondyloarthritis).

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients included in GESPIC were required to have a definite clinical diagnosis of axial SpA according to the treating rheumatologist.

In the Juvenile SpA group patients with juvenile disease onset (≤16 years) were included.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01277419

Locations
Germany
Charité Universitätsmedizin Berlin
Berlin, Germany
Sponsors and Collaborators
Charite University, Berlin, Germany
German Federal Ministry of Education and Research (BMBF): 2000-2007 and 2010-2014 through ANCYLOSS and ArthrotMark projects
AbbVie
Amgen
Centocor: 2008-2009
Schering-Plough (MSD): 2008-2009
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Principal Investigator: Joachim Sieper, Prof. Dr. Charite University, Berlin, Germany
Study Chair: Martin Rudwaleit, PD Dr. Charite University, Berlin, Germany
  More Information

Additional Information:
Publications:

Responsible Party: J. Sieper, Prof., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01277419     History of Changes
Other Study ID Numbers: GESPIC
Study First Received: January 14, 2011
Last Updated: November 29, 2013
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Spondylarthritis
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Ankylosis
Joint Diseases
Arthritis

ClinicalTrials.gov processed this record on October 19, 2014