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 (Abbott): since 2010
Amgen
Centocor: 2008-2009
Schering-Plough (MSD): 2008-2009
Wyeth (Pfizer): 2008-2009
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

January 14, 2011
November 29, 2013
July 2000
July 2018   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01277419 on ClinicalTrials.gov Archive Site
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German Spondyloarthritis Inception Cohort
German Spondyloarthritis Inception Cohort

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).

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

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.

  • Ankylosing Spondylitis
  • Non-radiographic Axial Spondyloarthritis
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  • 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).

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
803
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July 2018   (final data collection date for primary outcome measure)

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
Both
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No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01277419
GESPIC
Not Provided
J. Sieper, Charite University, Berlin, Germany
Charite University, Berlin, Germany
  • German Federal Ministry of Education and Research (BMBF): 2000-2007 and 2010-2014 through ANCYLOSS and ArthrotMark projects
  • AbbVie (Abbott): since 2010
  • Amgen
  • Centocor: 2008-2009
  • Schering-Plough (MSD): 2008-2009
  • Wyeth (Pfizer): 2008-2009
Principal Investigator: Joachim Sieper, Prof. Dr. Charite University, Berlin, Germany
Study Chair: Martin Rudwaleit, PD Dr. Charite University, Berlin, Germany
Charite University, Berlin, Germany
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP