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German Spondyloarthritis Inception Cohort (GESPIC)

This study is currently recruiting participants.
Verified March 2017 by Denis Poddubnyy, Charite University, Berlin, Germany
Sponsor:
ClinicalTrials.gov Identifier:
NCT01277419
First Posted: January 17, 2011
Last Update Posted: March 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
German Federal Ministry of Education and Research (BMBF): 2000-2007 and 2010-current
2010-current: AbbVie (Abbott)
Amgen
Centocor, Inc.
Schering-Plough
Wyeth is now a wholly owned subsidiary of Pfizer
2015-current: Berlin Institute of Health (BIH)
Information provided by (Responsible Party):
Denis Poddubnyy, Charite University, Berlin, Germany
January 14, 2011
January 17, 2011
March 14, 2017
July 2000
July 2020   (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 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).
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample
Patients included in GESPIC are required to have a definite clinical diagnosis of axial SpA / juvenile SpA (currently only adult patients with radiographic axial SpA = ankylosing spondylitis - AS are recruited) or a definite diagnosis of Crohn's disease.
  • 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).
  • Crohn's disease
    Crohn's disease with duration of symptoms ≤5 years

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
July 2020
July 2020   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact: Denis Poddubnyy, Prof. Dr. +4930450514544 denis.poddubnyy@charite.de
Germany
 
 
NCT01277419
GESPIC
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Denis Poddubnyy, Charite University, Berlin, Germany
Charite University, Berlin, Germany
  • German Federal Ministry of Education and Research (BMBF): 2000-2007 and 2010-current
  • 2010-current: AbbVie (Abbott)
  • Amgen
  • Centocor, Inc.
  • Schering-Plough
  • Wyeth is now a wholly owned subsidiary of Pfizer
  • 2015-current: Berlin Institute of Health (BIH)
Study Chair: Joachim Sieper, Prof. Dr. Charite University, Berlin, Germany
Study Chair: Martin Rudwaleit, Prof. Dr. Charite University, Berlin, Germany
Principal Investigator: Denis Poddubnyy, Prof. Dr. Charite University, Berlin, Germany
Charite University, Berlin, Germany
March 2017