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German Spondyloarthritis Inception Cohort (GESPIC)

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ClinicalTrials.gov Identifier: NCT01277419
Recruitment Status : Recruiting
First Posted : January 17, 2011
Last Update Posted : September 11, 2019
Sponsor:
Collaborators:
German Federal Ministry of Education and Research (BMBF): 2000-2007 and 2010-2019
AbbVie
Amgen
Centocor, Inc.
Schering-Plough
Wyeth is now a wholly owned subsidiary of Pfizer
Berlin Institute of Health
Novartis
Information provided by (Responsible Party):
Denis Poddubnyy, Charite University, Berlin, Germany

Study Description
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Brief Summary:
The German Spondyloarthritis Inception cohort (GESPIC) was started 2000 as a prospective, longitudinal, multicentre, nationwide study in Germany on patients with early SpA including ankylosing spondylitis (AS, also known as radiographic axial spondyloarthritis) and non-radiographic axial SpA. The objectives of GESPIC are to learn about the course of 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). GESPIC has been recently expanded to recruit patients with other forms of SpA / conditions associated with SpA: acute anterior uveitis, Crohn's disease as well as with psoriasis / axial psoriatic arthritis.

Condition or disease
Ankylosing Spondylitis Non-radiographic Axial Spondyloarthritis

Study Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: German Spondyloarthritis Inception Cohort
Study Start Date : July 2000
Estimated Primary Completion Date : July 2030
Estimated Study Completion Date : July 2030

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Ankylosing spondylitis
Ankylosing spondylitis according to the modified New York criteria
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.
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
Acute anterior uveitis
Patients with acute anterior uveitis
Axial psoriatic arthritis
Patients with psoriatic arthritis with axial involvement (sacroiliac joints and/or spine)


Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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 or a definite diagnosis of acute anterior uveitis or a definite diagnosis of psoriatic arthritis with axial involvement.
Criteria

Main inclusion Criteria:

  • Patients with definite diagnosis of axial spondyloarthritis or juvenile spondyloarthritis.
  • Patients with definite diagnosis of Crohn's disease.
  • Patients with definite diagnosis of acute anterior uveitis.
  • Patients with definite diagnosis of psoriatic arthritis with axial involvement.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01277419


Contacts
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Contact: Denis Poddubnyy, Prof. Dr. +4930450514582 denis.poddubnyy@charite.de

Locations
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Germany
Charité - Universitätsmedizin Berlin Recruiting
Berlin, Germany
Contact: Annegret Langdon       annegret.langdon@charite.de   
Sub-Investigator: Valeria Rios Rodriguez         
Sub-Investigator: Mikhail Protopopov, Dr.         
Sub-Investigator: Fabian Proft, Dr.         
Sub-Investigator: Judith Rademacher, Dr.         
Sponsors and Collaborators
Charite University, Berlin, Germany
German Federal Ministry of Education and Research (BMBF): 2000-2007 and 2010-2019
AbbVie
Amgen
Centocor, Inc.
Schering-Plough
Wyeth is now a wholly owned subsidiary of Pfizer
Berlin Institute of Health
Novartis
Investigators
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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
More Information
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Additional Information:

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Denis Poddubnyy, Prof., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01277419    
Other Study ID Numbers: GESPIC
First Posted: January 17, 2011    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Spondylitis
Spondylitis, Ankylosing
Spondylarthritis
Bone Diseases, Infectious
Infection
Bone Diseases
 Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Ankylosis
Joint Diseases
Arthritis