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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 : October 12, 2021
Sponsor:
Collaborators:
German Federal Ministry of Education and Research
AbbVie
Amgen
Centocor, Inc.
Schering-Plough
Wyeth is now a wholly owned subsidiary of Pfizer
Berlin Institute of Health
Novartis
UCB Pharma
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 (AS) / Radiographic Axial SpA (r-axSpA) Non-radiographic Axial Spondyloarthritis (Nr-axSpA) Axial Psoriatic Arthritis (axPsA) Acute Anterior Uveitis (AAU) Crohn Disease (CD) Ulcerative Colitis (UC)

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 or with the clinical diagnosis of AS/r-axSpA fulfilling the ASAS Classification Criteria AND the mNY criteria plus having the indiaction for starting a bDMARD therapy according to the treating rheumatologist
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 or with the clinical diagnosis of nr-axSpA fulfilling the ASAS Classification Criteria not fulfilling the mNY criteria and the indiaction for starting a bDMARD therapy according to the treating rheumatologist
Juvenile spondyloarthritis
Patients with juvenile spondyloarthritis (juvenile ankylosing spondylitis, juvenile non-AS-spondyloarthritis).
Crohn's disease
Patients with Crohn's disease
Acute anterior uveitis
Patients with acute anterior uveitis
Axial psoriatic arthritis
Patients with the clinical diagnosis of psoriatic arthritis with axial involvement (sacroiliac joints and/or spine) (axPsA)


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: Claudia Lorenz       Claudia.Lorenz@charite.de   
Principal Investigator: Valeria Rios Rodriguez         
Sub-Investigator: Mikhail Protopopov, Dr.         
Principal Investigator: Judith Rademacher, Dr.         
Sub-Investigator: Murat Torgutalp, Dr.         
Sponsors and Collaborators
Charite University, Berlin, Germany
German Federal Ministry of Education and Research
AbbVie
Amgen
Centocor, Inc.
Schering-Plough
Wyeth is now a wholly owned subsidiary of Pfizer
Berlin Institute of Health
Novartis
UCB Pharma
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
Study Chair: Denis Poddubnyy, Prof. Dr. Charite University, Berlin, Germany
Study Chair: Fabian Proft, MD 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: October 12, 2021
Last Verified: October 2021
Additional relevant MeSH terms:
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Spondylitis
Spondylarthritis
Arthritis, Psoriatic
Spondylitis, Ankylosing
Crohn Disease
Uveitis
Uveitis, Anterior
Iridocyclitis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
 Intestinal Diseases
Bone Diseases, Infectious
Infections
Bone Diseases
Spinal Diseases
Spondylarthropathies
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Uveal Diseases
Eye Diseases
Ankylosis
Panuveitis
Iris Diseases