German Spondyloarthritis Inception Cohort

NCT01277419

Last updated date
Study Location
Charité Universitätsmedizin Berlin
Berlin, , , Germany
Contact
+4930450514582

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ankylosing Spondylitis, Non-radiographic Axial Spondyloarthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +

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Ankylosing Spondylitis, Non-radiographic Axial SpondyloarthritisGerman Spondyloarthritis Inception Cohort
NCT01277419
  1. Berlin,
ALL GENDERS
0+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title German Spondyloarthritis Inception Cohort
Official Title German Spondyloarthritis Inception Cohort
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Ankylosing Spondylitis
  • Non-radiographic Axial Spondyloarthritis
Intervention Not Provided
Study Groups/Cohorts
  • 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)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 11, 2017)
1000
Original Actual Enrollment
 (submitted: January 14, 2011)
803
Estimated Study Completion Date July 2030
Estimated Primary Completion Date July 2030   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study:All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Denis Poddubnyy, Prof. Dr.+4930450514582[email protected]
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT01277419
Other Study ID Numbers GESPIC
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Denis Poddubnyy, Charite University, Berlin, Germany
Study Sponsor Charite University, Berlin, Germany
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
Investigators
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
PRS Account Charite University, Berlin, Germany
Verification Date September 2019