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German Spondyloarthritis Inception Cohort (GESPIC)

This study is currently recruiting participants.
See Contacts and Locations
Verified March 2017 by Denis Poddubnyy, Charite University, Berlin, Germany
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT01277419
First received: January 14, 2011
Last updated: March 11, 2017
Last verified: March 2017
  Purpose
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).

Condition
Ankylosing Spondylitis Non-radiographic Axial Spondyloarthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: German Spondyloarthritis Inception Cohort

Resource links provided by NLM:


Further study details as provided by Denis Poddubnyy, Charite University, Berlin, Germany:

Estimated Enrollment: 1000
Study Start Date: July 2000
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
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.
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01277419

Contacts
Contact: Denis Poddubnyy, Prof. Dr. +4930450514544 denis.poddubnyy@charite.de

Locations
Germany
Charité Universitätsmedizin Berlin Recruiting
Berlin, Germany
Contact: Petra Tietz       petra.tietz@charite.de   
Sub-Investigator: Valeria Rios Rodriguez         
Sub-Investigator: Mikhail Protopopov, Dr.         
Sub-Investigator: Fabian Proft, Dr.         
Sub-Investigator: Burkhard Muche, Dr.         
Sponsors and Collaborators
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)
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
  More Information

Additional Information:
Publications:

Responsible Party: Denis Poddubnyy, Prof., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01277419     History of Changes
Other Study ID Numbers: GESPIC
Study First Received: January 14, 2011
Last Updated: March 11, 2017

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Spondylarthritis
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Ankylosis
Joint Diseases
Arthritis

ClinicalTrials.gov processed this record on August 16, 2017