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

History of Changes

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:

Genetics Home Reference related topics: ankylosing spondylitis

MedlinePlus related topics: Ankylosing Spondylitis

Genetic and Rare Diseases Information Center resources: Spondylarthropathy

U.S. FDA Resources

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:

Coordinating study center: Department of rheumatology, Charité - Campus Benjamin Franklin This link exits the ClinicalTrials.gov site

Publications:

Rudwaleit M, Haibel H, Baraliakos X, Listing J, Märker-Hermann E, Zeidler H, Braun J, Sieper J. The early disease stage in axial spondylarthritis: results from the German Spondyloarthritis Inception Cohort. Arthritis Rheum. 2009 Mar;60(3):717-27. doi: 10.1002/art.24483.

Poddubnyy DA, Rudwaleit M, Listing J, Braun J, Sieper J. Comparison of a high sensitivity and standard C reactive protein measurement in patients with ankylosing spondylitis and non-radiographic axial spondyloarthritis. Ann Rheum Dis. 2010 Jul;69(7):1338-41. doi: 10.1136/ard.2009.120139. Epub 2010 May 24.

Poddubnyy D, Rudwaleit M, Haibel H, Listing J, Märker-Hermann E, Zeidler H, Braun J, Sieper J. Rates and predictors of radiographic sacroiliitis progression over 2 years in patients with axial spondyloarthritis. Ann Rheum Dis. 2011 Aug;70(8):1369-74. doi: 10.1136/ard.2010.145995. Epub 2011 May 27.

Poddubnyy DA, Märker-Hermann E, Kaluza-Schilling W, Zeidler H, Braun J, Listing J, Sieper J, Rudwaleit M. Relation of HLA-B27, tumor necrosis factor-α promoter gene polymorphisms, and T cell cytokine production in ankylosing spondylitis -- a comprehensive genotype-phenotype analysis from an observational cohort. J Rheumatol. 2011 Nov;38(11):2436-41. doi: 10.3899/jrheum.110130. Epub 2011 Sep 1.

Heiland GR, Appel H, Poddubnyy D, Zwerina J, Hueber A, Haibel H, Baraliakos X, Listing J, Rudwaleit M, Schett G, Sieper J. High level of functional dickkopf-1 predicts protection from syndesmophyte formation in patients with ankylosing spondylitis. Ann Rheum Dis. 2012 Apr;71(4):572-4. doi: 10.1136/annrheumdis-2011-200216. Epub 2011 Dec 20.

Poddubnyy D, Rudwaleit M, Haibel H, Listing J, Märker-Hermann E, Zeidler H, Braun J, Sieper J. Effect of non-steroidal anti-inflammatory drugs on radiographic spinal progression in patients with axial spondyloarthritis: results from the German Spondyloarthritis Inception Cohort. Ann Rheum Dis. 2012 Oct;71(10):1616-22. doi: 10.1136/annrheumdis-2011-201252. Epub 2012 Mar 29.

Poddubnyy D, Haibel H, Listing J, Märker-Hermann E, Zeidler H, Braun J, Sieper J, Rudwaleit M. Cigarette smoking has a dose-dependent impact on progression of structural damage in the spine in patients with axial spondyloarthritis: results from the GErman SPondyloarthritis Inception Cohort (GESPIC). Ann Rheum Dis. 2013 Aug;72(8):1430-2. doi: 10.1136/annrheumdis-2012-203148. Epub 2013 Apr 26.

Poddubnyy D, Conrad K, Haibel H, Syrbe U, Appel H, Braun J, Rudwaleit M, Sieper J. Elevated serum level of the vascular endothelial growth factor predicts radiographic spinal progression in patients with axial spondyloarthritis. Ann Rheum Dis. 2014 Dec;73(12):2137-43. doi: 10.1136/annrheumdis-2013-203824. Epub 2013 Aug 16.

Turina MC, Sieper J, Yeremenko N, Conrad K, Haibel H, Rudwaleit M, Baeten D, Poddubnyy D. Calprotectin serum level is an independent marker for radiographic spinal progression in axial spondyloarthritis. Ann Rheum Dis. 2014 Sep;73(9):1746-8. doi: 10.1136/annrheumdis-2014-205506. Epub 2014 May 20.

Syrbe U, Callhoff J, Conrad K, Poddubnyy D, Haibel H, Junker S, Frommer KW, Müller-Ladner U, Neumann E, Sieper J. Serum adipokine levels in patients with ankylosing spondylitis and their relationship to clinical parameters and radiographic spinal progression. Arthritis Rheumatol. 2015 Mar;67(3):678-85. doi: 10.1002/art.38968.

Poddubnyy D, Haibel H, Braun J, Rudwaleit M, Sieper J. Brief Report: Clinical Course Over Two Years in Patients With Early Nonradiographic Axial Spondyloarthritis and Patients With Ankylosing Spondylitis Not Treated With Tumor Necrosis Factor Blockers: Results From the German Spondyloarthritis Inception Cohort. Arthritis Rheumatol. 2015 Sep;67(9):2369-75. doi: 10.1002/art.39225.

Poddubnyy D, Protopopov M, Haibel H, Braun J, Rudwaleit M, Sieper J. High disease activity according to the Ankylosing Spondylitis Disease Activity Score is associated with accelerated radiographic spinal progression in patients with early axial spondyloarthritis: results from the GErman SPondyloarthritis Inception Cohort. Ann Rheum Dis. 2016 Dec;75(12):2114-2118. doi: 10.1136/annrheumdis-2016-209209. Epub 2016 Apr 28.


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 September 19, 2017

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