Clinical trial NCT01277419: German Spondyloarthritis Inception Cohort
Official title: German Spondyloarthritis Inception Cohort
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: 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)
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
name: AbbVie
name: Amgen
name: Centocor, Inc.
name: Schering-Plough
name: Wyeth is now a wholly owned subsidiary of Pfizer
name: Berlin Institute of Health
name: Novartis
name: UCB Pharma
First posted: 2011-01-17
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Joachim Sieper, Prof. Dr.
role: STUDY_CHAIR
affiliation: Charite University, Berlin, Germany
name: Martin Rudwaleit, Prof. Dr.
role: STUDY_CHAIR
affiliation: Charite University, Berlin, Germany
name: Denis Poddubnyy, Prof. Dr.
role: STUDY_CHAIR
affiliation: Charite University, Berlin, Germany
name: Fabian Proft, MD
role: STUDY_CHAIR
References:
citation: Rudwaleit M, Haibel H, Baraliakos X, Listing J, Marker-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.
citation: 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.
citation: Poddubnyy D, Rudwaleit M, Haibel H, Listing J, Marker-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.
citation: Poddubnyy DA, Marker-Hermann E, Kaluza-Schilling W, Zeidler H, Braun J, Listing J, Sieper J, Rudwaleit M. Relation of HLA-B27, tumor necrosis factor-alpha 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.
citation: 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.
citation: Poddubnyy D, Rudwaleit M, Haibel H, Listing J, Marker-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.
citation: Poddubnyy D, Haibel H, Listing J, Marker-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. No abstract available.
citation: 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.
citation: 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. No abstract available.
citation: Syrbe U, Callhoff J, Conrad K, Poddubnyy D, Haibel H, Junker S, Frommer KW, Muller-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.
citation: 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.
citation: 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.
citation: Protopopov M, Sieper J, Haibel H, Listing J, Rudwaleit M, Poddubnyy D. Relevance of structural damage in the sacroiliac joints for the functional status and spinal mobility in patients with axial spondyloarthritis: results from the German Spondyloarthritis Inception Cohort. Arthritis Res Ther. 2017 Oct 24;19(1):240. doi: 10.1186/s13075-017-1453-3.
citation: Poddubnyy D, Listing J, Haibel H, Knuppel S, Rudwaleit M, Sieper J. Functional relevance of radiographic spinal progression in axial spondyloarthritis: results from the GErman SPondyloarthritis Inception Cohort. Rheumatology (Oxford). 2018 Apr 1;57(4):703-711. doi: 10.1093/rheumatology/kex475.
citation: Boel A, Molto A, van der Heijde D, Ciurea A, Dougados M, Gensler LS, Santos MJ, De Miguel E, Poddubnyy D, Rudwaleit M, van Tubergen A, van Gaalen FA, Ramiro S. Do patients with axial spondyloarthritis with radiographic sacroiliitis fulfil both the modified New York criteria and the ASAS axial spondyloarthritis criteria? Results from eight cohorts. Ann Rheum Dis. 2019 Nov;78(11):1545-1549. doi: 10.1136/annrheumdis-2019-215707. Epub 2019 Jul 30.
citation: Llop M, Rios Rodriguez V, Redeker I, Sieper J, Haibel H, Rudwaleit M, Poddubnyy D. Incorporation of the anteroposterior lumbar radiographs in the modified Stoke Ankylosing Spondylitis Spine Score improves detection of radiographic spinal progression in axial spondyloarthritis. Arthritis Res Ther. 2019 May 24;21(1):126. doi: 10.1186/s13075-019-1913-z.
citation: de Winter JJ, Blijdorp IC, de Jong HM, Sauter J, Schmidt AH, van Gaalen FA, van der Heijde D, Poddubnyy D, Yeremenko NG, van de Sande MG, Baeten DL. HLA-C*07 in axial spondyloarthritis: data from the German Spondyloarthritis Inception Cohort and the Spondyloarthritis Caught Early cohort. Genes Immun. 2019 Nov;20(8):671-677. doi: 10.1038/s41435-019-0061-4. Epub 2019 Feb 26.
citation: Weiss A, Minden K, Listing J, Foeldvari I, Sieper J, Rudwaleit M. Course of patients with juvenile spondyloarthritis during 4 years of observation, juvenile part of GESPIC. RMD Open. 2017 Mar 21;3(1):e000366. doi: 10.1136/rmdopen-2016-000366. eCollection 2017.