German Spondyloarthritis Inception Cohort

Ulcerative Colitis (UC) Clinical Trial

— GESPIC  

Official title:

German Spondyloarthritis Inception Cohort

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01277419
• Other study ID #: GESPIC
• Status: Recruiting
• Start date: July 2000
• Est. completion date: July 2030

Study information

• Verified date: October 2021
• Source: Charite University, Berlin, Germany
• Contact: Denis Poddubnyy, Prof. Dr.
• Phone: +4930450514582
• Email: denis.poddubnyy[@]charite.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: July 2030
• Est. primary completion date: July 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis, Psoriatic
• Crohn Disease
• Crohn Disease (CD)
• Iridocyclitis
• Spondylarthritis
• Spondylitis
• Spondylitis, Ankylosing
• Ulcerative Colitis (UC)
• Uveitis
• Uveitis, Anterior

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin	Berlin

Sponsors (10)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	AbbVie, Amgen, Berlin Institute of Health, Centocor, Inc., German Federal Ministry of Education and Research, Novartis, Schering-Plough, UCB Pharma, Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Germany, 

References & Publications (17)

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 modifie — View 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 Spond — View 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 Rh — View 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 ax — View 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 — View 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: Re — View Citation

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 — View Citation

Poddubnyy D, Listing J, Haibel H, Knüppel 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 — View 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 spondyloa — View Citation

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 Spondyloart — View Citation

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: — View Citation

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-a promoter gene polymorphisms, and T cell cytokine production in ankylosing spondylitis -- a comprehensive — View 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- — View 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 Spondyloarthriti — View Citation

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. — View Citation

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 progress — View 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/ — View Citation

* Note: There are 17 references in all — Click here to view all references

External Links

•   Coordinating study center: Department of rheumatology, Charité - Campus Benjamin Franklin