Ankylosing Spondylitis (AS) / Radiographic Axial SpA (r-axSpA)GESPICNCT01277419
German Spondyloarthritis Inception Cohort
An observational study of Ankylosing Spondylitis (AS) / Radiographic Axial SpA (r-axSpA) and Non-radiographic Axial Spondyloarthritis (Nr-axSpA), run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ankylosing Spondylitis (AS) / Radiographic Axial SpA (r-axSpA), Non-radiographic Axial Spondyloarthritis (Nr-axSpA), Axial Psoriatic Arthritis (axPsA)
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2000to Jul 2030
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Charité - Universitätsmedizin Berlin
Berlin
Claudia Lorenz, Claudia.Lorenz@charite.de
Valeria Rios Rodriguez
About this study
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.
- 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)
- Medical subject headings
- Spondylitis, Ankylosing, Non-Radiographic Axial Spondyloarthritis, Uveitis, Anterior, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ankylosing spondylitis | Ankylosing spondylitis according to the modified New York criteria or with the clinical diagnosis of AS/r-axSpA fulfilling the ASAS Classification Criteria AND the mNY criteria plus having the indiaction for starting a bDMARD therapy according to the treating rheumatologist | |
| 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 or with the clinical diagnosis of nr-axSpA fulfilling the ASAS Classification Criteria not fulfilling the mNY criteria and the indiaction for starting a bDMARD therapy according to the treating rheumatologist | |
| Juvenile spondyloarthritis | Patients with juvenile spondyloarthritis (juvenile ankylosing spondylitis, juvenile non-AS-spondyloarthritis). | |
| Crohn's disease | Patients with Crohn's disease | |
| Acute anterior uveitis | Patients with acute anterior uveitis | |
| Axial psoriatic arthritis | Patients with the clinical diagnosis of psoriatic arthritis with axial involvement (sacroiliac joints and/or spine) (axPsA) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2011 (estimated)
- Study startJul 2000
- Primary completionJul 2030 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Ankylosing Spondylitis (AS) / Radiographic Axial SpA (r-axSpA)Studies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research, AbbVie, Amgen, Centocor, Inc., Schering-Plough, Wyeth is now a wholly owned subsidiary of Pfizer, Berlin Institute of Health, Novartis, UCB Pharma
- Responsible party
- Principal investigator, Denis Poddubnyy, Charite University, Berlin, Germany
- Investigators
- Joachim Sieper, Prof. Dr., Study chair, Charite University, Berlin, GermanyMartin Rudwaleit, Prof. Dr., Study chair, Charite University, Berlin, GermanyDenis Poddubnyy, Prof. Dr., Study chair, Charite University, Berlin, GermanyFabian Proft, MD, Study chair, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01277419
- Sponsor's protocol ID
- GESPIC
- Acronym
- GESPIC
- Status last verified
- Oct 2021
- First submitted
- 14 Jan 2011
- Last updated
- 12 Oct 2021
- Results posted
- No
Publications
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.
PubMed 19248087Poddubnyy 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.
PubMed 20498207Poddubnyy 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.
PubMed 21622969Poddubnyy 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.
PubMed 21885496Heiland 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.
PubMed 22186710Poddubnyy 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.
PubMed 22459541Poddubnyy 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.
PubMed 23625981Poddubnyy 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.
PubMed 23956246Turina 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.
PubMed 24845387Syrbe 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.
PubMed 25417763Poddubnyy 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.
PubMed 26017497Poddubnyy 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.
PubMed 27125522Protopopov 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.
PubMed 29065931Poddubnyy 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.
PubMed 29373733Boel 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.
PubMed 31362994