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RecruitingNCT01277419GESPICUpdated Oct 12, 2021

German Spondyloarthritis Inception Cohort

An observational study in Ankylosing Spondylitis (AS) / Radiographic Axial SpA (r-axSpA), Non-radiographic Axial Spondyloarthritis (Nr-axSpA) and Axial Psoriatic Arthritis (axPsA), sponsored by Charite University, Berlin, Germany. Recruiting at 1 site in Germany. Per ClinicalTrials.gov, last updated 2021-10-12.

Sponsored by Charite University, Berlin, Germany · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 13 studies in Spondylitis, Ankylosing by Charite University, Berlin, Germany — 1 open to participants now, 1 under way, none of them phase 3. Spondylitis, Ankylosing · Charite University, Berlin, Germany.

Started
2000
the only one that year
Observational
3 of 13
1 open now
Registered
10th of 13
by date

Among the 13 studies in Spondylitis, Ankylosing by Charite University, Berlin, Germany, this one is the only one that started in 2000, is one of 3 observational ones, and was the 10th registered.

By phase

13 studies; the count open now beside each. This study's row is marked.

Phase 25 · 0 open
Observationalthis study3 · 1 open
Phase 2/33 · 0 open
Phase 42 · 0 open

By the year they started

First in 2000; this study’s year is marked. 1 started in 2000.

Size and results

Median enrollment 38 across the 10 interventional studies, 992 across the 3 observational. Of the 4 that completed or were terminated, 0 (0%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 13 studies in Spondylitis, Ankylosing by Charite University, Berlin, Germany, or all of them as a file.
02

Study 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.

03

Conditions studied

  • 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)
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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 or a definite diagnosis of acute anterior uveitis or a definite diagnosis of psoriatic arthritis with axial involvement.

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)

Groups and cohorts

  • 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)

06

Study locations

1 of 1 sites recruiting
  • Charité - Universitätsmedizin Berlin
    Berlin, Germany
    Recruiting
    • Claudia Lorenz · ContactClaudia.Lorenz@charite.de
    • Valeria Rios Rodriguez · Principal investigator
    • Mikhail Protopopov, Dr. · Sub investigator
    • Judith Rademacher, Dr. · Principal investigator
    • Murat Torgutalp, Dr. · Sub investigator
07

References and documents

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 19248087 ↗
  • 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. PubMed 20498207 ↗
  • 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. PubMed 21622969 ↗
  • 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. PubMed 21885496 ↗
  • 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. PubMed 22186710 ↗
  • 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. PubMed 22459541 ↗
  • 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. PubMed 23625981 ↗
  • 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. PubMed 23956246 ↗
  • 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. PubMed 24845387 ↗
  • 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. PubMed 25417763 ↗
  • 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. PubMed 26017497 ↗
  • 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. PubMed 27125522 ↗
  • 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. PubMed 29065931 ↗
  • 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. PubMed 29373733 ↗
  • 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. PubMed 31362994 ↗
  • 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. PubMed 31126334 ↗
  • 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. Erratum In: Genes Immun. 2019 Nov;20(8):690. doi: 10.1038/s41435-019-0076-x. PubMed 30809016 ↗
  • 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. PubMed 28405472 ↗
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2000, a primary completion of Jul 2030 and a completion of Jul 2030. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 14, 2011
First posted
Jan 17, 2011
Start
Jul 2000
Primary completionEst.
Jul 2030
CompletionEst.
Jul 2030
Last update
Oct 12, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 12, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01277419
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
Denis Poddubnyy (Prof., Charite University, Berlin, Germany) — Principal investigator
First posted
Jan 17, 2011
Start date
Jul 2000
Primary completion
Jul 2030 (estimated)
Completion
Jul 2030 (estimated)
Last update
Oct 12, 2021

Study contacts

Denis Poddubnyy, Prof. Dr.
Contact
denis.poddubnyy@charite.de
+4930450514582
Joachim Sieper, Prof. Dr.
study chair · Charite University, Berlin, Germany
Martin Rudwaleit, Prof. Dr.
study chair · Charite University, Berlin, Germany
Denis Poddubnyy, Prof. Dr.
study chair · Charite University, Berlin, Germany
Fabian Proft, MD
study chair · Charite University, Berlin, Germany
View the source record on ClinicalTrials.gov ↗

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