Ankylosing SpondylitisEASIC registryNCT01286545
European Ankylosing Spondylitis Infliximab Cohort (EASIC) Follow up Registration Study
An observational study of Ankylosing Spondylitis, run by Rheumazentrum Ruhrgebiet at 19 sites in 6 countries.
Trial summary
Long term data on efficacy and safety of anti-TNF treatment with infliximab in patients with ankylosing spondylitis (AS) beyond 5 years is lacking. These data are important because patients with AS usually are younger and withdrawal of anti-TNF therapy in these patients almost always leads to a disease relapse. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Ankylosing Spondylitis
- How many people
- 100 participants
- Where
- 19 sitesin 6 countries
- Study dates
- Feb 2011to Oct 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ankylosing spondylitis who have completed: 1. the trials ASSERT, EASIC and EASIC extension (overall 7 years) 2. the trial DIKAS (overall 10 years) and who are still on infliximab or another anti-TNF agent wor who have terminated anti-TNF treatment
Who may be able to join
- Established diagnosis of ankylosing spondylitis according to the modified New York criteria
- Participation in the EASIC trial or participation in the DIKAS/TNF bei AS-trial
- Completion of the EASIC extension or the DIKAS trial
- Presence of written informed consent from the patient
Who cannot join
- None
Trial locations and contacts
19 sites in 6 countries.
19 sites in 6 countries
Germany9 sites
Charité Universitätsmedizin Mitte
Berlin, 10117
Eugen Feist, Dr., 004930450513133, eugen.feist@charite.de
Katrin Mattat, Mrs., 004930450513133, katrin.mattat@charite.de
Charité Campus Benjamin Franklin
Berlin, 12200
Hildrun Haibel, Dr-, 00493084454414, hildrun.haibel@charite.de
Renate Pauli, Mrs., 00493084452660, renate.pauli@charite.de
Immanuel Krankenhaus Berlin Buch
Berlin, 13125
Andreas Krause, Prof. Dr., 00493094792300, a.krause@immanuel.de
Carmen Herz, Mrs., 00493094792300, C.Herz@immanuel.de
Rheumatologie Schlosspark-Klinik
Berlin, 14059
Svitlana Dyachenko, Dr., 00493032641325, svitlana.dyachenko@schlosspark-klinik.de
Rieke Alten, Dr., 00493032641325, rieke.alten@schlosspark-klinik.de
Rheumapraxis Berlin
Berlin, 14163
Helmut Sörensen, Dr., 00493081810188, h.soerensen@rheuma-berlin.com
Pamela Sander, Mrs., 00493081810188, p.sander@rheuma-berlin.com
Rheumazentrum Düsseldorf, Universitätsklinik
Düsseldorf, 40225
Matthias Schneider, Prof. Dr., 00492118117817, schneider@rheumanet.org
Elsbeth Richter, Mrs., 00492118117817, Elsbeth.Richter@med.uni-duesseldorf.de
Klinik für Immunologie und Rheumatologie der MHH
Hanover, 30625
Markus Rihl, Dr., 00495115325252, Rihl.Markus@mh-hannover.de
Kathrin Scheiwe, Mrs., 00495115325252, Rht-Studienambulanz@mh-hannover.de
Rheumazentrum Ruhrgebiet
Herne, 44652
Frank Heldmann, 00492325592112, heldmann@rheumazentrum-ruhrgebiet.de
Jürgen Braun, Prof. Dr.
Klinikum der Universität München, Rheumaeinheit
München, 80336
Matthias Witt, Dr., 00498951603455, Matthias.Witt@med.uni-muenchen.de
Christine Strasser, Mrs., 00498951603455, Christine.Strasser@med.uni-muenchen.de
Belgium3 sites
Erasme University Hospital
Brussels
Thierry Appelboom, Prof. Dr., tappelbo@ulb.ac.be
Thierry Appelboom, Prof. Dr.
Universitair Ziekenhuis, Afdeling Rheumatologie
Ghent, 9000
Filip van den Bosch, Dr., filip.vandenbosch@ugent.be
Kristel de Boeck, Mrs., kristel.deboeck@ugent.be
University Hospital Leuven
Leuven, 3000
Kurt de Vlam, Dr., 003216332211, kurt.devlam@uz.kuleuven.ac.be
Jilke Beinsberger, Mrs., 003216332211, jilke.beinsberger@uz.leuven.be
France2 sites
Groupe Hopitalier Cochin
Boulogne
Maxime Breban, Prof. Dr., 0033149095672, maxime.breban@cch.ap-hop-paris.fr
Claire Ribet, Mrs., 0033149095672, claire.ribet@apr.ap-hop-paris.fr
Universitat R. Decartes, Hopital Cochin
Paris
Sami Kolta, Dr., 0033158412584, sami.kolta@cch.ap-hop-paris.fr
Nathalie Ménagé, Mrs
Netherlands2 sites
Academisch Ziekenhuis
Amsterdam, 1007 MB
Irene vander Horst-Bruinsma, Dr., 0031204443432, I.E.vanderHorst@vumc.nl
Silvy Weismann, Mrs., 0031204443432, S.Weismann@vumc.nl
University Hospital
Maastricht, 6202 AZ
Astrid van Tubergen, Dr., 0031433875026, a.van.tubergen@mumc.nl
Janine Geusen, Mrs., 0031433875026, j.geusen@mumc.nl
United Kingdom2 sites
University of Cambridge /Clin Med
Cambridge, CB2 QQ
Hill Gaston, Prof. Dr., 00441233330161, jshg2@medschl.cam.ac.uk
Dominique R Roy, Mrs., 00441233330161, dr314@medschl.cam.ac.uk
University of Leeds
Leeds, LS2 9N2
Laura C Coates, Dr., 004411339224848, L.C.Coates@leeds.ac.uk
David Pickles, Mr., 004411339224848, David.Pickles@leedsth.nhs.uk
Finland1 site
University Central Hospital, Division of Rheumatology
Helsinki, 00029HYKS
Marjatta Leirisalo-Repo, Prof. Dr., Marjatta.Leirisalo-Repo@hus.fi
Arja Karto, arja.karto@hus.fi
About this study
Long term data on efficacy and safety of anti-TNF treatment with infliximab in patients with ankylosing spondylitis (AS) beyond 5 years is lacking. These data are important because patients with AS usually are younger and withdrawal of anti-TNF therapy in these patients almost always leads to a disease relapse. Furthermore it is still unclear whether long term anti-TNF treatment in AS patients can inhibit radiographic progression. Patients who participated in the EASIC and the DIKAS trial respectively who were treated with infliximab within these studies for 7 and 10 years respectively are followed up by using clinical outcome parameters every 6 months assessing efficacy and safety of long term treatment. Furthermore radiographs of the spine, if done for clinical indication, are analyzed. It is hypothesized that anti-TNF treatment with infliximab is effective and safe over a time period of 9 and 12 years respectively and that long term anti-TNF therapy may inhibit radiographic progression of the spine.
Read the detailed description
Ankylosing spondylitis (AS) is the most frequent subtype of spondyloarthritides (SpA)(Braun et al.Lancet 2007, 369:1379-90). Treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) is the cornerstone of the treatment of the disease and is widely used to suppress inflammation and ameliorate spinal pain (Zochling et al.:Ann Rheum Dis 2006, 65:442-52). There is evidence that antitumour necrosis factor (TNF) therapy is highly effective in SpA, especially in AS and psoriatic arthritis. Thus, TNF blockers may even be considered as first line treatment in a patient with active AS whose condition is not sufficiently controlled with NSAIDs in the case of axial disease, and sulfasalazine or methotrexate in the case of peripheral arthritis (Zochling et al.:Ann Rheum Dis 2006, 65:442-52). Long-term data on anti-TNF therapy in patients with AS are rather limited. Infliximab in a dosage of 5mg/kg was shown to be efficacious over 5 years, including a short period of withdrawal and readministration (Baraliakos et al.:Arthritis Res Ther 2005, 7: R439-44; Baraliakos et al.:J Rheumatol 2007, 34: 510-5; Braun J et al: Ann Rheum Dis 2008, 67: 340-5). In our EASIC study the investigators have also shown the efficacy and safety of infliximab treatment in patients with AS over 5 years. Long term data for the treatment of AS with etanercept has proven the efficacy as well (Dijkmans B et al.:J Rheumatol 2009, 36: 1256-64). But long term data for efficacy and safety of treatment with anti-TNF therapy beyond a time period of 5 years is lacking. These data on long term treatment are essential for several reasons. At first patients with AS are predominantly of younger age. When taking into account that withdrawal of anti-TNF therapy leads to disease relapse in a very high proportion of patients , anti-TNF therapy in AS patients is most often designed as a continuous therapy on a long term basis. The second reason for the need of long term data beyond 5 years is the ongoing debate whether anti-TNF agents have the potential to inhibit radiographic progression (Baraliakos X et al.:Ann Rheum Dis 2005, 64:1462-6; van der heijde D et al:Arthritis Rheum 2008, 58: 3063-70). Radiographic data on a larger cohort of patients treated with infliximab or other anti-TNF blockers for a long time period could contribute to answer this important question.
- Conditions
- Ankylosing Spondylitis
- Keywords
- Ankylosing spondylitis, Infliximab, Radiographic progression
- Medical subject headings
- Spondylitis, Ankylosing
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, long term treatment with infliximab | Patients with ankylosing spondylitis under long term treatment with infliximab within the open label clinical trials EASIC and DIKAS are now followed up in a registration study. No intervention is planned. Patients will be followed up for clinical outcome parameters and for radiographic progression. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2011 (estimated)
- Study startFeb 2011
- Primary completionJul 2013 (estimated)
- Study completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rheumazentrum Ruhrgebiet
- Sponsor type
- University, hospital or other
- Collaborators
- Centocor Ortho Biotech Services, L.L.C.
- Investigators
- Jürgen Braun, Prof. Dr., Study director, Rheumazentrum Ruhrgebiet, Landgrafemstrasse 15, 44652 Herne, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01286545
- Sponsor's protocol ID
- EASIC 30505 registry
- Acronym
- EASIC registry
- Status last verified
- Jan 2011
- First submitted
- 27 Jan 2011
- Last updated
- 31 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Braun J, Sieper J. Ankylosing spondylitis. Lancet. 2007 Apr 21;369(9570):1379-1390. doi: 10.1016/S0140-6736(07)60635-7.
PubMed 17448825Zochling J, van der Heijde D, Burgos-Vargas R, Collantes E, Davis JC Jr, Dijkmans B, Dougados M, Geher P, Inman RD, Khan MA, Kvien TK, Leirisalo-Repo M, Olivieri I, Pavelka K, Sieper J, Stucki G, Sturrock RD, van der Linden S, Wendling D, Bohm H, van Royen BJ, Braun J; 'ASsessment in AS' international working group; European League Against Rheumatism. ASAS/EULAR recommendations for the management of ankylosing spondylitis. Ann Rheum Dis. 2006 Apr;65(4):442-52. doi: 10.1136/ard.2005.041137. Epub 2005 Aug 26.
PubMed 16126791Baraliakos X, Listing J, Brandt J, Zink A, Alten R, Burmester G, Gromnica-Ihle E, Kellner H, Schneider M, Sorensen H, Zeidler H, Rudwaleit M, Sieper J, Braun J. Clinical response to discontinuation of anti-TNF therapy in patients with ankylosing spondylitis after 3 years of continuous treatment with infliximab. Arthritis Res Ther. 2005;7(3):R439-44. doi: 10.1186/ar1693. Epub 2005 Feb 21.
PubMed 15899030Baraliakos X, Listing J, Rudwaleit M, Brandt J, Alten R, Burmester G, Gromnica-Ihle E, Haibel H, Schewe S, Schneider M, Sorensen H, Zeidler H, Visvanathan S, Sieper J, Braun J. Safety and efficacy of readministration of infliximab after longterm continuous therapy and withdrawal in patients with ankylosing spondylitis. J Rheumatol. 2007 Mar;34(3):510-5. Epub 2007 Feb 1.
PubMed 17299842Braun J, Baraliakos X, Listing J, Fritz C, Alten R, Burmester G, Krause A, Schewe S, Schneider M, Sorensen H, Zeidler H, Sieper J. Persistent clinical efficacy and safety of anti-tumour necrosis factor alpha therapy with infliximab in patients with ankylosing spondylitis over 5 years: evidence for different types of response. Ann Rheum Dis. 2008 Mar;67(3):340-5. doi: 10.1136/ard.2007.075879. Epub 2007 Oct 29.
PubMed 17967831Dijkmans B, Emery P, Hakala M, Leirisalo-Repo M, Mola EM, Paolozzi L, Salvarani C, Sanmarti R, Sibilia J, Sieper J, Van Den Bosch F, van der Heijde D, van der Linden S, Wajdula J. Etanercept in the longterm treatment of patients with ankylosing spondylitis. J Rheumatol. 2009 Jun;36(6):1256-64. doi: 10.3899/jrheum.081033. Epub 2009 May 1.
PubMed 19411393Baraliakos X, Listing J, Rudwaleit M, Brandt J, Sieper J, Braun J. Radiographic progression in patients with ankylosing spondylitis after 2 years of treatment with the tumour necrosis factor alpha antibody infliximab. Ann Rheum Dis. 2005 Oct;64(10):1462-6. doi: 10.1136/ard.2004.033472. Epub 2005 Mar 18.
PubMed 15778240van der Heijde D, Landewe R, Baraliakos X, Houben H, van Tubergen A, Williamson P, Xu W, Baker D, Goldstein N, Braun J; Ankylosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy Study Group. Radiographic findings following two years of infliximab therapy in patients with ankylosing spondylitis. Arthritis Rheum. 2008 Oct;58(10):3063-70. doi: 10.1002/art.23901.
PubMed 18821688Essers I, van Tubergen A, Heldmann F, Baraliakos X, Braun J, Kiltz U, Boonen A. Do patients with ankylosing spondylitis adapt to their disease? Evidence from a 'then-test' in patients treated with TNF inhibitors. RMD Open. 2015 Nov 17;1(1):e000164. doi: 10.1136/rmdopen-2015-000164. eCollection 2015.
PubMed 26629367
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Ankylosing Spondylitis Infliximab Cohort (EASIC) Follow up Registration Study
- ClinicalTrials.gov ID
- NCT01286545
- Acronym / sponsor ID
- EASIC registry / EASIC 30505 registry
- Conditions
- Ankylosing Spondylitis
- Keywords
- Ankylosing spondylitis, Infliximab, Radiographic progression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rheumazentrum RuhrgebietUniversity, hospital or other
- Collaborators
- Centocor Ortho Biotech Services, L.L.C.
- Study start
- Feb 2011
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 31 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Long term data on efficacy and safety of anti-TNF treatment with infliximab in patients with ankylosing spondylitis (AS) beyond 5 years is lacking. These data are important because patients with AS usually are younger and withdrawal of anti-TNF therapy in these patients almost always leads to a disease relapse. Furthermore it is still unclear whether long term anti-TNF treatment in AS patients can inhibit radiographic progression. Patients who participated in the EASIC and the DIKAS trial respectively who were treated with infliximab within these studies for 7 and 10 years respectively are followed up by using clinical outcome parameters every 6 months assessing efficacy and safety of long term treatment. Furthermore radiographs of the spine, if done for clinical indication, are analyzed. It is hypothesized that anti-TNF treatment with infliximab is effective and safe over a time period of 9 and 12 years respectively and that long term anti-TNF therapy may inhibit radiographic progression of the spine.
Detailed description
Ankylosing spondylitis (AS) is the most frequent subtype of spondyloarthritides (SpA)(Braun et al.Lancet 2007, 369:1379-90). Treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) is the cornerstone of the treatment of the disease and is widely used to suppress inflammation and ameliorate spinal pain (Zochling et al.:Ann Rheum Dis 2006, 65:442-52). There is evidence that antitumour necrosis factor (TNF) therapy is highly effective in SpA, especially in AS and psoriatic arthritis. Thus, TNF blockers may even be considered as first line treatment in a patient with active AS whose condition is not sufficiently controlled with NSAIDs in the case of axial disease, and sulfasalazine or methotrexate in the case of peripheral arthritis (Zochling et al.:Ann Rheum Dis 2006, 65:442-52). Long-term data on anti-TNF therapy in patients with AS are rather limited. Infliximab in a dosage of 5mg/kg was shown to be efficacious over 5 years, including a short period of withdrawal and readministration (Baraliakos et al.:Arthritis Res Ther 2005, 7: R439-44; Baraliakos et al.:J Rheumatol 2007, 34: 510-5; Braun J et al: Ann Rheum Dis 2008, 67: 340-5). In our EASIC study the investigators have also shown the efficacy and safety of infliximab treatment in patients with AS over 5 years. Long term data for the treatment of AS with etanercept has proven the efficacy as well (Dijkmans B et al.:J Rheumatol 2009, 36: 1256-64). But long term data for efficacy and safety of treatment with anti-TNF therapy beyond a time period of 5 years is lacking. These data on long term treatment are essential for several reasons. At first patients with AS are predominantly of younger age. When taking into account that withdrawal of anti-TNF therapy leads to disease relapse in a very high proportion of patients , anti-TNF therapy in AS patients is most often designed as a continuous therapy on a long term basis. The second reason for the need of long term data beyond 5 years is the ongoing debate whether anti-TNF agents have the potential to inhibit radiographic progression (Baraliakos X et al.:Ann Rheum Dis 2005, 64:1462-6; van der heijde D et al:Arthritis Rheum 2008, 58: 3063-70). Radiographic data on a larger cohort of patients treated with infliximab or other anti-TNF blockers for a long time period could contribute to answer this important question.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ankylosing spondylitis, long term treatment with infliximab | – | –Patients with ankylosing spondylitis under long term treatment with infliximab within the open label clinical trials EASIC and DIKAS are now followed up in a registration study. No intervention is planned. Patients will be followed up for clinical outcome parameters and for radiographic progression. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ankylosing spondylitis who have completed: 1. the trials ASSERT, EASIC and EASIC extension (overall 7 years) 2. the trial DIKAS (overall 10 years) and who are still on infliximab or another anti-TNF agent wor who have terminated anti-TNF treatment
Key inclusion criteria (4 listed)
- Established diagnosis of ankylosing spondylitis according to the modified New York criteria
- Participation in the EASIC trial or participation in the DIKAS/TNF bei AS-trial
- Completion of the EASIC extension or the DIKAS trial
- Presence of written informed consent from the patient
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2011.
- Background: PubMed 17448825Braun J, Sieper J. Ankylosing spondylitis. Lancet. 2007 Apr 21;369(9570):1379-1390. doi: 10.1016/S0140-6736(07)60635-7.
- Background: PubMed 16126791Zochling J, van der Heijde D, Burgos-Vargas R, Collantes E, Davis JC Jr, Dijkmans B, Dougados M, Geher P, Inman RD, Khan MA, Kvien TK, Leirisalo-Repo M, Olivieri I, Pavelka K, Sieper J, Stucki G, Sturrock RD, van der Linden S, Wendling D, Bohm H, van Royen BJ, Braun J; 'ASsessment in AS' international working group; European League Against Rheumatism. ASAS/EULAR recommendations for the management of ankylosing spondylitis. Ann Rheum Dis. 2006 Apr;65(4):442-52. doi: 10.1136/ard.2005.041137. Epub 2005 Aug 26.
- Background: PubMed 15899030Baraliakos X, Listing J, Brandt J, Zink A, Alten R, Burmester G, Gromnica-Ihle E, Kellner H, Schneider M, Sorensen H, Zeidler H, Rudwaleit M, Sieper J, Braun J. Clinical response to discontinuation of anti-TNF therapy in patients with ankylosing spondylitis after 3 years of continuous treatment with infliximab. Arthritis Res Ther. 2005;7(3):R439-44. doi: 10.1186/ar1693. Epub 2005 Feb 21.
- Background: PubMed 17299842Baraliakos X, Listing J, Rudwaleit M, Brandt J, Alten R, Burmester G, Gromnica-Ihle E, Haibel H, Schewe S, Schneider M, Sorensen H, Zeidler H, Visvanathan S, Sieper J, Braun J. Safety and efficacy of readministration of infliximab after longterm continuous therapy and withdrawal in patients with ankylosing spondylitis. J Rheumatol. 2007 Mar;34(3):510-5. Epub 2007 Feb 1.
- Background: PubMed 17967831Braun J, Baraliakos X, Listing J, Fritz C, Alten R, Burmester G, Krause A, Schewe S, Schneider M, Sorensen H, Zeidler H, Sieper J. Persistent clinical efficacy and safety of anti-tumour necrosis factor alpha therapy with infliximab in patients with ankylosing spondylitis over 5 years: evidence for different types of response. Ann Rheum Dis. 2008 Mar;67(3):340-5. doi: 10.1136/ard.2007.075879. Epub 2007 Oct 29.
- Background: PubMed 19411393Dijkmans B, Emery P, Hakala M, Leirisalo-Repo M, Mola EM, Paolozzi L, Salvarani C, Sanmarti R, Sibilia J, Sieper J, Van Den Bosch F, van der Heijde D, van der Linden S, Wajdula J. Etanercept in the longterm treatment of patients with ankylosing spondylitis. J Rheumatol. 2009 Jun;36(6):1256-64. doi: 10.3899/jrheum.081033. Epub 2009 May 1.
- Background: PubMed 15778240Baraliakos X, Listing J, Rudwaleit M, Brandt J, Sieper J, Braun J. Radiographic progression in patients with ankylosing spondylitis after 2 years of treatment with the tumour necrosis factor alpha antibody infliximab. Ann Rheum Dis. 2005 Oct;64(10):1462-6. doi: 10.1136/ard.2004.033472. Epub 2005 Mar 18.
- Background: PubMed 18821688van der Heijde D, Landewe R, Baraliakos X, Houben H, van Tubergen A, Williamson P, Xu W, Baker D, Goldstein N, Braun J; Ankylosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy Study Group. Radiographic findings following two years of infliximab therapy in patients with ankylosing spondylitis. Arthritis Rheum. 2008 Oct;58(10):3063-70. doi: 10.1002/art.23901.
- Derived from this study: PubMed 26629367Essers I, van Tubergen A, Heldmann F, Baraliakos X, Braun J, Kiltz U, Boonen A. Do patients with ankylosing spondylitis adapt to their disease? Evidence from a 'then-test' in patients treated with TNF inhibitors. RMD Open. 2015 Nov 17;1(1):e000164. doi: 10.1136/rmdopen-2015-000164. eCollection 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jürgen Braun, Prof. Dr. study director
Rheumazentrum Ruhrgebiet, Landgrafemstrasse 15, 44652 Herne, Germany
19 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankylosing Spondylitis, run by Rheumazentrum Ruhrgebiet at 19 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Germany, Belgium, France, Netherlands, United Kingdom and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jürgen Braun, Prof. Dr. (00492325592131, j.braun@rheumazentrum-ruhrgebiet.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01286545, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2011.