European Ankylosing Spondylitis Infliximab Cohort (EASIC) Follow up Registration Study

NCT ID: NCT01286545

Last Updated: 2011-01-31

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2013-10-31

Brief 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. 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.

Conditions

Ankylosing Spondylitis

Keywords

Ankylosing spondylitis; Infliximab; Radiographic progression

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• None

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centocor Ortho Biotech Services, L.L.C.

INDUSTRY

Sponsor Role: collaborator

Rheumazentrum Ruhrgebiet

OTHER

Sponsor Role: lead

Responsible Party

Rheumazentrum Ruhrgebiet, Landgrafenstrasse 15, 44652 Herne

Principal Investigators

Jürgen Braun, Prof. Dr.

Role: STUDY_DIRECTOR

Rheumazentrum Ruhrgebiet, Landgrafemstrasse 15, 44652 Herne, Germany

Locations

Erasme University Hospital

Brussels, , Belgium

Universitair Ziekenhuis, Afdeling Rheumatologie

Ghent, , Belgium

University Hospital Leuven

Leuven, , Belgium

University Central Hospital, Division of Rheumatology

Helsinki, , Finland

Groupe Hopitalier Cochin

Boulogne, , France

Universitat R. Decartes, Hopital Cochin

Paris, , France

Charité Universitätsmedizin Mitte

Berlin, , Germany

Charité Campus Benjamin Franklin

Berlin, , Germany

Immanuel Krankenhaus Berlin Buch

Berlin, , Germany

Rheumatologie Schlosspark-Klinik

Berlin, , Germany

Rheumapraxis Berlin

Berlin, , Germany

Rheumazentrum Düsseldorf, Universitätsklinik

Düsseldorf, , Germany

Klinik für Immunologie und Rheumatologie der MHH

Hanover, , Germany

Rheumazentrum Ruhrgebiet

Herne, , Germany

Klinikum der Universität München, Rheumaeinheit

München, , Germany

Academisch Ziekenhuis

Amsterdam, , Netherlands

University Hospital

Maastricht, , Netherlands

University of Cambridge /Clin Med

Cambridge, , United Kingdom

University of Leeds

Leeds, , United Kingdom

Countries

Belgium; Finland; France; Germany; Netherlands; United Kingdom

Central Contacts

Jürgen Braun, Prof. Dr.

Role: CONTACT

Phone: 00492325592131

Email: j.braun@rheumazentrum-ruhrgebiet.de

Frank Heldmann, Dr.

Role: CONTACT

Phone: 00492325592709

Email: heldmann@rheumazentrum-ruhrgebiet.de

Facility Contacts

Thierry Appelboom, Prof. Dr.

Role: primary

Filip van den Bosch, Dr.

Role: primary

Kristel de Boeck, Mrs.

Role: backup

Kurt de Vlam, Dr.

Role: primary

Jilke Beinsberger, Mrs.

Role: backup

Marjatta Leirisalo-Repo, Prof. Dr.

Role: primary

Arja Karto

Role: backup

Maxime Breban, Prof. Dr.

Role: primary

Claire Ribet, Mrs.

Role: backup

Sami Kolta, Dr.

Role: primary

Nathalie Ménagé, Mrs

Role: backup

Eugen Feist, Dr.

Role: primary

Katrin Mattat, Mrs.

Role: backup

Hildrun Haibel, Dr-

Role: primary

Renate Pauli, Mrs.

Role: backup

Andreas Krause, Prof. Dr.

Role: primary

Carmen Herz, Mrs.

Role: backup

Svitlana Dyachenko, Dr.

Role: primary

Rieke Alten, Dr.

Role: backup

Helmut Sörensen, Dr.

Role: primary

Pamela Sander, Mrs.

Role: backup

Matthias Schneider, Prof. Dr.

Role: primary

Elsbeth Richter, Mrs.

Role: backup

Markus Rihl, Dr.

Role: primary

Kathrin Scheiwe, Mrs.

Role: backup

Frank Heldmann

Role: primary

Matthias Witt, Dr.

Role: primary

Christine Strasser, Mrs.

Role: backup

Irene vander Horst-Bruinsma, Dr.

Role: primary

Silvy Weismann, Mrs.

Role: backup

Astrid van Tubergen, Dr.

Role: primary

Janine Geusen, Mrs.

Role: backup

Hill Gaston, Prof. Dr.

Role: primary

Dominique R Roy, Mrs.

Role: backup

Laura C Coates, Dr.

Role: primary

David Pickles, Mr.

Role: backup

References

Braun J, Sieper J. Ankylosing spondylitis. Lancet. 2007 Apr 21;369(9570):1379-1390. doi: 10.1016/S0140-6736(07)60635-7.

Reference Type: BACKGROUND

PMID: 17448825 (View on PubMed)

Zochling 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.

Reference Type: BACKGROUND

PMID: 16126791 (View on PubMed)

Baraliakos 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.

Reference Type: BACKGROUND

PMID: 15899030 (View on PubMed)

Baraliakos 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.

Reference Type: BACKGROUND

PMID: 17299842 (View on PubMed)

Braun 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.

Reference Type: BACKGROUND

PMID: 17967831 (View on PubMed)

Dijkmans 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.

Reference Type: BACKGROUND

PMID: 19411393 (View on PubMed)

Baraliakos 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.

Reference Type: BACKGROUND

PMID: 15778240 (View on PubMed)

van 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.

Reference Type: BACKGROUND

PMID: 18821688 (View on PubMed)

Essers 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.

Reference Type: DERIVED

PMID: 26629367 (View on PubMed)

Other Identifiers

EASIC 30505 registry

Identifier Type: -

Identifier Source: org_study_id