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

Ankylosing Spondylitis Clinical Trial

— EASIC registry  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01286545
• Other study ID #: EASIC 30505 registry
• Status: Not yet recruiting
• Phase: N/A
• First received: January 27, 2011
• Last updated: January 27, 2011
• Start date: February 2011
• Est. completion date: October 2013

Study information

• Verified date: January 2011
• Source: Rheumazentrum Ruhrgebiet
• Contact: Jürgen Braun, Prof. Dr.
• Phone: 00492325592131
• Email: j.braun[@]rheumazentrum-ruhrgebiet.de
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: October 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

Locations

Country	Name	City	State
Belgium	Erasme University Hospital	Brussels
Belgium	Universitair Ziekenhuis, Afdeling Rheumatologie	Gent
Belgium	University Hospital Leuven	Leuven
Finland	University Central Hospital, Division of Rheumatology	Helsinki
France	Groupe Hopitalier Cochin	Boulogne
France	Universitat R. Decartes, Hopital Cochin	Paris
Germany	Charité Campus Benjamin Franklin	Berlin
Germany	Charité Universitätsmedizin Mitte	Berlin
Germany	Immanuel Krankenhaus Berlin Buch	Berlin
Germany	Rheumapraxis Berlin	Berlin
Germany	Rheumatologie Schlosspark-Klinik	Berlin
Germany	Rheumazentrum Düsseldorf, Universitätsklinik	Düsseldorf
Germany	Klinik für Immunologie und Rheumatologie der MHH	Hannover
Germany	Rheumazentrum Ruhrgebiet	Herne
Germany	Klinikum der Universität München, Rheumaeinheit	München
Netherlands	Academisch Ziekenhuis	Amsterdam
Netherlands	University Hospital	Maastricht
United Kingdom	University of Cambridge /Clin Med	Cambridge
United Kingdom	University of Leeds	Leeds

Sponsors (2)

Lead Sponsor	Collaborator
Rheumazentrum Ruhrgebiet	Centocor Ortho Biotech Services, L.L.C.

Countries where clinical trial is conducted

Belgium,  Finland,  France,  Germany,  Netherlands,  United Kingdom, 

References & Publications (8)

Baraliakos X, Listing J, Brandt J, Zink A, Alten R, Burmester G, Gromnica-Ihle E, Kellner H, Schneider M, Sörensen 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. Epub 2005 Feb 21. Erratum in: Arthritis Res Ther. 2005;7(3):113. Zink, Angela [added];Alten, Rieke [added]; Burmester, Gerd [added]; Gromnica-Ihle, Erika [added]; Kellner, Herbert [added]; Schneider, Matthias [added]; Sörensen, Helmut [added]; Zeidler, Henning [added]; Rudwaleit, Martin [added]. — View Citation

Baraliakos X, Listing J, Rudwaleit M, Brandt J, Alten R, Burmester G, Gromnica-Ihle E, Haibel H, Schewe S, Schneider M, Sörensen 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. — View Citation

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. Epub 2005 Mar 18. — View Citation

Braun J, Baraliakos X, Listing J, Fritz C, Alten R, Burmester G, Krause A, Schewe S, Schneider M, Sörensen 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. Epub 2007 Oct 29. — View Citation

Braun J, Sieper J. Ankylosing spondylitis. Lancet. 2007 Apr 21;369(9570):1379-90. Review. — View Citation

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. Erratum in: J Rheumatol. 2010 Oct;37(10):2198. — View Citation

van der Heijde D, Landewé 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. — View Citation

Zochling J, van der Heijde D, Burgos-Vargas R, Collantes E, Davis JC Jr, Dijkmans B, Dougados M, Géher 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, Böhm 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. Epub 2005 Aug 26. — View Citation