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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01286545
Recruitment Status : Unknown
Verified January 2011 by Rheumazentrum Ruhrgebiet.
Recruitment status was:  Not yet recruiting
First Posted : January 31, 2011
Last Update Posted : January 31, 2011
Centocor Ortho Biotech Services, L.L.C.
Information provided by:
Rheumazentrum Ruhrgebiet

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.

Condition or disease
Ankylosing Spondylitis

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 Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: European Ankylosing Spondylitis Infliximab Cohort (EASIC) Follow up Registration Study
Study Start Date : February 2011
Estimated Primary Completion Date : July 2013
Estimated Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab

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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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


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:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01286545

Contact: Jürgen Braun, Prof. Dr. 00492325592131
Contact: Frank Heldmann, Dr. 00492325592709

Erasme University Hospital Not yet recruiting
Brussels, Belgium
Contact: Thierry Appelboom, Prof. Dr.   
Principal Investigator: Thierry Appelboom, Prof. Dr.         
Universitair Ziekenhuis, Afdeling Rheumatologie Not yet recruiting
Gent, Belgium, 9000
Contact: Filip van den Bosch, Dr.   
Contact: Kristel de Boeck, Mrs.   
Principal Investigator: Filip van den Bosch, Dr.         
University Hospital Leuven Not yet recruiting
Leuven, Belgium, 3000
Contact: Kurt de Vlam, Dr.    003216332211   
Contact: Jilke Beinsberger, Mrs.    003216332211   
Principal Investigator: Kurt de Vlam, Dr.         
University Central Hospital, Division of Rheumatology Not yet recruiting
Helsinki, Finland, 00029HYKS
Contact: Marjatta Leirisalo-Repo, Prof. Dr.   
Contact: Arja Karto   
Principal Investigator: Marjatta Leirisalo-Repo, Prof. Dr.         
Groupe Hopitalier Cochin Not yet recruiting
Boulogne, France
Contact: Maxime Breban, Prof. Dr.    0033149095672   
Contact: Claire Ribet, Mrs.    0033149095672   
Principal Investigator: Maxime Breban, Prof. Dr.         
Universitat R. Decartes, Hopital Cochin Not yet recruiting
Paris, France
Contact: Sami Kolta, Dr.    0033158412584   
Contact: Nathalie Ménagé, Mrs         
Principal Investigator: Maxime Dougados, Prof. Dr.         
Sub-Investigator: Sami Kolta, Dr.         
Charité Universitätsmedizin Mitte Not yet recruiting
Berlin, Germany, 10117
Contact: Eugen Feist, Dr.    004930450513133   
Contact: Katrin Mattat, Mrs.    004930450513133   
Principal Investigator: Gerd Burmester, Prof. Dr.         
Sub-Investigator: Eugen Feist, Dr.         
Charité Campus Benjamin Franklin Not yet recruiting
Berlin, Germany, 12200
Contact: Hildrun Haibel, Dr-    00493084454414   
Contact: Renate Pauli, Mrs.    00493084452660   
Principal Investigator: Joachim Sieper, Prof. Dr.         
Sub-Investigator: Hildrun Haibel, Dr.         
Immanuel Krankenhaus Berlin Buch Not yet recruiting
Berlin, Germany, 13125
Contact: Andreas Krause, Prof. Dr.    00493094792300   
Contact: Carmen Herz, Mrs.    00493094792300   
Principal Investigator: Andreas Krause, Prof. Dr.         
Rheumatologie Schlosspark-Klinik Not yet recruiting
Berlin, Germany, 14059
Contact: Svitlana Dyachenko, Dr.    00493032641325   
Contact: Rieke Alten, Dr.    00493032641325   
Principal Investigator: Rieke Alten, Dr.         
Sub-Investigator: Svitlana Dyachenko, Dr.         
Rheumapraxis Berlin Not yet recruiting
Berlin, Germany, 14163
Contact: Helmut Sörensen, Dr.    00493081810188   
Contact: Pamela Sander, Mrs.    00493081810188   
Principal Investigator: Helmut Sörensen, Dr.         
Rheumazentrum Düsseldorf, Universitätsklinik Not yet recruiting
Düsseldorf, Germany, 40225
Contact: Matthias Schneider, Prof. Dr.    00492118117817   
Contact: Elsbeth Richter, Mrs.    00492118117817   
Principal Investigator: Matthias Schneider, Prof. Dr.         
Klinik für Immunologie und Rheumatologie der MHH Not yet recruiting
Hannover, Germany, 30625
Contact: Markus Rihl, Dr.    00495115325252   
Contact: Kathrin Scheiwe, Mrs.    00495115325252   
Principal Investigator: R.E. Schmidt, Prof. Dr.         
Sub-Investigator: Markus Rihl, Dr.         
Rheumazentrum Ruhrgebiet Not yet recruiting
Herne, Germany, 44652
Contact: Frank Heldmann    00492325592112   
Principal Investigator: Jürgen Braun, Prof. Dr.         
Sub-Investigator: Frank Heldmann, Dr.         
Klinikum der Universität München, Rheumaeinheit Not yet recruiting
München, Germany, 80336
Contact: Matthias Witt, Dr.    00498951603455   
Contact: Christine Strasser, Mrs.    00498951603455   
Principal Investigator: Matthias Witt, Dr.         
Academisch Ziekenhuis Not yet recruiting
Amsterdam, Netherlands, 1007 MB
Contact: Irene vander Horst-Bruinsma, Dr.    0031204443432   
Contact: Silvy Weismann, Mrs.    0031204443432   
Principal Investigator: Irene van der Horst-Bruinsma, Dr.         
University Hospital Not yet recruiting
Maastricht, Netherlands, 6202 AZ
Contact: Astrid van Tubergen, Dr.    0031433875026   
Contact: Janine Geusen, Mrs.    0031433875026   
Principal Investigator: Astrid van Tubergen, Dr.         
United Kingdom
University of Cambridge /Clin Med Not yet recruiting
Cambridge, United Kingdom, CB2 QQ
Contact: Hill Gaston, Prof. Dr.    00441233330161   
Contact: Dominique R Roy, Mrs.    00441233330161   
Principal Investigator: Hill Gaston, Prof. Dr.         
University of Leeds Not yet recruiting
Leeds, United Kingdom, LS2 9N2
Contact: Laura C Coates, Dr.    004411339224848   
Contact: David Pickles, Mr.    004411339224848   
Principal Investigator: Paul Emery, Prof. Dr.         
Sub-Investigator: Laura C Coates, Dr.         
Sponsors and Collaborators
Rheumazentrum Ruhrgebiet
Centocor Ortho Biotech Services, L.L.C.
Study Director: Jürgen Braun, Prof. Dr. Rheumazentrum Ruhrgebiet, Landgrafemstrasse 15, 44652 Herne, Germany


Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Braun, Jürgen, Prof. Dr. med, Rheumazentrum Ruhrgebiet, Landgrafenstrasse 15, 44652 Herne Identifier: NCT01286545     History of Changes
Other Study ID Numbers: EASIC 30505 registry
First Posted: January 31, 2011    Key Record Dates
Last Update Posted: January 31, 2011
Last Verified: January 2011

Keywords provided by Rheumazentrum Ruhrgebiet:
Ankylosing spondylitis
Radiographic progression

Additional relevant MeSH terms:
Spondylitis, Ankylosing
Bone Diseases, Infectious
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Joint Diseases
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents