Try our beta test site

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2011 by Rheumazentrum Ruhrgebiet.
Recruitment status was:  Not yet recruiting
Centocor Ortho Biotech Services, L.L.C.
Information provided by:
Rheumazentrum Ruhrgebiet Identifier:
First received: January 27, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
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.

Ankylosing Spondylitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: European Ankylosing Spondylitis Infliximab Cohort (EASIC) Follow up Registration Study

Resource links provided by NLM:

Further study details as provided by Rheumazentrum Ruhrgebiet:

Estimated Enrollment: 100
Study Start Date: February 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
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.

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.

Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
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:

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01286545

Erasme University Hospital
Brussels, Belgium
Universitair Ziekenhuis, Afdeling Rheumatologie
Gent, Belgium, 9000
University Hospital Leuven
Leuven, Belgium, 3000
University Central Hospital, Division of Rheumatology
Helsinki, Finland, 00029HYKS
Groupe Hopitalier Cochin
Boulogne, France
Universitat R. Decartes, Hopital Cochin
Paris, France
Charité Universitätsmedizin Mitte
Berlin, Germany, 10117
Charité Campus Benjamin Franklin
Berlin, Germany, 12200
Immanuel Krankenhaus Berlin Buch
Berlin, Germany, 13125
Rheumatologie Schlosspark-Klinik
Berlin, Germany, 14059
Rheumapraxis Berlin
Berlin, Germany, 14163
Rheumazentrum Düsseldorf, Universitätsklinik
Düsseldorf, Germany, 40225
Klinik für Immunologie und Rheumatologie der MHH
Hannover, Germany, 30625
Rheumazentrum Ruhrgebiet
Herne, Germany, 44652
Klinikum der Universität München, Rheumaeinheit
München, Germany, 80336
Academisch Ziekenhuis
Amsterdam, Netherlands, 1007 MB
University Hospital
Maastricht, Netherlands, 6202 AZ
United Kingdom
University of Cambridge /Clin Med
Cambridge, United Kingdom, CB2 QQ
University of Leeds
Leeds, United Kingdom, LS2 9N2
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
  More Information


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 
Study First Received: January 27, 2011
Last Updated: January 27, 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 processed this record on February 17, 2017