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

January 27, 2011 updated by: Rheumazentrum Ruhrgebiet
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.

Study Overview

Status

Unknown

Conditions

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

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rheumazentrum Ruhrgebiet

Collaborators

Centocor Ortho Biotech Services, L.L.C.

Investigators

  • Study Director: Jürgen Braun, Prof. Dr., Rheumazentrum Ruhrgebiet, Landgrafemstrasse 15, 44652 Herne, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Anticipated)

July 1, 2013

Study Completion (Anticipated)

October 1, 2013

Study Registration Dates

First Submitted

January 27, 2011

First Submitted That Met QC Criteria

January 27, 2011

First Posted (Estimate)

January 31, 2011

Study Record Updates

Last Update Posted (Estimate)

January 31, 2011

Last Update Submitted That Met QC Criteria

January 27, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EASIC 30505 registry

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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