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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Rheumazentrum Ruhrgebiet.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Centocor Biotech
Information provided by:
Rheumazentrum Ruhrgebiet
ClinicalTrials.gov Identifier:
NCT01286545
First received: January 27, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

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
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)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
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

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
  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 ClinicalTrials.gov identifier: NCT01286545

Contacts
Contact: Jürgen Braun, Prof. Dr. 00492325592131 j.braun@rheumazentrum-ruhrgebiet.de
Contact: Frank Heldmann, Dr. 00492325592709 heldmann@rheumazentrum-ruhrgebiet.de

Locations
Belgium
Erasme University Hospital Not yet recruiting
Brussels, Belgium
Contact: Thierry Appelboom, Prof. Dr.       tappelbo@ulb.ac.be   
Principal Investigator: Thierry Appelboom, Prof. Dr.         
Universitair Ziekenhuis, Afdeling Rheumatologie Not yet recruiting
Gent, Belgium, 9000
Contact: Filip van den Bosch, Dr.       filip.vandenbosch@ugent.be   
Contact: Kristel de Boeck, Mrs.       kristel.deboeck@ugent.be   
Principal Investigator: Filip van den Bosch, Dr.         
University Hospital Leuven Not yet recruiting
Leuven, Belgium, 3000
Contact: Kurt de Vlam, Dr.    003216332211    kurt.devlam@uz.kuleuven.ac.be   
Contact: Jilke Beinsberger, Mrs.    003216332211    jilke.beinsberger@uz.leuven.be   
Principal Investigator: Kurt de Vlam, Dr.         
Finland
University Central Hospital, Division of Rheumatology Not yet recruiting
Helsinki, Finland, 00029HYKS
Contact: Marjatta Leirisalo-Repo, Prof. Dr.       Marjatta.Leirisalo-Repo@hus.fi   
Contact: Arja Karto       arja.karto@hus.fi   
Principal Investigator: Marjatta Leirisalo-Repo, Prof. Dr.         
France
Groupe Hopitalier Cochin Not yet recruiting
Boulogne, France
Contact: Maxime Breban, Prof. Dr.    0033149095672    maxime.breban@cch.ap-hop-paris.fr   
Contact: Claire Ribet, Mrs.    0033149095672    claire.ribet@apr.ap-hop-paris.fr   
Principal Investigator: Maxime Breban, Prof. Dr.         
Universitat R. Decartes, Hopital Cochin Not yet recruiting
Paris, France
Contact: Sami Kolta, Dr.    0033158412584    sami.kolta@cch.ap-hop-paris.fr   
Contact: Nathalie Ménagé, Mrs         
Principal Investigator: Maxime Dougados, Prof. Dr.         
Sub-Investigator: Sami Kolta, Dr.         
Germany
Charité Campus Benjamin Franklin Not yet recruiting
Berlin, Germany, 12200
Contact: Hildrun Haibel, Dr-    00493084454414    hildrun.haibel@charite.de   
Contact: Renate Pauli, Mrs.    00493084452660    renate.pauli@charite.de   
Principal Investigator: Joachim Sieper, Prof. Dr.         
Sub-Investigator: Hildrun Haibel, Dr.         
Rheumatologie Schlosspark-Klinik Not yet recruiting
Berlin, Germany, 14059
Contact: Svitlana Dyachenko, Dr.    00493032641325    svitlana.dyachenko@schlosspark-klinik.de   
Contact: Rieke Alten, Dr.    00493032641325    rieke.alten@schlosspark-klinik.de   
Principal Investigator: Rieke Alten, Dr.         
Sub-Investigator: Svitlana Dyachenko, Dr.         
Charité Universitätsmedizin Mitte Not yet recruiting
Berlin, Germany, 10117
Contact: Eugen Feist, Dr.    004930450513133    eugen.feist@charite.de   
Contact: Katrin Mattat, Mrs.    004930450513133    katrin.mattat@charite.de   
Principal Investigator: Gerd Burmester, Prof. Dr.         
Sub-Investigator: Eugen Feist, Dr.         
Rheumapraxis Berlin Not yet recruiting
Berlin, Germany, 14163
Contact: Helmut Sörensen, Dr.    00493081810188    h.soerensen@rheuma-berlin.com   
Contact: Pamela Sander, Mrs.    00493081810188    p.sander@rheuma-berlin.com   
Principal Investigator: Helmut Sörensen, Dr.         
Immanuel Krankenhaus Berlin Buch Not yet recruiting
Berlin, Germany, 13125
Contact: Andreas Krause, Prof. Dr.    00493094792300    a.krause@immanuel.de   
Contact: Carmen Herz, Mrs.    00493094792300    C.Herz@immanuel.de   
Principal Investigator: Andreas Krause, Prof. Dr.         
Rheumazentrum Düsseldorf, Universitätsklinik Not yet recruiting
Düsseldorf, Germany, 40225
Contact: Matthias Schneider, Prof. Dr.    00492118117817    schneider@rheumanet.org   
Contact: Elsbeth Richter, Mrs.    00492118117817    Elsbeth.Richter@med.uni-duesseldorf.de   
Principal Investigator: Matthias Schneider, Prof. Dr.         
Klinik für Immunologie und Rheumatologie der MHH Not yet recruiting
Hannover, Germany, 30625
Contact: Markus Rihl, Dr.    00495115325252    Rihl.Markus@mh-hannover.de   
Contact: Kathrin Scheiwe, Mrs.    00495115325252    Rht-Studienambulanz@mh-hannover.de   
Principal Investigator: R.E. Schmidt, Prof. Dr.         
Sub-Investigator: Markus Rihl, Dr.         
Rheumazentrum Ruhrgebiet Not yet recruiting
Herne, Germany, 44652
Contact: Frank Heldmann    00492325592112    heldmann@rheumazentrum-ruhrgebiet.de   
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    Matthias.Witt@med.uni-muenchen.de   
Contact: Christine Strasser, Mrs.    00498951603455    Christine.Strasser@med.uni-muenchen.de   
Principal Investigator: Matthias Witt, Dr.         
Netherlands
Academisch Ziekenhuis Not yet recruiting
Amsterdam, Netherlands, 1007 MB
Contact: Irene vander Horst-Bruinsma, Dr.    0031204443432    I.E.vanderHorst@vumc.nl   
Contact: Silvy Weismann, Mrs.    0031204443432    S.Weismann@vumc.nl   
Principal Investigator: Irene van der Horst-Bruinsma, Dr.         
University Hospital Not yet recruiting
Maastricht, Netherlands, 6202 AZ
Contact: Astrid van Tubergen, Dr.    0031433875026    a.van.tubergen@mumc.nl   
Contact: Janine Geusen, Mrs.    0031433875026    j.geusen@mumc.nl   
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    jshg2@medschl.cam.ac.uk   
Contact: Dominique R Roy, Mrs.    00441233330161    dr314@medschl.cam.ac.uk   
Principal Investigator: Hill Gaston, Prof. Dr.         
University of Leeds Not yet recruiting
Leeds, United Kingdom, LS2 9N2
Contact: Laura C Coates, Dr.    004411339224848    L.C.Coates@leeds.ac.uk   
Contact: David Pickles, Mr.    004411339224848    David.Pickles@leedsth.nhs.uk   
Principal Investigator: Paul Emery, Prof. Dr.         
Sub-Investigator: Laura C Coates, Dr.         
Sponsors and Collaborators
Rheumazentrum Ruhrgebiet
Centocor Biotech
Investigators
Study Director: Jürgen Braun, Prof. Dr. Rheumazentrum Ruhrgebiet, Landgrafemstrasse 15, 44652 Herne, Germany
  More Information

Publications:

Responsible Party: Braun, Jürgen, Prof. Dr. med, Rheumazentrum Ruhrgebiet, Landgrafenstrasse 15, 44652 Herne
ClinicalTrials.gov Identifier: NCT01286545     History of Changes
Other Study ID Numbers: EASIC 30505 registry
Study First Received: January 27, 2011
Last Updated: January 27, 2011
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Rheumazentrum Ruhrgebiet:
Ankylosing spondylitis
Infliximab
Radiographic progression

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
Infliximab
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents
Gastrointestinal Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 28, 2014