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Home » Clinical Trials » Ankylosing Spondylitis

Clinical Trial Details

Overview

Research Study Summary

A clinical research study of infliximab for the treatment of Ankylosing Spondylitis

Research Study Title

An Open Label Extension, Investigator Initiated Trial to Examine Radiographic Progression , Efficacy and Safety of Long-Term Treatment With Infliximab in Patients With Ankylosing Spondylitis. EASIC (European Ankylosing Spondylitis Infliximab Cohort)

Purpose

Ankylosing spondylitis (AS) is a chronic inflammatory disease that involves the sacroiliac joints, axial skeleton, entheses and peripheral joints. Current therapy for AS is mainly NSAIDs and physiotherapy which are oft insufficient. Treatment with the TNF-alpha blocking agent infliximab was shown to have definite clinical efficacy in patients with active AS on a short- and a long-term-basis over 2 years. We want to show that treatment with infliximab on a long-term basis over 4 years is safe and efficient and can prevent radiographic progression over a long period of time. Further we want to learn about the outcome after discontinuation of anti-TNF-alpha therapy.

To Learn more
Gender

Both Male and Female

Age

18 and up

Overall Status

Recruiting

Lead Sponsor

Rheumazentrum Ruhrgebiet

Duration

59 Months

Facility Type

N/A

Eligibility

Both Male and Female ages 18 Years and up

Inclusion Criteria:

  • All patients in Europe who have completed visit "week 96" of ASSERT (last infusion of infliximab)

  • Capacity to understand and sign an informed consent form

  • Capacity to read and understand subject assessment forms

  • Using adequate birth control measures for the duration of the study and for 6 months after receiving the last infusion, if the patient is of childbearing potential

  • Serum creatinine < 1,4 mg/dl

  • Hemoglobin > 9,0 mg /dl for males and > 8,5 mg/dl for females

  • Serum transaminase levels within 3 times the upper limit of normal range

Exclusion Criteria:

  • Have used systemic prednisolone > 20 mg during the 2 weeks prior to screening

  • Have used cytotoxic drugs after the end of ASSERT including chlorambucil, cyclophosphamide and alkylating agents

  • Have received any previous treatment with etanercept or any other anti-TNF agent (other than infliximab) after the end of the ASSERT trial

  • General medical exclusion criteria

  • Use of any investigational drug within 30 days prio to screening

  • Concomitant diagnosis or history of congestive heart failure

  • History of latent or active tuberculosis

  • Signs or symptoms suggestive of active tuberculosis

  • Recent close contact with a person with active tuberculosis

Site Locations (15)

Country State City Zip Facility and Contact
Belgium Brussels Erasme University Hospital
Serge Steinfeld, Prof. Dr.
+32 (0) 25 556 745
ssteinfe@ulb.ac.be

Serge Steinfeld, Prof.Dr.
Principal Investigator
Belgium Diepenbeek Limburg University Centre
Piet Geusens, Prof. Dr.
+32 (0) 89 362977
piet.geusens@ping.be

Piet Geusens, Prof. Dr.
Principal Investigator
Belgium Gent 9000 Universitair Ziekenhuis, Afdeling Rheumatologie
Filip Van den Bosch, Dr.
filip.vandenbosch@skynet.be

Filip van den Bosch, Dr.
Principal Investigator
Belgium Leuven 3000 University Hospital Leuven
Kurt de Vlam, Dr.
+32 (0) 16 332 211
kurt.devlam@pi.be

Rene Westhovens, Prof.Dr.
Principal Investigator
Finland Helsinki 00029HYKS University Central Hospital, Division of Rheumatology
Marjatta Leirisalo-Repo, Prof
Marjatta.Leirisalo-Repo@hus.fi

Marjatta Leirisalo-Repo, Prof. Dr.
Principal Investigator
France Paris Groupe Hopitalier Cochin
Maxime Breban, Prof.Dr.
+33 (0) 1 49095672
maxime.breban@cch.ap-hop-paris.fr

Maxime Breban, Prof.Dr.
Principal Investigator
France Paris Universitat R. Descartes, Hopital Cochin
Sami Kolta, Dr.
+33 (0) 1 5841 2584
sami.kolta@cch.ap-hop-paris.fr

Maxime Dougados, Prof.Dr.
Principal Investigator
Germany Berlin 12200 Charite Klinikum Steglitz
Henning Brandt, Dr.
+49 (0) 30 8445 4414
henning.brandt@charite.de

Joachim Sieper, Prof.Dr.
Principal Investigator
Germany Berlin 10117 Charite Mitte
Gerd Burmester, Prof. Dr.
+49 (0) 30 45051 3082
gerd.burmester@charite.de

Gerd Burmester, Prof. Dr.
Principal Investigator
Germany Herne 44652 Rheumazentrum Ruhrgebiet
Frank Heldmann, Dr.
+49 (0) 2325 592138
heldmann@rheumazentrum-ruhrgebiet.de

Jürgen Braun, Prof. Dr.
Principal Investigator
Germany München 80336 Ludwigs-Maximilian-Universität
Christine Strasser
+49 (0) 89 51603511
Christine.Strasser@med.uni-muenchen.de

Stefan Schewe, Prof.Dr.
Principal Investigator

Matthias Gruenke, Dr. med.
Sub-Investigator
Netherlands Amsterdam 1007MB Academic Ziekenhuis
I.E van der Horst-Bruinsma, Dr.
+31 (0) 20 4443432
IE.vanderHorst@vumc.nl

B.A.C Dijkmans, Prof. Dr.
Principal Investigator
Netherlands Maastricht 6202 AZ University Hospital Maastricht
Annelies Boonen
+ 31 (0) 43 388 42 33
aboo@sint.azm.nl

Robert Landewe, Prof.Dr.
Principal Investigator
United Kingdom Cambridge CB2 QQ University of Cambridge/ Clin Med
Hill Gaston, Prof. Dr.
+44 (0) 1233 330161
jshg2@medschl.cam.ac.uk

Hill Gaston, Prof.Dr.
Principal Investigator
United Kingdom Leeds LS2 9N2 University of Leeds
Mrs. Keen, Dr.
+44 (0) 113 392 24848

Paul Emery, Prof.Dr.
Principal Investigator

Contact

Jürgen Braun, Prof. Dr.
+49 (0) 2325 592131
E-mail:

NCT ID: NCT00237419

Date Last Changed: May 30, 2008

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