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

NCT01286545 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2011-01-31

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • Centocor Ortho Biotech Services, L.L.C.

    collaborator INDUSTRY

  • Rheumazentrum Ruhrgebiet

    lead OTHER

Principal Investigators

  • Jürgen Braun, Prof. Dr. · Rheumazentrum Ruhrgebiet, Landgrafemstrasse 15, 44652 Herne, Germany

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2013-07-31
Completion
2013-10-31

Countries

  • Belgium
  • Finland
  • France
  • Germany
  • Netherlands
  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01286545 on ClinicalTrials.gov