MedTrace Logo

Examination of Radiographic Progression, Efficacy and Safety of Long-Term Treatment With Infliximab in Patients With Ankylosing Spondylitis

NCT00237419 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 149

Last updated 2008-06-03

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

infliximab

Infliximab infusions 5 mg/kg body-weight each 6 to 8 weeks

Sponsors & Collaborators

  • Centocor BV

    collaborator INDUSTRY

  • Trial Coordination Center, 9713 GZ Groningen

    collaborator UNKNOWN

  • PPD Development, LP

    collaborator INDUSTRY

  • Rheumazentrum Ruhrgebiet

    lead OTHER

Principal Investigators

  • Jürgen Braun, Prof. Dr. · Rheumazentrum Ruhrgebiet

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2010-11-30
Completion
2011-04-30

Countries

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

Study Locations

More Related Trials

Entities

Drugs
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 NCT00237419 on ClinicalTrials.gov