Status:
UNKNOWN
Examination of Radiographic Progression, Efficacy and Safety of Long-Term Treatment With Infliximab in Patients With Ankylosing Spondylitis
Lead Sponsor:
Rheumazentrum Ruhrgebiet
Collaborating Sponsors:
Centocor BV
Trial Coordination Center, 9713 GZ Groningen
Conditions:
Ankylosing Spondylitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 physiothe...
Detailed Description
Ankylosing spondylitis (AS) is a chronic inflammatory disease of unknown etiology that involves the sacroiliac joints, axial skeleton, entheses and peripheral joints. Chronic inflammation of entheses ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2011
Estimated Enrollment :
149 Patients enrolled
Trial Details
Trial ID
NCT00237419
Start Date
December 1 2005
End Date
April 1 2011
Last Update
June 3 2008
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
Erasme University Hospital
Brussels, Belgium
2
Limburg University Centre
Diepenbeek, Belgium
3
Universitair Ziekenhuis, Afdeling Rheumatologie
Ghent, Belgium, 9000
4
University Hospital Leuven
Leuven, Belgium, 3000