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

• Status: Unknown status
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rheumazentrum Ruhrgebiet
• Collaborators: Centocor BV; PPD; Trial Coordination Center, 9713 GZ Groningen
• Treatments: Infliximab

Criteria

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