Cardiovascular: Systemic vasculitis Circulatory System Other necrotizing vasculopathies
Conditions
Interventions
This is a randomised controlled trial comparing Infliximab and placebo. Patients will receive either a single infusion of infliximab (5mg/kg) or placebo and will be followed for 3 months. Patients wi
Sponsors
Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
Eligibility
Inclusion criteria
Inclusion criteria: There are no previously published studies of infliximab in systemic vasculitis. However, a similar study of IVIG demonstrated a 50% reduction in disease activity after 3 months in a total of 34 patients (17 each in active and placebo group). Therefore in order to give a similar power of 0.8, we plan to recruit 40 patients (20 patients in each group) to give a significance level of 0.05 in a two-tailed study. Randomization will be done with minimisation protocol to ensure patients with similar characteristics in each group.
Exclusion criteria
Exclusion criteria: 1. Positive pregnancy test or a planned pregnancy during treatment with infliximab or within 6 months of the last infusion 2. Prior administration of REMICADE or any other therapeutic agent targeted at reducing TNF (e.g., Etanercept, pentoxifylline, thalidomide or anti-CD4+ antibody) within the previous 3 months 3. A history of known allergies to murine proteins 4. Rapidly progressive glomerulonephritis 5. Severe pulmonary haemorrhage 6. History of Chronic/Serious infections, such as pneumonia, pyelonephritis and bacterial peritonitis in the previous 3 months. Less serious infections in the previous 3 months, such as acute upper respiratory tract infection (colds) or uncomplicated urinary tract infection if not fully resolved need not be considered exclusions at the discretion of the treating physician. 7. History of opportunistic infections such as herpes zoster within 2 months of screening. Evidence of active CMV, active Pneumocystis carinii, drug resistant atypical mycobacterium, etc. 8. Severe and/or chronic renal / pulmonary infections or sinusitis in the last 3 months 9. Known active tuberculosis requiring treatment during the last 3 years. 10. Documented HIV infection. 11. Any history of other autoimmune diseases. 12. Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic or cerebral disease. 13. Known lymphoproliferative disease including lymphoma or signs suggestive of lymphoproliferative disease such as lymphadenoma of unusual size and localization or splenomegaly. 14. Any currently known malignancy or pre-malignant lesions or any history of malignancy within the past five years.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Primary
| Measure | Time frame |
|---|---|
| Response will be judged by 50% reduction in BVAS score, CRP, ESR, patient and physician global score, reduction in prednisolone and concomitant immunosuppressive therapy. | — |
Countries
United Kingdom
Outcome results
None listed