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ISRCTN
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ISRCTN76658104
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ClinicalTrials.gov identifier
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Public title
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A randomised controlled trial of Infliximab in ANCA associated systemic vasculitis.
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0013129680
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Study hypothesis
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To confirm that TNF a levels are elevated and correlate with disease activity in our cohort of vasculitis patients. To study the efficacy of infliximab in the treatment of ANCA associated vasculitis resistant to conventional immunosuppressive therapy.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Cardiovascular: Systemic vasculitis
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Participants - inclusion criteria
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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.
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Participants - exclusion criteria
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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.
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Anticipated start date
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04/06/2003
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Anticipated end date
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31/05/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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40
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Interventions
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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 will continue to receive their current immunosuppressive therapy. Birmingham Vasculitis activity score (BVAS) will be used to judge the response. The responders will continue to receive infliximab (5mg/kg) infusion at 6, 14, 22 and 26 weeks.
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Primary outcome measure(s)
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Response will be judged by 50% reduction in BVAS score, CRP, ESR, patient and physician global score, reduction in prednisolone and concomitant immunosuppressive therapy.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Guy's and St. Thomas' NHS Foundation Trust (UK)
Own account
NHS R&D Support Funding
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Trial website
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Publications
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2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17360788
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Contact name
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Dr
David
D'Cruz
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Address
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Louise Coote Lupus Unit
Ground Floor, Gassiot House
St. Thomas' Hospital
Lambeth Palace Road
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City/town
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London
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Zip/Postcode
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SE1 7EH
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Country
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United Kingdom
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Email
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Sponsor
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Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2005
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Last edited
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21/07/2009
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Date ISRCTN assigned
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30/09/2005
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