Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
37 participants
INTERVENTIONAL
2003-01-31
2006-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Patients with active vasculitis who receive infliximab in addition to standard immunosuppressive therapy
Infliximab
5 mg/kg intravenous infusion at weeks 0, 2, 6 and 10 of study
Cyclophosphamide
Daily oral 2 mg/kg or pulsed intravenous 15mg/kg every 2-3 weeks for 3-6 months (until patient has been in remission for 3 months).
Prednisolone
Daily oral 1mg/kg tapered over 12 months
Azathioprine
Daily oral 2 mg/kg started once patient is in remission and cyclophosphamide has been discontinued.
Mycophenolate mofetil
Daily oral up to 1.5 g twice daily as tolerated. Used as alternative to azathioprine at lead physicians discretion.
Methylprednisolone
500 mg intravenous infusion daily for three days at lead physicians discretion.
2
Patients with active ANCA associated vasculitis who receive standard immunosuppression but no infliximab
Cyclophosphamide
Daily oral 2 mg/kg or pulsed intravenous 15mg/kg every 2-3 weeks for 3-6 months (until patient has been in remission for 3 months).
Prednisolone
Daily oral 1mg/kg tapered over 12 months
Azathioprine
Daily oral 2 mg/kg started once patient is in remission and cyclophosphamide has been discontinued.
Plasma exchange
Additional therapy for patients with severe vasculitis (creatinine \> 500 mcmol/L or pulmonary haemorrhage). 7x 4L exchanges over 10 days.
Mycophenolate mofetil
Daily oral up to 1.5 g twice daily as tolerated. Used as alternative to azathioprine at lead physicians discretion.
Methylprednisolone
500 mg intravenous infusion daily for three days at lead physicians discretion.
Interventions
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Infliximab
5 mg/kg intravenous infusion at weeks 0, 2, 6 and 10 of study
Cyclophosphamide
Daily oral 2 mg/kg or pulsed intravenous 15mg/kg every 2-3 weeks for 3-6 months (until patient has been in remission for 3 months).
Prednisolone
Daily oral 1mg/kg tapered over 12 months
Azathioprine
Daily oral 2 mg/kg started once patient is in remission and cyclophosphamide has been discontinued.
Plasma exchange
Additional therapy for patients with severe vasculitis (creatinine \> 500 mcmol/L or pulmonary haemorrhage). 7x 4L exchanges over 10 days.
Mycophenolate mofetil
Daily oral up to 1.5 g twice daily as tolerated. Used as alternative to azathioprine at lead physicians discretion.
Methylprednisolone
500 mg intravenous infusion daily for three days at lead physicians discretion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Malignancy
* Pregnancy
* Diagnosis of Churg-Strauss syndrome or anti-glomerular basement membrane antibody disease
18 Years
ALL
No
Sponsors
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University Hospital Birmingham NHS Foundation Trust
OTHER
Responsible Party
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University Hospitals Birmingham NHS Foundation Trust/University of Birmingham
Principal Investigators
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Lorraine Harper, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Birmingham
Locations
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University Hospitals Birmingham NHS Foundation Trust
Birmingham, West Midlands, United Kingdom
Countries
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Other Identifiers
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RRK2031
Identifier Type: -
Identifier Source: org_study_id