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Phase II Pilot Cohort Study to Investigate the Safety and Efficacy of Infliximab as Additional Therapy in the Treatment if Anti-Neutrophil Cytoplasm Antibody Associated Vasculitis


Phase 2
18 Years
N/A
Not Enrolling
Both
Wegener's Granulomatosis, Renal Limited Vasculitis, Microscopic Polyangiitis

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Trial Information

Phase II Pilot Cohort Study to Investigate the Safety and Efficacy of Infliximab as Additional Therapy in the Treatment if Anti-Neutrophil Cytoplasm Antibody Associated Vasculitis


Anti-neutrophil cytoplasm antibody (ANCA) associated vasculitis is a life-threatening
systemic inflammatory autoimmune disease. Current treatment regimes using corticosteroids
and cyclophosphamide have improved patient survival but are associated with treatment
associated morbidity and mortality. Tumour necrosis factor alpha (TNF) is a proinflammatory
cytokine which has been implicated in the pathogenesis of ANCA vasculitis. Anti-TNF
therapies have been used successfully in the management of other inflammatory autoimmune
diseases. This phase II cohort study has been designed to investigate the safety and
efficacy of anti-TNF monoclonal antibody (Infliximab) therapy for patients with ANCA
associated vasculitis when used in addition to standard immunosuppressive therapy.


Inclusion Criteria:



- Either newly diagnosed or relapsed ANCA associated vasculitis (Wegener's
granulomatosis, microscopic polyangiitis, renal limited vasculitis)

Exclusion Criteria:

- Active infection

- Malignancy

- Pregnancy

- Diagnosis of Churg-Strauss syndrome or anti-glomerular basement membrane antibody
disease

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to clinical remission (Birmingham Vasculitis Activity Score 0 or 1)

Outcome Time Frame:

0, 6, 10, 14, 26, 39 and 52 weeks

Safety Issue:

No

Principal Investigator

Lorraine Harper, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Birmingham

Authority:

United Kingdom: Research Ethics Committee

Study ID:

RRK2031

NCT ID:

NCT00753103

Start Date:

January 2003

Completion Date:

July 2006

Related Keywords:

  • Wegener's Granulomatosis
  • Renal Limited Vasculitis
  • Microscopic Polyangiitis
  • Infliximab
  • Vasculitis
  • antitnf monoclonal antibody
  • Vasculitis
  • Wegener Granulomatosis
  • Systemic Vasculitis
  • Microscopic Polyangiitis

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