Anti-Cytokine Therapy for Vasculitis

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Brief Title

Anti-Cytokine Therapy for Vasculitis

Official Title

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

Brief Summary

      The purpose of this study is to determine whether Infliximab (monoclonal anti-tumour necrosis
      factor alpha antibodies) are safe and effective in the treatment of anti-neutrophil cytoplasm
      antibody (ANCA) associated vasculitis.
    

Detailed Description

      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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 Adverse events

Condition

Wegener's Granulomatosis

Intervention

Infliximab

Study Arms / Comparison Groups

 1
Description:  Patients with active vasculitis who receive infliximab in addition to standard immunosuppressive therapy

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

37

Start Date

January 2003

Completion Date

July 2006

Primary Completion Date

July 2006

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Lorraine Harper, PhD, , 

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT00753103

Organization ID

RRK2031



Study Sponsor

University Hospital Birmingham NHS Foundation Trust


Study Sponsor

Lorraine Harper, PhD, Principal Investigator, University of Birmingham


Verification Date

September 2008