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Completed

NCT Number: NCT00753103

Anti-Cytokine Therapy for Vasculitis

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.

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Key information

Conditions

Wegener's Granulomatosis Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Autoimmune Diseases Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Small Vessel Diseases Cerebrovascular Disorders Granulomatosis with Polyangiitis Immune System Diseases Lung Diseases Lung Diseases, Interstitial Microscopic Polyangiitis Nervous System Diseases Renal Limited Vasculitis Respiratory Tract Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Systemic Vasculitis Vascular Diseases Vasculitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospitals Birmingham NHS Foundation Trust

Birmingham, West Midlands, B15 2TT, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Infliximab

Biological

5 mg/kg intravenous infusion at weeks 0, 2, 6 and 10 of study

Other names: Remicade

Cyclophosphamide

Drug

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

Drug

Daily oral 1mg/kg tapered over 12 months

azathioprine

Drug

Daily oral 2 mg/kg started once patient is in remission and cyclophosphamide has been discontinued.

Plasma Exchange

Procedure

Additional therapy for patients with severe vasculitis (creatinine > 500 mcmol/L or pulmonary haemorrhage). 7x 4L exchanges over 10 days.

Mycophenolate mofetil

Drug

Daily oral up to 1.5 g twice daily as tolerated. Used as alternative to azathioprine at lead physicians discretion.

methylprednisolone

Drug

500 mg intravenous infusion daily for three days at lead physicians discretion.

Primary outcomes

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

    Time frame: 0, 6, 10, 14, 26, 39 and 52 weeks

Secondary outcomes

  1. Adverse events

    Time frame: Weeks 2, 6, 10, 14, 26, 39, 52

  2. Vasculitis Damage Index Score

    Time frame: Weeks 0, 14, 26, 39, 52

  3. Renal function

    Time frame: Weeks 0, 2, 6, 10, 14, 26, 39, 52

Sponsors and collaborators

Lead sponsor

University Hospital Birmingham NHS Foundation Trust

Other

Registry information

Official study 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

Acronym: ACTIVE

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Sep 16, 2008
Registry last updated
Sep 16, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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