Anti-Cytokine Therapy for Vasculitis

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00753103

Acronym

ACTIVE

Enrollment

Registered

2008-09-16

Start date

2003-01-31

Completion date

2006-07-31

Last updated

2008-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microscopic Polyangiitis, Renal Limited Vasculitis, Wegener's Granulomatosis

Keywords

Infliximab, Vasculitis, antitnf monoclonal antibody

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.

Interventions

BIOLOGICALInfliximab

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

DRUGCyclophosphamide

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).

DRUGPrednisolone

Daily oral 1mg/kg tapered over 12 months

DRUGAzathioprine

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

PROCEDUREPlasma exchange

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

DRUGMycophenolate mofetil

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

DRUGMethylprednisolone

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Time to clinical remission (Birmingham Vasculitis Activity Score 0 or 1)	0, 6, 10, 14, 26, 39 and 52 weeks

Secondary

Measure	Time frame
Adverse events	Weeks 2, 6, 10, 14, 26, 39, 52
Vasculitis Damage Index Score	Weeks 0, 14, 26, 39, 52
Renal function	Weeks 0, 2, 6, 10, 14, 26, 39, 52

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026