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Anti-Cytokine Therapy for Vasculitis

NCT00753103 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2008-09-16

No results posted yet for this study

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.

Conditions

  • Wegener's Granulomatosis
  • Renal Limited Vasculitis
  • Microscopic Polyangiitis

Interventions

BIOLOGICAL

Infliximab

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

DRUG

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).

DRUG

Prednisolone

Daily oral 1mg/kg tapered over 12 months

DRUG

Azathioprine

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

PROCEDURE

Plasma exchange

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

DRUG

Mycophenolate mofetil

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

DRUG

Methylprednisolone

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

Sponsors & Collaborators

  • University Hospital Birmingham NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Lorraine Harper, PhD · University of Birmingham

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-01-31
Primary Completion
2006-07-31
Completion
2006-07-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00753103 on ClinicalTrials.gov