NCT00753103

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2003

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2008

Completed
Last Updated

September 16, 2008

Status Verified

September 1, 2008

Enrollment Period

3.5 years

First QC Date

September 15, 2008

Last Update Submit

September 15, 2008

Conditions

Wegener's GranulomatosisRenal Limited VasculitisMicroscopic Polyangiitis

Keywords

InfliximabVasculitisantitnf monoclonal antibody

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (3)

  • 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

Study Arms (2)

1

EXPERIMENTAL

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

Biological: InfliximabDrug: CyclophosphamideDrug: PrednisoloneDrug: AzathioprineDrug: Mycophenolate mofetilDrug: Methylprednisolone

2

ACTIVE COMPARATOR

Patients with active ANCA associated vasculitis who receive standard immunosuppression but no infliximab

Drug: CyclophosphamideDrug: PrednisoloneDrug: AzathioprineProcedure: Plasma exchangeDrug: Mycophenolate mofetilDrug: Methylprednisolone

Interventions

InfliximabBIOLOGICAL

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

Also known as: Remicade
1
CyclophosphamideDRUG

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).

12
PrednisoloneDRUG

Daily oral 1mg/kg tapered over 12 months

12
AzathioprineDRUG

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

12
Plasma exchangePROCEDURE

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

2
Mycophenolate mofetilDRUG

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

12
MethylprednisoloneDRUG

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

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Active infection
  • Malignancy
  • Pregnancy
  • Diagnosis of Churg-Strauss syndrome or anti-glomerular basement membrane antibody disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Birmingham NHS Foundation Trust

Birmingham, West Midlands, B15 2TT, United Kingdom

Location

MeSH Terms

Conditions

Granulomatosis with PolyangiitisMicroscopic PolyangiitisVasculitis

Interventions

InfliximabCyclophosphamidePrednisoloneAzathioprinePlasma ExchangeMycophenolic AcidMethylprednisolone

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesAnti-Neutrophil Cytoplasmic Antibody-Associated VasculitisSystemic VasculitisVascular DiseasesCardiovascular DiseasesSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesCerebral Small Vessel DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsThionucleosidesSulfur CompoundsMercaptopurinePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesBlood TransfusionBiological TherapyTherapeuticsPlasmapheresisBlood Component RemovalSorption DetoxificationExtracorporeal CirculationSurgical Procedures, OperativeCaproatesAcids, AcyclicCarboxylic AcidsFatty AcidsLipids

Study Officials

  • Lorraine Harper, PhD

    University of Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 15, 2008

First Posted

September 16, 2008

Study Start

January 1, 2003

Primary Completion

July 1, 2006

Study Completion

July 1, 2006

Last Updated

September 16, 2008

Record last verified: 2008-09

Locations

GB(1)