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Anti-Cytokine Therapy for Vasculitis (ACTIVE)

Primary Purpose

Wegener's Granulomatosis, Renal Limited Vasculitis, Microscopic Polyangiitis

Status

Completed

Phase

Phase 2

Locations

United Kingdom

Study Type

Interventional

Intervention

Infliximab

Cyclophosphamide

Prednisolone

Azathioprine

Plasma exchange

Mycophenolate mofetil

Methylprednisolone

About this trial

This is an interventional treatment trial for Wegener's Granulomatosis focused on measuring Infliximab, Vasculitis, antitnf monoclonal antibody

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University Hospitals Birmingham NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Adverse events

Vasculitis Damage Index Score

Renal function

Full Information

NCT ID

NCT00753103

First Posted

September 15, 2008

Last Updated

September 15, 2008

Sponsor

University Hospital Birmingham NHS Foundation Trust

1. Study Identification

Unique Protocol Identification Number

NCT00753103

Brief Title

Anti-Cytokine Therapy for Vasculitis

Acronym

ACTIVE

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2008

Overall Recruitment Status

Completed

Study Start Date

January 2003 (undefined)

Primary Completion Date

July 2006 (Actual)

Study Completion Date

July 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital Birmingham NHS Foundation Trust

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Wegener's Granulomatosis, Renal Limited Vasculitis, Microscopic Polyangiitis

Keywords

Infliximab, Vasculitis, antitnf monoclonal antibody

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

37 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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

Arm Title

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Infliximab

Other Intervention Name(s)

Remicade

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Cyclophosphamide

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Prednisolone

Intervention Description

Daily oral 1mg/kg tapered over 12 months

Intervention Type

Drug

Intervention Name(s)

Azathioprine

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Plasma exchange

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Mycophenolate mofetil

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Methylprednisolone

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Adverse events

Time Frame

Weeks 2, 6, 10, 14, 26, 39, 52

Title

Vasculitis Damage Index Score

Time Frame

Weeks 0, 14, 26, 39, 52

Title

Renal function

Time Frame

Weeks 0, 2, 6, 10, 14, 26, 39, 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lorraine Harper, PhD

Organizational Affiliation

University of Birmingham

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospitals Birmingham NHS Foundation Trust

City

Birmingham

State/Province

West Midlands

ZIP/Postal Code

B15 2TT

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Anti-Cytokine Therapy for Vasculitis

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