Anti-Cytokine Therapy for Vasculitis (ACTIVE)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00753103 |
Recruitment Status :
Completed
First Posted : September 16, 2008
Last Update Posted : September 16, 2008
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Wegener's Granulomatosis Renal Limited Vasculitis Microscopic Polyangiitis | Biological: Infliximab Drug: Cyclophosphamide Drug: Prednisolone Drug: Azathioprine Procedure: Plasma exchange Drug: Mycophenolate mofetil Drug: Methylprednisolone | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 37 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 Start Date : | January 2003 |
Actual Primary Completion Date : | July 2006 |
Actual Study Completion Date : | July 2006 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Patients with active vasculitis who receive infliximab in addition to standard immunosuppressive therapy
|
Biological: Infliximab
5 mg/kg intravenous infusion at weeks 0, 2, 6 and 10 of study
Other Name: Remicade 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. 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. |
Active Comparator: 2
Patients with active ANCA associated vasculitis who receive standard immunosuppression but no infliximab
|
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. |
- Time to clinical remission (Birmingham Vasculitis Activity Score 0 or 1) [ Time Frame: 0, 6, 10, 14, 26, 39 and 52 weeks ]
- Adverse events [ Time Frame: Weeks 2, 6, 10, 14, 26, 39, 52 ]
- Vasculitis Damage Index Score [ Time Frame: Weeks 0, 14, 26, 39, 52 ]
- Renal function [ Time Frame: Weeks 0, 2, 6, 10, 14, 26, 39, 52 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00753103
United Kingdom | |
University Hospitals Birmingham NHS Foundation Trust | |
Birmingham, West Midlands, United Kingdom, B15 2TT |
Principal Investigator: | Lorraine Harper, PhD | University of Birmingham |
Responsible Party: | Dr Lorraine Harper, University Hospitals Birmingham NHS Foundation Trust/University of Birmingham |
ClinicalTrials.gov Identifier: | NCT00753103 |
Other Study ID Numbers: |
RRK2031 |
First Posted: | September 16, 2008 Key Record Dates |
Last Update Posted: | September 16, 2008 |
Last Verified: | September 2008 |
Infliximab Vasculitis antitnf monoclonal antibody |
Granulomatosis with Polyangiitis Microscopic Polyangiitis Vasculitis Vascular Diseases Cardiovascular Diseases Systemic Vasculitis Lung Diseases, Interstitial Lung Diseases Respiratory Tract Diseases Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Autoimmune Diseases Immune System Diseases Cerebral Small Vessel Diseases Cerebrovascular Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Mycophenolic Acid Methylprednisolone Prednisolone Cyclophosphamide Azathioprine Infliximab Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action |