Wegener's GranulomatosisPhase 2ACTIVENCT00753103
Anti-Cytokine Therapy for Vasculitis
A Phase 2 study testing Infliximab, Cyclophosphamide and Prednisolone in people with Wegener's Granulomatosis and Renal Limited Vasculitis, run by University Hospital Birmingham NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wegener's Granulomatosis, Renal Limited Vasculitis, Microscopic Polyangiitis
- What is being tested?
- Infliximab, Cyclophosphamide and Prednisolone
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2003to Jul 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Either newly diagnosed or relapsed ANCA associated vasculitis (Wegener's granulomatosis, microscopic polyangiitis, renal limited vasculitis)
Who cannot join
- Active infection
- Malignancy
- Pregnancy
- Diagnosis of Churg-Strauss syndrome or anti-glomerular basement membrane antibody disease
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals Birmingham NHS Foundation Trust
Birmingham, West Midlands, B15 2TT
About this study
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
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.
Read the 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.
- Being tested
- Infliximab, Cyclophosphamide, Prednisolone, Azathioprine, Plasma exchange
- Keywords
- Infliximab, Vasculitis, antitnf monoclonal antibody
- Medical subject headings
- Granulomatosis with Polyangiitis, Microscopic Polyangiitis, Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfliximabBiological
Also called Remicade
5 mg/kg intravenous infusion at weeks 0, 2, 6 and 10 of study
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).
PrednisoloneDrug
Daily oral 1mg/kg tapered over 12 months
AzathioprineDrug
Daily oral 2 mg/kg started once patient is in remission and cyclophosphamide has been discontinued.
Plasma exchangeProcedure or surgery
Additional therapy for patients with severe vasculitis (creatinine > 500 mcmol/L or pulmonary haemorrhage). 7x 4L exchanges over 10 days.
Daily oral up to 1.5 g twice daily as tolerated. Used as alternative to azathioprine at lead physicians discretion.
500 mg intravenous infusion daily for three days at lead physicians discretion.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients with active vasculitis who receive infliximab in addition to standard immunosuppressive therapy Receives: Biological: Infliximab; Drug: Cyclophosphamide; Drug: Prednisolone; Drug: Azathioprine; Drug: Mycophenolate mofetil; Drug: Methylprednisolone |
| 2 | Active comparator | Patients with active ANCA associated vasculitis who receive standard immunosuppression but no infliximab Receives: Drug: Cyclophosphamide; Drug: Prednisolone; Drug: Azathioprine; Procedure: Plasma exchange; Drug: Mycophenolate mofetil; Drug: Methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to clinical remission (Birmingham Vasculitis Activity Score 0 or 1)
Measured: 0, 6, 10, 14, 26, 39 and 52 weeks
Secondary outcomes (3)
Adverse events
Measured: Weeks 2, 6, 10, 14, 26, 39, 52
Vasculitis Damage Index Score
Measured: Weeks 0, 14, 26, 39, 52
Renal function
Measured: Weeks 0, 2, 6, 10, 14, 26, 39, 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2008 (estimated)
- Study startJan 2003
- Primary completionJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wegener's GranulomatosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Birmingham NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Investigators
- Lorraine Harper, PhD, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00753103
- Sponsor's protocol ID
- RRK2031
- Acronym
- ACTIVE
- Status last verified
- Sep 2008
- First submitted
- 15 Sep 2008
- Last updated
- 16 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00753103
- Acronym / sponsor ID
- ACTIVE / RRK2031
- Keywords
- Infliximab, Vasculitis, antitnf monoclonal antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University Hospital Birmingham NHS Foundation TrustUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 16 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Infliximab, Drug: Cyclophosphamide, Drug: Prednisolone, Drug: Azathioprine, Drug: Mycophenolate mofetil, Drug: MethylprednisolonePatients with active vasculitis who receive infliximab in addition to standard immunosuppressive therapy |
| 2 | Active comparator | Drug: Cyclophosphamide, Drug: Prednisolone, Drug: Azathioprine, Procedure: Plasma exchange, Drug: Mycophenolate mofetil, Drug: MethylprednisolonePatients with active ANCA associated vasculitis who receive standard immunosuppression but no infliximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Either newly diagnosed or relapsed ANCA associated vasculitis (Wegener's granulomatosis, microscopic polyangiitis, renal limited vasculitis)
Key exclusion criteria (4 listed)
- Active infection
- Malignancy
- Pregnancy
- Diagnosis of Churg-Strauss syndrome or anti-glomerular basement membrane antibody disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InfliximabAlso: Remicade5 mg/kg intravenous infusion at weeks 0, 2, 6 and 10 of study | Biological | 1 |
| CyclophosphamideDaily 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 | 1, 2 |
| PrednisoloneDaily oral 1mg/kg tapered over 12 months | Drug | 1, 2 |
| AzathioprineDaily oral 2 mg/kg started once patient is in remission and cyclophosphamide has been discontinued. | Drug | 1, 2 |
| Plasma exchangeAdditional therapy for patients with severe vasculitis (creatinine > 500 mcmol/L or pulmonary haemorrhage). 7x 4L exchanges over 10 days. | Procedure or surgery | 2 |
| Mycophenolate mofetilDaily oral up to 1.5 g twice daily as tolerated. Used as alternative to azathioprine at lead physicians discretion. | Drug | 1, 2 |
| Methylprednisolone500 mg intravenous infusion daily for three days at lead physicians discretion. | Drug | 1, 2 |
Primary outcome
Time to clinical remission (Birmingham Vasculitis Activity Score 0 or 1)
Time frame: 0, 6, 10, 14, 26, 39 and 52 weeks
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorraine Harper, PhD principal investigator
University of Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Infliximab, Cyclophosphamide and Prednisolone in people with Wegener's Granulomatosis and Renal Limited Vasculitis, run by University Hospital Birmingham NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to clinical remission (Birmingham Vasculitis Activity Score 0 or 1) (time frame: 0, 6, 10, 14, 26, 39 and 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2008.