VasculitisPhase 4ALEVIATENCT01405807
Alemtuzumab for ANCA Associated Refractory Vasculitis
A Phase 4 study testing Alemtuzumab in people with Vasculitis and Microscopic Polyangiitis, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Overview: This open label, randomized, multi-centre study will enroll and treat 24 patients with refractory AAV. Aims: To determine the clinical response and severe adverse event rates associated with alemtuzumab therapy among patients with relapsing or refractory ANCA associated vasculitis (AAV). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Vasculitis, Microscopic Polyangiitis, Granulomatosis With Polyangiitis
- What is being tested?
- Alemtuzumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2011to Mar 2014
- Phase
- Phase 4
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- A diagnosis of AAV, according to a standardized definition
- Active vasculitis with at least one severe or three non severe items of BVAS/WG activity (equivalent to BVAS/WG>3)
- Previous therapy with either cyclophosphamide or methotrexate, in combination with prednisolone for at least 3 months.
Who cannot join
- Age less than 18 or greater than 60 years
- Creatinine > 150μmol/l (1.7mg/dl)
- Total white count < 4x109/l or lymphocyte count < 0.5x109/l, or IgG < 5g/L, or neutrophil count < 1.5x109/l.
- Severe lung haemorrhage with hypoxia (<85% on room air)
- Severe gastrointestinal, central nervous system or cardiac vasculitis
- Previous therapy with:
Show all 17Show fewer
- Alemtuzumab at any time
- IVIg, infliximab, etanercept, adalimumab, abatacept, anti-thymocyte globulin or plasma exchange in past three months
- Rituximab within the past 6 months
- Intensive care unit requirement
- Active infection with HIV, hepatitis B or hepatitis C or other infection requiring parenteral or long-term oral antibiotics
- History of ITP or platelet count at screening below 50,000 x 106/l
- Pregnancy or inadequate contraception in pre-menopausal women
- Breast feeding
- Any condition judged by the investigator that would cause the study to be detrimental to the patient.
- Any other multisystem autoimmune disease including Churg Strauss angiitis, systemic lupus erythematosus, anti-GBM disease and cryoglobulinaemia
- Any previous or current history of malignancy (other than resected basal cell carcinoma)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Addenbrooke's Hospital, University of Cambridge NHS Foundation Trust
Cambridge, CB20QQ
David RW Jayne, MD FRCP, 00441223586796, dj106@cam.ac.uk
David RW Jayne, MD FRCP
About this study
Official title: Alemtuzumab for ANCA Associated Refractory Vasculitis - a Study of Safety and Efficacy
Overview:
This open label, randomized, multi-centre study will enroll and treat 24 patients with refractory AAV.
Aims:
To determine the clinical response and severe adverse event rates associated with alemtuzumab therapy among patients with relapsing or refractory ANCA associated vasculitis (AAV).
Hypothesis:
Treatment with alemtuzumab induces sustained remission in AAV and will reduce immunosuppressive and steroid exposure.
- Being tested
- Alemtuzumab
- Keywords
- Vasculitis, ANCA, Refractory
- Medical subject headings
- Vasculitis, Microscopic Polyangiitis, Granulomatosis with Polyangiitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlemtuzumabDrug
Also called Campath 1H
Alemtuzumab will be administered on Day 1 and Day 2 at 0 and 6 months
| Study group | Role | What they receive |
|---|---|---|
| Alemtuzumab - high dose (60mg) | Experimental | Alemtuzumab 30mg will be administered on Day 1 and Day 2 at 0 and 6 months Receives: Drug: Alemtuzumab |
| Alemtuzumab - low dose (30mg) | Experimental | Alemtuzumab 15mg will be administered on Day 1 and Day 2 at 0 and 6 months Receives: Drug: Alemtuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with a vasculitis response at 6 months
Response includes patients in complete and partial remission. Complete remission (CR) is defined as a BVAS/WG of 0 for at least one month. Partial response (PR) is the absence of severe BVAS/WG items and at least 50% fall in BVAS/WG score from baseline.
Measured: 6 months
Proportion of patients with a severe adverse event
Measured: 6 months
Secondary outcomes (7)
Proportion of patients with treatment failure
Treatment failure is defined as the failure to achieve a vasculitis response by six months or a vasculitis relapse between 6 and 12 months
Measured: 12 months
Combined damage assessment (CDA) scores
Measured: 12 months
Non severe adverse events
Measured: 12 months
Cumulative dose of corticosteroids
Measured: 12 months
Time to remission
Complete and partial
Measured: 6 months
Relapse
Measured: 12 months
Change in SF-36
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2011 (estimated)
- Study startFeb 2011
- Primary completionMar 2014 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for VasculitisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Investigators
- David RW Jayne, MD MRCP, Principal investigator, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01405807
- Sponsor's protocol ID
- AL1.1
- Other IDs
- 2009-017087-17, 2009
- Acronym
- ALEVIATE
- Status last verified
- Jul 2011
- First submitted
- 27 Jul 2011
- Last updated
- 29 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Gopaluni S, Smith R, Goymer D, Cahill H, Broadhurst E, Wallin E, McClure M, Chaudhry A, Jayne D. Alemtuzumab for refractory primary systemic vasculitis-a randomised controlled dose ranging clinical trial of efficacy and safety (ALEVIATE). Arthritis Res Ther. 2022 Apr 1;24(1):81. doi: 10.1186/s13075-022-02761-6.
PubMed 35365179
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alemtuzumab for ANCA Associated Refractory Vasculitis - a Study of Safety and Efficacy
- ClinicalTrials.gov ID
- NCT01405807
- Acronym / sponsor ID
- ALEVIATE / AL1.1
- Keywords
- Vasculitis, ANCA, Refractory
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 29 Jul 2011 (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.
Overview:
This open label, randomized, multi-centre study will enroll and treat 24 patients with refractory AAV.
Aims:
To determine the clinical response and severe adverse event rates associated with alemtuzumab therapy among patients with relapsing or refractory ANCA associated vasculitis (AAV).
Hypothesis:
Treatment with alemtuzumab induces sustained remission in AAV and will reduce immunosuppressive and steroid exposure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alemtuzumab - high dose (60mg) | Experimental | Drug: AlemtuzumabAlemtuzumab 30mg will be administered on Day 1 and Day 2 at 0 and 6 months |
| Alemtuzumab - low dose (30mg) | Experimental | Drug: AlemtuzumabAlemtuzumab 15mg will be administered on Day 1 and Day 2 at 0 and 6 months |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- A diagnosis of AAV, according to a standardized definition
- Active vasculitis with at least one severe or three non severe items of BVAS/WG activity (equivalent to BVAS/WG>3)
- Previous therapy with either cyclophosphamide or methotrexate, in combination with prednisolone for at least 3 months.
Key exclusion criteria (17 listed)
- Age less than 18 or greater than 60 years
- Creatinine > 150μmol/l (1.7mg/dl)
- Total white count < 4x109/l or lymphocyte count < 0.5x109/l, or IgG < 5g/L, or neutrophil count < 1.5x109/l.
- Severe lung haemorrhage with hypoxia (<85% on room air)
- Severe gastrointestinal, central nervous system or cardiac vasculitis
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 |
|---|---|---|
| AlemtuzumabAlso: Campath 1HAlemtuzumab will be administered on Day 1 and Day 2 at 0 and 6 months | Drug | Alemtuzumab - high dose (60mg), Alemtuzumab - low dose (30mg) |
Primary outcome
Proportion of patients with a vasculitis response at 6 months
Time frame: 6 months
Response includes patients in complete and partial remission. Complete remission (CR) is defined as a BVAS/WG of 0 for at least one month. Partial response (PR) is the absence of severe BVAS/WG items and at least 50% fall in BVAS/WG score from baseline.
Proportion of patients with a severe adverse event
Time frame: 6 months
7 secondary outcomes
Proportion of patients with treatment failure
Time frame: 12 months
Combined damage assessment (CDA) scores
Time frame: 12 months
Non severe adverse events
Time frame: 12 months
Cumulative dose of corticosteroids
Time frame: 12 months
Time to remission
Time frame: 6 months
Relapse
Time frame: 12 months
Change in SF-36
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2011.
- Derived from this study: PubMed 35365179Gopaluni S, Smith R, Goymer D, Cahill H, Broadhurst E, Wallin E, McClure M, Chaudhry A, Jayne D. Alemtuzumab for refractory primary systemic vasculitis-a randomised controlled dose ranging clinical trial of efficacy and safety (ALEVIATE). Arthritis Res Ther. 2022 Apr 1;24(1):81. doi: 10.1186/s13075-022-02761-6.
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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.
David RW Jayne, MD MRCP principal investigator
Cambridge University Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alemtuzumab in people with Vasculitis and Microscopic Polyangiitis, run by Cambridge University Hospitals 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 3 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 29 Jul 2011. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David RW Jayne, MD FRCP (00441223586796, dj106@cam.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with a vasculitis response at 6 months (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01405807, which also lists 1 linked publication.
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 29 Jul 2011.