ANCA-associated VasculitisPhase 2ABAVASNCT00482066
Abatacept in ANCA Associated Vasculitis
A Phase 2 study testing Abatacept (Orencia) in people with ANCA-associated Vasculitis, run by Imperial College London at 1 site in United Kingdom.
Trial summary
The purpose of this study is to investigate whether abatacept can prevent relapse in patients with ANCA associated vasculitis(AAV). This is a randomised double blinded placebo controlled trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ANCA-associated Vasculitis
- What is being tested?
- Abatacept (Orencia)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2007to Nov 2008
- 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
- Acute AAV, presenting at first diagnosis or relapse, defined by clinical presentation
- ANCA positivity (anti-MPO or anti-PR3 positive)
- BVAS score of > 8.
Who cannot join
- Severe life-threatening disease, i.e. lung haemorrhage at the time of presentation, renal impairment with SCr>150 micromol/l, or severe CNS dysfunction thought to be due to vasculitis.
- Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological or cerebral disease, or other medical conditions that might place the subject at unacceptable risk for participation in this study.
- Any other non-vasculitic multisystem autoimmune disease
- Serious acute or bacterial infection unless treated and completely resolved with antibiotics prior to enrolment
- With any severe chronic or recurrent bacterial infection
- With Hepatitis B or C or HIV
Show all 26Show fewer
- With Herpes zoster infection that resolved less than 2 months prior to enrolment
- Subjects who have received any live vaccines within 3 months of the first dose of study medication or who will have need of a live vaccine at any time in the year following enrolment
- Subjects with current clinical or laboratory evidence of active or latent tuberculosis (TB) and subjects with a history of active TB treated within the last 3 years
- With any previous malignancy, with the exception of non-melanoma skin malignancies, adequately treated previously
- Subjects with a mammogram that is suspicious for malignancy and in whom the possibility of malignancy cannot be reasonably excluded following additional evaluations. Mammograms (females only) must be performed within 6 months of study entry or if documentation is not on file.
- With MTX treatment in prior 3 months
- Subjects with prior therapy with rituximab, anti-TNF therapy, or IL-1 receptor antagonists within last year or cyclophosphamide within last six months
- Subjects with a history of intolerance to methotrexate
- Subjects who have at any time received treatment with abatacept
- Subjects who have received treatment with any investigational drug within 28 days (or less than 5 terminal half-lives of elimination) of the Day 1 dose
- Subject receiving approved or investigational biologics
- Subjects with any of the following laboratory values:
- Hgb < 8.5 g/dL.
- WBC < 3,000/mm3 (3 x 109/L)
- Platelets < 100,000/mm3 (100 x 109/L).
- Serum ALT or AST > 2 times upper limit of normal.
- Any other laboratory test results that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study.
- Subjects participating concurrently in another clinical trial
- Pregnancy, breast feeding or inadequate contraception if female.
- Allergy to a study medication
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial College London, Hammersmith Hospital
London, W12 0NN
About this study
Official title: A Pilot Study Examining the Effect of Abatacept in ANCA Associated Vasculitis
The purpose of this study is to investigate whether abatacept can prevent relapse in patients with ANCA associated vasculitis(AAV). This is a randomised double blinded placebo controlled trial.
Read the detailed description
The drugs that are normally used to treat patients with AAV are quite effective, but up to 20% of patients relapse within 18 months. The drugs used can also have significant side effects. Abatacept, also known as CTLA4Ig, acts by blocking vital costimulatory signals required for T lymphocytes to be activated. As ANCA associated vasculitis is believed to be an autoimmune condition and dependent on autoreactive T cells, there is some reason to believe this drug would be effective. Abatacept has already received a license by the FDA for use in Rheumatoid arthritis where it has proven to be effective even in patients unresponsive to Etanercept (TNF blockade).
120 patients with AAV will be invited to take part in this study, from hospitals in the UK and Europe. The patients will receive standard therapy with methotrexate and steroids as well as 12 months of abatacept or placebo. They will be followed for a further 12 months.
The primary objective of this study is to assess the relapse rate over 24 months, in patients with acute AAV, presenting at first diagnosis or relapse, in the two arms of the study.
- Conditions
- ANCA-associated Vasculitis
- Being tested
- Abatacept (Orencia)
- Keywords
- Wegener's granulomatosis, Microscopic polyangiitis, Churg Strauss Syndrome, ANCA
- Medical subject headings
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Granulomatosis with Polyangiitis, Microscopic Polyangiitis, Churg-Strauss Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abatacept (Orencia)Drug
500mg for patients under 60kg 750mg for patients 60-100kg
1g for patients>100kg given as i.v. infusion over 30 minutes at day 0, 14, 28 and then monthly for a further 11 months 914 infusions in total) placebo groups receive saline only I.v.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Abatacept (Orencia) Receives: Drug: Abatacept (Orencia) |
| 2 | Placebo comparator | saline placebo Receives: Drug: Abatacept (Orencia) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse rate over 24 months.
Measured: 2 years
Secondary outcomes (8)
Proportion of patients in sustained remission (i.e. remission at 3 months sustained for 6 months and remission at 6 months sustained for a further 12 months);
Measured: 2 years
Time to remission;
Measured: 2 years
The average steroid dosage at 6 months, 1 year, 18 months and 2 years in abatacept and placebo groups respectively;
Measured: 2 years
Time to ANCA negativity by immunofluorescence or negative anti-PR3 or anti-MPO Ab test by ELISA.
Measured: 2 years
Proportion of patients defaulting to cyclophosphamide (MMF, azathioprine or other rescue) therapy.
Measured: 2 years
Proportion of patients unable to stick with trial protocol.
Measured: 2 years
Degree of chronic disease activity
Measured: 2 years
Health related quality of life
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2007 (estimated)
- Study startNov 2007
- Primary completionNov 2008
- Study completionNov 2008
Why it stopped: Funders withdrew funding due to slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ANCA-associated VasculitisStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Alan Salama, Study director, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00482066
- Sponsor's protocol ID
- cro632
- Other IDs
- 2006-001859-35, BMS protocol No: IST110
- Acronym
- ABAVAS
- Status last verified
- Mar 2015
- First submitted
- 1 Jun 2007
- Last updated
- 29 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Examining the Effect of Abatacept in ANCA Associated Vasculitis
- ClinicalTrials.gov ID
- NCT00482066
- Acronym / sponsor ID
- ABAVAS / cro632
- Conditions
- ANCA-associated Vasculitis
- Keywords
- Wegener's granulomatosis, Microscopic polyangiitis, Churg Strauss Syndrome, ANCA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funders withdrew funding due to slow recruitment
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Nov 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 4 Jun 2007 (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 investigate whether abatacept can prevent relapse in patients with ANCA associated vasculitis(AAV). This is a randomised double blinded placebo controlled trial.
Detailed description
The drugs that are normally used to treat patients with AAV are quite effective, but up to 20% of patients relapse within 18 months. The drugs used can also have significant side effects. Abatacept, also known as CTLA4Ig, acts by blocking vital costimulatory signals required for T lymphocytes to be activated. As ANCA associated vasculitis is believed to be an autoimmune condition and dependent on autoreactive T cells, there is some reason to believe this drug would be effective. Abatacept has already received a license by the FDA for use in Rheumatoid arthritis where it has proven to be effective even in patients unresponsive to Etanercept (TNF blockade).
120 patients with AAV will be invited to take part in this study, from hospitals in the UK and Europe. The patients will receive standard therapy with methotrexate and steroids as well as 12 months of abatacept or placebo. They will be followed for a further 12 months.
The primary objective of this study is to assess the relapse rate over 24 months, in patients with acute AAV, presenting at first diagnosis or relapse, in the two arms of the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Abatacept (Orencia)Abatacept (Orencia) |
| 2 | Placebo comparator | Drug: Abatacept (Orencia)saline placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acute AAV, presenting at first diagnosis or relapse, defined by clinical presentation
- ANCA positivity (anti-MPO or anti-PR3 positive)
- BVAS score of > 8.
Key exclusion criteria (26 listed)
- Severe life-threatening disease, i.e. lung haemorrhage at the time of presentation, renal impairment with SCr>150 micromol/l, or severe CNS dysfunction thought to be due to vasculitis.
- Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological or cerebral disease, or other medical conditions that might place the subject at unacceptable risk for participation in this study.
- Any other non-vasculitic multisystem autoimmune disease
- Serious acute or bacterial infection unless treated and completely resolved with antibiotics prior to enrolment
- With any severe chronic or recurrent bacterial infection
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 |
|---|---|---|
| Abatacept (Orencia)500mg for patients under 60kg 750mg for patients 60-100kg 1g for patients>100kg given as i.v. infusion over 30 minutes at day 0, 14, 28 and then monthly for a further 11 months 914 infusions in total) placebo groups receive saline only I.v. | Drug | 1, 2 |
Primary outcome
Relapse rate over 24 months.
Time frame: 2 years
8 secondary outcomes
Proportion of patients in sustained remission (i.e. remission at 3 months sustained for 6 months and remission at 6 months sustained for a further 12 months);
Time frame: 2 years
Time to remission;
Time frame: 2 years
The average steroid dosage at 6 months, 1 year, 18 months and 2 years in abatacept and placebo groups respectively;
Time frame: 2 years
Time to ANCA negativity by immunofluorescence or negative anti-PR3 or anti-MPO Ab test by ELISA.
Time frame: 2 years
Proportion of patients defaulting to cyclophosphamide (MMF, azathioprine or other rescue) therapy.
Time frame: 2 years
Proportion of patients unable to stick with trial protocol.
Time frame: 2 years
Degree of chronic disease activity
Time frame: 2 years
Health related quality of life
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Funders withdrew funding due to slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2015.
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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.
Alan Salama study director
Imperial College London
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 Abatacept (Orencia) in people with ANCA-associated Vasculitis, run by Imperial College London 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 26 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: stopped early, as of the sponsor's last update on 29 May 2015. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Funders withdrew funding due to slow recruitment). Results are not available in the source record.
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?
Relapse rate over 24 months. (time frame: 2 years). 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 29 May 2015.