Abatacept in ANCA Associated Vasculitis (ABAVAS)
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ClinicalTrials.gov Identifier: NCT00482066 |
Recruitment Status
:
Terminated
(Funders withdrew funding due to slow recruitment)
First Posted
: June 4, 2007
Last Update Posted
: May 29, 2015
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Tracking Information | ||||
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First Submitted Date ICMJE | June 1, 2007 | |||
First Posted Date ICMJE | June 4, 2007 | |||
Last Update Posted Date | May 29, 2015 | |||
Study Start Date ICMJE | November 2007 | |||
Actual Primary Completion Date | November 2008 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Relapse rate over 24 months. [ Time Frame: 2 years ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT00482066 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Abatacept in ANCA Associated Vasculitis | |||
Official Title ICMJE | A Pilot Study Examining the Effect of Abatacept in ANCA Associated Vasculitis | |||
Brief 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. | |||
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. |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Prevention |
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Condition ICMJE | ANCA-associated Vasculitis | |||
Intervention ICMJE | Drug: 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. |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE |
7 | |||
Original Estimated Enrollment ICMJE |
112 | |||
Actual Study Completion Date | November 2008 | |||
Actual Primary Completion Date | November 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United Kingdom | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00482066 | |||
Other Study ID Numbers ICMJE | cro632 2006-001859-35 ( EudraCT Number ) BMS protocol No: IST110 ( Other Grant/Funding Number: Bristol Myers Squib funder ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Imperial College London | |||
Study Sponsor ICMJE | Imperial College London | |||
Collaborators ICMJE | Bristol-Myers Squibb | |||
Investigators ICMJE |
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PRS Account | Imperial College London | |||
Verification Date | March 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |