Objective
Nearly all biopharmaceuticals induce antibodies. Although the impact of these antibodies varies widely, it is clear that the immunogenicity of biopharmaceuticals may hamper optimum treatment strategies. The effectiveness of interferon beta (IFNb) is well established in relapsing-remitting multiple sclerosis (MS). Nevertheless, the use of this drug in clinical practice is complex, especially because it may induce neutralising antibodies (NABs). These NABs cause a reduction in IFNb bioavailability as measured by reduced levels of biomarkers. Moreover, there is evidence that persistent NABs reduce therapeutic efficacy. Because a standardised assay is lacking, the relevant clinical and biological level of NABs has not yet been defined. We here propose to setup a European wide network to provide standardised testing and to define the titres which are clinically relevant. We also want to develop in-vitro and in-vivo assays and models that predict immunogenicity, allowing strategies to prevent or modulate the induction of NABs. This project will increase the efficient use of IFNb in MS and safe money (approximately 100 million Euros per year) for the EU health systems by avoiding the use of this expensive treatment in patients in whom the drug is not effective. We want to achieve these goals by: 1 Validation and standardisation of a recently CHMP approved common assay for the detection of NABs. 2 Developing new assays. 3 Evaluating clinical effects in large cohorts of patients. 4 Studying bio-activity markers. 5 Studying immunogenicity. This research may lead to an evidence-based approach for dealing with the clinical problems of NABs and to improve care of MS patients by deciding what a clinically significant level of NABs is and recommending a strategy that will reduce clinical sequelae. Moreover, these studies may lead to data that can be applied more generally on the induction of antibodies by other biopharmaceuticals.
Fields of science (EuroSciVoc)
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
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Programme(s)
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Topic(s)
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Call for proposal
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
FP6-2004-LIFESCIHEALTH-5
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Funding Scheme
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
Coordinator
AMSTERDAM
Netherlands
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Participants (14)
UTRECHT
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DÜSSELDORF
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ORBASSANO (TO)
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LONDON
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INNSBRUCK
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COPENHAGEN
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BARCELONA
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STOCKHOLM
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COPENHAGEN
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BAGSVAERD
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FAREHAM
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BASEL
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LONDON
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PRAHA
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