Rezultaty
Update on key risk predictors for the transition from the atrisk status to clinical arthritis
ARIAA Report on status of posting resultsClinical trial ARIAA Report on status of posting results UKER BMS
Report on progress of the prospective at-risk RTCure cohortEstablish an RTCure prospective cohort of atrisk individualsWhile the analysis of already existing cohorts will allow us to obtain valuable information on the potential parameters which predict progression to RA the establishment of a new prospective cohort of atrisk individuals with contribution from all partners and with a harmonized mode of data acquisition will be an important step further which will allow i study of larger sample size of atrisk individuals with ii a higher possibility to better compare data based on standardized protocols of data acquisition and iii to provide a basis for future clinical trials see also WP6 For establishing this cohort the use of methods such as Multiple Randomised Controlled Trial MRCT design will be considered The plan is that each academic partner contributes at least 50 atrisk individuals to this joint RTCure cohort allowing a total number of at least 600 atrisk individuals with identical data collection to be studied by the RTCure consortium Immunomonitoring techniques applied and developed in WP3 and WP4 will also feed into this cohort
Identification of auto-antigens associated with pathogenesis of RAReport on the identification of auto-antigens associated with pathogenesis of RA
Standard operating procedures for the application of immune profilingD43 Standard operating procedures for the application of immune profiling Type R Dissemination level PU Delivery Date Month 42 Responsible partner KCL and DRFZ
Final review of Data and knowledge management planReport on immune profiling across the disease spectrum, including the enumeration of autoantigenic peptide specific T and B cells defined at different stages of the disease
Report on immune profiling across the disease spectrum including the enumeration of autoantigenic peptide specific T and B cells defined at different stages of the disease
Report on the validation of immune tolerance signatures in relevant experimental medicine studiesReport on the validation of immune tolerance signatures in relevant experimental medicine studies Type R Dissemination level PU Delivery Date Month 60 Responsible partners KCL LUMC KI
Suitable strategy for testing of multiple tolerogenic therapiesAgreement on a suitable strategy for testing of multiple tolerogenic therapies (UNEW, UCB)
Report on the core data set for characterisation of individuals at-risk for developing RAReport on the core data set for characterisation of individuals at-risk for developing rheumatoid arthritis. In this part of WP2 the existing cohorts of individuals at-risk for development of RA from the RTCure partners will be analyzed and compared for their type of data acquisition in order to define an essential core data set for describing the “at-risk” state. This approach will comprise clinical parameters (such for instance the documentation of inflammatory arthralgia), laboratory parameters (such as ultrasensitive C-reactive protein and autoantibody titers against various autoantigens and peptides thereof, citrullinated proteins and other relevant antigenic protein modifications), and other relevant biomarkers (such as autoantibody profiles, protein biomarkers, RNA expression profiles, epigenetic profiles) as well as imaging parameters (such as subclinical synovitis, osteitis or tenosynovitis). Core parameters will be identified, which allow a comprehensive but also feasible description of the nature of the at-risk state in these individuals. In addition, novel more experimental parameters, in particular approaches coming from the immune-phenotyping of T and B cell populations done in WP3 and WP4 will be added to this parameter set, if shown to be relevant for a better characterization of the at-risk state. Importantly, the agreed key parameters will allow for harmonization of patient criteria that can be applied across clinical sites so as to ensure data comparability.
Characterisation of pathogenic T- and B- cell receptors and antibodiesReport on the characterisation of pathogenic T cell receptors B cell receptors and antibodies
Comparison of serologic features of at-risk individuals and recent onset arthritis patientsCompare at-risk individuals with recent-onset/early arthritis patients RTCure partners have already established well characterized cohorts of recent onset/early arthritis patients such as the TACERA, the Leiden Early Arthritis and the Scottish Early RA (SERA) cohorts, which provide an excellent possibility to compare the clinical, serologic and cellular features of patients who have recently moved into the inflammatory phase of the disease with those of imminent risk of developing the disease. Additional biobanks of recent onset/early arthritis patients from other RTCure partners (MUW, KI) provide valuable information of the serologic features of recent onset/early arthritis patients.
Development of at least 3 mechanistically oriented clinical studies of different tolerising therapies.Development of at least 3 mechanistically oriented clinical studies of different tolerising therapies In terms of deliverables development implies all stages up to but excluding first patient first visit Whether the studies can be initiated or indeed completed during this IMI will depend on several factors including validation of the specific technology with a GMP process and regulatory documentation availability of funding approval of a protocol by partners ethical approvals and a trial sponsor
Screening and analysis of biological and clinical datasetsScreening and analysis of biological and clinical datasets generated within the project. Responsible partners LUMC and Pfizer.
Algorithm for predicting the development of arthritisEstablishment of an algorithm for predicting the development of arthritis. The aim of this part is to develop a risk prediction model for development of RA, which is based on the parameters collected in the at-risk cohorts of the RTCure partners. Many of these cohorts contain longitudinal follow-ups, which allow to evaluate which of the at-risk individuals developed RA and which one remained in the at-risk stage. A particular focus will be drawn on parameters which predict progression to RA in several different cohorts. In addition, additive risk prediction by using several different parameters such as combination of clinical, laboratory and imaging parameters will be addressed.
ARIAA Midterm recruitment reportClinical trial ARIAA Midterm recruitment report (UKER, BMS)
Report on the link between immune signatures and clinical outcomesD46 Report on the link between immune signatures and clinical outcomes including those associated with immune tolerance and deep remission
Key risk predictors for the transition from the at-risk status to clinical arthritisEstablishment of key risk predictors for the transition from the at-risk status to clinical arthritis (UA or RA). Core data sets extracted from existing cohorts in the first part of WP2 will be evaluated for their role in predicting the risk to progress from the at-risk state to the clinical state of arthritis (either undifferentiated arthritis or rheumatoid arthritis).
Regulatory briefing docRegulatory briefing doc to be used in interactions with regulatory agencies
Bioinformatic planBioinformatic plan for data generated and collected in RTCure
Report on the development of strategies for the depletion of pathogenic cells refractory to tolerance inductionReport on the outcome of experimental and therapeutic tolerance induction in pre-clinical animal models
Report on the outcome of experimental and therapeutic tolerance induction in preclinical animal models This includes information on cellularautoimmune biological pathways in animal models and a prioritizing strategy of the best candidates for clinical development
Optimal participant population(s) for clinical studies of tolerogenic interventionsDefinition of the optimal participant population(s) for clinical studies of tolerogenic interventions (UKER and UQ). The target population is critical for testing tolerogenic therapies and will be a topic for ongoing debate among WP6 members, with input from WPs 1 and 2 in particular.
Status on ongoing clinical trials in RTCureStatus on ongoing clinical trials in RTCure. Including: First study subject approvals package (ASCARA, ICosRA, APPIPRA), All approval package (ICosRA and APIPPRA), Midterm recruitment report (ICosRA, APIPPRA)
Compendium on current researches for inducing clinical therapeutic tolerance (4 papers published in Lancet Rheumatology)Compendium on current researches for inducing clinical therapeutic tolerancea previous and current attempts to induce clinical therapeutic tolerance with a focus on RA but including other autoimmune allergic and transplant settingsb postulated autoantigens and supporting data in RA c information on the preRA state including data on B and T cell epitope spreading involving key autoantigens illustrating how tolerance is lost over timed potential biomarkers of the tolerant stateThis will be published reviews in a per reviewed journal
Set up external website with a RTCure logo and an internal communication platform where partners can store and share data and information and communicate about publications.
Build a multidisciplinary task forceBuild a multidisciplinary task force with expertise on biology, statistics, database management, including clinicians and ethicists.
Design a tool(s) and also a long-term solution that allow access to and analysis of RTcure clinical, genetic, transcriptional, cytometry data (pre-existing and new). (KI, Pfizer, LUMC)
Arrange thematic workshops in collaboration with the other WPs. Approximately one every year.
Publikacje
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