Work packages

WP1 – Management & Ethics

WP1, led by the Medical University of Vienna with support from EUTEMA Research Services, is focused on developing robust ethical management frameworks to coordinate the SQUEEZE consortium effectively.

This involves ensuring adherence to national and international regulatory and ethical standards, such as aligning protocols with ICH-GCP (International Council for Harmonisation of Good Clinical Practice) and the Declaration of Helsinki, obtaining patient consent, maintaining independent ethical oversight, implementing robust data security measures, and promptly addressing any unexpected ethical or legal issues that may arise.

The main aim of WP1 is to coordinate the consortium effectively by means of monitoring, reporting and organising regular meetings, while proactively addressing ethical and legal issues.

WP2 – Data science infrastructure

WP2, led by the Karolinska Institute, is working on setting up the data systems needed to make it easy to use different RA data sources for analysis in the SQUEEZE project. This involves:

• Creating a biobank inventory to match clinical and biobank data
• Developing a data warehouse to store project protocols, scripts, and generated data
• Ensuring that different RA data sources can be accessed and used together efficiently.

WP3 – Applied precision medicine

WP3, led by Leiden University Medical Center, is focused on simplifying and enhancing RA treatment decisions. This work package aims to:

• Develop tools to assess the safety and effectiveness of different DMARD therapies
• Assist healthcare providers in selecting the best treatment for each patient
• Analyze data from clinical trials and patient demographics to create predictive models for guiding treatment choices
• Improve patient outcomes in managing RA by offering personalized treatment recommendations based on individual needs

WP4 – Experimental Precision Medicine

The BioTest Trial by Queen Mary University of London (QMUL) wants to find out which specific findings in arthritic tissue are connected to how well medications work.

The trial looks at the biopsies of two groups of patients: those who respond very well to treatment (top responders) and those who don’t respond as well (bottom responders). This will help to validate the results.

QMUL is working with the Medical University of Vienna (MUW) to create an online synovial pathology atlas. This atlas will be a collection of information and images about the tissues affected by arthritis.

The goal is to make progress in arthritis research by working together and building on the success of previous projects, like the PEAC dataset.

WP5 – Maximising DMARD benefit: synthetics

WP5, led by the Medical University of Vienna, aims to figure out how people with rheumatoid arthritis react to MTX treatment.

• The team will create a plan for a clinical trial to find the best way to use MTX, which will be tested in multiple hospitals.

• They will explore non-invasive methods to check how MTX is working, like analyzing sweat from fingers.

• By looking at lots of data, they hope to identify different patterns of how patients respond to MTX based on their characteristics and disease.

• WP5 will work with patients and regulatory bodies to develop a detailed plan for the MethMax trial, which will test different MTX dosages and ways of taking the medicine.

• The trial will be coordinated by the Medical University of Vienna and take place in multiple locations.

• The team will test the finger sweat analysis method in regular patients first, then use it in the MethMax trial to see how well it works for monitoring MTX effectiveness and if patients are taking their medicine as prescribed.

WP6 – Therapeutic drug monitoring – bDMARDs

The RA-DRUM trial is a study led by Diakonhjemmet Sykehus AG in Oslo, Norway.

It aims to find out if regularly checking drug levels in the blood (called therapeutic drug monitoring or TDM) can help improve the effectiveness of certain arthritis medications called biologics.

Biologics are a type of drug that helps reduce inflammation and joint damage in people with rheumatoid arthritis.

The study will look at the relationship between the amount of drug in the blood, the presence of antibodies against the drug, and how well the treatment works for patients.

It will also develop guidelines for using TDM to guide treatment decisions.

A clinical trial will be conducted to test whether using TDM to adjust biologic doses is better than standard treatment.

After the trial is finished, the researchers will work with the MAGIC organization to quickly share their findings and recommendations with doctors who treat rheumatoid arthritis patients.

WP7 – Functional drug monitoring

The Medical University of Vienna and Leiden University Medical Center are working together on Work Package 7.

The goal is to create a large dataset of information about a virus called Torque Teno Virus (TTV) in people with rheumatoid arthritis (RA) who are taking medications called disease-modifying antirheumatic drugs (DMARDs).

The team wants to see how the TTV virus changes over time in people taking different DMARDs.

They will check if the TTV virus can help predict if the DMARD treatment is working well and if the TTV virus is linked to a higher risk of getting infections.

The project will define the best levels of the TTV virus for each DMARD to make the treatment as effective and safe as possible.

They will measure the TTV virus levels in people taking different DMARDs and will then use the TTV virus levels to predict if a DMARD will work well for each person.

They will check if the TTV virus can be used as a sign that someone is at higher risk of getting an infection.

They will define the ideal TTV virus levels for each DMARD based on how well the treatment is working and how safe it is.

WP8 – The SQUEEZE Care Model

Work Package 8 is developing a new healthcare model called SCM-DTx.

SCM-DTx combines ideas from chronic illness care and precision medicine.

The University of Basel is leading this work package, and together with their team of experts they will look at how healthcare is provided in different European countries to help develop the new model.

Patients will work with the researchers to create the different parts of the SCM-DTx program.

This will use methods from behavior science, implementation science, and computer science.

The new model will be tested in two medical centers to see how well it works.

The team will also look at digital behavior markers, shared decision-making, disease activity, and ultimately how well the model is put into practice.

WP9 – Dissemination, Communication and Exploitation

Work Package 9 manages communication, sharing, and use of information and results of the SQUEEZE project.

EUTEMA Research Services GmbH leads this work with help from the Medical University of Vienna, INMUSC, and EULAR.

Tasks include creating a plan for communication and sharing, preparing information material, spreading project findings, and aiding in planning how to use the results.

They will keep improving how they best share information as the project goes on.

Patients involved in the research will also help prepare content for communication.