Clinical study - patient info
The ImmUniverse clinical study
ImmUniverse wants to improve the quality of life for people living with atopic dermatitis and ulcerative colitis and ultimately those with other immune-mediated inflammatory diseases. This shall be achieved through a more personalised treatment tailored to the individual patient.
To this end, ImmUniverse conducts a clinical study at different sites across Europe for which we require patients with atopic dermatitis and ulcerative colitis willing to participate.
Are you interested in taking part? For more information about the study and how to take part, please read below.
- What exactly is ImmUniverse and what can it do for me, as a patient with atopic dermatitis or ulcerative colitis, that my local physician can’t do?
Of course, your local physician is always your first point of contact for your routine treatments. Complementary to that, in ImmUniverse some of the world’s leading experts have joined forces. They are treating and monitoring thousands of patients, so they see all the different shapes the diseases can have. All the observations made are analysed and used to create a much more personalised treatment, better adapting to the needs of each individual patient.
- Who are the people behind ImmUniverse?
Clinicians and drug developers, basic immunologists, bioinformaticians as well as biotechnology and clinical development experts from several European universities, pharmaceutical companies and three European patient organisations (see below for details) joined forces in ImmUniverse. The project is funded by the Innovative Medicines Initiative (IMI JU), a partnership between the European Union and the European pharmaceutical industry. For you as a patient that also means that this project fosters the collaborative work of research and healthcare communities across different diseases like atopic dermatitis and ulcerative colitis.
- Is there a possibility for me to participate – and if so, what would be the direct benefits for me?
Naturally, you can participate. We are specifically looking for patients with moderate or severe disease symptoms and planned biological treatment. If you participate, you will benefit by receiving very close monitoring by experts in the field and you will get access to the most recent treatment developments. Also, participants will receive the latest news and have the chance to get in touch not only with experts but also with other patients facing similar problems which may help you in your daily routine.
- I want to participate, what do I have to do?
Simply get in touch with one of the recruitment centers, where you would be enrolled for regular treatment and monitoring for up to two years for each drug. That would include answering questionnaires in the waiting room and donating blood, tissue and stool samples (so called biomaterials) at multiple time points, when you are having your regular appointments. These regular appointments will not be prolonged by these study procedures. The recruitment centers are Kiel, Aarhus, Munich and Nijmegen for atopic dermatitis and Leuven, Amsterdam, Kiel, Nancy and Cambridge for ulcerative colitis.
- Does COVID-19 affect this in any way? Is recruitment still open?
Recruitment is open, with all recruitment centers having specific hygiene measures in place in order to ensure appropriate protection against SARS-CoV-2 or other infections.
- Do I have to pay for participating?
No, the costs are covered by ImmUniverse, which is funded by the IMI JU. However, please note that no travel costs to the centres are reimbursed.
- After registering, how long am I required to participate?
We request patients to participate for at least 12 months. If, for any reason, you need or want to discontinue, you have the legal right to withdraw from the study at any time – without any disadvantages.
- If you work with my data – is that really safe?
The European Union is very strict when it comes to data safety, so is ImmUniverse. No personal data and no data that can be tracked back to an individual will be shared or published. Everything is anonymised – so even if data were visible, nobody would ever see your name or be able to connect this data with you in any way. As an example, please find work from participating centres within ImmUniverse here. At any time of the study and even afterwards, you can quit the trial and ask for your data to be deleted. However, once these anonymised data have been published, this will not be possible anymore. ImmUniverse will provide regular updates on the study progress and results. Your individual study data will however not be shared, as the kind of data is difficult to interpret at this state of research.
- Should I have more questions, who can I contact?
For patients with ulcerative colitis:
EFCCA - European Federation of Crohn’s and Ulcerative Colitis Associations
Luisa Avedano CEO, Isabella Haaf Deputy Director
Rue Des Chartreux, 33-35
1000 Brussels, Belgium
Tel. +32 2 540 84 34
For patients with atopic dermatitis:
EFA - European Federation of Allergy and Airways Diseases Patients’ Associations
Markaya Henderson, Projects and Patient Engagement Officer
Rue du Congrès 35,
1000 Brussels, Belgium
Tel. +32 2 227 27 12
Thank you for considering to participate! And remember, you can contact us at any time.
The three involved patient organisations are:
- The European Federation of Allergy and Airways Diseases Patients’ Associations (EFA)
- The European Federation of Crohn’s and Ulcerative Colitis Associations (EFCCA)
- The European Patients’ Forum (EPF)