For Participants

How to register?

You are interested to join CURE, the Chronic Urticaria Registry? All chronic urticaria and urticarial vasculitis treating physicians and centers are highly welcome to contribute to this important effort. However, before you can start entering data into the registry some steps need to be taken:

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Colaboration agreement

You need to date and sign a collaboration agreement with the UNEV gGmbH, a non-profit limited liability company, that is hosting CURE.

You can also request the documents from the cureoffice@unev-ggmbh.de

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Ethics Approval

You need to obtain approval for taking part in CURE from your responsible ethics committee (institutional review board – IRB) and your responsible data protection officer/unit.

Since the start of the registry in 2014, three ethics approvals have been issued for the Berlin CURE Center under the reference number EA1/146/14. Additionally, a separate ethics approval (EA1/173/24) was obtained in preparation for collaborative projects with other registries and studies, such as CARE and CRUSE. However, all approvals are site-specific and therefore not valid for other locations. Please also note that the requirements regarding approvals for participation may vary from site to site. In case of any doubt, please check with your institution, which approvals are needed for your participation.

In order to facilitate the obtaining of approvals, here you can find a template for ethics submission of 2025 (please check before using it if all information is correct for your center or if it has to be adjusted for your center), the CURE patient information as well as the CURE written informed consent:

Templates for the ethics application
Patient information (German)
Patient information (English)
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Send the completed Consent to Data Use

Anyone who wishes to be involved in the CURE project (e.g. data collection, receiving updates, etc.) must complete and sign a Consent to Data Use (CTDU) form:

This is required to allow data processing in compliance with data protection regulations.

Please send the signed form to cureoffice@unev-ggmbh.de.
Without this consent, participation in CURE is not possible.

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Send a copy of the ethics approval to the CURE Office

After a signed collaboration agreement is in place and after regulatory approval is obtained, please send a scanned copy of the approval to cureoffice@unev-ggmbh.de. The administrator of the registry will send you your login information for REDCap and/or SecuTrial system and you can start entering data into the registry. The link to the data entering masks can be found below.

Online Data Collection – Start with REDCap!

REDCap (Research Electronic Data Capture) is a secure, web-based application for managing and collecting research data. It is a new tool within the CURE registry for online data collection directly by the patient. Additional information will be added by the treating physician after the patient has completed the questionnaire.

You are directed to REDCap by clicking this link. Data entry is performed online by the patient and the treating physician.

Login

Classic Data Collection – Start with secuTrial!

SecuTrial is a secure, web-based software platform designed for managing clinical trial data, offering features for data collection, monitoring, and compliance with regulatory standards. It was implemented when CURE was launched in 2014.

By clicking the link below, you will be directed to secuTrial. Since data collection is done offline via paper questionnaires for both the patient and the doctor, the data must be manually entered into the secuTrial data form afterward.

Login

How to participate in CURE?

This video walks you through the key steps to join and participate in CURE.

How to add Patient ID’s in REDCap?

This video guides you through creating a patient ID in REDCap in a simple and intuitive way.

ON-GOING PROJECT

CURIOUS-D: Real-World Dupilumab Utilization and Outcomes in chronic spontaneous Urticaria – An ambispective multi-center, non-interventional observational study conducted in Germany

Study Type: Registry
Project Duration: October 2025 – December 2028
Status: Active
Number of patients: at least 100 patients
Location / Centers: CURE Centers in Germany
Publication / Results: expected in 2028
Sponsor: UNEV gGmbH
Scientific Coordinators: Dr. P. Kolkhir, Dr. K.Weller, S. Neisinger

Contact: cureoffice@unev-ggmbh.de

Summary

This observational study is a non-interventional registry study that collects real-world data on the use of Dupilumab in routine clinical practice. Its aim is to close key evidence gaps by documenting effectiveness, safety, and treatment outcomes across diverse patient populations. The real-world data generated will support decision-making in healthcare and provide valuable insights into treatment adherence, peak response, and long-term disease control beyond traditional clinical trials.

Objectives

PRIMARY STUDY OBJECTIVES:

To analyze dupilumab real-world utilization in patients with CSU in the context of the dupilumab launch as an in-label treatment option in CSU, including patient demographics, disease characteristics, comorbidities, prior therapies, dupilumab dosing, concomitant therapies, and laboratory values

 

SECONDARY STUDY OBJECTIVES:

To analyze dupilumab real-world outcomes in patients with chronic spontaneous urticaria (CSU) in the context of the dupilumab launch as an in-label treatment option in CSU, including onset, magnitude, and durability of clinical response, drug persistence, discontinuation and re-treatment, and impact of dupilumab on disease burden (clinical, humanistic, economic)

Important

Ethics Approval / Registration
Each participating site has obtained local ethics approval for registry participation where required. Secondary analyses and subprojects that use registry data are covered by the central registry approval and do not require a separate ethics vote, provided they remain within the approved registry scope and do not collect additional data outside the registry protocol.

Pharmacovigilance Notice
The Chronic Urticaria Registry (CURE) is not responsible for the collection or reporting of pharmacovigilance information. Each participating center remains responsible for reporting any adverse events or suspected adverse drug reactions directly to the marketing authorization holder (Sanofi), in accordance with local regulatory requirements.
The CURE Team (cureoffice@unev-ggmbh.de) may assist with clarifications but does not perform safety reporting on behalf of sites.

Disease Tracker

Chronic Urticaria Self Evaluation App

CURE is now also connected to the CRUSE® App. CRUSE® is developed by renowned dermatologists and allergists to help patients with Chronic Urticaria to take control of their disease. Patients are able to document and track their disease activity on a daily basis and provide CURE real-time data to complement our research efforts. Through this valuable add-on, future analyses will benefit from even more accurate and timely information to help researchers advance the understanding and treatment of urticaria. Details on how to integrate CURE with CRUSE can be found in the Members Area.

For more information on CRUSE®, please visit the website.