Patient-reported real-world experience of risankizumab onbody injector
Research type
Research Study
Full title
Patient-reported real-world experience of risankizumab on-body injector (OBI) for the treatment of Crohn’s disease in the UK: a before-and-after survey of participants among patients that transition from maintenance treatment (360 mg applied by 4x90 mg PFS) within the Early Access to Medicine Scheme / Pre-Approval Access Schemes to Free-Of-Charge use of OBI
IRAS ID
326609
Contact name
Rachel Horsfall
Contact email
Sponsor organisation
AbbVie Ltd
Duration of Study in the UK
0 years, 11 months, 29 days
Research summary
Risankizumab is a medicine that has undergone regulatory approval for the treatment of Crohn's disease and other inflammatory diseases in the United Kingdom, European Union and elsewhere. In the UK, risankizumab has been available to patients with Crohn’s disease who are participating in Pre-Approval Access and Early Access to Medicines Schemes since 2019 and 2022, respectively.
At present, risankizumab is administered by self-injection using multiple pre-filled syringes. However, these pre-filled syringes will be replaced by an on-body injector (OBI), a medical device, that automatically delivers risankizumab in a single injection at the push of a button.
In 2023, up to 153 patients receiving risankizumab as part of these schemes will switch administration method from pre-filled syringes to the OBI. This presents the first opportunity to characterise patient satisfaction with OBI for the treatment of Crohn’s disease in the real-world.
REC name
North West - Preston Research Ethics Committee
REC reference
23/NW/0195
Date of REC Opinion
28 Jul 2023
REC opinion
Further Information Favourable Opinion