INSPIRE
Research type
Research Study
Full title
An observatIonal post-marketing study on the effectiveness and safety of darvadstrocel in Patients with CRohn’s disease and complex perianal fistulas (INSPIRE)
IRAS ID
249620
Contact name
Alan Lobo
Contact email
Sponsor organisation
Takeda Pharmaceuticals International AG
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
5 years, 1 months, 30 days
Research summary
Crohn’s Disease (CD) is a condition that causes inflammation of the digestive system, and can lead to the development of anal fistulas. Fistulas are like tunnels that connect either two different parts of the bowel or the bowel to other organs, Fistulas are a disabling symptom which diminish patient’s quality of life and can lead to pain associated with the swelling around the anus, fever in case of abscess formation, and drainage of pus, stool, or blood from fistula openings in the skin. The symptoms and complications of anal fistulas can be quite debilitating and lead to limitations on a patient’s life.
The aim of treatment with Alofisel ® (darvadstrocel, a stem cell therapy) is to have a complete closure of the fistula(s) openings without development of abscesses, prevent incontinence, avoid surgery and improve patient’s quality of life. Available treatments for fistulas are often not successful and surgical treatment is often necessary.
This study is an observational study with the purpose to collect medical information and patient perspectives on the treatment and management of the condition and to evaluate patients’ outcomes after treatment with Alofisel ® given by injection.
Alofisel ® has already been approved for use in the treatment of anal fistula in adult patients with CD. Patients will be invited to participate in the registry only after the patient and their doctor has decided to initiate treatment with Alofisel ®.
Information related to participants routine care and standard assessments will be collected from visits that occurred up to 6 months prior to when their doctor decided to treat them with Alofisel ® and after treatment at 12 weeks, 6 months, 12 months, 24 months and 36 months. The information will be collected, if available, from medical records and from questionnaires about symptoms and impact on life and work.REC name
East of England - Essex Research Ethics Committee
REC reference
19/EE/0015
Date of REC Opinion
15 Apr 2019
REC opinion
Further Information Favourable Opinion