Study identification

PURI

https://redirect.ema.europa.eu/resource/45045

EU PAS number

EUPAS24267

Study ID

45045

Official title and acronym

Alofisel-5003: An Observational Post-Marketing Registry on the Effectiveness and Safety of Darvadstrocel in Patients With Crohn's Disease and Complex Perianal Fistulas (INSPIRE)

DARWIN EU® study

No

Study countries

Austria
Belgium
Czechia
Finland
France
Germany
Greece
Hungary
Ireland
Israel
Italy
Netherlands
Norway
Portugal
Romania
Slovakia
Slovenia
Spain
Switzerland
United Kingdom

Study description

In this study, participants with Crohn's disease with complex perianal fistulas will be treated with darvadstrocel according to their clinic's standard practice. A perianal fistula is an abnormal passageway that develops between the rectum and the skin near the anus. The fistula is considered complex if it branches into several openings or has a difficult anatomical location. The main aims of the study are to check if the fistulas are healing, the wellbeing of the participants and any side effects from the treatment.

Study status

Ongoing
Research institution and networks

Institutions

Lead Coordinating Investigator
Hospital La Paz
First published:
01/02/2024
Institution
Medizinische Universitat Innsbruck, Allgemeines Krankenhaus der Stadt Wien, Krankenanstalt Rudolfstiftung, Ordensklinikum Elisabethinen, AUSTRIA, UZ Leuven, UZ Gent, BELGIUM, Clinical Hospital Sestre Milosrdnice, CROATIA Nemocnice Horovice a.s, Czech Republic, Tampereen yliopistollinen sairaala, Jorvi Hospital, FINLAND, Hôpital de la Croix Saint-Simon, CHRU Lille, Hôpital Pontchaillou, Centre Hospitalier Lyon Sud, Hôpital Beaujon, Fondation Hôpital Saint Joseph, FRANCE, Universitätsklinikum, Carl Gustav Carus an der TU Dresden, St. Josefs-Hospital Wiesbaden GmbH, Städtisches Klinikum Lüneburg, Universitatsklinikum Munster, Kliniken Essen Mitte, Isar Kliniken GmbH, Universitatsklinikum Schleswig-Holstein, Charité -, Universitätsmedizin, Berlin, Verein Krankenhaus Waldfriede Ev, GERMANY, Aretaieio Hospital of Athens, GREECE, Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, Magyar Honvédség Egészségügyi Központ, HUNGARY, St Vincent's University Hospital, University Hospital Galway, IRELAND, Hadassah Medical Center – PPDS, Rabin Medical Center – PPDS, Meir Medical Center, Sheba Medical Center – PPDS, Tel Aviv Sourasky Medical Center PPDS, Edith Wolfson Medical Center, ISREAL, ASST Fatebenefratelli Sacco, Ospedale Luigi Sacco - INCIPIT – – PIN, Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi, Fondazione Policlinico Universitario A Gemelli, Azienda Ospedaliera Ospedali Riuniti Villa Sofia- Cervello, Azienda Ospedaliera Universitaria Federico II, ITALY, Universitair Medisch Centrum Utrecht, Maastricht University Medical Center, Leids Universitair Medisch Centrum, Academisch Medisch, Centrum Amsterdam, Radboud University Nijmegen Medical Centre, Universitair Medisch, Centrum Groningen, NETHERLANDS, Akershus Universitetssykehus, NORWAY, Hospital de São Teotónio, Centro Hospitalar E Universitário de Coimbra EPE, Centro Hospitalar de São João, E.P.E. Centro Hospitalar Lisboa Norte, E.P.E. – Hospital de Santa Maria, PORTUGAL, Fundeni Clinical Institute, ROMANIA, Gastroenterologicke centrum Ruzinov, SLOVAKIA, University Medical Centre Ljubljana, SLOVENIA, CHUS – H. Clinico U. de Santiago, Hospital Universitario Virgen de La Arrixaca, Hospital Universitario Miguel, Servet, Hospital Universitario de Donostia, Hospital Universitario Nuestra Sra de La Candelaria, Hospital Universitario Vall d'Hebrón – PPDS, Hospital Universitario La Paz – PPDS, Hospital Clinico Universitario de Valencia, Hospital Universitario Virgen del Rocio – PPDS, Hospital Universitario Fundacion Jimenez Diaz, Hospital Universitari i Politecnic La Fe de Valencia, Hospital Clinic de Barcelona, Hospital Universitario Virgen Macarena, Complejo Hospitalario, de Navarra, Hospital de Montecelo, Hospital General Universitario de Elche, SPAIN, Universitätsspital Zürich, Centre Hospitalier Universitaire Vaudois, Gastroentérologie Beaulieu SA, SWITZERLAND, Royal Hallamshire Hospital, St Mark's Hospital, UK

Contact details

Study Lead

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Data collection

Planned:
Actual:

Start date of data analysis

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Takeda
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable