Study identification

EU PAS number

EUPAS27731

Study ID

42062

Official title and acronym

INSPECT: A retrospectIve chart review study evaluating the longer-term effectiveness of darvadstrocel in patients who completed ADMIRE-CD

DARWIN EU® study

No

Study countries

Austria
Belgium
France
Germany
Israel
Italy
Netherlands
Spain

Study description

This is a multi-site, retrospective chart review study of patients with Crohn’s disease (CD), who received darvadstrocel or placebo and completed at least 52 weeks of follow-up in the ‘Adipose Derived Mesenchymal Stem Cell for Induction of Remission in Perianal Fistulising Crohn’s Disease (ADMIRE-CD)’ clinical trial. This study will review patients’ medical records to collect additional longer-term data over a period of 104 weeks post-trial completion for all patients who completed at least 52 weeks of follow up within the ADMIRE-CD trial. The study objectives are to evaluate the following over 52 weeks (1 year) and 104 weeks (2 years) post-trial completion: the time in remission and the proportion of patients who sustained remission, the incidence of ADMIRE-CD treated fistula relapse, the proportion of patients with new fistula occurrence, and the response, remission and relapse status of new onset fistula, changes in perianal and luminal disease activity, biologic and non-biologic medical treatment patterns, surgical and non-surgical procedures and healthcare resource utilisation (HRU), and the incidence of adverse events of special interest (AESIs). The data is anticipated to be collected between March 2019 and August 2019. The study aims to enroll as many as possible of the 131 patients who completed at least 52 weeks of follow up within the ADMIRE-CD trial. The study will be conducted at a maximum of 25 sites in 8 countries (Austria, Belgium, France, Germany, Israel, Italy, Netherlands, and Spain). As part of this study, new data will only be collected from the chart review study period (with the exception of some specific prior fistula history data which was not collected during ADMIRE-CD). No additional data from the ADMIRE-CD study period will be collected. The analysis for this study will therefore leverage previously collected and analysed trial data.

Study status

Finalised
Research institutions and networks

Institutions

A.ö. Krankenhaus der Barmherzigen Brüder, Medizinische Universitat Wien Austria, Shaare Zedek Medical Center, Tel Aviv Sourasky Medical Center, Rambam Health Corporation, Chaim Sheba Medical Center Israel, Hospital Universitario La Paz, Hospital Clinic de Barcelona, Hospital General Juan Ramon Jimenez, Hospital Universitario Virgen del Rocio, Hospital Universitario Fundacion Jimenez Diaz, Hospital Provincial de Pontevedra Spain, Hospital Universitario 12 de Octubre, Hospital Clinico San Carlos, Hospital Universitario Ramon y Cajal, Hospital Universitario de La Princesa, Hospital de Manises Spain, VU Medisch Centrum, Academisch Medisch Centrum Amsterdam Netherland, CHRU Lille, Hopital Cote de Nacre, CHU Amiens Picardie- Hôpital Nord, Hopital Nord AP-HM, Groupe Hospitalier Archet I Et II France, H.-Hartziekenhuis Roeselare-Menen vzw, UZ Gent, Universitair Ziekenhuis Belgium, Azienda Ospedaliera Di Padova, Complesso Integrato Columbus, Istituto Clinico Humanitas, AOU dell'Università degli Studi della Campania Luigi Vanvitelli Italy, Städtisches Klinikum Lüneburg, Evangelisches Krankenhaus Kalk gGmbH Germany, C.H. Regional Reina Sofia, Hospital de Sagunto Y C.E. Hospital Universitario Son Espases Spain

Contact details

Julián Panés

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Actual:
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