Vedolizumab-4018: Observational Study of the Effectiveness of Vedolizumab on Treatment Outcomes and HRQoL in biologic naïve Patients with Inflammatory Bowel Diseases in Greece (TROVE)

11/05/2018
30/10/2025
EU PAS number:
EUPAS23580
Study
Finalised
Study identification

EU PAS number

EUPAS23580

Study ID

46995

Official title and acronym

Vedolizumab-4018: Observational Study of the Effectiveness of Vedolizumab on Treatment Outcomes and HRQoL in biologic naïve Patients with Inflammatory Bowel Diseases in Greece (TROVE)

DARWIN EU® study

No

Study countries

Greece

Study description

This is a prospective, observational, multi-center and a cohort study of biologic naïve patients with moderate to severe ulcerative colitis (UC) or Crohn’s disease (CD) who have had an inadequate response with, lost response to, or were intolerant to conventional therapy. This study will assess long-term clinical benefits in patients who are initiating treatment with vedolizumab. Patients that are initiated on treatment with vedolizumab will be recruited into cohorts of UC or CD. This study will enroll approximately 200 patients (100 patients with UC and 100 with CD) into 2 cohorts who have initiated a treatment with vedolizumab in a clinical practice. The study will be conducted at 23 sites in Greece. The data will be collected for up to 2 years or until discontinuation of vedolizumab treatment, whichever occurs earlier after enrolment in the study.

Study status

Finalised
Research institutions and networks

Institutions

3rd Academic Dpt. of Internal Medicine,GI-Unit
1st Pathological Area, Pathological Clinic, Rio Hospital, Kymothois Crossroad 6, Patras, Gastroenterology Clinic of Medical School of University of Athens, Laiko Hospital, Agiou Thoma 17, Athens Greece, Gastroenterology Clinic, Alexandra Hospital, Lourou 1, Athens, Endoscopic-Operational Departmet, Iatriko Kentro Athinon, Distomou 5, Marousi, Athens Greece, Gastroenterology Clinic of Medical School of University of Larisa, Panepistimiou 3, Larisa, Gastroenterology Clinic, Theageneio Hospital, Al.Papanastasiou 11, Thessaloniki Greece, Gastroenterology Clinic A, Euaggelismos Hospital, Ipsilantou 45, Athens, Gastroenterology Clinic, Metropolitan Hospital, E.Makariou 1, Peiraias Greece, Pathological Department, Gastroenterology Clinic, Univ. Hospital of Ioannina, L. Stavrou Niarxou, Ioannina, B Pathological Clinic, Medical School of University of Athens, Ippokrateio Hospital, Vasilissis Sofias 114, Athens Greece, Pathological Department, Gastroenterology Clinic, Mitera Hospital, Erithrou Stavrou 6, Marousi, Athens, Gastroenterology Clinic, Tzaneio Hospital, l.Afentouli & Zanni, Peiraias Greece, Gastroenterology Clinic, Hospital of Heraklion, Voutes Herakliou, Heraklion, Crete, Gastroenterological Department, Venizeleio Hospital, L. Knosou 44 Heraklion, Crete Greece, Gastroenterological Department, General Hospital of Nikaia, Ikoniou 150, Nikaia, Peiraias, Gastroenterological Clinic, General Hospital “G.Papanikolaou” of Thessaloniki, Exochi Thessalonikis, Exochi Greece, D Pathological Clinic, Ippokrateio Hospital, Konstantinoupoleos 49, Thessaloniki, Gastroenterological Laboratory, Un. General Hospital of Alexandroupolis, Dragana, Alexandroupoli, Kianos Stauros Hospital, Vizyis and Vizantos 1, Thessaloniki Greece, A’ Pathologiki Clinic, Univ. General Hospital of Alexandroupolis, Dragana, Alexandroupoli, Gastroenterological Department, “G.Gennimatas” Hospital, Mesogeion Av. 154, Athens, Kianos Stauros Hospital, Vizyis and Vizantos 1, Thessaloniki Greece

Contact details

George Bamias

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:
Actual:

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