A Swedish Observational Study on Vedolizumab Assessing Effectiveness And Healthcare Resource Utilization in Patients with Inflammatory Bowel Disease (IBD) (SVEAH)

Study identification

• EU PAS number:
  EUPAS22735
• Study ID:
  42810
• Official title and acronym:
  A Swedish Observational Study on Vedolizumab Assessing Effectiveness And Healthcare Resource Utilization in Patients with Inflammatory Bowel Disease (IBD) (SVEAH)
• DARWIN EU® study:
  No
• Study countries:
  Sweden
• Study description:
  This is a prospective, multi-center, observational and cohort study for patients with IBD. This study will assess the effectiveness of vedolizumab for achieving clinical response at Week 12 and remission at Week 52 in participants with confirmed and active disease of ulcerative colitis (UC) and Crohn’s disease (CD), and will assess the long term effectiveness of vedolizumab treatment among 3 months responders or remitters in clinical practice. Patients that are initiated on treatment with vedolizumab will be recruited into the cohort. Patients may either be naive to biologic treatment or may have previous experience with biologic treatment. Patients must not have previous experience with vedolizumab at entry. The study will have two phases: Phase 1 and Phase 2. Phase 1 will enrol approximately 300 participants (125 participants with UC and 175 with CD) in a cohort who have initiated a treatment with vedolizumab in a clinical practice. Participants from Phase 1 who will be on vedolizumab treatment at Week 52 will be asked to continue in Phase 2. This study will be conducted at approximately 20 sites in Sweden. The data will be collected for up to 52 weeks in Phase 1 and for up to 156 weeks in Phase 2 of this study.
• Study status:
  Finalised

Research institutions and networks

Institutions

Department of Medicine, Karolinska University hospital, Department of Gastroenterology, Linköping University hospital, Department of Gastroenterology, Skånes University hospital Lund, Department of Gastroenterology, Akademiska university hospital Uppsala, Department of Gastroenterology, Skånes University Malmö, Department of Medicine, Falun hospital, Department of Gastroenterology, Sahlgrenska University hospital, Department of Gastroenterology, Norra Älvsborgs hospital Trollhättan, Department of Medicine, Norrlands University hospital, Department of Gastroenteroloigy, Ryhov’s hospital Jönköping, Department of Medicine, Sunderby hospital, Department of Internal Medicine, Södra Älvsborg hospital Borås, Department of Gastroenerology, Ersta diakoni hospital, Department of Internal Medicine, Skaraborgs hospital Lidköping, Department of Gastroenterology, Danderyd’s hospital, Department of Gastroenterology, Västerås hospital, Department of Gastroenterology, Södersjukhuset, Department of Internal Medicine, Hallands hospital Kungsbacka, Department of Internal Medicine, Capio S:t Görans hospital, Department of Medicine, Hallands hospital Halmstad

Study timelines

Date when funding contract was signed

Actual:30/03/2015

Study start date

Actual:01/06/2015

Data analysis start date

Actual:01/09/2020

Date of final study report

Planned:01/09/2021

Actual:01/09/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Takeda Pharma AB

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable