A Post-Authorization Safety Study of Golimumab in Ulcerative Colitis Using the Spanish ENEIDA Registry

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/50619
• EU PAS number:
  EUPAS15752
• Study ID:
  50619
• Official title and acronym:
  A Post-Authorization Safety Study of Golimumab in Ulcerative Colitis Using the Spanish ENEIDA Registry
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD) of unknown etiology that may be associated with severe symptoms and impaired quality of life. UC may affect all ages and medical treatment depends on disease severity and extent. In the case of intractable disease, colectomy may be indicated. Patients with UC are at increased risk of developing colorectal cancer (CRC) and dysplasia compared to the general population. Simponi (golimumab; GLM) received European marketing authorization for treatment of moderately to severely active ulcerative colitis on 19-Sep-2013. This long-term, non-interventional observational study will use data from ENEIDA, a large prospectively maintained registry of patients with IBD in Spain to evaluate whether the use of GLM is associated with a risk of colectomy for intractable disease, advanced neoplasia (colorectal cancer or high grade dysplasia), and Hepatosplenic T-Cell Lymphoma (HSTCL) in patients with UC as compared with alternative therapies for similar severity of disease. It will use a new user bi-directional cohort design with the option for a nested case-control (NCC) analysis. The cohort study will use data that are primarily collected for the Spanish ENEIDA IBD registry, and the NCC analysis will also use data from retrospective review of selected medical charts.
• Study status:
  Finalised

Research institutions and networks

Institutions

RTI Health Solutions (RTI-HS)

France

Spain

Sweden

United Kingdom

United Kingdom (Northern Ireland)

United States

Multiple centres: 30 centres are involved in the study

Networks

Grupo Español Trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU)

Study timelines

Date when funding contract was signed

Planned: 29/02/2016

Actual: 29/02/2016

Study start date

Planned: 20/09/2016

Actual: 20/09/2016

Data analysis start date

Planned: 31/10/2022

Actual: 01/06/2022

Date of final study report

Planned: 30/09/2023

Actual: 26/09/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck Sharp & Dohme LLC

Study protocol

Initial protocol

MK8259-042-00_Redacted

Updated protocol

MK8259-042-00_v1.1_Redacted

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)