Status: Ongoing First registered on: 10/10/2016
Last updated on: 18/06/2020
1. Study identification
EU PAS Register NumberEUPAS15752
Official titleA Post-Authorization Safety Study of Golimumab in Ulcerative Colitis Using the Spanish ENEIDA Registry
Study title acronym
Study typeObservational study
Brief description of the studyUlcerative 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.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsRTI-HS
Department/Research groupPharmacoepidemiology & Risk Management
Organisation/affiliationRTI Health Solutions
Website/Homepagehttps://www.rtihs.org/services/pharmacoepidemiology-and-risk-management
Details of (Primary) lead investigator
Title Dr
Last name Fortuny
First name Joan
Is this study being carried out with the collaboration of a research network?
Yes
Grupo Español Trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU)
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?30
Countries in which this study is being conducted
National study

Spain
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed29/02/201629/02/2016
Start date of data collection20/09/201620/09/2016
Start date of data analysis31/10/2022
Date of interim report, if expected
Date of final study report31/03/2023
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesMerck Sharp & Dohme Corporation100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Fortuny
First name Joan
Address line 1Av. Diagonal 605, 9-1
Address line 2 
Address line 3 
CityBarcelona 
Postcode08028 
CountrySpain
Phone number (incl. country code)34933622814 
Alternative phone number 
Fax number (incl. country code)34937608507 
Email address jfortuny@rti.org
Public Enquiries
Title Dr 
Last name Fortuny 
First name Joan 
Address line 1Av. Diagonal 605, 9-1 
Address line 2 
Address line 3 
CityBarcelona 
Postcode08028 
CountrySpain 
Phone number (incl. country code)34933622814 
Alternative phone number 
Fax number (incl. country code)34937608507 
Email address jfortuny@rti.org 
Top