Ulcerative ColitisPASS TOFANCT06469424
An Active Surveillance, Post-Authorization Study to Characterize the Safety of Tofacitinib in Patients With Moderately to Severely Active Ulcerative Colitis in the Real-World Setting Using Data From the United Registries for Clinical Assessment and Research (UR-CARE) in the European Union (EU)
An observational study of Ulcerative Colitis, run by Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa at 5 sites in 4 countries.
Trial summary
The purpose of this study is to estimate the incidence rates of malignancy, excluding non-melanoma skin cancer (NMSC), venous thromboembolic events VTE (deep venous thrombosis [DVT] and pulmonary embolism [PE]), NMSC, major adverse cardiac events (MACE), progressive multifocal leukoencephalopathy (PML), infections… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- How many people
- 104 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 11 Jan 2024to 31 Mar 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with UC aged ≥18 years treated with tofacitinib compared to patient receiving alternative treatment or not treatment. The study will use secondary data collected in the UR-CARE platform, which is an ongoing, prospective, observational, cohort of European Union (EU) patients with inflammatory bowel disease (IBD) with the primary aim of facilitating daily patient care and research studies in IBD. This study will focus only on patients with UC enrolled in the UR-CARE platform.
Who may be able to join
- Adult patients aged ≥18 years,
- With Ulcerative colitis diagnosis per ECCO guidelines,
- Enrolled in UR-CARE registry with 12 months of medical history available in UR-CARE prior to the index date,
- With an informed consent signed. A minimum follow-up duration of 12 months will allow evaluation of safety events of interest.
Who cannot join
- Patients not meeting the inclusion criteria
- Patients who have any records of Crohn's Diseases (CD) or IBD unspecified in UR-CARE between the last UC diagnosis and index date [i.e. date of first prescription for tofacitinib].
Trial locations and contacts
5 sites in 4 countries.
Manuel MD Barreiro, PhD contact
5 sites in 4 countries
Belgium2 sites, 2 recruiting
- Recruiting
Imelda General Hospital
Bonheiden, 28202
Peter BOSSUYT, MD, peter.bossuyt@imelda.be
- Recruiting
AZ Delta vzw
Roeselare, 8800
Filip BAERT, MD, filip.baert@azdelta.be
Bulgaria1 site, 1 recruiting
- Recruiting
Acibadem City Clinic Tokuda University Hospital
Sofia, 1407
Anelia DECHEVA, MD, andecheva@gmail.com
Greece1 site, 1 recruiting
- Recruiting
General Hospital of Athens "Evangelismos"
Ellinikó, Attica, 16777
Nikolaos VIAZIS, MD, nikos.viazis@gmail.com
Lithuania1 site, 1 recruiting
- Not yet recruiting
Lithuanian University of Life Sciences
Kaunas, 44307
Gediminas KIUDELIS, MD, gediminas.kiudelis@kaunoklinikos.lt
About this study
The purpose of this study is to estimate the incidence rates of malignancy, excluding non-melanoma skin cancer (NMSC), venous thromboembolic events VTE (deep venous thrombosis [DVT] and pulmonary embolism [PE]), NMSC, major adverse cardiac events (MACE), progressive multifocal leukoencephalopathy (PML), infections, hospitalization and specific antibiotic or antiviral treatment, lung cancer, lymphoma, herpes zoster, myocardial infarction (MI), gastrointestinal (GI) perforations, fractures, surgery for UC and death; through 4 sub-groups: adult patients with UC who initiate tofacitinib in the course of routine clinical care compared to other medications approved to treat UC.
Read the detailed description
Rationale and background:
Tofacitinib, an inhibitor of the Janus kinase (JAK) family of kinases, was approved in the European Union (EU) in July 2018 at a dose of 5 mg twice daily or 10 mg twice daily for the treatment of adults with moderate-to-severe ulcerative colitis (UC), who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent. Malignancy excluding non-melanoma skin cancer (NMSC) is an important potential risk and venous thromboembolism (VTE) is an important identified risk associated with the use of tofacitinib, and follow-up of large cohorts of patients over a long period is needed to evaluate the risks of these safety events, as well as other potential safety events of interest, that may be associated with tofacitinib treatment. Pfizer will implement a post approval, active surveillance study of tofacitinib exposed and unexposed patients using actively collected prospective data included in the UR-CARE platform.
Research question:
What are the incidence rates of safety events of interest in adult patients with UC treated with tofacitinib in routine clinical care, as compared to the incidence rates in patients with UC treated with other approved systemic agents, and patients with UC naïve to biologics and immunomodulators/immunosuppressants (hereafter referred to as immunosuppressants)?
Study design:
This is an active cohort study of adult patients with UC aged ≥18 years treated with tofacitinib compared to patient receiving alternative treatment or not treatment. The study will use secondary data collected in the UR-CARE platform, which is an ongoing, prospective, observational, cohort of European Union (EU) patients with inflammatory bowel disease (IBD) with the primary aim of facilitating daily patient care and research studies in IBD. This study will focus only on patients with UC enrolled in the UR-CARE platform.
Variables:
The study variables include baseline patient characteristics (i.e., clinical and demographic characteristics, comorbidities, and current and past therapies), the primary outcomes of interest, and other safety events of interest.
Data sources:UR-CARE will be used as the only data source.
Study size:
This study is descriptive, and all eligible patients in UR-CARE registry during the study period who have consented to participate in the study will be included, with no upper limit on the sample size.
Data analysis:
All statistical analysis will be performed by GETECCU using SAS software v9.4, SAS Institute Inc, Cary, NC, USA. Detailed methodology for summary and statistical analyses of data collected in this study will be documented in a statistical analysis plan (SAP).
- Conditions
- Ulcerative Colitis
- Keywords
- prospective observational study with medication
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (Tofacitinib cohort): | Initiation of tofacitinib (i.e., first ever prescription) from 01 July 2018 through to 31 March 2025 | |
| Cohort 2 (Biologics cohort): | * Initiation (i.e., first ever prescription) of a specific biologic agent (any TNFi or non-TNFi agent) from 01 July 2018 through to 31 March 2025 * No prior use of specific biologic agent prior to index date using all available data | |
| Cohort 3 (Immunosuppressants cohort): | * Initiation (i.e., first ever prescription) of a specific immunosuppressant agent (without concurrent biologic therapy) from 01 July 2018 through to 31 March 2025 * No prior use of specific immunosuppressant prior to index date using all available data | |
| Cohort 4 (Naïve cohort): | * Patients diagnosed with UC since 01 July 2018 through to 31 March 2025 * Patients with no history of surgery for UC (surgery suggests more severe disease, and such patients would not be representative of patients with generally mild disease in Cohort 4) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Malignancy excluding non-melanoma skin cancer (NMSC)
Malignancy excluding non-melanoma skin cancer (NMSC). As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event.
Measured: from 01 July 2018 through to 31 March 2025
venous thromboembolic events (VTE),(deep venous thrombosis [DVT] and pulmonary embolism [PE])
deep venous thrombosis [DVT] and pulmonary embolism [PE]. As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event.
Measured: from 01 July 2018 through to 31 March 2025
Secondary outcomes (13)
Non melanoma skin cancer (NMSC)
Non melanoma skin cancer (NMSC). As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event.
Measured: from 01 July 2018 through to 31 March 2025
Lung cancer
Lung cancer. As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event.
Measured: from 01 July 2018 through to 31 March 2025
Lymphoma
Lymphoma (including 3 main subtypes Hodgkin's lymphoma, non-Hodgkin's lymphoma, and chronic lymphocytic lymphoma).
As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event.
Measured: from 01 July 2018 through to 31 March 2025
Serious infections
Serious infections. As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event.
Measured: from 01 July 2018 through to 31 March 2025
Opportunistic infections (e.g., tuberculosis)
Opportunistic infections (e.g., tuberculosis). As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event.
Measured: from 01 July 2018 through to 31 March 2025
Herpes zoster(HZ)
Herpes zoster(HZ). As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event.
Measured: from 01 July 2018 through to 31 March 2025
Major adverse cardiac events (MACE)
Major adverse cardiac events (MACE)
Measured: from 01 July 2018 through to 31 March 2025
Myocardial infarction (MI)
Myocardial infarction (MI). As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event.
Measured: from 01 July 2018 through to 31 March 2025
Progressive multifocal leukoencephalopathy (PML)
Progressive multifocal leukoencephalopathy (PML). As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event.
Measured: from 01 July 2018 through to 31 March 2025
Gastrointestinal (GI) perforations
Gastrointestinal (GI) perforations. As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event.
Measured: from 01 July 2018 through to 31 March 2025
Fractures
Fractures. As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event.
Measured: from 01 July 2018 through to 31 March 2025
All-cause mortality
All-cause mortality
Measured: from 01 July 2018 through to 31 March 2025
surgery for Ulcerative colitis (UC)
surgery for Ulcerative colitis (UC). As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event.
Measured: from 01 July 2018 through to 31 March 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start11 Jan 2024
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 104 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Manuel MD Barreiro, PhD, Principal investigator, Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06469424
- Sponsor's protocol ID
- PASS TOFA
- Acronym
- PASS TOFA
- Status last verified
- Jun 2024
- First submitted
- 7 Jun 2024
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Burisch J, Pedersen N, Cukovic-Cavka S, Brinar M, Kaimakliotis I, Duricova D, Shonova O, Vind I, Avnstrom S, Thorsgaard N, Andersen V, Krabbe S, Dahlerup JF, Salupere R, Nielsen KR, Olsen J, Manninen P, Collin P, Tsianos EV, Katsanos KH, Ladefoged K, Lakatos L, Bjornsson E, Ragnarsson G, Bailey Y, Odes S, Schwartz D, Martinato M, Lupinacci G, Milla M, De Padova A, D'Inca R, Beltrami M, Kupcinskas L, Kiudelis G, Turcan S, Tighineanu O, Mihu I, Magro F, Barros LF, Goldis A, Lazar D, Belousova E, Nikulina I, Hernandez V, Martinez-Ares D, Almer S, Zhulina Y, Halfvarson J, Arebi N, Sebastian S, Lakatos PL, Langholz E, Munkholm P; EpiCom-group. East-West gradient in the incidence of inflammatory bowel disease in Europe: the ECCO-EpiCom inception cohort. Gut. 2014 Apr;63(4):588-97. doi: 10.1136/gutjnl-2013-304636. Epub 2013 Apr 20.
PubMed 23604131Sjoberg D, Holmstrom T, Larsson M, Nielsen AL, Holmquist L, Ekbom A, Ronnblom A. Incidence and natural history of ulcerative colitis in the Uppsala Region of Sweden 2005-2009 - results from the IBD cohort of the Uppsala Region (ICURE). J Crohns Colitis. 2013 Oct;7(9):e351-7. doi: 10.1016/j.crohns.2013.02.006. Epub 2013 Mar 9.
PubMed 23491313Molodecky NA, Soon IS, Rabi DM, Ghali WA, Ferris M, Chernoff G, Benchimol EI, Panaccione R, Ghosh S, Barkema HW, Kaplan GG. Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology. 2012 Jan;142(1):46-54.e42; quiz e30. doi: 10.1053/j.gastro.2011.10.001. Epub 2011 Oct 14.
PubMed 22001864Busch K, Ludvigsson JF, Ekstrom-Smedby K, Ekbom A, Askling J, Neovius M. Nationwide prevalence of inflammatory bowel disease in Sweden: a population-based register study. Aliment Pharmacol Ther. 2014 Jan;39(1):57-68. doi: 10.1111/apt.12528. Epub 2013 Oct 16.
PubMed 24127738The Committee for Medicinal Products for Human Use. Guideline on the development of new medicinal products for the treatment of ulcerative colitis. CHMP/EWP/18463/2006 Revision 1. Available at: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-development-new-medicinal-products-treatment-ulcerative-colitis-revision-1_en.pdf
Coward S, Clement F, Benchimol EI, Bernstein CN, Avina-Zubieta JA, Bitton A, Carroll MW, Hazlewood G, Jacobson K, Jelinski S, Deardon R, Jones JL, Kuenzig ME, Leddin D, McBrien KA, Murthy SK, Nguyen GC, Otley AR, Panaccione R, Rezaie A, Rosenfeld G, Pena-Sanchez JN, Singh H, Targownik LE, Kaplan GG. Past and Future Burden of Inflammatory Bowel Diseases Based on Modeling of Population-Based Data. Gastroenterology. 2019 Apr;156(5):1345-1353.e4. doi: 10.1053/j.gastro.2019.01.002. Epub 2019 Jan 10.
PubMed 30639677Dahlhamer JM, Zammitti EP, Ward BW, Wheaton AG, Croft JB. Prevalence of Inflammatory Bowel Disease Among Adults Aged >/=18 Years - United States, 2015. MMWR Morb Mortal Wkly Rep. 2016 Oct 28;65(42):1166-1169. doi: 10.15585/mmwr.mm6542a3.
PubMed 27787492Everhov AH, Halfvarson J, Myrelid P, Sachs MC, Nordenvall C, Soderling J, Ekbom A, Neovius M, Ludvigsson JF, Askling J, Olen O. Incidence and Treatment of Patients Diagnosed With Inflammatory Bowel Diseases at 60 Years or Older in Sweden. Gastroenterology. 2018 Feb;154(3):518-528.e15. doi: 10.1053/j.gastro.2017.10.034. Epub 2017 Nov 2.
PubMed 29102619Khalili, H., Söderling, J., Everhov, Å. H., et al. 15 - Health Care Use, Work Loss, and Total Costs in Incident and Prevelant Ulcerative Colitis: Results from a Nationwide Study in Sweden. Gastroenterology 2018, 154(Supplement 1), S-5-5. http://doi.org/10.1016/S0016-5085(18)30504-3
Sandborn WJ, Ghosh S, Panes J, Vranic I, Su C, Rousell S, Niezychowski W; Study A3921063 Investigators. Tofacitinib, an oral Janus kinase inhibitor, in active ulcerative colitis. N Engl J Med. 2012 Aug 16;367(7):616-24. doi: 10.1056/NEJMoa1112168.
PubMed 22894574Lichtenstein GR, Abreu MT, Cohen R, Tremaine W; American Gastroenterological Association. American Gastroenterological Association Institute technical review on corticosteroids, immunomodulators, and infliximab in inflammatory bowel disease. Gastroenterology. 2006 Mar;130(3):940-87. doi: 10.1053/j.gastro.2006.01.048. No abstract available.
PubMed 16530532McAuliffe ME, Lanes S, Leach T, Parikh A, Faich G, Porter J, Holick C, Esposito D, Zhao Y, Fox I. Occurrence of adverse events among patients with inflammatory bowel disease in the HealthCore Integrated Research Database. Curr Med Res Opin. 2015;31(9):1655-64. doi: 10.1185/03007995.2015.1065242. Epub 2015 Aug 20.
PubMed 26135040Ludvigsson JF, Svedberg P, Olen O, Bruze G, Neovius M. The longitudinal integrated database for health insurance and labour market studies (LISA) and its use in medical research. Eur J Epidemiol. 2019 Apr;34(4):423-437. doi: 10.1007/s10654-019-00511-8. Epub 2019 Mar 30.
PubMed 30929112Biemans VBC, van der Meulen-de Jong AE, van der Woude CJ, Lowenberg M, Dijkstra G, Oldenburg B, de Boer NKH, van der Marel S, Bodelier AGL, Jansen JM, Haans JJL, Theeuwen R, de Jong D, Pierik MJ, Hoentjen F. Ustekinumab for Crohn's Disease: Results of the ICC Registry, a Nationwide Prospective Observational Cohort Study. J Crohns Colitis. 2020 Jan 1;14(1):33-45. doi: 10.1093/ecco-jcc/jjz119.
PubMed 31219157Zabana Y, Panes J, Nos P, Gomollon F, Esteve M, Garcia-Sanchez V, Gisbert JP, Barreiro-de-Acosta M, Domenech E; en representacion de GETECCU. The ENEIDA registry (Nationwide study on genetic and environmental determinants of inflammatory bowel disease) by GETECCU: Design, monitoring and functions. Gastroenterol Hepatol. 2020 Nov;43(9):551-558. doi: 10.1016/j.gastrohep.2020.05.007. Epub 2020 Jul 14. English, Spanish.
PubMed 32674882
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Active Surveillance, Post-Authorization Study to Characterize the Safety of Tofacitinib in Patients With Moderately to Severely Active Ulcerative Colitis in the Real-World Setting Using Data From the United Registries for Clinical Assessment and Research (UR-CARE) in the European Union (EU)
- ClinicalTrials.gov ID
- NCT06469424
- Acronym / sponsor ID
- PASS TOFA / PASS TOFA
- Conditions
- Ulcerative Colitis
- Keywords
- prospective observational study with medication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis UlcerosaUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 11 Jan 2024 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 21 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to estimate the incidence rates of malignancy, excluding non-melanoma skin cancer (NMSC), venous thromboembolic events VTE (deep venous thrombosis [DVT] and pulmonary embolism [PE]), NMSC, major adverse cardiac events (MACE), progressive multifocal leukoencephalopathy (PML), infections, hospitalization and specific antibiotic or antiviral treatment, lung cancer, lymphoma, herpes zoster, myocardial infarction (MI), gastrointestinal (GI) perforations, fractures, surgery for UC and death; through 4 sub-groups: adult patients with UC who initiate tofacitinib in the course of routine clinical care compared to other medications approved to treat UC.
Detailed description
Rationale and background:
Tofacitinib, an inhibitor of the Janus kinase (JAK) family of kinases, was approved in the European Union (EU) in July 2018 at a dose of 5 mg twice daily or 10 mg twice daily for the treatment of adults with moderate-to-severe ulcerative colitis (UC), who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent. Malignancy excluding non-melanoma skin cancer (NMSC) is an important potential risk and venous thromboembolism (VTE) is an important identified risk associated with the use of tofacitinib, and follow-up of large cohorts of patients over a long period is needed to evaluate the risks of these safety events, as well as other potential safety events of interest, that may be associated with tofacitinib treatment. Pfizer will implement a post approval, active surveillance study of tofacitinib exposed and unexposed patients using actively collected prospective data included in the UR-CARE platform.
Research question:
What are the incidence rates of safety events of interest in adult patients with UC treated with tofacitinib in routine clinical care, as compared to the incidence rates in patients with UC treated with other approved systemic agents, and patients with UC naïve to biologics and immunomodulators/immunosuppressants (hereafter referred to as immunosuppressants)?
Study design:
This is an active cohort study of adult patients with UC aged ≥18 years treated with tofacitinib compared to patient receiving alternative treatment or not treatment. The study will use secondary data collected in the UR-CARE platform, which is an ongoing, prospective, observational, cohort of European Union (EU) patients with inflammatory bowel disease (IBD) with the primary aim of facilitating daily patient care and research studies in IBD. This study will focus only on patients with UC enrolled in the UR-CARE platform.
Variables:
The study variables include baseline patient characteristics (i.e., clinical and demographic characteristics, comorbidities, and current and past therapies), the primary outcomes of interest, and other safety events of interest.
Data sources:UR-CARE will be used as the only data source.
Study size:
This study is descriptive, and all eligible patients in UR-CARE registry during the study period who have consented to participate in the study will be included, with no upper limit on the sample size.
Data analysis:
All statistical analysis will be performed by GETECCU using SAS software v9.4, SAS Institute Inc, Cary, NC, USA. Detailed methodology for summary and statistical analyses of data collected in this study will be documented in a statistical analysis plan (SAP).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (Tofacitinib cohort): | – | –Initiation of tofacitinib (i.e., first ever prescription) from 01 July 2018 through to 31 March 2025 |
| Cohort 2 (Biologics cohort): | – | –* Initiation (i.e., first ever prescription) of a specific biologic agent (any TNFi or non-TNFi agent) from 01 July 2018 through to 31 March 2025 * No prior use of specific biologic agent prior to index date using all available data |
| Cohort 3 (Immunosuppressants cohort): | – | –* Initiation (i.e., first ever prescription) of a specific immunosuppressant agent (without concurrent biologic therapy) from 01 July 2018 through to 31 March 2025 * No prior use of specific immunosuppressant prior to index date using all available data |
| Cohort 4 (Naïve cohort): | – | –* Patients diagnosed with UC since 01 July 2018 through to 31 March 2025 * Patients with no history of surgery for UC (surgery suggests more severe disease, and such patients would not be representative of patients with generally mild disease in Cohort 4) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with UC aged ≥18 years treated with tofacitinib compared to patient receiving alternative treatment or not treatment. The study will use secondary data collected in the UR-CARE platform, which is an ongoing, prospective, observational, cohort of European Union (EU) patients with inflammatory bowel disease (IBD) with the primary aim of facilitating daily patient care and research studies in IBD. This study will focus only on patients with UC enrolled in the UR-CARE platform.
Key inclusion criteria (4 listed)
- Adult patients aged ≥18 years,
- With Ulcerative colitis diagnosis per ECCO guidelines,
- Enrolled in UR-CARE registry with 12 months of medical history available in UR-CARE prior to the index date,
- With an informed consent signed. A minimum follow-up duration of 12 months will allow evaluation of safety events of interest.
Key exclusion criteria (2 listed)
- Patients not meeting the inclusion criteria
- Patients who have any records of Crohn's Diseases (CD) or IBD unspecified in UR-CARE between the last UC diagnosis and index date [i.e. date of first prescription for tofacitinib].
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Malignancy excluding non-melanoma skin cancer (NMSC)
Time frame: from 01 July 2018 through to 31 March 2025
Malignancy excluding non-melanoma skin cancer (NMSC). As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event.
venous thromboembolic events (VTE),(deep venous thrombosis [DVT] and pulmonary embolism [PE])
Time frame: from 01 July 2018 through to 31 March 2025
deep venous thrombosis [DVT] and pulmonary embolism [PE]. As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event.
13 secondary outcomes
Non melanoma skin cancer (NMSC)
Time frame: from 01 July 2018 through to 31 March 2025
Lung cancer
Time frame: from 01 July 2018 through to 31 March 2025
Lymphoma
Time frame: from 01 July 2018 through to 31 March 2025
Serious infections
Time frame: from 01 July 2018 through to 31 March 2025
Opportunistic infections (e.g., tuberculosis)
Time frame: from 01 July 2018 through to 31 March 2025
Herpes zoster(HZ)
Time frame: from 01 July 2018 through to 31 March 2025
Major adverse cardiac events (MACE)
Time frame: from 01 July 2018 through to 31 March 2025
Myocardial infarction (MI)
Time frame: from 01 July 2018 through to 31 March 2025
Progressive multifocal leukoencephalopathy (PML)
Time frame: from 01 July 2018 through to 31 March 2025
Gastrointestinal (GI) perforations
Time frame: from 01 July 2018 through to 31 March 2025
Fractures
Time frame: from 01 July 2018 through to 31 March 2025
All-cause mortality
Time frame: from 01 July 2018 through to 31 March 2025
surgery for Ulcerative colitis (UC)
Time frame: from 01 July 2018 through to 31 March 2025
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Background: PubMed 23604131Burisch J, Pedersen N, Cukovic-Cavka S, Brinar M, Kaimakliotis I, Duricova D, Shonova O, Vind I, Avnstrom S, Thorsgaard N, Andersen V, Krabbe S, Dahlerup JF, Salupere R, Nielsen KR, Olsen J, Manninen P, Collin P, Tsianos EV, Katsanos KH, Ladefoged K, Lakatos L, Bjornsson E, Ragnarsson G, Bailey Y, Odes S, Schwartz D, Martinato M, Lupinacci G, Milla M, De Padova A, D'Inca R, Beltrami M, Kupcinskas L, Kiudelis G, Turcan S, Tighineanu O, Mihu I, Magro F, Barros LF, Goldis A, Lazar D, Belousova E, Nikulina I, Hernandez V, Martinez-Ares D, Almer S, Zhulina Y, Halfvarson J, Arebi N, Sebastian S, Lakatos PL, Langholz E, Munkholm P; EpiCom-group. East-West gradient in the incidence of inflammatory bowel disease in Europe: the ECCO-EpiCom inception cohort. Gut. 2014 Apr;63(4):588-97. doi: 10.1136/gutjnl-2013-304636. Epub 2013 Apr 20.
- Background: PubMed 23491313Sjoberg D, Holmstrom T, Larsson M, Nielsen AL, Holmquist L, Ekbom A, Ronnblom A. Incidence and natural history of ulcerative colitis in the Uppsala Region of Sweden 2005-2009 - results from the IBD cohort of the Uppsala Region (ICURE). J Crohns Colitis. 2013 Oct;7(9):e351-7. doi: 10.1016/j.crohns.2013.02.006. Epub 2013 Mar 9.
- Background: PubMed 22001864Molodecky NA, Soon IS, Rabi DM, Ghali WA, Ferris M, Chernoff G, Benchimol EI, Panaccione R, Ghosh S, Barkema HW, Kaplan GG. Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology. 2012 Jan;142(1):46-54.e42; quiz e30. doi: 10.1053/j.gastro.2011.10.001. Epub 2011 Oct 14.
- Background: PubMed 24127738Busch K, Ludvigsson JF, Ekstrom-Smedby K, Ekbom A, Askling J, Neovius M. Nationwide prevalence of inflammatory bowel disease in Sweden: a population-based register study. Aliment Pharmacol Ther. 2014 Jan;39(1):57-68. doi: 10.1111/apt.12528. Epub 2013 Oct 16.
- BackgroundThe Committee for Medicinal Products for Human Use. Guideline on the development of new medicinal products for the treatment of ulcerative colitis. CHMP/EWP/18463/2006 Revision 1. Available at: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-development-new-medicinal-products-treatment-ulcerative-colitis-revision-1_en.pdf
- Background: PubMed 30639677Coward S, Clement F, Benchimol EI, Bernstein CN, Avina-Zubieta JA, Bitton A, Carroll MW, Hazlewood G, Jacobson K, Jelinski S, Deardon R, Jones JL, Kuenzig ME, Leddin D, McBrien KA, Murthy SK, Nguyen GC, Otley AR, Panaccione R, Rezaie A, Rosenfeld G, Pena-Sanchez JN, Singh H, Targownik LE, Kaplan GG. Past and Future Burden of Inflammatory Bowel Diseases Based on Modeling of Population-Based Data. Gastroenterology. 2019 Apr;156(5):1345-1353.e4. doi: 10.1053/j.gastro.2019.01.002. Epub 2019 Jan 10.
- Background: PubMed 27787492Dahlhamer JM, Zammitti EP, Ward BW, Wheaton AG, Croft JB. Prevalence of Inflammatory Bowel Disease Among Adults Aged >/=18 Years - United States, 2015. MMWR Morb Mortal Wkly Rep. 2016 Oct 28;65(42):1166-1169. doi: 10.15585/mmwr.mm6542a3.
- Background: PubMed 29102619Everhov AH, Halfvarson J, Myrelid P, Sachs MC, Nordenvall C, Soderling J, Ekbom A, Neovius M, Ludvigsson JF, Askling J, Olen O. Incidence and Treatment of Patients Diagnosed With Inflammatory Bowel Diseases at 60 Years or Older in Sweden. Gastroenterology. 2018 Feb;154(3):518-528.e15. doi: 10.1053/j.gastro.2017.10.034. Epub 2017 Nov 2.
- BackgroundKhalili, H., Söderling, J., Everhov, Å. H., et al. 15 - Health Care Use, Work Loss, and Total Costs in Incident and Prevelant Ulcerative Colitis: Results from a Nationwide Study in Sweden. Gastroenterology 2018, 154(Supplement 1), S-5-5. http://doi.org/10.1016/S0016-5085(18)30504-3
- Background: PubMed 22894574Sandborn WJ, Ghosh S, Panes J, Vranic I, Su C, Rousell S, Niezychowski W; Study A3921063 Investigators. Tofacitinib, an oral Janus kinase inhibitor, in active ulcerative colitis. N Engl J Med. 2012 Aug 16;367(7):616-24. doi: 10.1056/NEJMoa1112168.
- Background: PubMed 16530532Lichtenstein GR, Abreu MT, Cohen R, Tremaine W; American Gastroenterological Association. American Gastroenterological Association Institute technical review on corticosteroids, immunomodulators, and infliximab in inflammatory bowel disease. Gastroenterology. 2006 Mar;130(3):940-87. doi: 10.1053/j.gastro.2006.01.048. No abstract available.
- Background: PubMed 26135040McAuliffe ME, Lanes S, Leach T, Parikh A, Faich G, Porter J, Holick C, Esposito D, Zhao Y, Fox I. Occurrence of adverse events among patients with inflammatory bowel disease in the HealthCore Integrated Research Database. Curr Med Res Opin. 2015;31(9):1655-64. doi: 10.1185/03007995.2015.1065242. Epub 2015 Aug 20.
- Individual participant dataSharing planned: No
Related trials for Ulcerative Colitis
Active, not recruitingObservational study
A Study to Learn About the Effectiveness of Etrasimod in People With Ulcerative Colitis
Colitis, Ulcerative
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
ALPCO Calprotectin CLIA Assay - Measurement of Calprotectin Levels in Human Stool
Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), Inflammatory Bowel Syndrome
RecruitingPhase 1/2
Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis
Ulcerative Colitis (UC)
RecruitingPhase 3
Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)
Crohn Disease, Colitis, Ulcerative
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuel MD Barreiro, PhD contact
Manuel MD Barreiro, PhD principal investigator
Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis, run by Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium, Bulgaria, Greece, Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eva María Rodríguez (+34 691 08 42 07, secretariacientifica1@geteccu.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Malignancy excluding non-melanoma skin cancer (NMSC) (time frame: from 01 July 2018 through to 31 March 2025). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06469424, which also lists 31 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.