Severe Ulcerative ColitisELEVATE-ASUCNCT03907631
Multi-centre Acute Severe Ulcerative Colitis Prospective Cohort Study (Elevate ASUC)
An observational study of Severe Ulcerative Colitis, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Up to one third of patients with Ulcerative Colitis (UC) will require hospitalisation for severe disease (ASUC - Acute Severe Ulcerative Colitis), often within the first 12 months of diagnosis. 30-40% of people admitted to hospital with ASUC will require colectomy during the emergency admission. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Severe Ulcerative Colitis
- How many people
- 189 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Oct 2019to 31 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalised patients with Acute severe ulcerative colitis
Who may be able to join
- age 18 - 80 years.
- Confirmed acute severe ulcerative colitis based on modified Truelove and Witts criteria requiring hospital admission.
- Need for at least 2 days of intravenous steroids
- Able to sign consent
Who cannot join
- Crohn's disease
- Admission for elective colectomy
- Infective colitis confirmed on stool culture, assays for C. difficile or cytomegalovirus
- Pregnancy
- Inability to sign consent
- Prior colitis related surgery - pouch, stoma
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Gastroenterology, Hull Royal Infirmary, Hull University Teaaching Hospitals NHS Trust
Hull
About this study
Official title: Elevate ASUC - Evaluating Clinical and Endoscopic Variables in Assessment, Treatment and Outcome Endpoints in Acute Severe Ulcerative Colitis
Up to one third of patients with Ulcerative Colitis (UC) will require hospitalisation for severe disease (ASUC - Acute Severe Ulcerative Colitis), often within the first 12 months of diagnosis. 30-40% of people admitted to hospital with ASUC will require colectomy during the emergency admission. Investigators will develop a multi-centre prospective inception cohort of patients with ASUC with homogeneously collected detailed longitudinal clinical, endoscopic and laboratory data.
Read the detailed description
ASUC can be a life threatening condition for which optimal management strategies within the acute setting are required. Such strategies remain largely ill-defined with approximately 30 - 40% of ASUC inpatient admissions requiring emergency colectomy.
Intravenous corticosteroids have been the mainstay of management during the inpatient admission but approximately 40% of this patient group will be steroid resistant. Although mortality following emergency colectomy has indeed fallen over time, it still remains as high as 10% at the 12 week marker. Patients with steroid refractory disease salvage therapy with infliximab can be considered to avoid colectomy.
Currently there are no predictive indices to identify patients needing rescue therapy. Hence health care professionals have no tools to 'personalise' care for ASUC by predicting up front which patients fail initial medical therapy and thus predict those who may benefit from rescue therapy or early surgery.
Traditionally the Truelove and Witts severity Index is used to define the clinical severity of disease on admission, but this long-standing index has yet to be validated as a predictor for the need for colectomy during the acute hospitalised phase. Similarly, endoscopic indices, including the only validated endoscopic severity score in UC (UCEIS - Ulcerative Colitis Endoscopic Index of Severity) have not been prospectively evaluated in the setting of ASUC.
Approximately 30% of ASUC patients treated with rescue anti TNF will fail to respond and require urgent colectomy. The optimal dosing regimes for rescue therapy with infliximab remains uncertain.Recently, there have been reports of increasing use of accelerated induction anti - TNF regimes in patients with ASUC (10mg/kg or shorter intervals) despite lack of clear evidence to support this practice. Randomised trial evidence for selecting patients suitable for accelerated induction regimes is not yet currently available and will require large sample size to elucidate clearly the variables that predict the need for individual dosing strategies.
Another consideration in the management of ASUC patients is the wide variability in practices among institutions and clinicians; this may potentially affect quality of care and outcomes within this cohort.
Investigators will develop a multi-centre prospective inception cohort of patients with ASUC with homogeneously collected detailed longitudinal clinical, endoscopic, laboratory and pharmacological data. This will facilitate development of risk prediction models in ASUC helping early risk stratification and supporting optimized medical and surgical algorithms in ASUC. The study will also facilitate development of a learning network in participating centres to improve quality of care.
- Conditions
- Severe Ulcerative Colitis
- Being tested
- Standard of care
- Keywords
- Rescue, Infliximab, Outcomes, Risk Stratification
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of careOther
care decisions driven by local physicians; this is an observational cohort
| Study group | Role | What they receive |
|---|---|---|
| Acute Severe Ulcerative Colitis | Patients hospitalised for acute severe ulcerative colitis will be invited to participate. Participants will be treated at the discretion of their treating physicians as per standard of care. We expect some participants will undergo an endoscopic assessment, some participants will be treated with standard versus accelerated infliximab dosing, permitting comparisons, in addition to other treatment strategies. Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
In Hospital Outcomes
Response assessed by the following clinical care decisions based on binary outcomes: need for rescue therapy (yes = 1 or no =), need for accelerated induction (yes = 1 or no = 0), need for surgery during index admission (yes = 1 or no = 0)
Measured: 30 days
Colectomy rates
Proportion of patients needing colectomy
Measured: 30 days
Secondary outcomes (2)
Long-term response to medical management
Response assessed by the following clinical care decisions based on binary outcomes: Colectomy free survival at strategic time points (yes = 1 or no = 0)
Measured: day 90 and 12 month time points
Risk factors for need for rescue
Analysis of risk factors predicting need for rescue
Measured: 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start18 Oct 2019
- Primary completion31 Jan 2024
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe 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
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hull University Teaching Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03907631
- Sponsor's protocol ID
- 259837
- Acronym
- ELEVATE-ASUC
- Status last verified
- Feb 2026
- First submitted
- 5 Apr 2019
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elevate ASUC - Evaluating Clinical and Endoscopic Variables in Assessment, Treatment and Outcome Endpoints in Acute Severe Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT03907631
- Acronym / sponsor ID
- ELEVATE-ASUC / 259837
- Conditions
- Severe Ulcerative Colitis
- Keywords
- Rescue, Infliximab, Outcomes, Risk Stratification
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Hull University Teaching Hospitals NHS TrustOther government
- Study start
- 18 Oct 2019 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 9 Apr 2019 (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.
Up to one third of patients with Ulcerative Colitis (UC) will require hospitalisation for severe disease (ASUC - Acute Severe Ulcerative Colitis), often within the first 12 months of diagnosis. 30-40% of people admitted to hospital with ASUC will require colectomy during the emergency admission. Investigators will develop a multi-centre prospective inception cohort of patients with ASUC with homogeneously collected detailed longitudinal clinical, endoscopic and laboratory data.
Detailed description
ASUC can be a life threatening condition for which optimal management strategies within the acute setting are required. Such strategies remain largely ill-defined with approximately 30 - 40% of ASUC inpatient admissions requiring emergency colectomy.
Intravenous corticosteroids have been the mainstay of management during the inpatient admission but approximately 40% of this patient group will be steroid resistant. Although mortality following emergency colectomy has indeed fallen over time, it still remains as high as 10% at the 12 week marker. Patients with steroid refractory disease salvage therapy with infliximab can be considered to avoid colectomy.
Currently there are no predictive indices to identify patients needing rescue therapy. Hence health care professionals have no tools to 'personalise' care for ASUC by predicting up front which patients fail initial medical therapy and thus predict those who may benefit from rescue therapy or early surgery.
Traditionally the Truelove and Witts severity Index is used to define the clinical severity of disease on admission, but this long-standing index has yet to be validated as a predictor for the need for colectomy during the acute hospitalised phase. Similarly, endoscopic indices, including the only validated endoscopic severity score in UC (UCEIS - Ulcerative Colitis Endoscopic Index of Severity) have not been prospectively evaluated in the setting of ASUC.
Approximately 30% of ASUC patients treated with rescue anti TNF will fail to respond and require urgent colectomy. The optimal dosing regimes for rescue therapy with infliximab remains uncertain.Recently, there have been reports of increasing use of accelerated induction anti - TNF regimes in patients with ASUC (10mg/kg or shorter intervals) despite lack of clear evidence to support this practice. Randomised trial evidence for selecting patients suitable for accelerated induction regimes is not yet currently available and will require large sample size to elucidate clearly the variables that predict the need for individual dosing strategies.
Another consideration in the management of ASUC patients is the wide variability in practices among institutions and clinicians; this may potentially affect quality of care and outcomes within this cohort.
Investigators will develop a multi-centre prospective inception cohort of patients with ASUC with homogeneously collected detailed longitudinal clinical, endoscopic, laboratory and pharmacological data. This will facilitate development of risk prediction models in ASUC helping early risk stratification and supporting optimized medical and surgical algorithms in ASUC. The study will also facilitate development of a learning network in participating centres to improve quality of care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute Severe Ulcerative Colitis | – | Other: Standard of carePatients hospitalised for acute severe ulcerative colitis will be invited to participate. Participants will be treated at the discretion of their treating physicians as per standard of care. We expect some participants will undergo an endoscopic assessment, some participants will be treated with standard versus accelerated infliximab dosing, permitting comparisons, in addition to other treatment strategies. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalised patients with Acute severe ulcerative colitis
Key inclusion criteria (4 listed)
- age 18 - 80 years.
- Confirmed acute severe ulcerative colitis based on modified Truelove and Witts criteria requiring hospital admission.
- Need for at least 2 days of intravenous steroids
- Able to sign consent
Key exclusion criteria (6 listed)
- Crohn's disease
- Admission for elective colectomy
- Infective colitis confirmed on stool culture, assays for C. difficile or cytomegalovirus
- Pregnancy
- Inability to sign consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of carecare decisions driven by local physicians; this is an observational cohort | Other | Acute Severe Ulcerative Colitis |
Primary outcome
In Hospital Outcomes
Time frame: 30 days
Response assessed by the following clinical care decisions based on binary outcomes: need for rescue therapy (yes = 1 or no =), need for accelerated induction (yes = 1 or no = 0), need for surgery during index admission (yes = 1 or no = 0)
Colectomy rates
Time frame: 30 days
Proportion of patients needing colectomy
2 secondary outcomes
Long-term response to medical management
Time frame: day 90 and 12 month time points
Risk factors for need for rescue
Time frame: 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Ulcerative Colitis, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
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 6 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: under way, not looking for participants, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In Hospital Outcomes (time frame: 30 days). 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?
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 17 Feb 2026.