Ulcerative ColitisPhase 4PREDICT UCNCT02770040
Optimising Infliximab Induction Therapy for Acute Severe Ulcerative Colitis
A Phase 4 study testing Infliximab in people with Ulcerative Colitis, run by Austin Health at 1 site in Australia.
Trial summary
The purpose of this study is to identify whether an Accelerated or Intensified Infliximab induction regimen is superior to Standard induction in Acute Severe Ulcerative Colitis in an open label multi-centre randomised controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Infliximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteAustralia
- Study dates
- 18 Jul 2016to 7 Sep 2022
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years old
- Diagnosis of Ulcerative Colitis
- Acute Severe Colitis according to the Truelove and Witt's Criteria
- Steroid refractory according to the Oxford Criteria
Who cannot join
- Participant unable to consent for themselves
- Indication for immediate surgery (acute abdomen, perforation of the bowel, haemorrhage)
- Crohn's disease
- Participants with enteric infection confirmed on stool microscopy, culture or toxin
- Haemodynamic instability (mean arterial pressure <60) and not responsive to fluids
- Participants with clinically significant Cytomegalovirus infection (positive inclusion bodies, immunohistochemistry and signs of viraemia such as fever and abnormal liver function tests)
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- Participants who are pregnant or currently breast-feeding
- Participants with current malignancy, excluding basal cell carcinoma
- Participants with flat low or high grade colonic dysplasia; sporadic adenomas permitted
- Participants with serious co-morbidities including: Immunodeficiency; Myocardial infarction or acute stroke within the last 3 months; Moderate or severe heart failure (New York Heart Association class III or IV); Active or suspected tuberculosis; Renal failure; Hepatic failure; other severe infections
- Participants with history of hypersensitivity to infliximab or infliximab biosimilar
- Participants who have received other immunosuppressive agents including but not limited to: Anti-TNF therapies within 3 months of screening (Infliximab, Infliximab biosimilar, Golimumab, Etanercept, Certolizumab or Adalimumab); Anti-integrins (Vedolizumb, Etrolizumab) within 4 months of screening; Calcineurin inhibitors (Cyclosporine, Tacrolimus) within 4 weeks of screening; T or B cell depleters (Rituximab, Alemtuzumab) within 12 months of screening; other investigational agents (eg. Ustekinumab) within 6 months of screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PREDICT UC: Optimising Infliximab Induction Therapy for Acute Severe Ulcerative Colitis
The purpose of this study is to identify whether an Accelerated or Intensified Infliximab induction regimen is superior to Standard induction in Acute Severe Ulcerative Colitis in an open label multi-centre randomised controlled trial.
- Conditions
- Ulcerative Colitis
- Being tested
- Infliximab
- Keywords
- Acute Severe Ulcerative Colitis, Steroid Refractory Ulcerative Colitis
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfliximabDrug
Also called Remicade
INFLIXIMAB (REMICADE) in the form of a freeze-dried compound is conditioned in 100mg vials. Treatment will first be reconstituted in 250ml isotonic saline solution and infused
| Study group | Role | What they receive |
|---|---|---|
| Intensified Infliximab Induction | Active comparator | Infliximab 10mg/kg at Week 0 and Week 1 Receives: Drug: Infliximab |
| Accelerated Infliximab Induction | Active comparator | Infliximab 5mg/kg at Week 0, Week 1 and Week 3 Receives: Drug: Infliximab |
| Standard Infliximab Induction | Active comparator | Infliximab 5mg/kg at Week 0, Week 2 and Week 6 Receives: Drug: Infliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response by day 7
Defined as a reduction in the Lichtiger score below 10 with a decrease of at least 3 points and an improvement in rectal bleeding and stool frequency to ≤4 per day
Measured: Day 7
Secondary outcomes (2)
Time to clinical response
Measured: Up to 3 months
Colectomy by Day 7
Measured: From Day 0 to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study start18 Jul 2016
- Primary completion1 Oct 2021
- Study completion7 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Austin Health
- Sponsor type
- Other government
- Collaborators
- University of Melbourne
- Responsible party
- Principal investigator, Dr Peter De Cruz, Austin Health
- Investigators
- Peter De Cruz, MBBS PhD FRACP, Principal investigator, Austin Health, MelbourneMatthew C Choy, MBBS BMedSci FRACP, Principal investigator, Austin Health, Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02770040
- Sponsor's protocol ID
- HREC/14/Austin/595
- Acronym
- PREDICT UC
- Status last verified
- Oct 2024
- First submitted
- 9 May 2016
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Choy MC, Li Wai Suen CFD, Con D, Boyd K, Pena R, Burrell K, Rosella O, Proud D, Brouwer R, Gorelik A, Liew D, Connell WR, Wright EK, Taylor KM, Pudipeddi A, Sawers M, Christensen B, Ng W, Begun J, Radford-Smith G, Garg M, Martin N, van Langenberg DR, Ding NS, Beswick L, Leong RW, Sparrow MP, De Cruz P. Intensified versus standard dose infliximab induction therapy for steroid-refractory acute severe ulcerative colitis (PREDICT-UC): an open-label, multicentre, randomised controlled trial. Lancet Gastroenterol Hepatol. 2024 Nov;9(11):981-996. doi: 10.1016/S2468-1253(24)00200-0. Epub 2024 Sep 2.
PubMed 39236736
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREDICT UC: Optimising Infliximab Induction Therapy for Acute Severe Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT02770040
- Acronym / sponsor ID
- PREDICT UC / HREC/14/Austin/595
- Conditions
- Ulcerative Colitis
- Keywords
- Acute Severe Ulcerative Colitis, Steroid Refractory Ulcerative Colitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Austin HealthOther government
- Collaborators
- University of Melbourne
- Study start
- 18 Jul 2016 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 7 Sep 2022 (actual)
- First posted
- 12 May 2016 (estimated)
- 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 identify whether an Accelerated or Intensified Infliximab induction regimen is superior to Standard induction in Acute Severe Ulcerative Colitis in an open label multi-centre randomised controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intensified Infliximab Induction | Active comparator | Drug: InfliximabInfliximab 10mg/kg at Week 0 and Week 1 |
| Accelerated Infliximab Induction | Active comparator | Drug: InfliximabInfliximab 5mg/kg at Week 0, Week 1 and Week 3 |
| Standard Infliximab Induction | Active comparator | Drug: InfliximabInfliximab 5mg/kg at Week 0, Week 2 and Week 6 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >18 years old
- Diagnosis of Ulcerative Colitis
- Acute Severe Colitis according to the Truelove and Witt's Criteria
- Steroid refractory according to the Oxford Criteria
Key exclusion criteria (12 listed)
- Participant unable to consent for themselves
- Indication for immediate surgery (acute abdomen, perforation of the bowel, haemorrhage)
- Crohn's disease
- Participants with enteric infection confirmed on stool microscopy, culture or toxin
- Haemodynamic instability (mean arterial pressure <60) and not responsive to fluids
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 |
|---|---|---|
| InfliximabAlso: RemicadeINFLIXIMAB (REMICADE) in the form of a freeze-dried compound is conditioned in 100mg vials. Treatment will first be reconstituted in 250ml isotonic saline solution and infused | Drug | Accelerated Infliximab Induction, Intensified Infliximab Induction, Standard Infliximab Induction |
Primary outcome
Clinical response by day 7
Time frame: Day 7
Defined as a reduction in the Lichtiger score below 10 with a decrease of at least 3 points and an improvement in rectal bleeding and stool frequency to ≤4 per day
2 secondary outcomes
Time to clinical response
Time frame: Up to 3 months
Colectomy by Day 7
Time frame: From Day 0 to Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Results publication: PubMed 39236736Choy MC, Li Wai Suen CFD, Con D, Boyd K, Pena R, Burrell K, Rosella O, Proud D, Brouwer R, Gorelik A, Liew D, Connell WR, Wright EK, Taylor KM, Pudipeddi A, Sawers M, Christensen B, Ng W, Begun J, Radford-Smith G, Garg M, Martin N, van Langenberg DR, Ding NS, Beswick L, Leong RW, Sparrow MP, De Cruz P. Intensified versus standard dose infliximab induction therapy for steroid-refractory acute severe ulcerative colitis (PREDICT-UC): an open-label, multicentre, randomised controlled trial. Lancet Gastroenterol Hepatol. 2024 Nov;9(11):981-996. doi: 10.1016/S2468-1253(24)00200-0. Epub 2024 Sep 2.
- Individual participant dataSharing planned: No
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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.
Peter De Cruz, MBBS PhD FRACP principal investigator
Austin Health, Melbourne
Matthew C Choy, MBBS BMedSci FRACP principal investigator
Austin Health, Melbourne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Infliximab in people with Ulcerative Colitis, run by Austin Health at 1 site in Australia.
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 12 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: finished, as of the sponsor's last update on 8 Oct 2024. 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 Australia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical response by day 7 (time frame: Day 7). 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 NCT02770040, which also lists 1 linked publication.
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 8 Oct 2024.