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| Name | Class |
|---|---|
| University of Melbourne | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensified Infliximab Induction | Active Comparator | Infliximab 10mg/kg at Week 0 and Week 1 |
|
| Accelerated Infliximab Induction | Active Comparator | Infliximab 5mg/kg at Week 0, Week 1 and Week 3 |
|
| Standard Infliximab Induction | Active Comparator | Infliximab 5mg/kg at Week 0, Week 2 and Week 6 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infliximab | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to clinical response | Up to 3 months | |
| Colectomy by Day 7 | From Day 0 to Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Colectomy free survival at 1 month, 3 months and 12 months | Effect estimates between different dose regimens | Up to 12 months |
| Steroid free remission at 3 months | Defined as a Mayo disease activity index score ≤2 with an endoscopic subscore ≤1 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter De Cruz, MBBS PhD FRACP | Austin Health, Melbourne | Principal Investigator |
| Matthew C Choy, MBBS BMedSci FRACP | Austin Health, Melbourne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Austin Health | Melbourne | Victoria | 3084 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39236736 | Result | 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. |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000069285 | Infliximab |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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|
| Day 90 |
| Endoscopic remission rates at 3 and 12 months | Defined by a Mayo endoscopic subscore of ≤1 | Up to 12 months |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |