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The goal of this clinical trial is to learn comparative effectiveness and safety of Upadacitinib vs Corticosteroids as First-Line Therapy for Acute Severe Ulcerative Colitis. The main questions it aims to answer are:
Researchers will compare upadacitinib with corticosteroids to evaluate the efficacy of upadacitinib in the treatment of acute severe ulcerative colitis.Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Upadacitinib group | Experimental | Upadacitinib extended-release tablets 45 mg once daily for 8 weeks, then adjusted to 30 mg once daily. |
|
| Corticosteroid group | Active Comparator | Methylprednisolone for injection 60 mg/day. If clinical response is achieved, switch to oral prednisone acetate tablets after 5 days (calculated at 0.75 mg/kg/day), followed by a weekly prednisone taper of 5 mg. When the dose is reduced to 20 mg, taper by 2.5 mg weekly until discontinued, with mesalazine 4 g/day as maintenance therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Upadacitinib | Drug | Safety and efficacy of the drug |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome Measure | clinical response by day 7 (defined as a reduction in Lichtiger score to <10 points with a decrease of ≥3 points from baseline improvement in rectal bleeding, and decreased stool frequency to ≤4 per day). | The primary outcome was assessed by the investigator between days 3 and 7, with patients recorded as clinical responders if they had the primary outcome on any day in this assessment window. |
| Measure | Description | Time Frame |
|---|---|---|
| clinical response by day 14 | Defined as mayo score decrease of ≥30% and ≥3 points from baseline, accompanied by a decrease in the rectal bleeding subscore of ≥1 point or an absolute rectal bleeding subscore of 0 or 1. | day 14 |
| clinical remission by day 28, day 42, and day 90 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongquan Shi | Contact | +8602984771535 | von15991351319@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankang Central Hospital | Recruiting | Ankang | Shaanxi | 710005 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11313301 | Background | D'Haens G, Lemmens L, Geboes K, Vandeputte L, Van Acker F, Mortelmans L, Peeters M, Vermeire S, Penninckx F, Nevens F, Hiele M, Rutgeerts P. Intravenous cyclosporine versus intravenous corticosteroids as single therapy for severe attacks of ulcerative colitis. Gastroenterology. 2001 May;120(6):1323-9. doi: 10.1053/gast.2001.23983. | |
| 39236736 |
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| ID | Term |
|---|---|
| C000613732 | upadacitinib |
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| Corticosteroid |
| Drug |
Safety and efficacy of the drug |
|
Total Mayo score ≤2 points and no individual subscore >1 point. |
| day 28, day 42, and day 90 |
| Endoscopic response by day 90 | A decrease in MES score of ≥1 point, or a decrease of ≥50% from baseline. | day 90 |
| Endoscopic remission by day 90 | MES score ≤1 | day 90 |
| Endoscopic+clinical response | Partial Mayo score ≤1 and MES ≤1 | day 90 |
| Clinical +FcP remission | Partial Mayo score ≤1 and FcP≤250mg/kg | day 90 |
| Clinical +CRP remission | Partial Mayo score ≤1 and CRP≤5mg/L | day 90 |
| Histologic remission | typically defined as the absence of signs of neutrophilic infiltration. The specific criterion is a score below 2B.0, i.e., no increased neutrophils in the lamina propria. | day 90 |
| Histologic improvement | when assessing treatment efficacy, a score ≤ 3.1 (intraepithelial neutrophilic infiltration involving < 50% of crypts) is used as the threshold for histologic improvement. | day 90 |
| Adverse Reactions | Adverse Reactions | day 90 |
| IBDQ and fatigue questionnaire scores | IBDQ and fatigue questionnaire scores | day 0 and day 90 |
| 3201 Hospital | Recruiting | Hanzhong | Shaanxi | 710005 | China |
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| Xijing Hospital | Recruiting | Xi'an | Shaanxi | 710005 | China |
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| Shaanxi Provincial Nuclear Industry 215 Hospital | Recruiting | Xianyang | Shaanxi | 710005 | China |
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| 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. |