[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Berinstein, Jeffrey\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":72},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100612837","phase-4-upadacitinib-combined-with-corticosteroids-vs-corticosteroid-monotherapy-induction-for-inpatients-and-outpatients-with-acute-severe-ulcerative-colitis-100612837",false,"NCT07258771","Upadacitinib Combined With Corticosteroids vs Corticosteroid Monotherapy Induction for Inpatients and Outpatients With Acute Severe Ulcerative Colitis","Acute Severe Ulcerative Colitis- Upadacitinib Combined With Corticosteroids vs Corticosteroid Monotherapy Induction While Transitioning Away From the Emergency Setting (ACUTE): A Phase IV, Single Center, Partially Blinded, Randomized Study","ACUTE","Inclusion Criteria:\n\n* Patient ≥ 18 to 75 years of age at the time of consent\n* Diagnosis of ulcerative colitis (verified by a typical clinical history as well as characteristic appearance on endoscopy and histology)\n* Meeting the following definition of acute severe ulcerative colitis as defined as having ≥ 6 bowel movements per day with visible blood in the 7 days prior to Day 0 plus at least one of the following:\n\n  i. Temperature \\> 37.8 Celsius(C) per patient report or documented in Electronic Health Record (EHR) in the 7 days prior to Day 0.\n\nii. Pulse ≥ 90 beats per minute (BPM) per patient report or documented in EHR iin the 7 days prior to Day 0 iii. Hemoglobin ≤ 10.5 grams per deciliter (g\u002FdL) in the 7 days prior to Day 0 iv. Erythrocyte sedimentation rate ≥ 30 millimeters per hour (mm\u002Fh) in the 7 days prior to Day 0 v. C-reactive protein ≥ 3.0mg\u002FdL in the 7 days prior to Day 0 vi. Fecal calprotectin \\>782 Milligrams per kilogram (mg\u002Fkg) in the 7 days prior to consent.\n\nvii. Oral corticosteroid use for ≥ 7 days in the month prior to consent at a dose equivalent to ≥ 20 milligrams per day (mg\u002Fday)\n\n* For a person of reproductive\u002Fchildbearing potential (i.e., presence of intact ovaries and fallopian tubes and are considered premenopausal by standard assessment), a negative lab-based (serum\u002Furine) pregnancy test is required.\n* For a person of reproductive potential (i.e., presence of intact ovaries and fallopian tubes) and has childbearing potential, intent to use at least one effective method of birth control from study Day 0 through the end of blinding or at least 30 days after the last dose of upadacitinib or week 48, whichever occurs most recently. A person without reproductive or childbearing potential does not require an intent to use effective birth control.\n* Participants enrolled in the outpatient cohort must be under the care of an outpatient gastroenterologist affiliated with the University of Michigan.\n* Ability to take oral medication and be willing to adhere to the study intervention regimen.\n* Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, daily bowel movement symptoms surveys, and other study procedures.\n* Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study.\n\nExclusion Criteria:\n\n* On IV corticosteroids for \\> 72 hours immediately prior to enrollment continuously (at any institution) which is equivalent to a cumulative dose of 180mg of IV Methylprednisolone in the 3 days prior to enrollment.\n* Patients with a prior exposure upadacitinib. Previous exposure to other Janus kinase (JAK) inhibitors (e.g., tofacitinib, baricitinib, or filgotinib) are permissible.\n* History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months prior to Baseline. (Note: A Urine Drug Screen does not need to be performed).\n* A history of two or more prior episodes of herpes zoster, or one or more episodes of disseminated herpes zoster.\n* Patients with ongoing severe active infection (as determined by the study team) per investigator. Patients with active serious infection(s) requiring treatment with intravenous anti-infectives or oral\u002Fintramuscular anti-infectives may consider infectious disease clearance.\n* Active tuberculosis (TB) or untreated latent TB as described in the protocol.\n* In participants that tested positive for Coronavirus disease 2019 (COVID-19), at least 5 days must have passed between a COVID-19 positive test result and the baseline visit of asymptomatic participants. Participants with mild\u002Fmoderate COVID-19 infection can be enrolled if fever is resolved without use of antipyretics for 24 hours and other symptoms improved, or if 5 days have passed since the COVID-19 positive test result (whichever comes last). Participants may be rescreened if deemed appropriate by the investigator based upon the participant's health status.\n* Recent (within past 6 months) cerebrovascular accident, myocardial infarction, coronary stenting, or aorto-coronary bypass surgery.\n* Known hypersensitivity to the following drugs or constituents (and its excipients): methylprednisolone, prednisone, upadacitinib, or upadacitinib placebo. The following ingredients can be found in upadacitinib and upadacitinib placebo: colloidal silicon dioxide, hypromellose, iron oxide yellow and iron oxide red, magnesium stearate, mannitol, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol, talc, tartaric acid and titanium dioxide. This includes a known or suspected hypersensitivity to cow's milk for patients expected to be in the inpatient cohort (component of methylprednisolone).\n* Participants that are currently pregnant or breastfeeding. Participants with a borderline serum pregnancy test at Screening must have absence of clinical suspicion of pregnancy or other pathological causes of borderline results and a serum pregnancy test ≥ 3 days later to document continued lack of a positive result. Participants with a urine pregnancy test at Baseline that is borderline or ambiguous must have a serum pregnancy test performed. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.\n* Participants that have received any live vaccine with replicating potential within 30 days prior to the first dose of study drug or are expected to need a live vaccination with any replicating potential during study participation or within 30 days of study completion.\n* Patients that meet diagnostic criteria for toxic megacolon as determined by the study and treatment team. Patients are expected to have dilation of the transverse colon \\> 6 centimeters (cm) or cecum\u002Fright colon \\> 9cm and three of the following signs of systemic toxicity (Temperature \\> 38◦C, Heart rate (HR) \\> 120 beats per minute (BPM), white blood cells (WBC) \\> 10500\u002Fmicroliter (µL), Hemoglobin \\\u003C 10.5mg\u002FdL) and one of the following (dehydration, altered mental status, severe electrolyte disturbances, or hypotension)\n* Patients with active Cytomegalovirus (CMV) colitis as defined as having \\> 5 CMV inclusion bodies per high powered field in any one ulcer at baseline. If CMV colitis is confirmed, the patient can remain in the trial if permissible by the infectious disease and primary treatment team and if concomitant anti-viral therapy is initiated.\n* Patients that had received any investigational agent or procedure within 30 days or five half-lives prior to baseline, whichever is longer, or were enrolled in an interventional study.\n* Patients with an active malignancy with the exception of non-metastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.\n* Patients that had a history of colectomy (total or subtotal), ileoanal pouch, Kock pouch, or ileostomy or were planning bowel surgery (partial colectomy is permissible)\n* Patients with certain laboratory abnormalities suggestive of moderate or severe renal, hematological, or gastrointestinal\u002Fliver impairment (per protocol).\n* History of or clinical evidence of liver cirrhosis\n* History of inherited or acquired conditions that predispose to hypercoagulability (per protocol). Please note, that patients with a remote history of provoked thromboembolic event or recent thromboembolic event on systemic anticoagulation are NOT exclusionary.\n* Active Hepatitis B Infection: Hepatitis B surface antigen (HBsAg) positive with detectable deoxyribonucleic acid (DNA) not on therapy. Patients with serologic evidence of a resolved prior hepatitis B virus (HBV) infection (i.e., HBsAg-negative and anti-HB Core-positive) or patients with HBsAg positive on suppressive HBV therapy with low DNA (\\\u003C105 copies\u002Fmilliliter (mL) or \\\u003C104 IU\u002FmL negative) are not exclusionary.\n* Active Hepatitis C Infection: Hepatitis C Virus (HCV) ribonucleic acid detectable in any patient with anti-HCV antibody.\n* Acquired Immunodeficiency Syndrome: Confirmed positive anti-human immunodeficiency virus (HIV) antibody with cluster of differentiation 4 (CD4) counts \\\u003C350 cells\u002Fmicroliter (uL) or Acquired Immune Deficiency Syndrome (AIDS)- defining opportunist infection.\n* Solid organ or bone marrow transplant within 1 year or expected transplant within 6 months of randomization.\n* Patients that had a history of spontaneous GI perforation (other than appendicitis or mechanical injury) or are at significantly increased risk of GI perforation per investigator's judgment.\n* Actively receiving strong CYP3A4 inducers or inhibitors prior to the first dose of study drug or are expected to receive any of these medications during the study period. This includes grapefruit and grapefruit juice.\n* The presence of any condition possibly affecting oral drug absorption (e.g., gastrectomy, clinically significant diabetic gastroenteropathy, or certain types of bariatric surgery) as determined by the investigator. Procedures such as gastric banding that simply divide the stomach into separate chambers are not exclusionary.\n* Patients that had a history of a clinically significant medical condition per protocol.","ALL","18 Years","75 Years",{"count":21,"type":22},110,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","This trial is being conducted to learn more about the optimal sequence of various medications in the management of acute severe ulcerative colitis (ASUC).\n\nThis research is studying multiple drugs already approved by the Food and Drug Administration (FDA). The goal of this study is to test the early efficacy and safety of upadacitinib (Rinvoq) and corticosteroids compared to corticosteroids alone as induction therapy for both inpatients and outpatients with ASUC.",[28],"Ulcerative Colitis Acute",[30,31,32,33,34,35],"Acute Severe Ulcerative Colitis","Inpatient","Outpatient","Optimal sequence","Upadacitinib","Corticosteroids","RECRUITING","2026-01-29",{"date":39,"type":40},"2026-02-02","ACTUAL",{"date":42,"type":40},"2026-01-16",{"date":44,"type":22},"2030-12",{"name":46,"class":47},"Berinstein, Jeffrey","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":56,"minAge":18,"maxAge":19,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":60,"conditions":61,"keywords":62,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":48},"100505895","phase-4-feasibility-pilot-sequential-multiple-assignment-randomized-trial-smart-for-acute-severe-ulcerative-colitis-100505895","NCT05867329","Feasibility Pilot Sequential Multiple Assignment Randomized Trial (SMART) for Acute Severe Ulcerative Colitis","A Sequential Multiple Assignment Randomized Trial (SMART) Feasibility Pilot Developing and Optimizing Patient-Tailored Adaptive Treatment Strategies (ATS) for Acute Severe Ulcerative Colitis (ASUC)","Inclusion Criteria for Clinical trial patients:\n\n1. Patient ≥ 18 to 75 years of age at baseline\n2. Diagnosis of ulcerative colitis (verified by a typical clinical history as well as characteristic appearance on endoscopy and histology)\n3. Current hospital admission for ulcerative colitis treatment (expecting IV corticosteroid initiation)\n4. Meeting the following definition of acute severe ulcerative colitis as defined as having ≥ 4 bowel movements per day with visible blood and one of the following:\n\n   1. Temperature \\> 37.5C\n   2. Pulse \\> 90 BPM\n   3. Hemoglobin \\\u003C 10.5g\u002FdL\n   4. Erythrocyte sedimentation rate ≥ 30mm\u002Fh\n   5. Weight loss \\> 5 lbs over 3 months\n   6. C-reactive protein ≥ 3.0mg\u002FdL\n   7. Fecal calprotectin \\>782 mg\u002Fkg (within 4 weeks)\n   8. Oral corticosteroid use for ≥ 14 days at a dose equivalent to ≥ 30mg\u002Fday\n5. Prior history of receiving at least one dose of adalimumab, certolizumab, infliximab, or golimumab originator or biosimilars\n6. Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, daily bowel movement symptoms surveys, and other study procedures\n7. Evidence of a personally signed and dated informed consent document indicating that the participant (or a legal representative) has been informed of all pertinent aspects of the study\n8. Ability to take oral medication and be willing to adhere to the study intervention regimen\n9. For females of reproductive potential (i.e., females \\\u003C55 years of age with intact ovaries and fallopian tubes): A negative pregnancy test on admission and intent to use highly effective contraception during 3-month follow-up period which include the following.\n\n   1. Combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal, injectable) associated with the inhibition of ovulation, initiated at least 30 days prior to study baseline\n   2. Progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation, initiated at least 30 days prior to study baseline\n   3. Bilateral tubal occlusion\u002Fligation (could be via hysteroscopy, provided a hysterosalpingogram confirmed success of the procedure)\n   4. Vasectomized partner(s) provided the vasectomized partner had received medical confirmation of the surgical success and was the sole sexual partner of the trial participant\n   5. Intrauterine device or intrauterine hormone-releasing system\n   6. Lifestyle abstinence (refraining from heterosexual intercourse when this is in line with the preferred and usual lifestyle of the patient)\n   7. Periodic abstinence (eg, calendar, ovulation, symptothermal, postovulation methods)\n   8. Consistent use of barrier contraception\n\nExclusion Criteria for Clinical trial patients:\n\n1. Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease\n2. On IV corticosteroids for ≥ 72 hours prior to enrollment continuously (at any institution)\n3. Currently pregnant or breastfeeding\n4. Patients who meet diagnostic criteria for toxic megacolon during this current admission. This will be determined by the study team and inpatient treatment team according to the following supportive criteria: Having dilation of the colon \\> 6m and three of the following (Temperature\\>38C, HR \\>120 BPM, WBC\\>10500\u002FµL, Hemoglobin \\\u003C 10.5mg\u002FdL) and one of the following (dehydration, altered mental status, severe electrolyte disturbances, and hypotension)\n5. Known hypersensitivity to any of the following drugs or constituents: methylprednisolone, cyclosporine, tofacitinib, or upadacitinib\n6. Patients who had previous exposure to upadacitinib. Previous exposure to other Janus kinase (JAK) inhibitors (eg, tofacitinib, baricitinib, or filgotinib) are permissible.\n7. Patients with ongoing severe infection (as determined by the study team), including untreated or inadequately treated latent or active tuberculosis (TB)\n\n   1. Active CMV colitis is defined as having \\> 5 CMV inclusion bodies per high powered field in any one ulcer at baseline. If CMV colitis is confirmed, the patient can remain in the trial if permissible by the infectious disease and primary treatment team and if concomitant anti-viral therapy is initiated.\n   2. Patients with a positive stool exam for enteric pathogens can remain in the trial. Initiation of treatment at the discretion of the treatment team and infectious disease team if needed.\n8. Patients who had received any investigational agent or procedure within 30 days or five half-lives prior to baseline, whichever is longer, or were enrolled in an interventional study\n9. Current malignancy with the exception of non-metastatic basal cell or squamous cell carcinoma of the skin.\n10. Patients who had a history of colectomy (total or subtotal), ileoanal pouch, Kock pouch, or ileostomy or were planning bowel surgery\n11. Moderate or severe renal, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, neurological, or psychiatric condition including the following:\n\n    1. Neutropenia - ANC \\\u003C1200 cells\u002Fmm3 or Total white blood cell count \\\u003C2500\u002FµL\n    2. Hemoglobin \\\u003C 8mg\u002FdL\n    3. Platelet count \\\u003C80,000\u002FµL\n    4. Moderate\u002Fsevere renal impairment with eGFR \\\u003C30mL\u002Fmin\u002F1.73m2 (by simplified four-variable Modification of Diet in Renal)\n    5. ALT and AST liver biochemistry levels that are ≥ 2 times the upper limit of normal (ULN)\n12. Cirrhosis with mild to severe hepatic impairment (defined as a Child-Pugh score ≥5)\n13. History of uncontrolled hypertension (systolic blood pressure \\>160mmHg or diastolic blood pressure \\> 100mmHg despite anti-hypertensives)\n14. Any of the following cardiovascular conditions:\n\n    1. Recent (within previous 6 months) cerebrovascular accident, myocardial infarction, or coronary stenting\n    2. Recent (within previous 6 months) moderate-to-severe congestive heart failure (New York Heart Association class III or IV)\n15. History of inherited or acquired conditions that predispose to hypercoagulability including the following. Please note, that patients with a remote history of provoked thrombotic event or recent thrombotic event on systemic anticoagulation are NOT exclusionary.\n\n    1. Antiphospholipid syndrome\n    2. Factor V Leiden mutation\n    3. Prothrombin G20210A mutations\n    4. Deficiencies of antithrombin\n\n    f. Deficiency of protein C g. Deficiency of protein S h. Heparin cofactor II deficiency i. Plasminogen and plasminogen activator inhibitor-1 j. Dysfibrinogenemia k. Factor XII deficiency\n16. Patients with total cholesterol \\\u003C80 mg\u002FdL at baseline\n17. Patients who had a history of an allergic reaction or significant sensitivity to constituents of the treatment (and its excipients) and\u002For other products in the same class of medication (ex., tofacitinib)\n18. Patients who had hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection defined as:\n\n    1. HBV: hepatitis B surface antigen (HBsAg) positive with detectable deoxyribonucleic acid (DNA) not on therapy. Patients with serologic evidence of a resolved prior HBV infection (i.e., HBsAg-negative and anti-HB Core-positive) or patients with HBsAg positive on suppressive HBV therapy with low DNA (\\\u003C105 copies\u002FmL or \\\u003C104 IU\u002FmL negative) are not exclusionary\n    2. HCV: HCV ribonucleic acid detectable in any patient with anti-HCV antibody\n    3. HIV: Confirmed positive anti-HIV antibody with CD4 counts \\\u003C350 cells\u002FuL or acquired immunodeficiency syndrome (AIDS)- defining opportunist infection\n19. Solid organ or bone marrow transplant within 1 year or expected transplant within 6 months\n20. History of more than one episode of herpes zoster, a history of disseminated herpes zoster or disseminated herpes simplex\n21. Current use of medications which significantly increase the risk of venous thromboembolic event as determined by the investigator including:\n\n    1. Hormone replacement therapy\n    2. Testosterone\n    3. Tamoxifen\n22. Vaccination with live or attenuated live vaccines within 6 weeks of baseline or scheduled to receive these vaccines during study period or within 140 days (20 weeks) after last dose of study medication.\n23. History of any lymphoproliferative disorder (such as EBV-related lymphoproliferative disorder), history of lymphoma, leukemia, myeloproliferative disorders, multiple myeloma, or signs and symptoms suggestive of current hematologic disease.\n24. Patients who had a history of spontaneous GI perforation (other than appendicitis or mechanical injury), diverticulitis, or significantly increased risk of GI perforation per investigator's judgement\n25. Actively receiving strong CYP3A4 inducers or inhibitors prior to the first dose of study drug or are expected to receive any of these medications during the study period. This includes grapefruit and grapefruit juice.\n26. The presence of any condition possibly affecting oral drug absorption (e.g., gastrectomy, clinically significant diabetic gastroenteropathy, or certain types of bariatric surgery such as gastric bypass). Procedures such as gastric banding that simply divide the stomach into separate chambers are NOT exclusionary.\n27. Patients who had a history of a clinically significant medical condition or any other reason which, in the opinion of the investigator, would have interfered with the patient's participation in this study, would have made the patient an unsuitable candidate to receive treatment, or would have put the patient at risk by participating in the protocol\n\nInclusion criteria for Physicians:\n\n1\\. Clinicians (Internal medicine residents, gastroenterology fellows, and attending gastroenterologists or colorectal surgeons) caring for the patients enrolled in the clinical trial\n\nExclusion criteria for Physicians:\n\n1\\. Non-clinicians not caring for the enrolled patient","FEMALE",{"count":58,"type":22},162,[25],"The goal of this trial is to create personalized treatments for each patient admitted to the hospital with acute severe ulcerative colitis (ASUC). The study will test the feasibility and acceptability of these treatment strategies among patients and physicians so that the study team can later do a larger trial to test whether the medication treatment pathways help patients avoid colectomy while ensuring patient's are safe.",[28],[30,63],"Ulcerative colitis flare","2025-04-10",{"date":66,"type":40},"2025-04-15",{"date":68,"type":40},"2023-09-30",{"date":70,"type":22},"2026-05",{"name":46,"class":47},""]