A Sequential Multiple Assignment Randomized Trial (SMART) Feasibility Pilot Developing and Optimizing Patient-Tailored Adaptive Treatment Strategies (ATS) for Acute Severe Ulcerative Colitis (ASUC)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Adherence to intervention based on the proportion of participants who received the assigned Adaptive Treatment Strategy (ATS) (without receiving added/removed therapy outside of assignment) during first stage of therapy
研究概览
简要总结
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.
详细描述
Group 1: SMART Intervention (n=62):
Adult patients (ages 18+) admitted with Acute Severe Ulcerative Colitis (ASUC) who meet all eligibility criteria and provide informed consent for the interventional component of the trial.
Cohort 2: Qualitative Patient Interviews (up to n=38) Eligible patients with ASUC who decline enrollment in the interventional component. These participants will undergo qualitative interviews to identify and characterize barriers to trial participation. Recruitment for this cohort will conclude once thematic saturation is achieved.
Cohort 3: Clinician Stakeholder Interviews (up to n=100) Clinicians (including attending physicians and house staff) providing direct care for participants enrolled in the interventional arm. Qualitative interviews will be conducted to assess the feasibility and acceptability of the study protocol within the clinical workflow. Recruitment will conclude once thematic saturation is achieved.
Cohort 4: Observational Comparator Group (up to n=500) A retrospective and prospective observational cohort of patients admitted with ASUC during the trial period who were not enrolled in the intervention. This group will serve as a contemporary control to provide comparative data on standard-of-care outcomes and help mitigate selection bias.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for Clinical trial patients:
- •Patient ≥ 18 to 75 years of age at baseline
- •Diagnosis of ulcerative colitis (verified by a typical clinical history as well as characteristic appearance on endoscopy and histology)
- •Current hospital admission for ulcerative colitis treatment (expecting IV corticosteroid initiation). Note this includes patients seen in emergency room who are expected to be admitted for UC treatment
- •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:
- •a. Temperature > 37.8 Celsius b. Pulse > 90 Beats per minute (BPM) c. Hemoglobin < 10.5g/dL d. Erythrocyte sedimentation rate ≥ 30mm/h e. Weight loss > 5 lbs over 3 months f. C-reactive protein ≥ 3.0mg/dL g. Fecal calprotectin >782 mg/kg (within 4 weeks) h. Oral corticosteroid use for ≥ 14 days at a dose equivalent to ≥ 30mg/day
- •Prior history of receiving at least one dose of adalimumab, certolizumab, infliximab, or golimumab originator or biosimilars or a prior history of receiving at least one approved systemic therapy in the event tumor necrosis factors blockers are clinically inadvisable
- •Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, daily bowel movement symptoms surveys, and other study procedures
- •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
- •Ability to take oral medication and be willing to adhere to the study intervention regimen
- •For females of reproductive potential (i.e., females <55 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.
- •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
- •Progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation, initiated at least 30 days prior to study baseline
- •Bilateral tubal occlusion/ligation (could be via hysteroscopy, provided a hysterosalpingogram confirmed success of the procedure)
- •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
- •Intrauterine device or intrauterine hormone-releasing system
- •Lifestyle abstinence (refraining from heterosexual intercourse when this is in line with the preferred and usual lifestyle of the patient)
- •Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods)
- •Consistent use of barrier contraception
排除标准
- •for Clinical trial patients:
- •Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease
- •On IV corticosteroids for ≥ 72 hours prior to enrollment continuously (at any institution)
- •Currently pregnant or breastfeeding
- •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>38 Celsius, Heart Rate >120 BPM, white blood cells (WBC) >10500/µL, Hemoglobin < 10.5mg/dL) and one of the following (dehydration, altered mental status, severe electrolyte disturbances, and hypotension)
- •Known hypersensitivity to any of the following drugs or constituents: methylprednisolone, cyclosporine, tofacitinib, or upadacitinib
- •Patients who had previous exposure to upadacitinib. Previous exposure to other Janus kinase (JAK) inhibitors (e.g., tofacitinib, baricitinib, or filgotinib) are permissible.
- •Patients with ongoing severe infection (as determined by the study team), including untreated or inadequately treated latent or active tuberculosis (TB)
- •a. Active Cytomegalovirus (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.
- •b. 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.
- •Patients who have received any investigational pharmacological agent or invasive investigational procedure within 30 days or five half-lives of study initiation with potential efficacy for UC or that could interact with study medications, as determined by the Principal Investigator. Participation in studies with non-invasive investigational procedures or standard-of-care invasive procedures are permitted.
- •Current malignancy with the exception of non-metastatic basal cell or squamous cell carcinoma of the skin.
- •Patients who had a history of colectomy (total or subtotal), ileoanal pouch, Kock pouch, or ileostomy or were planning bowel surgery
- •Moderate or severe renal, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, neurological, or psychiatric condition including the following:
- •Neutropenia - Absolute Neutrophil Count (ANC) <1200 cells/mm3 or Total white blood cell count <2500/µL
- •Hemoglobin < 7mg/dL without plans for a transfusion
- •Platelet count <80,000/µL
- •Moderate/severe renal impairment with estimated glomerular filtration rate (eGFR) <30milliliter (mL)/min/1.73m2 (by simplified four-variable Modification of Diet in Renal)
- •Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) liver biochemistry levels that are ≥ 2 times the patient's baseline (as determined based on the principal investigator's judgement)
- •Cirrhosis with mild to severe hepatic impairment (defined as a Child-Pugh score ≥5)
- •History of uncontrolled hypertension (systolic blood pressure >160 millimeters of mercury (mmHg) or diastolic blood pressure > 100 millimeters of mercury (mmHg) despite anti-hypertensives)
- •Any of the following cardiovascular conditions:
- •a. Recent (within previous 6 months) cerebrovascular accident, myocardial infarction, or coronary stenting b. Recent (within previous 6 months) moderate-to-severe congestive heart failure (New York Heart Association class III or IV)
- •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.
- •a. Antiphospholipid syndrome b. Factor V Leiden mutation c. Prothrombin G20210A mutations d. Deficiencies of antithrombin 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
- •Patients with total cholesterol <80 mg/dL at baseline
- •Patients who had a history of an allergic reaction or significant sensitivity to constituents of the treatment (and its excipients) and/or other products in the same class of medication (ex., tofacitinib)
- •Patients who had hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection defined as:
- •a. 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 (<105 copies/mL or <104 IU/mL negative) are not exclusionary b. HCV: HCV ribonucleic acid detectable in any patient with anti-HCV antibody c. HIV: Confirmed positive anti-HIV antibody with Cluster of Differentiation 4 (CD4) counts <350 cells/microliter (uL) or acquired immunodeficiency syndrome (AIDS)- defining opportunist infection
- •Solid organ or bone marrow transplant within 1 year or expected transplant within 6 months
- •History of more than one episode of herpes zoster, a history of disseminated herpes zoster or disseminated herpes simplex
- •Current use of medications which significantly increase the risk of venous thromboembolic event as determined by the investigator including:
- •Hormone replacement therapy
- •Testosterone
- •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.
- •History of any lymphoproliferative disorder (such as Epstein-Barr Virus (EBV)-related lymphoproliferative disorder), history of lymphoma, leukemia, myeloproliferative disorders, multiple myeloma, or signs and symptoms suggestive of current hematologic disease.
- •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
- •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.
- •The presence of any condition significantly affecting oral drug absorption (e.g., gastrectomy, clinically significant diabetic gastroenteropathy, or certain types of bariatric surgery such as gastric bypass), as determined by the Principal Investigator. Procedures such as gastric banding that simply divide the stomach into separate chambers are NOT exclusionary.
- •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
- •Inclusion criteria for Physicians:
- •1. Clinicians (Internal medicine residents, gastroenterology fellows, and attending gastroenterologists or colorectal surgeons) caring for the patients enrolled in the clinical trial
- •Exclusion criteria for Physicians:
- •1. Non-clinicians not caring for the enrolled patient
研究组 & 干预措施
Methylprednisolone
Methylprednisolone Intravenous (IV) 30 milligram (mg) twice a day (BID)
干预措施: Prednisone Oral Product (Drug)
Methylprednisolone then Cyclosporine
Methylprednisolone IV 30 mg BID Stage 1 and if determined to be a non-responder to Methylprednisolone, patient will receive rescue Cyclosporine (2milligram/kilogram (mg/kg) per day aiming for levels 200-400 nanograms per milliliter (ng/mL)) in addition to continuing Methylprednisolone for stage 2.
干预措施: Intravenous Methylprednisolone (Drug)
Methylprednisolone plus Upadacitinib then cyclosporine
Methylprednisolone IV 30mg BID and Oral Upadacitinib 45mg everyday stage 1 and then Cyclosporine 2 mg/kg per day aiming for levels 200-400ng/mL for stage 2.
干预措施: Cyclosporine Injection (IV) (Drug)
Methylprednisolone plus Upadacitinib then cyclosporine
Methylprednisolone IV 30mg BID and Oral Upadacitinib 45mg everyday stage 1 and then Cyclosporine 2 mg/kg per day aiming for levels 200-400ng/mL for stage 2.
干预措施: Intravenous Methylprednisolone (Drug)
Methylprednisolone plus Upadacitinib then increased Upadacitinib
Methylprednisolone IV 30mg BID and Oral Upadacitinib 45mg everyday stage 1 and if determined to be a non-responder to Methylprednisolone and 45 mg Oral Upadacitinib, patient will receive rescue Upadacitinib 30mg BID in addition to continuing Methylprednisolone for stage 2.
干预措施: Intravenous Methylprednisolone (Drug)
Methylprednisolone plus Upadacitinib then increased Upadacitinib
Methylprednisolone IV 30mg BID and Oral Upadacitinib 45mg everyday stage 1 and if determined to be a non-responder to Methylprednisolone and 45 mg Oral Upadacitinib, patient will receive rescue Upadacitinib 30mg BID in addition to continuing Methylprednisolone for stage 2.
干预措施: Prednisone Oral Product (Drug)
Oral Upadacitinib then Methylprednisolone plus cyclosporine infusion
Upadacitinib 30 mg BID for stage 1. If a patient is a non-responder to Upadacitinib 30 mg, then the study team will stop Upadacitinib and initiate Methylprednisolone IV 30mg twice a day plus Cyclosporine (2 milligram/kilogram (mg/kg) per day aiming for levels 200-400 nanograms per milliliter (ng/mL)) for stage 2.
干预措施: Upadacitinib Extended Release Oral Tablet (Drug)
Oral Upadacitinib then Methylprednisolone plus cyclosporine infusion
Upadacitinib 30 mg BID for stage 1. If a patient is a non-responder to Upadacitinib 30 mg, then the study team will stop Upadacitinib and initiate Methylprednisolone IV 30mg twice a day plus Cyclosporine (2 milligram/kilogram (mg/kg) per day aiming for levels 200-400 nanograms per milliliter (ng/mL)) for stage 2.
干预措施: Prednisone Oral Product (Drug)
Methylprednisolone plus Upadacitinib then increased Upadacitinib
Methylprednisolone IV 30mg BID and Oral Upadacitinib 45mg everyday stage 1 and if determined to be a non-responder to Methylprednisolone and 45 mg Oral Upadacitinib, patient will receive rescue Upadacitinib 30mg BID in addition to continuing Methylprednisolone for stage 2.
干预措施: Upadacitinib Extended Release Oral Tablet (Drug)
Methylprednisolone then Cyclosporine
Methylprednisolone IV 30 mg BID Stage 1 and if determined to be a non-responder to Methylprednisolone, patient will receive rescue Cyclosporine (2milligram/kilogram (mg/kg) per day aiming for levels 200-400 nanograms per milliliter (ng/mL)) in addition to continuing Methylprednisolone for stage 2.
干预措施: Cyclosporine Injection (IV) (Drug)
Methylprednisolone then Upadacitinib
Methylprednisolone IV 30mg twice a day Stage 1 and if determined to be a non-responder to Methylprednisolone, patient will receive rescue Upadacitinib 30mg BID in addition to continuing Methylprednisolone for stage 2
干预措施: Intravenous Methylprednisolone (Drug)
Methylprednisolone
Methylprednisolone Intravenous (IV) 30 milligram (mg) twice a day (BID)
干预措施: Intravenous Methylprednisolone (Drug)
Methylprednisolone plus Upadacitinib
Methylprednisolone IV 30mg BID plus Upadacitinib 45mg every day.
干预措施: Upadacitinib Extended Release Oral Tablet (Drug)
Methylprednisolone plus Upadacitinib
Methylprednisolone IV 30mg BID plus Upadacitinib 45mg every day.
干预措施: Intravenous Methylprednisolone (Drug)
Oral Upadacitinib then Methylprednisolone
Oral Upadacitinib 30mg BID for stage 1 then for patients that are non-responders, add rescue Methylprednisolone IV 30mg twice a day in addition to continuing Upadacitinib for stage 2.
干预措施: Intravenous Methylprednisolone (Drug)
Oral Upadacitinib
Upadacitinib 30 mg BID
干预措施: Upadacitinib Extended Release Oral Tablet (Drug)
Oral Upadacitinib then Methylprednisolone
Oral Upadacitinib 30mg BID for stage 1 then for patients that are non-responders, add rescue Methylprednisolone IV 30mg twice a day in addition to continuing Upadacitinib for stage 2.
干预措施: Prednisone Oral Product (Drug)
Methylprednisolone then Cyclosporine
Methylprednisolone IV 30 mg BID Stage 1 and if determined to be a non-responder to Methylprednisolone, patient will receive rescue Cyclosporine (2milligram/kilogram (mg/kg) per day aiming for levels 200-400 nanograms per milliliter (ng/mL)) in addition to continuing Methylprednisolone for stage 2.
干预措施: Cyclosporine Oral Product (Drug)
Methylprednisolone then Upadacitinib
Methylprednisolone IV 30mg twice a day Stage 1 and if determined to be a non-responder to Methylprednisolone, patient will receive rescue Upadacitinib 30mg BID in addition to continuing Methylprednisolone for stage 2
干预措施: Upadacitinib Extended Release Oral Tablet (Drug)
Oral Upadacitinib then Methylprednisolone
Oral Upadacitinib 30mg BID for stage 1 then for patients that are non-responders, add rescue Methylprednisolone IV 30mg twice a day in addition to continuing Upadacitinib for stage 2.
干预措施: Upadacitinib Extended Release Oral Tablet (Drug)
Methylprednisolone plus Upadacitinib then cyclosporine
Methylprednisolone IV 30mg BID and Oral Upadacitinib 45mg everyday stage 1 and then Cyclosporine 2 mg/kg per day aiming for levels 200-400ng/mL for stage 2.
干预措施: Cyclosporine Oral Product (Drug)
Oral Upadacitinib then Methylprednisolone plus cyclosporine infusion
Upadacitinib 30 mg BID for stage 1. If a patient is a non-responder to Upadacitinib 30 mg, then the study team will stop Upadacitinib and initiate Methylprednisolone IV 30mg twice a day plus Cyclosporine (2 milligram/kilogram (mg/kg) per day aiming for levels 200-400 nanograms per milliliter (ng/mL)) for stage 2.
干预措施: Intravenous Methylprednisolone (Drug)
结局指标
主要结局
Adherence to intervention based on the proportion of participants who received the assigned Adaptive Treatment Strategy (ATS) (without receiving added/removed therapy outside of assignment) during first stage of therapy
时间窗: Day 3
Target ≥60%
Adherence to intervention based on the proportion of participants who received the assigned Adaptive Treatment Strategy (ATS) (without receiving added/removed therapy outside of assignment) during second stage of therapy
时间窗: Days 4 through day 10 (maximum 7 days from initiation of second stage of treatment)
Target ≥60%
Proportion of eligible enrolled patients who were randomized during the first stage of intervention and who received treatment (regardless of ATS assignment)
时间窗: Randomized day 0 - up to day 3
Target ≥ 80%
Proportion of eligible enrolled patients initiated on first stage therapy who were randomized during second stage of intervention and who received their assigned treatment (regardless of ATS assignment)
时间窗: Days 4 through day 10
Target ≥ 60%
Proportion of eligible enrolled patients who initiated first stage therapy who successfully transitioned to the second stage of intervention
时间窗: Day 3 - Day 4
Intervention (randomized and received treatment if deemed to be a non-responder or continued treatment/were discharged if deemed to be first stage responder) Target ≥ 50%.
Proportion of eligible enrolled patients with complete data records for C-Reactive Protein (CRP) and Ulcerative Colitis Patient reported outcomes (UC-PRO) prior to second stage allocation
时间窗: Day 0 to Day 3 of intervention
Target ≥ 60% with CRP and UC-PRO recorded on Day 3 or day of intervention phase completion if occurring before Day 3.
Proportion of eligible patients who enroll (not including screen failures) in the trial throughout the enrollment period
时间窗: 5 years
Target ≥50%
Proportion of eligible enrolled participants followed until discharge or colectomy (whichever comes first)
时间窗: up to approximately 10 days
The proportion is regardless of ATS adherence (target ≥ 70%)
Proportion of eligible enrolled participants without colectomy that were followed for 90 days with completion of one of the required study items
时间窗: 90 days
Participants followed for 90 days with completion of one of the required study items at Day 90 (UC-PRO, Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), CRP, fecal calprotectin (FCP), research stool) (target ≥ 70%).
Proportion of eligible enrolled participants without colectomy that were followed for 90 days with completion of all of the required study items at Day 90
时间窗: 90 days
Proportion of eligible enrolled participants without colectomy that were followed for 90 days with completion of all of the required study items at Day 90 (UC-PRO, CBC, CMP, CRP, FCP, research stool) (target ≥ 50%).
Percentage of participants with complete colectomy status and safety data via 90-day chart review
时间窗: 90 days
Target ≥ 90%
Proportion of eligible enrolled participants with complete UC-PROs on each day of hospitalization from enrollment to discharge or colectomy (whichever comes first regardless of intervention phase completion/ATS adherence)
时间窗: up to approximately 10 days
Target ≥ 50% completion across all eligible days
Proportion of eligible enrolled participants without colectomy that were followed for 90 days with completion of all requested study items
时间窗: Day 30, Day 60, Day 90
Completion of all requested study items at Day 30, Day 60, and Day 90 (target ≥ 50%)
Proportion of participants who were enrolled prior to receiving their first dose of intravenous (IV) methylprednisolone
时间窗: Baseline
Target ≥ 70%
Proportion of participants who were enrolled who satisfied Truelove and Witts' disease severity criteria as measured by stool frequency
时间窗: Baseline
This is measured by stool frequency \> 6 Bowel Movements (BMs)/day with blood and 1 feature of systemic disturbance (fever \>37.8 Celsius, pulse \>90 beats/minute, hemoglobin \>10.5 grams per deciliter (g/dL), or erythrocyte sedimentation rate \>30 millimetres per hour (mm/h) or C-reactive protein \>30 mg/L) (target ≥ 50%).
Proportion of eligible enrolled patients who initiated first stage therapy (regardless of ATS adherence) within 12 hours of randomization
时间窗: up to 12 hours after randomization
Target ≥ 50%
Proportion of enrolled participants who completed endoscopic evaluation within 72 hours of enrollment and had an endoscopic Mayo score ≥ 2
时间窗: up to 72 hours
This excludes those that did not complete endoscopic evaluation within 1 week of enrollment. Target ≥75%
Proportion of eligible enrolled participants reporting trial design acceptable as measured by semi-structured interviews
时间窗: up to approximately 10 days (prior to discharge)
Interviews will assess perceptions of the ATS, trial burden, and willingness to participate in a similar study again (target ≥ 60%)
Proportion of inpatient physicians interviewed reporting trial design acceptable
时间窗: Up to approximately 10 days
Interviews assess the feasibility, practicality, complexity, workload imposed by the SMART design and clarity, and clinical appropriateness of the ATS (target ≥ 60%)
次要结局
- Proportion of participants in initial clinical response without rescue therapy or colectomy at 120 hours (5 days) after initiating first stage therapy(5 days)
- Proportion of participants undergoing same-admission colectomy per first stage treatment and ATS(Day 0 to Day 4)
- Proportion of participants undergoing 90-day colectomy per first stage treatment and ATS(90 days from enrollment)
- Proportion of participants who are in steroid-free remission at 90 days per first stage treatment and ATS.(At 90-day follow-up)
- Proportion of participants without rescue therapy during intervention period or colectomy within 90 days per first stage treatment and ATS.(90 days)
- Proportion of participants meeting first stage response criteria per first-stage treatment(Day 3)
- Proportion of first stage non-responders who are re-randomized who avoid colectomy within 90 days(90 days)
- Proportion of patients who are steroid-free at 90 days among eligible enrolled patients in SMART compared to non-enrolled patients(90 days)
- Proportion of patients who experience a UC-related readmission within 90 days among eligible enrolled patients in SMART compared to non-enrolled patients(90 days)
- Proportion of patients without rescue therapy during hospitalization among eligible enrolled patients in SMART compared to non-enrolled patients(Day 0 up to Day 10)
- Proportion of patients without rescue therapy during hospitalization or colectomy within 90 days among eligible enrolled patients in SMART compared to non-enrolled patients(90 days)
- Incidence and severity of adverse events(Up to 100 days (intervention plus follow-up))
研究者
Berinstein, Jeffrey
Assistant Professor Internal Medicine
University of Michigan