Clinical trial for Ulcerative Colitis Acute
Official title Feasibility Pilot Sequential Multiple Assignment Randomized Trial (SMART) for Acute Severe Ulcerative Colitis
ClinicalTrials.gov ID: NCT05867329
What this study is testing
What is Cyclosporine Injection (IV)?
investigational intravenous medicine being studied for acute severe ulcerative colitis is designed to inhibit calcineurin, reducing immune system activity
Also referred to as Sandimmune.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study checks if a personalized treatment plan is practical and acceptable for doctors and patients. It aims to prepare for a larger study to see if this plan helps people avoid bowel surgery.
- Who it's for
- People in the hospital with a severe flare-up of ulcerative colitis.
- What's involved
- Participants will follow a specific treatment path chosen by their doctor. The team will check if this approach is safe and workable for both patients and medical staff.
- Time commitment
- The duration and specific visit schedule are not listed in the provided text.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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).
- Meeting the following definition of acute severe ulcerative colitis as defined as having ≥ 4 bowel movements per day with visible blood and one of...
- Prior history of receiving at least one dose of adalimumab, certolizumab, infliximab, or golimumab originator or biosimilars or a prior history of...
You likely can't join if
- 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.
- 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...
See the full eligibility criteria
Who can join
- 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.
- 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...
- 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...
- 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
What rules you out
- 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...
- 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.
- Patients who have received any investigational pharmacological agent or invasive investigational procedure within 30 days or five half-lives of study initiation with potential how well it works for UC or that could...
- 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
- 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.
- History of inherited or acquired conditions that predispose to hypercoagulability including the following.
- 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.
- 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
- Hormone replacement therapy
- Testosterone
- Tamoxifen
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Ann Arbor, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Ann Arbor, Michigan, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.