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New treatment option for Ulcerative Colitis
Official title Comparison of Ustekinumab, Infliximab and Combination Therapy in Moderately to Severely Active Ulcerative Colitis
ClinicalTrials.gov ID: NCT06453317
What this study is testing
What is Infliximab?
Infliximab is an investigational medicine, being studied as a potential treatment for ulcerative colitis.
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
- The goal of this clinical trial is to learn if combined therapy with infliximab and ustekinumab works better than using these drugs alone in adult patients with ulcerative colitis. It will also learn about the safety of this combination.
- Phase 2: a mid-size study of how well it works
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 64
You may be able to join if
- Obtaining informed, written consent for the patient's participation in the in the study and for all planned procedures.
- Age ≥ 18 years and ≤65 at the time of screening.
- In the case of women of reproductive potential, agreement to not donate oocytes for the entire period of participation in the in the study and 6...
- For women of reproductive potential, agreement to use effective contraception (Table 4) during the entire period, during which the patient...
- Negative serum or urine pregnancy test in women of childbearing age.
You likely can't join if
- Previous use of the study drug IFX or UST.
- Hypersensitivity to the active substance or excipients.
- Moderate or severe myocardial insufficiency (NYHA III or IV).
- Unstable coronary artery disease.
- History of serious cerebrovascular disease (stroke, intracranial hemorrhage, transient cerebral ischemia) within the last 24 weeks prior to screening.
- Chronic respiratory failure.
See the full eligibility criteria
- Obtaining informed, written consent for the patient's participation in the in the study and for all planned procedures.
- Age ≥ 18 years and ≤65 at the time of screening.
- In the case of women of reproductive potential, agreement to not donate oocytes for the entire period of participation in the in the study and 6 months after receiving the last dose of the drug.
- For women of reproductive potential, agreement to use effective contraception (Table 4) during the entire period, during which the patient participates in the study and for a period counted from the last dose of 15...
- Negative serum or urine pregnancy test in women of childbearing age.
- Diagnosis of UC a minimum of. 3 months prior to screening documented by: (a) medical source documentation of the patient with the result of an endoscopic examination that diagnosed features typical of UC. (b) a...
- UC with moderate or severe activity defined as a Mayo scale score (Appendix 2) of 7 to 12 including the following sub-item values (each sub-item 0-3 points depending on the severity of the lesions): \- Frequency of...
- Bowel bleeding
- Endoscopic image of the colonic mucosa
- General medical evaluation and:
- with inadequate response to standard treatment, including corticosteroids and 6-mercaptopurine or azathioprine, or.
- intolerant of treatment with corticosteroids and 6-mercaptopurine or azathioprine, or
- having contraindications to treatment with corticosteroids and 6-mercaptopurine or azathioprine, or
- with loss of response to standard treatment, including to treatment with corticosteroids and 6-mercaptopurine or azathioprine, including patients:
- Steroid-resistant - in whom there is no clinical improvement despite the use of a daily steroid up to 0.75 mg/kg prednisolone for 4 weeks;
- Steroid-dependent - in whom failure to reduce the steroid dose below 10 mg/day, converted to prednisolone, within 3 months of starting steroid therapy or relapse of complaints within 3 months of steroid withdrawal.
- Refractory patients/about inadequate response to immunosuppressive treatment, defined as lack of remission or recurrence of complaints despite immunosuppressive treatment for at least 3 months at appropriate doses...
- Patients taking 5-ASA derivatives, corticosteroids, immunosuppressants may be included in the study if they are taking a fixed and specified dose of the above drugs 14 days before the day of randomization.
- Previous use of the study drug IFX or UST.
- Hypersensitivity to the active substance or excipients.
- Moderate or severe myocardial insufficiency (NYHA III or IV).
- Unstable coronary artery disease.
- History of serious cerebrovascular disease (stroke, intracranial hemorrhage, transient cerebral ischemia) within the last 24 weeks prior to screening.
- Chronic respiratory failure.
- Severe chronic renal failure.
- Severe chronic liver failure.
- Demyelinating syndrome or symptoms resembling the syndrome.
- Alcoholic disease, post-alcoholic liver damage.
- Diagnosis of malignant neoplasms, including within 5 years preceding the time of eligibility for the program (except for carcinoma in situ of the cervix, and non-melanoma skin cancers). 12 Complications requiring other...
- ALT activity \>3x the upper limit of normal (GGN)
- AST activity \>3x GGN
- Total bilirubin level \>2x GGN (exception is Gilbert syndrome when other causes of isolated hyperbilirubinemia are excluded).
- ALP or GGTP activity \>3x GGN
- Creatinine level \>2x GGN or impaired renal function (eGFR) \<45mL/min calculated by MDRD formula.
- Hemoglobin level \<9g/dL
- Absolute leukocyte count \<3000/mm3
- Absolute lymphocyte count \<750/mm3
- Neutrophil level \<1000/mm3
- Platelet level \<100000/mm3. 36. Positive stool culture for bacteria/fungus (if clinically relevant in the opinion of the investigator). 37.Positive stool culture for Clostridioides difficile. 38. Use of treatment not...
The study team makes the final eligibility decision.
Where it's taking place
- Lodz, Poland
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 - 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 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lodz, Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.