Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:57 PM
Ignite Modification Date:
2025-12-24 @ 1:57 PM
NCT ID:
NCT01287195
Eligibility Criteria:
1.1 Inclusion Criteria
* Ability to provide informed consent
* Age between 18 and 65 years
* Confirmed diagnosis of UC for at least 3 months with the extent defined within the previous year
* Moderate to severe UC as defined by a Mayo score of 6-12
* Concomitant medications: Can be on 5-amino salicylate (5-ASA) medications and stable doses (same dose \> 4 weeks) of oral steroids
* Concomitant medications cannot include Infliximab, Adalimumab, Certolizumab or Natalizumab for 4 weeks; rectal steroids, 6-mercaptopurine (6-MP), Azathioprine, Tacrolimus, Methotrexate, Thalidomide, Cellcept for 4 weeks; Theophylline, sulfonylureas, non-steroidal anti-inflammatory drug (NSAIDs) or aspirin for 10 days
* Negative serum pregnancy test within 2 weeks prior to receiving the first dose of study drug in female participants of child-bearing potential
* Female participants of child-bearing potential must be willing to use birth control during the study and for 4 weeks following the last dose of study drug.
1.2 Exclusion Criteria
* Crohn's disease or indeterminate colitis
* Mayo score of \<6 (mild UC)
* Hospitalized or exhibiting signs of toxicity (abdominal distension, severe abdominal tenderness, fever, nausea, vomiting, or tachycardia)
* A history of colorectal cancer or colorectal dysplasia
* Pregnant or breastfeeding females or females wishing to become pregnant within the next 6 months or unwilling to use birth control
* Serum creatinine ≥ 2.0 milligrams per deciliter (mg/dL)
* Alkaline phosphatase, aspartate aminotransferase (AST), alanine aminotransferase (ALT), or direct bilirubin \>1.5x normal: elevated indirect bilirubin related to likely Gilbert's disease permissible
* Use of any of the following medications: Azathioprine, 6-MP, Methotrexate, Mycophenolate Mofetil, Tacrolimus, Cyclosporine, Thalidomide, Adalimumab, Infliximab, Certolizumab, Natalizumab, rectal steroids. Theophylline, sulfonylureas, NSAIDs or aspirin within 10 days of study enrollment
* Psychiatric illness or substance abuse that would interfere with ability to comply with protocol requirements or give informed consent
* Surgery within the last 3 months
* Prior gastrointestinal surgery
* Clinically significant infectious, immune mediated or malignant disease
* Receiving an elemental diet or parenteral nutrition
* History of coagulopathy
* Human immunodeficiency virus (HIV) positive
* Hepatitis B surface antigen (HBsAg) positive
* Active cytomegalovirus (CMV)
* Anemia: hemoglobin (Hb) \< 8 grams/deciliter (g/dL). If the subject has known significant cardiac disease, subjects with Hb \< 10.5 g/dL will be excluded.
* Thrombocytopenia (platelets \< 100,000 per microliter \[100K/mcL\])
* Lymphopenia (absolute lymphocyte count \<0.7)
* Immunoglobulin G (IgG) anti-cardiolipin antibody positive \>16 International Units (IU)
* Prior exposure to OKT3
* Positive quantiferon gold, tuberculosis (TB) spot test, or purified protein derivative (PPD) test
* Known sensitivity to any ingredients in the study drug
* Anti-mouse antibody titer \>1:1000
* Any known autoimmune disease except for ulcerative colitis
* Allergy or hypersensitivity to Omeprazole
* Participated in another clinical trial within 30 days of screening for this trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01287195
Study Brief:
Protocol Section:
NCT01287195