Evaluation of the efficacy and safety of dual biologic and/or small molecule therapy in patients with induction-resistant ulcerative colitis (RESPECT).

You likely can't join if

• Allergies to any of the excipients of infliximab or tofacitinib or any other murine and/or human proteins or has hypersensitivity to immunoglobulin products.
• Use of exclusive enteral nutrition for more than 3 consecutive days within a month or any single day of exclusive enteral nutrition within 2 weeks prior to the randomization.
• Live or live - attenuated vaccine within 4 weeks prior to the randomization.
• Abnormalities in laboratory tests performed at screening: a. Serum creatinine ≥ 1.5 × upper limit of normal (ULN) or an estimated creatinine clearance level (eGFR) ≤ 50 ml/min (calculated from the Cockcroft-Gault formula), b. Serum alanine aminotransferase ≥ 2.0 × ULN, c. Serum aspartate aminotransferase ≥ 2.0 × ULN, d. Serum total bilirubin ≥ 1.5 × ULN, e. Hemoglobin < 8.5 g/dl (SI units: < 85 g/l or 5.28 mmol/l ), f. White blood cell count < 3.5 × 10^3 cells/μl (SI units: <3.5×10^9 cells/l), g. Neutrophil count < 1.5 × 10^3 cells/μl (SI units: <1.5×10^9 cells/l), h. Platelet count < 100 × 10^3 cells/μl (SI units: <100×10^9 cells/l). i. Positive HBsAg result, j. Positive HBV DNA result, k. Positive HCV RNA result, l. Positive anti-HIV result, m. Positive or twice inconclusive Quantiferon-TB Gold test result.
• Patient who has a current or history of any of the following infections: a. Known infection with hepatitis B or hepatitis C (active or carrier state). However, a patient who is without cirrhosis of liver and recovered from a past hepatitis B or hepatitis C infection can be enrolled. A patient with a history of cured hepatitis B or C who does not have cirrhosis of liver can be enrolled but the following conditions must be met on screening: -a negative HBsAg and HBV DNA result for a patient with hepatitis B, - a negative HCV RNA result in the case of a patient with hepatitis C. b. Known infection with human immunodeficiency virus (HIV). c. Acute infection requiring oral antibiotics within 7 days or parenteral injection within 2 weeks prior to the randomization. d. Recurrent hemiplegia. e. Other recurrent or chronic infection, significant in the investigator’s opinion, within 6 weeks prior to the randomization. f. Current or past granulomatous infections or opportunistic infections (e.g., Pneumocystis carinii, aspergillosis, or mycobacteriosis [infection caused by nontuberculous mycobacteria]) or invasive fungal infection (e.g., histoplasmosis). g. Known cytomegalovirus infection within 6 months prior to the randomization. h. Evidence of Clostridioides difficile toxin in stool within 30 days prior to the randomization. i. Patient who has a current diagnosis of active TB or a history of active TB. Patient who has any evidence of history of active TB cannot be enrolled despite sufficient documentation of complete resolution of active TB. j. Patient who has had exposure to person(s) with active TB (e.g., first-degree relative, co-worker, roommate). k. Current diagnosis of latent TB at screening (defined as a positive interferon gamma assay [IGRA] without clinical signs of active tuberculosis and with a negative examination of chest x-ray from the qualifying visit for vedolizumab treatment). l. Other serious infections, in the investigator’s opinion, within 6 months prior to the randomization.
• Medical condition including 1 or more of the following: a. Evidence of toxic megacolon b. Diagnose of Crohn’s disease or indeterminate colitis. c. Evidence of fixed symptomatic stenosis or obstruction of the large intestine d. Evidence of colonic mucosal dysplasia or adenomatous polyps. However, a patient whose adenomatous polyps are completely removed and free of polyps at the randomization can be enrolled. For a patient who has an increased risk for colorectal cancer, it is necessary to confirm the absence of adenomatous polyps and mucosal dysplasia with a colonoscopy (the result must be available in the source documentation): - if the patient is ≥ 45 years of age, a colonoscopy within 5 years prior to the randomization is required - if the patient, regardless of age, has extensive colitis for ≥ 8 years or disease limited to left side of colon (distal to splenic flexure) for ≥10 years, a colonoscopy performed within 1 year prior to the randomization is required e. Body mass index ≥ 35 kg/m2. f. Uncontrolled diabetes mellitus. g. Uncontrolled hypertension (as defined by systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg). h. A known malignancy within 5 years prior to the randomization, except completely excised and cured squamous carcinoma in situ of the uterine cervix, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma. i. History of lymphoma, lymphoproliferative disease, or bone marrow hyperplasia. j. New York Heart Association (NYHA) class III or IV heart failure, severe uncontrolled cardiac disease (unstable angina or clinically significant electrocardiogram [ECG] abnormalities), or myocardial infarction within 6 months prior to the randomization. k. History of organ transplantation, including corneal graft/transplantation. l. Any uncontrolled, clinically significant respiratory disease in the investigator’s opinion, including but not limited to chronic obstructive pulmonary disease, asthma, bronchiectasis, or pleural effusion. m. Previous diagnosis or symptoms suggestive of demyelinating disorders, including multiple sclerosis and Guillain-Barré syndrome. n. Any condition significantly affecting the nervous system (e.g., neuropathic conditions or nervous system damage). o. Any other serious acute or chronic medical, or psychiatric conditions that may increase the risk associated with study participation or investigational product administration or that may interfere with the interpretation of study results.