Evaluation of the efficacy and safety of dual biologic and/or small molecule therapy in patients with induction-resistant ulcerative colitis (RESPECT). - ABM/RESPECT/2023

Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy0 sites180 target enrollmentJanuary 18, 2024

Conditionslcerative colitis MedDRA version: 20.1Level: LLTClassification code: 10045365Term: Ulcerative colitis Class: 10017947 Therapeutic area: Diseases [C] - Immune System Diseases [C20]Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: lcerative colitis
Sponsor: Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Enrollment: 180
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 18, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy

Eligibility Criteria

Inclusion Criteria

•Patient has given written informed consent form to participate in the clinical trial., Patient is male or female aged 18 to 75 years, inclusive., Patient who has ulcerative colitis, confirmed by endoscopic or radiographic and histological criteria. Histopathology report supporting the diagnosis must be available in the source documents prior to the randomization., Patient who has not achieved clinical remission, defined as the total Mayo score of \= 2 with all subscores of \= 1 and Mayo rectal bleeding subscore of 0, despite 8\-weeks of treatment with vedolizumab., The following treatments for ulcerative colitis are allowed: a. budesonide taken orally at a dose not exceeding 9 mg/day, if taken at a stable dose for at least 2 weeks prior to the randomization, b. other corticosteroids taken orally at a dose not exceeding 20 mg/day of prednisone, if taken at a stable dose for at least 2 weeks prior to the randomization, c. 5\-Aminosalicylates (5\-ASA), if taken at a stable dose for at least 4 weeks prior to the randomization., For female patients of childbearing potential and male patients and their partners of childbearing potential who agree to use one of the following medically acceptable methods of contraception during the course of the study and for 6 moths following the discontinuation of study drug: \- highly effective method of contraception that are user independent, with a failure rate of \<1% per year when used consistently and correctly: •implantable progestogen\-only hormone contraception associated with inhibition of ovulation; •intrauterine device (IUD); •bilateral tubal occlusion; •vasectomy in the only sexual partner of the woman of childbearing potential with confirmed absence of sperm; \- highly effective method of contraception that are user dependent, with a failure rate of \<1% per year when used consistently and correctly: •progestogen\-only hormone contraception associated with inhibition of ovulation (oral or injectable) •combined (estrogen\- and progestogen\-containing) hormonal contraception associated with inhibition of ovulation: \-oral \-intravaginal \-transdermal \-injectable The use of the aforementioned methods also applies to women and men who have had surgical sterilization within 6 months prior to the date of informed consent. Menopausal females must have experienced their last period more than 12 months prior to the date of informed consent to be classified as not childbearing potential. Women and men who have had surgical sterilization more than 6 months prior to the date of informed consent are considered as not childbearing potential.

Exclusion Criteria

•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\.5 × ULN, c.Serum aspartate aminotransferase \= 2\.5 × ULN, d.Serum total bilirubin \= 2 × 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 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 2 weeks or parenteral injection within 4 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 3 months 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. Evide