CTIS2023-506626-37-00进行中（未招募）1 期
Evaluation of the efficacy and safety of dual biological therapy in patients with refractory Crohn's disease resistant to induction (FLAMING). - ABM/FLAMING/2023
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy0 个研究点目标入组 192 人开始时间: 2024年1月10日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 192
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Patient has given written informed consent from to participate in the clinical trial., Patient is male or female aged 18 to 75 years, inclusive., Patient who has CD, confirmed at any time in the past by radiography, histology, or endoscopy, of at least 3 months prior to the randomization., Patients with active Crohn's Disease (CD) who have at least moderately active CD, defined by an absolute CDAI score of at least =220, despite 12-weeks of treatment with vedolizumab (VEDO)., The following treatments for CD are allowed: a. azathioprine (AZA), 6-mercaptopurine (6-MP) or methotrexate (MTX), if taken at a stable dose for more than 8 weeks prior to the randomization, b. 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, c. 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, d. 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); •intrauterine hormone - releasing system (IUS), •bilateral tubal occlusion; •partner after a documented vasectomy (provided that the partner is the sole sexual partner of the woman of childbearing potential and the absence of sperm has been confirmed); - 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. A woman of childbearing potential is defined as a woman from the onset of her first menarche and until becoming postmenopausal (defined as age >45 and no menses for at least 12 months without an alternative medical cause), unless permanently sterile (permanent sterilization methods include hysterectomy, bilateral salpingectomy, bilateral oophorectomy). 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.
排除标准
- •Allergies to any of the excipients of infliximab or ustekinumab or any other murine and/or human proteins or has hypersensitivity to immunoglobulin products., Use of total parenteral nutrition within a month prior to the randomization., 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 × 103 cells/µl (SI units: <3.5×109 cells/l), g.Neutrophil count < 1.5 × 103 cells/µl (SI units: <1.5×109 cells/l), h.Platelet count < 100 × 103 cells/µl (SI units: <100×109 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 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 Quantiferon-TB-Gold without clinical signs of active tuberculosis and with a negative examination of chest x-ray from the qualifying visit for vedolizumab treatment). k.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.Diagnose of UC (ulcerative colitis) or indeterminate colitis. b.Short bowel syndrome. c.Evidence of fix
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