2023-508584-72-00已完成3 期
Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous as Induction Therapy in Patients with Active Crohn’s Disease or Ulcerative Colitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 3
- 主要终点
- Ctrough measurement (residual concentration of CT-P13) at Week 6.
研究概览
简要总结
To demonstrate that induction treatment with CT-P13 SC is non-inferior to CT-P13 IV in terms of pharmacokinetics at Week 6.
研究设计
- 分配方式
- Randomized
- 主要目的
- Passport cohort
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged at least 18 years old.
- •Diagnosis of inflammatory bowel disease according to the ECCO criteria for at least 3 months: ● CD (Crohn’s disease) ● UC (Ulcerative colitis)
- •Patients had received conventional therapy for active UC (corticosteroids alone or in combination with thiopurines and 5-aminosalicylates) or CD (corticosteroids and/or immunomodulators) but had not responded despite an adequate course of therapy.
- •Patient has active CD or UC with at least one objective sign of disease activity on biology, endoscopy or imaging.
- •Initiation of infliximab CT-P13 as part of standard of care.
- •Patient suffering from anal suppuration related to CD can be included.
- •Person who has received full information about the organization of the research, who has not objected to his or her participation and to the use of his or her data.
- •Person affiliated to or beneficiary of a social security plan.
排除标准
- •Combination therapy with an immunomodulator except for patients suffering from anal suppuration related to CD.
- •Patient who has allergies to any of the excipients of infliximab CT-P13 or any other murine and/or human proteins or patient with a hypersensitivity to immunoglobulin product.
- •Patient who had current or past history of chronic infection with hepatitis C or human immunodeficiency virus (HIV)-1 or -2 or current infection with hepatitis B.
- •Patient who had acute infection requiring oral antibiotics within 2 weeks or parenteral injection of antibiotics within 4 weeks prior to the first administration of the study drug, other serious infection within 6 months prior to the first administration of study drug or recurrent herpes zoster or other chronic or recurrent infection within 6 weeks prior to the first administration of the study drug.
- •Patients with a positive interferon-γ release assay (IGRA) or latent tuberculosis (TB) prior to initiation of biologic therapy.
- •Person referred in articles L.1121-5, L. 1121-7 and L.1121-8 of the Public Health Code: pregnant woman, parturient, or breastfeeding woman, minor person (non-emancipated), adult person under legal protection (any form of public guardianship), adult person incapable of giving consent.
- •Person deprived of liberty for judicial or administrative decision, person under psychiatric care as referred in articles L. 3212-1 and L. 3213-1.
结局指标
主要结局
Ctrough measurement (residual concentration of CT-P13) at Week 6.
Ctrough measurement (residual concentration of CT-P13) at Week 6.
次要结局
- Ctrough measurement at Week 24.
- AUC assessed at Week 24.
- Clinical response at Week 6: • Defined for UC as a decrease in the partial Mayo score from baseline of 30% or more and 3 or more points, along with either a rectal bleeding subscore of 0 or 1 or a decrease in the rectal bleeding subscore of 1 point or more; • Defined for CD as a decrease from baseline in CDAI score of at least 100 points or a total CDAI score < 150.
- IBD disability index collected at Week 6.
- Fecal calprotectin at Week 24 (the samples are collected at Weeks 0, 6 and 24).
- Clinical remission at Week 24: • Defined for UC as a total Mayo score of ≤ 2 with no individual subscore >1, and a rectal bleeding subscore of 0 at week 24 in active UC patients evaluated in semi-blind (assessment will be done by another investigator without information on the treatment); • Defined for CD as a CDAI score < 150 evaluated in semi-blind (assessment will be done by another investigator without information on the treatment).
- Presence of antibodies to infliximab at Week 6 and Week 24.
- Concentration of CRP up to week 6 (the samples are collected at weeks 0, 6 and 24).
- Adverse events, including injection site reactions and hypersensitivity reactions (from Baseline up to 6 weeks and 24 weeks).
- Treatment Satisfaction Questionnaire for Medication (TSQM) collected at Week 6 and Week 24.
研究者
Clinical Project Manager
Scientific
Centre Medico Chirurgical Ambroise Pare Hartmann
研究点 (3)
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