A Multicenter, Single-Arm Study to Evaluate the Effectiveness and Safety of Tabellvi® (Adalimumab) in Chinese Adult Subjects With Moderate to Severe Active Crohn's Disease in the Real-World Setting
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 14
- 主要终点
- Adverse Event (AE)
研究概览
简要总结
This is a post-marketing real-world study designed to evaluate the efficacy and safety of Tabellvi® (Adalimumab Injection) in Chinese adult subjects with moderate to severe active Crohn's disease via a single-arm trial. A total of 50 subjects are planned to be enrolled. The primary endpoints include the incidence rates of adverse events (AEs), serious adverse events (SAEs), adverse drug reactions (ADRs) and serious ADRs, as well as the proportion of subjects achieving clinical remission (CDAI score < 150) at Week 26.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject must sign the informed consent form.
- •Aged 18 to 70 years inclusive, no gender restriction.
- •Subjects with definite diagnosis of Crohn's disease in accordance with Chinese Guidelines for the Diagnosis and Treatment of Crohn's Disease (Guangzhou, 2023), presenting moderate to severe active Crohn's disease with inadequate response, intolerance or contraindication to adequate glucocorticoid and/or immunosuppressant therapy.
- •Adult patients with Crohn's disease who are prescribed Tabellvi® Adalimumab Injection by physicians following thorough risk-benefit assessment.
- •Female subjects of childbearing potential must agree to use one contraceptive method approved by the investigator.
排除标准
- •Subjects who are not suitable for treatment with Tabellvi® Adalimumab Injection based on the prescribing information of Tabellvi® Adalimumab Injection and the judgment of the treating physician.
- •Female subjects who are pregnant or breastfeeding, or who plan to become pregnant during the study period.
- •Subjects with hypersensitivity to any component of Tabellvi® Adalimumab Injection.
- •Subjects with active, chronic or recurrent infections, or a medical history of invasive infections (e.g., listeriosis, histoplasmosis).
- •Subjects with active infections requiring intravenous anti-infective therapy within 30 days prior to the first dose, or those who have received oral anti-infective drugs within 14 days prior to the first dose.
- •Subjects with active tuberculosis infection; or latent tuberculosis infection without adequate treatment; subjects infected with human immunodeficiency virus (HIV); subjects positive for hepatitis C virus antibody (HCV Ab) indicating previous or current infection; subjects positive for hepatitis B surface antigen (HBsAg), or positive for total hepatitis B core antibody (total Hepatitis B core Ab) with positive hepatitis B virus (HBV)-DNA polymerase chain reaction test result.
- •Subjects with syphilis infection requiring treatment.
- •Subjects with moderate to severe heart failure (NYHA Class III/IV), recent cerebrovascular accident, or other medical conditions that may put the subject at risk by participating in this study.
- •Subjects with current evidence of dysplasia or a history of malignant tumors (including lymphoma and leukemia), except cured non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma or localized cervical carcinoma in situ.
- •Subjects with a history of demyelinating diseases (including myelitis), or neurological symptoms suggestive of demyelinating diseases.
- •Subjects who have undergone intestinal resection within the past 6 months, or plan to undergo intestinal resection at any time in the future.
- •Subjects receiving total parenteral nutrition (TPN), or planning to receive TPN at any time during the study period.
- •Subjects with an ostomy or an ileal pouch-anal anastomosis (IPAA) pouch.
- •Subjects with internal or external fistulas, except perianal fistulas without abscess.
- •Subjects with known symptomatic obstructive intestinal strictures.
- •Subjects diagnosed with ulcerative colitis or indeterminate colitis.
- •Subjects with any of the following abnormal laboratory or other examination results during the screening period: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 1.5 times the upper limit of the reference range; white blood cell count < 3.0×10⁹/L; electrocardiogram (ECG) with clinically significant abnormalities; total bilirubin ≥3 mg/dL (isolated elevated indirect bilirubin caused by Gilbert's syndrome excluded); serum creatinine >1.6 mg/dL.
- •Subjects with other clinically significant abnormal laboratory test results (other than those listed above) identified by the investigator during screening.
- •Subjects who have received other tumor necrosis factor-alpha (TNF-α) inhibitor therapy within 12 weeks before receiving the first dose of Tabellvi® Adalimumab Injection.
- •Subjects currently participating in another clinical study.
- •Subjects deemed unsuitable for participation in this trial by the investigator.
研究组 & 干预措施
Tabellvi® Adalimumab Injection
The induction dosage is 160 mg at Week 0, followed by 80 mg at Week 2. After induction therapy, the recommended maintenance dosage is 40 mg administered subcutaneously once every 2 weeks.
Administer subcutaneously once every two weeks. For induction therapy, the dosage is 160 mg at Week 0, followed by 80 mg at Week 2. After induction therapy, the recommended maintenance dose is 40 mg administered subcutaneously once every two weeks.
干预措施: TyboWe® Adalimumab Injection (Drug)
结局指标
主要结局
Adverse Event (AE)
时间窗: Baseline up to 54 weeks
Incidence rate of adverse events，the severity will be graded according to the NCI CTCAE Version 6.0 grading scale.
Adverse Drug Reaction (ADR)
时间窗: Baseline up to 54 weeks
Incidence rate of adverse drug reaction，the severity will be graded according to the NCI CTCAE Version 6.0 grading scale.
Serious Adverse Event (SAE)
时间窗: Baseline up to 54 weeks
Incidence rate of serious adverse events，the severity will be graded according to the NCI CTCAE Version 6.0 grading scale.
Serious Adverse Drug Reaction
时间窗: Baseline up to 54 weeks
Incidence rate of serious adverse drug reaction，the severity will be graded according to the NCI CTCAE Version 6.0 grading scale.
Clinical remission (CDAI < 150)
时间窗: At Week 26 post-dose
The proportion of subjects achieving clinical remission (CDAI score\<150) at Week 26
次要结局
- Clinical remission (CDAI < 150)(At Weeks 4, 12, and 52 post-dose)
- Clinical response (reduction in CDAI ≥70 points from baseline)(At Weeks 4, 12, 26 and 52 post-dose)
- Endoscopic remission(At Week 26 post-dose)
- C-reactive protein (CRP)(At Weeks 12, 26, and 52 post-dose)
- Fecal calprotectin (FC)(At Weeks 12, 26, and 52 post-dose)