POST-MARKETING OBSERVATIONAL COHORT STUDY OF PATIENTS WITH INFLAMMATORY BOWEL DISEASE (IBD) TREATED WITH CT-P13 IN USUAL CLINICAL PRACTICE (CONNECT-IBD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 2,565
- 试验地点
- 139
- 主要终点
- Disease Characteristics of Participants: Disease Duration
研究概览
简要总结
This is a post-marketing observational study of patients with Inflammatory Bowel Disease (specifically, Crohn's disease or Ulcerative Colitis) who have been prescribed CT-P13 (infliximab) or Remicade (infliximab) for treatment. CT-P13 (brand names Inflectra and Remsima) is a biosimilar medicine to Remicade, meaning it is a biologic medicine that contains the same active substance as Remicade (infliximab). The key study objectives are as follows:
- To characterize the population and drug utilization patterns of patients treated with CT-P13 for Crohn's Disease (CD) or Ulcerative Colitis (UC) in the context of standard of care Remicade
- To explore the long-term safety profile of CT-P13 in the treatment of patients with CD or UC in the context of standard of care Remicade
- To assess the effectiveness of CT-P13 in the treatment of patients with CD or UC in the context of standard of care Remicade
详细描述
The study will be conducted in accordance with legal and regulatory requirements with scientific purpose, value and rigor following generally accepted research practices described in Guidelines for Good Pharmacoepidemiology Practices (GPP), Good Epidemiological Practice (GEP), Good Practices for Outcomes Research, International Ethical Guidelines for Epidemiological Research, European Medicines Agency (EMA) European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) Guide on Methodological Standards in Pharmacoepidemiology, and FDA Guidance for Industry. Data sources will be validated and will consist of the hospital medical records and monitoring will be organized on a regular basis. Data for the study will be entered into a web based electronic data capture (EDC) system at enrolment and then approximately every 3 months (at a minimum) thereafter up to 2 years. Adverse events will be encoded according to MedDRA 17.1 or later. The sample size will be approximately 2500 patients recruited over a 30 month period and followed up to 2 years. No inferential analyses are planned. Statistical analysis will be descriptive in nature.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 12 years of age at the time of initial confirmed diagnosis of CD or UC and at least 18 years of age at the time of enrolment to the study.
- •Patients who are prescribed CT-P13 or Remicade for the treatment of CD or UC prescribed according to the corresponding summary of product characteristics (SmPC) as determined by the Investigator. Patients with stomas or surgery/pouch will be included.
排除标准
- •Any reported contraindications for CT-P13 or Remicade, according to the SmPC.
- •Known hypersensitivity (including severe, acute infusion reactions) to infliximab, its excipients or other murine proteins, at the time of enrolment.
- •Prior history of failure to respond to Remicade or CT-P13.
研究组 & 干预措施
CT-P13
biosimilar infliximab
干预措施: CT-P13 (Drug)
Remicade
infliximab
干预措施: Remicade (Drug)
结局指标
主要结局
Disease Characteristics of Participants: Disease Duration
时间窗: Baseline (Day 1)
Disease duration was defined as the number of months from initial diagnosis of inflammatory bowel disease (CD or UC) to the date of informed consent, which was recorded at the time of enrollment into the study (baseline).
Number of Participants Who Switched Treatment
时间窗: From baseline to follow-up period (up to a maximum duration of 2 years)
Here, number of participants with either UC or CD, who switched from remicade to CT-P13; switched from CT-P13 to remicade and multiple switchers were reported.
Reasons for Switching Treatment by Participants
时间窗: From baseline to follow-up period (up to a maximum duration of 2 years)
Total Dose of Infusion Received
时间窗: From baseline to follow-up period (up to a maximum duration of 2 years)
Total dose of infusion received by the participants was calculated.
Number of Participants by Frequency of Infusion Received
时间窗: Baseline (Day 1)
Number of participants by infusion frequency (weeks) were reported at baseline and categorized as follows: once a week; once every 2 weeks; once every 3 weeks; once every 4 weeks; once every 5 weeks; once every 6 weeks; once every 7 weeks; once every 8 weeks and others. Here, 'Others' category included all the frequencies apart from the mentioned categories.
Number of Participants Who Took Concomitant Medications Related to the Treatment of Crohn's Disease (CD) or Ulcerative Colitis (UC)
时间窗: From baseline to follow-up period (up to a maximum duration of 2 years)
Number of Participants With Treatment-Emergent Adverse Event (AEs), Serious Adverse Events (SAEs) and Adverse Event With Special Interest (AESIs)
时间窗: From baseline to follow-up period (up to a maximum duration of 2 years)
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Treatment-emergent were events between first dose of infusion up to month 24, that were absent before treatment or that worsened relative to pretreatment state. Hypersensitivity was the pre-defined TEAE of special Interest for this study. AEs included both serious and non-serious adverse events.
Number of Participants Who Had Change in Infusion Dose
时间窗: From baseline to follow-up period (up to a maximum duration of 2 years)
Participants who had change in the dose of infusion (either dose reduction or increase in dose) were included and reported.
Number of Participants Who Had Change in Infusion Dose Categorized Based on Reasons of Change
时间窗: From baseline to follow-up period (up to a maximum duration of 2 years)
Participants who had change in infusion dose due to various reasons such as principal investigator's decision, participant's decisions, loss of response, lack of compliance, hypersensitivity, occurrence of adverse event (including adverse event special interest \[AESI\]/ serious adverse event \[SAE\]), positive for antibodies and other were reported. Here, 'Others' category included all reasons apart from the mentioned categories. A participant could have different reasons of dose change across visits, hence could be counted in more than one category.
次要结局
- Number of Participants Remaining in Clinical Remission or Relapse(Months 6, 12, 18 and 24)
- Crohn's Disease: Number of Participants With Shift From Baseline in Harvey Bradshaw Index (HBI) According to Clinical Remission(Baseline, Months 6, 12, 18 and 24)
- Crohn's Disease: Number of Participants With Shift From Baseline in Harvey Bradshaw Index According to Disease Activity(Baseline, Months 6, 12, 18 and 24)
- Ulcerative Colitis: Number of Participants With Shift From Baseline in Partial Mayo Scoring System According to Clinical Remission(Baseline, Months 6, 12, 18 and 24)
- Ulcerative Colitis: Number of Participants With Shift From Baseline in Partial Mayo Scoring System According to Disease Activity(Baseline, Months 6, 12, 18 and 24)
- Crohn's Disease: Number of Participants Categorized on the Basis of Montreal Classification Index by Age at Diagnosis(At Baseline)
- Crohn's Disease: Number of Participants Categorized on the Basis of Montreal Classification Index by Location(Baseline, Months 6, 12, 18 and 24)
- Crohn's Disease: Number of Participants Categorized on the Basis of Montreal Classification Index by Behavior of the Disease Activity(Baseline, Months 6, 12, 18 and 24)
- Ulcerative Colitis: Number of Participants Categorized on the Basis of Montreal Classification Index by Extent(Baseline, Months 6, 12, 18 and 24)
- Ulcerative Colitis: Number of Participants Categorized on the Basis of Montreal Classification Index by Severity(Baseline, Months 6, 12, 18 and 24)
- Crohn's Disease: Number of Participants Categorized on the Basis of Fistula Drainage Assessment Index(Baseline, Months 6, 12, 18 and 24)
- Mean Change From Baseline in Laboratory Test Results: C-Reactive Protein at Months 6, 12, 18, and 24(Baseline, Months 6, 12, 18 and 24)
- Mean Change From Baseline in Laboratory Test Results: Fecal Calprotectin at Months 6, 12, 18, and 24(Baseline, Months 6, 12, 18, and 24)
- Number of Participants With Imaging Test Results(From baseline up to follow-up period (a maximum of 2 years))