Ulcerative Colitis European Registry: A Prospective, Observational, Non-interventional, Post-Marketing Safety Surveillance Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,239
- 主要终点
- Percentage of Participants Within Each of Nine Pre-specified Adverse Event (AE) Categories
研究概览
简要总结
This is a prospective, safety surveillance registry in participants with moderate-to-severe active ulcerative colitis (UC).
详细描述
This is a prospective, observational, post-marketing safety surveillance registry of UC participants treated with Remicade or another standard therapy. Registry centers are targeted to enroll a total of 2000 participants (1000 Remicade participants and 1000 standard therapy participants) and to follow them for a period of up to 5 years. Participants who started the registry on standard therapy may switch over to Remicade.
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
- •18 years of age, of either sex, and of any race.
- •Moderate-to-severe active UC, as defined by assessment by the treating physician.
- •Must, within 30 days of Baseline, either:
- •Initiate or have a dose increase of immunosuppressive drug(s), including but not limited to systemic steroids (budesonide is considered a topical steroid), azathioprine (AZA), or methotrexate (participants in this category must be Remicade naïve) or
- •Initiate Remicade. Participants who have been treated in the past with Remicade, but who have discontinued for any reason and who are scheduled to receive Remicade within 30 days of the baseline visit must have a Remicade-free interval of no less than 90 days from the date of the next expected infusion
- •Must be willing to give written informed consent and must be able to adhere to the procedural requirements of the registry.
- •Must be evaluated for active and inactive (latent) tuberculosis (TB) as suggested by local guidelines or as required by the Remicade label for participants starting Remicade.
排除标准
- •Female who is known to be pregnant or nursing.
- •Previously treated with any other (investigational) biological drug for UC( other than Remicade) prior to Baseline.
- •In a situation or have any condition that, in the opinion of the treating physician, may interfere with their optimal participation in the registry.
- •Participating in a blinded trial.
- •In addition, participants with conditions that are contraindicated in the Remicade Summary of Product Characteristics (SPC) should not be treated with Remicade.
研究组 & 干预措施
Remicade Group
Participants with no prior exposure to Remicade or who have been treated with Remicade in the past, who at the time of enrollment are scheduled to receive Remicade within 30 days of the Baseline Visit. Participants who have been treated in the past with Remicade must have a Remicade-free interval of no less than 90 days from the date of the next expected infusion.
干预措施: infliximab (Biological)
Standard Therapy Group
Participants who are scheduled to receive standard therapy (defined as initiation or dose-increase of corticosteroids and/or immunosuppressants) that does not include Remicade. Standard therapy participants must not have previously received Remicade for UC or any other condition.
干预措施: Standard Therapy (Drug)
结局指标
主要结局
Percentage of Participants Within Each of Nine Pre-specified Adverse Event (AE) Categories
时间窗: Up to 5 years.
The nine AE categories are as follows: 1) Serious infections, including infections listed as Serious AEs, tuberculosis, invasive fungal infections, other opportunistic infections, salmonellosis; 2) Infusion-related reactions including delayed hypersensitivity and anaphylactic reactions, and change in severity of infusion-related reactions over time; 3) Fatalities, analyzed by cause; 4)Worsening or new congestive heart failure; 5) Central and peripheral demyelinating neurological disorders; 6) Hematologic conditions such as idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura, thrombocytopenia, pancytopenia, granulocytopenia, leucopenia, hemolytic anemia, aplastic anemia, and thromboembolic events; 7) Malignancies, especially lymphoma, colorectal cancer, and skin cancer; 8) Autoimmune disorders such as lupus and lupus-like syndromes; 9) Hepatobiliary events including autoimmune hepatitis, primary sclerosing cholangitis, and liver function test abnormalities.
次要结局
未报告次要终点