Long-term Exposure Registry of Adult Patients With Moderate-to-Severe Ulcerative Colitis
概览
- 阶段
- 不适用
- 干预措施
- Thiopurine cohort
- 疾病 / 适应症
- Ulcerative Colitis
- 发起方
- Janssen Biotech, Inc.
- 入组人数
- 537
- 试验地点
- 63
- 主要终点
- Long-term Safety: Participants with Adverse Events of Interest (AEIs) and Serious Adverse Events (AEs) Including Malignancies, Pregnancies, and Non-serious Malignancies
- 状态
- 进行中（未招募）
- 最后更新
- 11天前
概览
简要总结
The purpose of this study is to describe the long-term safety risks in adult participants with moderate-to-severe ulcerative colitis who are treated with Simponi.
研究者
入排标准
入选标准
- •Have moderate-to-severe ulcerative colitis of at least 3 months' duration prior to enrollment, confirmed by endoscopy at any time in the past
- •For enrollment into the Simponi-exposed cohort meets one of the following:
- •The participant is currently receiving Simponi ,or
- •The participant is continuing to receive Simponi after participation in an ulcerative colitis study, or
- •The participant is scheduled to receive Simponi within 30 days after enrollment
- •For Thiopurine cohort:
- •The participant is currently receiving thiopurines, having received at least 12 consecutive weeks of therapy prior to registry entry
- •Participant must not be receiving other approved biologic agents, including Simponi, or any investigational agents at enrollment
- •Participant may have received biologics other than Simponi or investigational agents prior to enrollment
排除标准
- •Participants who cannot be treated with Simponi or thiopurines
- •Participants with a previous diagnosis of lymphoma or hematologic malignancy at any time prior to enrollment
- •Participants currently receiving an investigational or biologic agent other than Simponi
- •Participants with any condition for which, in the opinion of the investigator, participation in the registry would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments
研究组 & 干预措施
Thiopurine cohort
Participants currently receiving thiopurines, having received at least 12 consecutive weeks of therapy prior to registry entry. Participants must not be receiving approved biologic agents, including Simponi, or investigational agents at enrollment. These patients may have received biologics other than Simponi or investigational agents prior to enrollment.
Simponi-exposed cohort
Participants receiving Simponi at enrollment and are still receiving Simponi after participation in a therapeutic trial or participants scheduled to receive Simponi within 30 days after enrollment. Participants in this cohort may be receiving Simponi alone or in combination with thiopurines but must not be receiving other approved biologics or investigational agents at enrollment. Participants may have received other approved biologics or investigational agents prior to enrollment.
结局指标
主要结局
Long-term Safety: Participants with Adverse Events of Interest (AEIs) and Serious Adverse Events (AEs) Including Malignancies, Pregnancies, and Non-serious Malignancies
时间窗: 6 years
Descriptive analysis of serious adverse events, adverse events of interest (including lymphoma \& other malignancies), pregnancies, and non-serious malignancies in participants less than (\<) 30 years of age will be reported.
次要结局
- Health Care Utilization: Evaluate the Number of Each Hospitalizations in Participants in Each Cohort(6 years)
- Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score(6 years)
- EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) Score(6 years)
- Work Productivity and Activity Impairment Questionnaire - Ulcerative Colitis (WPAI-UC)(6 years)
- Clinical Disease Status as Assessed by Partial Mayo Score(6 years)
- Treatment Satisfaction Questionnaire for Medication (TSQM) Score(6 years)
- Health Care Utilization: Evaluate the Reasons for Hospitalization in Participants in Each Cohort(6 years)