Prospective Observational Study on Stelara Assessing Efficacy and Healthcare Resource Utilization in Crohn's Disease (PROSE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Percentage of Participants with Clinical Response at Week 16, Based on Harvey Bradshaw Index (HBI)
研究概览
简要总结
The main purpose of this study is to assess ustekinumab's ability to induce clinical response and remission ("effectiveness") at Week 16 and remission at Week 52 and Week 104 in participants with Crohn's disease (CD). Response and remission will be assessed using clinical parameters. Retention rate at week 52 and 104 will also be studied.
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
- •Participant has a diagnosis of CD confirmed by investigator
- •Participants with active CD who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic therapy or have medical contraindications to such therapies
- •The participant must sign informed consent before enrollment in the study. The consent form permits extraction of data from SWIBREG at baseline and during participation of the study and linkages to the Patient Registry (Patientregistret), SCB's registry USA for occupational details (Longitudinell integrationsdatabas for sjukforsakrings- och arbetsmarknadsstudi er), the Social Insurance registry on long-term sick leave (Forsakringskassans register gallande sjukskrivningar) and the Prescription registry (Lakemedelsregistret)
- •The participant must have been initiated on treatment with ustekinumab within the last 2 weeks (that is including those who already discontinued) or started on ustekinumab treatment less than (<) 3 months ago if treatment start was documented in SWIBREG within 2 weeks of onset and has a record of Harvey Bradshaw Index (HBI) when starting ustekinumab
排除标准
- •The participant is enrolled in a clinical trial (randomized or non-randomized) in which the treatment of CD is dictated by a study protocol. If the participant is participating in another observational study (non-interventional), the participant may be included in this observational study
- •Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 60 days before the start of the study or the first data collection time point
- •Participants who started ustekinumab despite contraindications for use
- •Participants with planned stop of treatment with ustekinumab within 24 months from onset of treatment, that is bridging to other treatment or pregnancy planned
研究组 & 干预措施
Participants with Crohn's Disease (CD)
Participants with CD will be assessed for the effectiveness of ustekinumab in accordance with national guidelines and routine standard of care. Data will be prospectively collected with the aid of the Swedish inflammatory bowel disease (IBD) registry, SWIBREG and medical records of each participant. Data will also be collected retrospectively from SWIBREG and other databases including national databases such as the participant registry in which cases the national databases will be considered source data.
干预措施: Ustekinumab (Drug)
结局指标
主要结局
Percentage of Participants with Clinical Response at Week 16, Based on Harvey Bradshaw Index (HBI)
时间窗: Week 16
Clinical response for Crohn's disease (CD) is assessed by Harvey Bradshaw Index (HBI) and is defined as decrease of 3 points in baseline HBI score. HBI consists of clinical parameters: general well-being (0-4, where higher score means lower well-being), abdominal pain (0-3, higher score means more severe pain), number of liquid stools per day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score is the sum of individual parameters. The score ranges from a minimum score of 0 to no pre-specified maximum score as it depends on the number of liquid stools per day and number of complications, where higher scores indicates more severe disease and, score is presented as: less than (\<)5 (remission), 5-7 (mild disease), 8-16 (moderate disease), and greater than (\>)16 (severe disease).
Percentage of Participants with Clinical Remission at Week 104, Based on HBI
时间窗: Week 104
Clinical remission for CD is assessed by HBI and is defined as HBI \<5. HBI consists of clinical parameters: general well-being (0-4, where higher score means lower well-being), abdominal pain (0-3, higher score means more severe pain), number of liquid stools per day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score is the sum of individual parameters. The score ranges from a minimum score of 0 to no pre-specified maximum score as it depends on the number of liquid stools per day and number of complications, where higher scores indicates more severe disease and, score is presented as: less than (\<)5 (remission), 5-7 (mild disease), 8-16 (moderate disease), and greater than (\>)16 (severe disease).
Percentage of Participants with Clinical Remission at Week 52, Based on HBI
时间窗: Week 52
Clinical remission for CD is assessed by HBI and is defined as HBI \<5. HBI consists of clinical parameters: general well-being (0-4, where higher score means lower well-being), abdominal pain (0-3, higher score means more severe pain), number of liquid stools per day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score is the sum of individual parameters. The score ranges from a minimum score of 0 to no pre-specified maximum score as it depends on the number of liquid stools per day and number of complications, where higher scores indicates more severe disease and, score is presented as: less than (\<)5 (remission), 5-7 (mild disease), 8-16 (moderate disease), and greater than (\>)16 (severe disease).
Percentage of Participants with Clinical Remission at Week 16, Based on HBI
时间窗: Week 16
Clinical remission for CD is assessed by HBI and is defined as HBI less than (\<)5. HBI consists of clinical parameters: general well-being (0-4, where higher score means lower well-being), abdominal pain (0-3, higher score means more severe pain), number of liquid stools per day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score is the sum of individual parameters. The score ranges from a minimum score of 0 to no pre-specified maximum score as it depends on the number of liquid stools per day and number of complications, where higher scores indicates more severe disease and, score indicates: less than (\<)5 (remission), 5-7 (mild disease), 8-16 (moderate disease), and greater than (\>)16 (severe disease).
次要结局
- Percentage of Participants with Clinical Remission at Week 52 and 104 who are Remitters at 16 Weeks(Week 52 and 104)
- Percentage of Participants with Clinical Response at Week 52 and 104, Based on HBI(Week 52 and 104)
- Percentage of Participants with Clinical Remission at Week 104 who are Remitters at 52 Weeks(Week 104)
- Percentage of Participants in Clinical Remission Overtime(Up to Week 104)
- Mean Change from Baseline in Fecal Calprotectin (fCal) Levels at Week 16, 52 and 104(Baseline, Week 16, 52 and 104)
- Change from Baseline in EQ-5D-5L Visual Analog Scale (VAS) at Week 16, 52 and 104(Baseline, Week 16, 52 and 104)
- Change from Baseline in the Presence of Extra Intestinal Manifestations at Week 16, 52 and 104(Baseline, Week 16, 52 and 104)
- Healthcare Resource: Number of Days of Hospitalization(Up to Week 104)
- Percentage of Participants with Clinical Remission at Week 52 and 104 who are Responders at 16 Weeks(Week 52 and 104)
- Healthcare Resource: Number of Participants Using Concomitant Treatment(Up to Week 104)
- Percentage of Participants with Corticosteroid Free Remission at Week 52 and 104(Week 52 and 104)
- Percentage of Participants in Every 12 weeks/8 weeks (q12 w/q8 w) maintenance groups at Week 16(Week 16)
- Percentage of Participants with fCal Less Than (<)250 milligram per kilogram (mg/kg)(Week 16, 52 and 104)
- Percentage of Participants with Normalization of Plasma-CRP (P-CRP)(Week 16, 52 and 104)
- Change from Baseline in Short Health Scale (SHS) Score at Week 16, 52 and 104(Baseline, Week 16, 52 and 104)
- Participant's Time off Corticosteroids(Up to week 104)
- Average Maintenance Dose per Month(Week 52 and 104)
- Mean Change from Baseline in C-reactive Protein (CRP) Levels at Week 16, 52 and 104(Baseline, Week 16, 52 and 104)
- Change from Baseline in EuroQoL 5-Dimension 5-Level Health Status (EQ-5D-5L) Questionnaire at Week 16, 52 and 104(Baseline, Week 16, 52 and 104)
- Healthcare Resource: Number of Imaging Procedures(Up to week 104)
- Healthcare Resource: Number of Laboratory Test(Up to Week 104)
- Healthcare Resource: Number of Surgical Procedures(Up to Week 104)
- Healthcare Resource: Number of Sick-Leaves(Up to Week 104)
- Percentage of Participants on Initial q12 w Maintenance Dose Escalated from q12 w to q8 w in Year 1 and 2(Year 1 and 2)
- Percentage of Participants with Dose Optimization(Year 1 and 2)
- Percentage of Participants with fCal levels <250 mg/kg at Week 16, 52 and 104(Week 16, 52 and 104)
- Healthcare Resource: Number of Dual Energy X-ray Absorptiometry (DEXA) Scans(Up to Week 104)
- Healthcare Resource: Number of Participants with Endoscopies Performed(Up to Week 104)
- Healthcare Resource: Number of Health Care Visits(Up to Week 104)
- Number of Participants with Malignancy(Up to Week 104)
- Number of Participants Requiring Antibiotics for any Infection Occurred During the Study(Up to Week 104)