NCT05069259终止不适用
A LOW-INTERVENTIONAL, PROSPECTIVE, MULTI-CENTER STUDY TO EVALUATE REAL-WORLD CLINICAL, BIOCHEMICAL AND PATIENT-REPORTED RESPONSES TO TOFACITINIB INDUCTION THERAPY IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS IN SWITZERLAND
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 18
- 试验地点
- 5
- 主要终点
- Percentage of Participants Who Achieved Clinical Response at Week 8
研究概览
简要总结
This study is expected to contribute to the body of real-world data of tofacitinib's safety and efficacy profile in ulcerative colitis. Conventional clinical outcomes will give a better understanding of response and remission rates in a representative, post-marketing population.
Regular patient questionnaires and measurement of a biomarker of gut inflammation will provide detail on how patients experience induction treatment and contextualise the efficacy data.
详细描述
This is a low-interventional study in which the intervention under study is home fecal calprotectin testing which falls outside of normal standard of care in ulcerative colitis. Tofacitinib is prescribed and administered as per the Swiss prescribing information. Accordingly, this study is registered on ClinicalTrials.gov as an interventional study. Under Swiss law, this study is considered and approved as a non-interventional study (Category A, Human Research Ordinance, Swiss Confederation).
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
- •Male or female participants 18 years of age or older at screening visit
- •Participants with confirmed diagnosis of UC and who are prescribed tofacitinib (Xeljanz®) for moderately to severely active UC as per the Swiss label
- •Participants who are willing and able to comply with all scheduled visits, treatment plan, study interventions, and other study procedures
- •Capable of giving personally signed informed consent
排除标准
- •Presence of clinical findings suggestive of Crohn's disease
- •Any previous exposure to tofacitinib including participation in the tofacitinib clinical program
- •Co-medication with any other advanced therapies for UC (biologics*, azathioprine, mercaptopurine and methotrexate) or any other JAK inhibitor
- •Any identified contra-indications for use of tofacitinib as per the Swiss label
- •Not owning a handheld digital device compatible with the Sidekick Health App, not willing to have it installed on this device or not capable of using the App
- •Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
结局指标
主要结局
Percentage of Participants Who Achieved Clinical Response at Week 8
时间窗: Week 8
Clinical response was defined as a reduction in the partial Mayo score (PMS) from baseline of \>=2 points or achieving clinical remission. Clinical remission was defined as PMS of \<= 2 with no subscore \>1. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity.
次要结局
- Percentage of Participants Who Achieved Clinical Remission at Week 8(Week 8)
- Percentage of Participants Who Achieved Clinical Response at Week 16(Week 16)
- Percentage of Participants Who Achieved Clinical Remission at Week 16(Week 16)
- Percentage of Participants Who Achieved Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 8(Week 8)
- Percentage of Participants Who Achieved IBDQ Remission at Week 16(Week 16)
- Percentage of Participants Who Achieved IBDQ Response at Week 8(Week 8)
- Percentage of Participants Who Achieved IBDQ Response at Week 16(Week 16)
- Percentage of Participants Who Achieved Biochemical Remission at Week 8(Week 8)
- Percentage of Participants Who Achieved Biochemical Remission at Week 16(Week 16)
- Median Change From Baseline in Stool Frequency Measured by Mayo Score Stool Frequency Subscore at Weeks 8 and 16(Baseline, Week 8 and Week 16)
- Median Change From Baseline in Rectal Bleeding Measured by Mayo Score Rectal Bleeding Subscore at Weeks 8 and 16(Baseline, Week 8 and Week 16)
- Median Change From Baseline in Urgency of Defecation Assessed Using Numeric Rating Scale (NRS) at Weeks 8 and 16(Baseline, Week 8 and Week 16)
- Median Change From Baseline in Abdominal Pain Assessed Using Pain NRS at Weeks 8 and 16(Baseline, Week 8 and Week 16)
- Median Change From Baseline in Quality of Sleep Assessed Using NRS at Weeks 8 and 16(Baseline, Week 8 and Week 16)
- Median Change From Baseline in Daily Fatigue Assessed Using NRS at Weeks 8 and 16(Baseline, Week 8 and Week 16)
- Median Change From Baseline in Weekly Fatigue Assessed Using FACIT-F at Weeks 8 and 16(Baseline, Week 8 and Week 16)
- Median Change From Baseline in IBDQ Score (Total) at Weeks 8 and 16(Baseline, Week 8 and Week 16)
- Median Change From Baseline in fCAL at Weeks 8 and 16(Baseline, Week 8 and Week 16)
- Correlations Between PMS and IBDQ Score(Baseline, Week 8 and Week 16)
- Correlations Between PMS and fCAL Concentration(Baseline, Week 8 and Week 16)
- Correlations Between Stool Frequency and fCAL Concentration(Baseline, Week 8 and Week 16)
- Correlations Between Rectal Bleeding and fCAL Concentration(Baseline, Week 8 and Week 16)
- Correlations Between Urgency of Defecation and fCAL Concentration(Baseline, Week 8 and Week 16)
- Correlations Between Abdominal Pain and fCAL Concentration(Baseline, Week 8 and Week 16)
- Correlations Between Quality of Sleep and fCAL Concentration(Baseline, Week 8 and Week 16)
- Correlations Between Daily Fatigue and fCAL Concentration(Baseline, Week 8 and Week 16)
- Correlations Between Weekly Fatigue and fCAL Concentration(Baseline, Week 8 and Week 16)
- Correlations Between IBDQ Score and fCAL Concentration(Baseline, Week 8 and Week 16)
- Correlations Between Stool Frequency and IBDQ Score(Baseline, Week 8 and Week 16)
- Correlations Between Rectal Bleeding and IBDQ Score(Baseline, Week 8 and Week 16)
- Correlations Between Urgency of Defecation and IBDQ Score(Baseline, Week 8 and Week 16)
- Correlations Between Abdominal Pain and IBDQ Score(Baseline, Week 8 and Week 16)
- Correlations Between Quality of Sleep and IBDQ Score(Baseline, Week 8 and Week 16)
- Correlations Between Daily Fatigue and IBDQ Score(Baseline, Week 8 and Week 16)
- Correlations Between Weekly Fatigue and IBDQ Score(Baseline, Week 8 and Week 16)
- Correlations Between PMS and Stool Frequency(Baseline, Week 8 and Week 16)
- Correlations Between PMS and Rectal Bleeding(Baseline, Week 8 and Week 16)
- Correlations Between PMS and Urgency of Defecation(Baseline, Week 8 and Week 16)
- Correlations Between PMS and Abdominal Pain(Baseline, Week 8 and Week 16)
- Correlations Between PMS and Quality of Sleep(Baseline, Week 8 and Week 16)
- Correlations Between PMS and Daily Fatigue(Baseline, Week 8 and Week 16)
- Correlations Between PMS and Weekly Fatigue(Baseline, Week 8 and Week 16)
- Median fCAL Concentrations Over Time Stratified by Week 8 Clinical Remission Status(Baseline, Week 8 and Week 16)
- Median fCAL Concentrations Over Time Stratified by Week 16 Clinical Remission Status(Baseline, Week 8 and Week 16)
- Median fCAL Concentrations Over Time Stratified by Week 8 Clinical Response Status(Baseline, Week 8 and Week 16)
- Median fCAL Concentrations Over Time Stratified by Week 16 Clinical Response Status(Baseline, Week 8 and Week 16)
研究者
研究点 (5)
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