Generate Real World Data On Tofacitinib Induction Therapy and Changes In Clinical and Patient Reported Outcomes. (KIC-START)

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

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.

Study Overview

• Status: Terminated
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Other: Stool sample collection

Detailed Description

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).

• Study Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland
    • Clarunis, Universitätsspital
  • Bern, Switzerland, CH - 3012
    • Verein IBD Study Group
  • Fribourg, Switzerland
    • Centre Fribourgeois de Gastroenterologie
  • Liestal, Switzerland
    • Kantonsspital Baselland
  • Canton of St. Gallen
    • Sankt Gallen, Canton of St. Gallen, Switzerland, 9007
      • Kantonsspital St, Gallen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

60 adults both male and female who are prescribed tofacitinib for moderately to severely active UC will be enrolled in the study.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with active Ulcerative Colitis	Other: Stool sample collection; collection for measuring calprotectin levels

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Achieved Clinical Response at 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.	Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Achieved Clinical Remission at Week 8	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.	Week 8
Percentage of Participants Who Achieved Clinical Response at Week 16	Clinical response was defined as a reduction in the 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.	Week 16
Percentage of Participants Who Achieved Clinical Remission at Week 16	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.	Week 16
Percentage of Participants Who Achieved Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 8	IBDQ remission was defined as an IBDQ score >= 170. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.	Week 8
Percentage of Participants Who Achieved IBDQ Remission at Week 16	IBDQ remission was defined as an IBDQ score >= 170. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.	Week 16
Percentage of Participants Who Achieved IBDQ Response at Week 8	IBDQ response was defined as an IBDQ score >=16 points higher than IBDQ baseline score. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.	Week 8
Percentage of Participants Who Achieved IBDQ Response at Week 16	IBDQ response was defined as an IBDQ score >=16 points higher than IBDQ baseline score. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.	Week 16
Percentage of Participants Who Achieved Biochemical Remission at Week 8	Biochemical remission was defined as a fecal calprotectin (fCAL) concentration <=250 micrograms per gram (mcg/g). fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.	Week 8
Percentage of Participants Who Achieved Biochemical Remission at Week 16	Biochemical remission was defined as a fCAL concentration <=250 mcg/g. fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.	Week 16
Median Change From Baseline in Stool Frequency Measured by Mayo Score Stool Frequency Subscore at Weeks 8 and 16	The stool frequency patient reported outcome (PRO) was assessed with one question about the number of stools on a given day. The Mayo Score stool frequency subscore was used for scoring. Scores ranged from 0 to 3 (0= normal number of stools; 1= 1-2 stools more than normal; 2= 3-4 stools more than normal and 3= 5 or more stools than normal) where higher scores indicated more severe disease activity.	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	The rectal bleeding PRO was assessed with one question about most severe rectal bleeding on a given day. The Mayo Score rectal bleeding subscore was used for scoring. Scores ranged from 0 to 3 (0= no blood seen; 1= streaks of blood with stool less than half the time; 2= obvious blood with stool most of the time and 3= blood alone passes) where higher scores indicated more severe bleeding of the day.	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	The urgency of defecation was assessed with the urgency NRS. Scoring was done on a 11-point NRS. Participant provided a score from 0 (no urgency) to 10 (worst possible urgency). Higher scores indicated more severe urgency.	Baseline, Week 8 and Week 16
Median Change From Baseline in Abdominal Pain Assessed Using Pain NRS at Weeks 8 and 16	The abdominal pain was assessed with the pain NRS. Scoring was done on a 10-point horizontal NRS. Participant provided a score from 1 (none) to 10 (very severe). Higher scores indicated more severe pain.	Baseline, Week 8 and Week 16
Median Change From Baseline in Quality of Sleep Assessed Using NRS at Weeks 8 and 16	The quality of sleep was assessed with a question from the sleep quality visual analogue scale survey. Scoring was done on a 11 NRS. Participant provided a score from 0 (very bad) to 10 (great). Higher scores indicated better quality of sleep.	Baseline, Week 8 and Week 16
Median Change From Baseline in Daily Fatigue Assessed Using NRS at Weeks 8 and 16	The daily fatigue was assessed with the fatigue NRS. Scoring was done on a 11-point NRS. Participant provided a score from 0 (no fatigue) to 10 (as bad as you can imagine). Higher scores indicated more severe fatigue.	Baseline, Week 8 and Week 16
Median Change From Baseline in IBDQ Score (Total) at Weeks 8 and 16	The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.	Baseline, Week 8 and Week 16
Median Change From Baseline in fCAL at Weeks 8 and 16	fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.	Baseline, Week 8 and Week 16
Correlations Between PMS and IBDQ Score	Correlation between PMS and IBDQ score was assessed by Spearman correlation coefficient. 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. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.	Baseline, Week 8 and Week 16
Correlations Between PMS and fCAL Concentration	Correlation between PMS and fCAL concentration was assessed by Spearman correlation coefficient. 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. fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.	Baseline, Week 8 and Week 16
Correlations Between Stool Frequency and fCAL Concentration	Correlation between stool frequency PRO and fCAL concentration was assessed by Spearman correlation coefficient. The stool frequency PRO was assessed with one question about the number of stools on a given day. The mayo score stool frequency subscore was used for scoring. Scores ranged from 0 to 3 (0= normal number of stools; 1= 1-2 stools more than normal; 2= 3-4 stools more than normal and 3= 5 or more stools than normal) where higher scores indicated more severe disease activity. fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.	Baseline, Week 8 and Week 16
Correlations Between Rectal Bleeding and fCAL Concentration	Correlation between rectal bleeding PRO and fCAL concentration was assessed by Spearman correlation coefficient. The rectal bleeding PRO was assessed with one question about most severe rectal bleeding on a given day. The Mayo Score rectal bleeding subscore was used for scoring. Scores ranged from 0 to 3 (0= no blood seen; 1= streaks of blood with stool less than half the time; 2= obvious blood with stool most of the time and 3= blood alone passes) where higher scores indicated more severe bleeding of the day. fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.	Baseline, Week 8 and Week 16
Correlations Between Urgency of Defecation and fCAL Concentration	Correlation between urgency of defecation and fCAL concentration was assessed by Spearman correlation coefficient. The urgency of defecation was assessed with the urgency NRS. Scoring was done on a 11-point NRS. Participant provided a score from 0 (no urgency) to 10 (worst possible urgency). Higher scores indicated more severe urgency. fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.	Baseline, Week 8 and Week 16
Correlations Between Abdominal Pain and fCAL Concentration	Correlation between abdominal pain and fCAL was assessed by Spearman correlation coefficient. The abdominal pain was assessed with the pain NRS. Scoring was done on a 10-point horizontal NRS. Participant provided a score from 1 (none) to 10 (very severe). Higher scores indicated more severe pain. fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.	Baseline, Week 8 and Week 16
Correlations Between Quality of Sleep and fCAL Concentration	Correlation between quality of sleep and fCAL concentration was assessed by Spearman correlation coefficient. The quality of sleep was assessed with a question from the sleep quality visual analogue scale survey. Scoring was done on a 11-point NRS. Participant provided a score from 0 (very bad) to 10 (great). Higher scores indicated better quality of sleep. fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.	Baseline, Week 8 and Week 16
Correlations Between Daily Fatigue and fCAL Concentration	Correlation between daily fatigue and fCAL concentration was assessed by Spearman correlation coefficient. The daily fatigue was assessed with the fatigue NRS. Scoring was done on a 11-point NRS. Participant provided a score from 0 (no fatigue) to 10 (as bad as you can imagine). Higher scores indicated more severe fatigue. fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.	Baseline, Week 8 and Week 16
Correlations Between IBDQ Score and fCAL Concentration	Correlation between IBDQ score and fCAL concentration was assessed by Spearman correlation coefficient. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life. fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.	Baseline, Week 8 and Week 16
Correlations Between Stool Frequency and IBDQ Score	Correlation between stool frequency PRO and IBDQ score was assessed by Spearman correlation coefficient. The stool frequency PRO was assessed with one question about the number of stools on a given day. The Mayo Score stool frequency subscore was used for scoring. Scores ranged from 0 to 3 (0= normal number of stools; 1= 1-2 stools more than normal; 2= 3-4 stools more than normal and 3= 5 or more stools than normal) where higher scores indicated more severe disease activity. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.	Baseline, Week 8 and Week 16
Correlations Between Rectal Bleeding and IBDQ Score	Correlation between rectal bleeding PRO and IBDQ score was assessed by Spearman correlation coefficient. The rectal bleeding PRO was assessed with one question about most severe rectal bleeding on a given day. The Mayo Score rectal bleeding subscore was used for scoring. Scores ranged from 0 to 3 (0= no blood seen; 1= streaks of blood with stool less than half the time; 2= obvious blood with stool most of the time and 3= blood alone passes) where higher scores indicated more severe bleeding of the day. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.	Baseline, Week 8 and Week 16
Correlations Between Urgency of Defecation and IBDQ Score	Correlation between urgency of defecation and IBDQ score was assessed by Spearman correlation coefficient. The urgency of defecation was assessed with the urgency NRS. Scoring was done on a 11-point NRS. Participant provided a score from 0 (no urgency) to 10 (worst possible urgency). Higher scores indicated more severe urgency. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.	Baseline, Week 8 and Week 16
Correlations Between Abdominal Pain and IBDQ Score	Correlation between abdominal pain and IBDQ score was assessed by Spearman correlation coefficient. The abdominal pain was assessed with the pain NRS. Scoring was done on a 10-point horizontal NRS. Participant provided a score from 1 (none) to 10 (very severe). Higher scores indicated more severe pain. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.	Baseline, Week 8 and Week 16
Correlations Between Quality of Sleep and IBDQ Score	Correlation between quality of sleep and IBDQ score was assessed by Spearman correlation coefficient. The quality of sleep was assessed with a question from the sleep quality visual analogue scale survey. Scoring was done on a 11-point NRS. Participant provided a score from 0 (very bad) to 10 (great). Higher scores indicated better quality of sleep. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.	Baseline, Week 8 and Week 16
Correlations Between Daily Fatigue and IBDQ Score	Correlation between daily fatigue and IBDQ score was assessed by Spearman correlation coefficient. The daily fatigue was assessed with the fatigue NRS. Scoring was done on a 11-point NRS. Participant provided a score from 0 (no fatigue) to 10 (as bad as you can imagine). Higher scores indicated more severe fatigue. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.	Baseline, Week 8 and Week 16
Correlations Between PMS and Stool Frequency	Correlation between PMS and stool frequency PRO was assessed by Spearman correlation coefficient. 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. The stool frequency PRO was assessed with one question about the number of stools on a given day. The Mayo Score stool frequency subscore was used for scoring. Scores ranged from 0 to 3 (0= normal number of stools; 1= 1-2 stools more than normal; 2= 3-4 stools more than normal and 3= 5 or more stools than normal) where higher scores indicated more severe disease activity.	Baseline, Week 8 and Week 16
Correlations Between PMS and Rectal Bleeding	Correlation between PMS and rectal bleeding PRO was assessed by Spearman correlation coefficient. 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. The rectal bleeding PRO was assessed with one question about most severe rectal bleeding on a given day. The Mayo Score rectal bleeding subscore was used for scoring. Scores ranged from 0 to 3 (0= no blood seen; 1= streaks of blood with stool less than half the time; 2= obvious blood with stool most of the time and 3= blood alone passes) where higher scores indicated more severe bleeding of the day.	Baseline, Week 8 and Week 16
Correlations Between PMS and Urgency of Defecation	Correlation between PMS and urgency of defecation was assessed by Spearman correlation coefficient. 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. The urgency of defecation was assessed with the urgency NRS. Scoring was done on a 11-point NRS. Participant provided a score from 0 (no urgency) to 10 (worst possible urgency). Higher scores indicated more severe urgency.	Baseline, Week 8 and Week 16
Correlations Between PMS and Abdominal Pain	Correlation between PMS and abdominal pain was assessed by Spearman correlation coefficient. 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. The abdominal pain was assessed with the pain NRS. Scoring was done on a 10-point horizontal NRS. Participant provided a score from 1 (none) to 10 (very severe). Higher scores indicated more severe pain.	Baseline, Week 8 and Week 16
Correlations Between PMS and Quality of Sleep	Correlation between PMS and quality of sleep was assessed by Spearman correlation coefficient. 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. The quality of sleep was assessed with a question from the sleep quality visual analogue scale survey. Scoring was done on a 11-point NRS. Participant provided a score from 0 (very bad) to 10 (great). Higher scores indicated better quality of sleep.	Baseline, Week 8 and Week 16
Correlations Between PMS and Daily Fatigue	Correlation between PMS and daily fatigue was assessed by Spearman correlation coefficient. 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. The daily fatigue was assessed with the fatigue NRS. Scoring was done on a 11-point NRS. Participant provided a score from 0 (no fatigue) to 10 (as bad as you can imagine). Higher scores indicated more severe fatigue.	Baseline, Week 8 and Week 16
Median fCAL Concentrations Over Time Stratified by Week 8 Clinical Remission Status	Clinical remission was defined as PMS of <= 2 with no subscore >1. Partial mayo score 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. In this outcome measure, fCAL concentration are reported at specified time points in those participants who had clinical remission at Week 8 and in those participants who did not have clinical remission at Week 8.	Baseline, Week 8 and Week 16
Median fCAL Concentrations Over Time Stratified by Week 16 Clinical Remission Status	Clinical remission was defined as PMS of <= 2 with no subscore >1. Partial mayo score 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. In this outcome measure, fCAL concentration are reported at specified time points in those participants who had clinical remission at Week 16 and in those participants who did not have clinical remission at Week 16.	Baseline, Week 8 and Week 16
Median fCAL Concentrations Over Time Stratified by Week 8 Clinical Response Status	Clinical response was defined as a reduction in the 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. In this outcome measure, fCAL concentration are reported at specified time points in those participants who had clinical response at Week 8 and in those participants who did not have clinical response at Week 8.	Baseline, Week 8 and Week 16
Median fCAL Concentrations Over Time Stratified by Week 16 Clinical Response Status	Clinical response was defined as a reduction in the 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. In this outcome measure, fCAL concentration are reported at specified time points in those participants who had clinical response at Week 16 and in those participants who did not have clinical response at Week 16.	Baseline, Week 8 and Week 16
Median Change From Baseline in Weekly Fatigue Assessed Using FACIT-F at Weeks 8 and 16	The weekly fatigue was assessed with 13 questions from the functional assessment of chronic illness therapy - fatigue (FACIT-F) version (v)4. Participants rated the intensity of their fatigue symptoms on a scale of 0 (not at all) to 4 (very much) for each 13 questions. Total score ranged from 0 to 52, with higher scores representing lower fatigue.	Baseline, Week 8 and Week 16
Correlations Between Weekly Fatigue and fCAL Concentration	Correlation between weekly fatigue and fCAL concentration was assessed by Spearman correlation coefficient. The weekly fatigue was assessed with 13 questions from the FACIT-F v4. Participants rated the intensity of their fatigue symptoms on a scale of 0 (not at all) to 4 (very much) for each 13 questions. Total score ranged from 0 to 52, with higher scores representing lower fatigue. fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.	Baseline, Week 8 and Week 16
Correlations Between Weekly Fatigue and IBDQ Score	Correlation between weekly fatigue and IBDQ score was assessed by Spearman correlation coefficient. The weekly fatigue was assessed with 13 questions from the FACIT-F v4. Participants rated the intensity of their fatigue symptoms on a scale of 0 (not at all) to 4 (very much) for each 13 questions. Total score ranged from 0 to 52, with higher scores representing lower fatigue. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.	Baseline, Week 8 and Week 16
Correlations Between PMS and Weekly Fatigue	Correlation between PMS and weekly fatigue was assessed by Spearman correlation coefficient. 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. The weekly fatigue was assessed with 13 questions from the FACIT-F v4. Participants rated the intensity of their fatigue symptoms on a scale of 0 (not at all) to 4 (very much) for each 13 questions. Total score ranged from 0 to 52, with higher scores representing lower fatigue.	Baseline, Week 8 and Week 16

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2022
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: September 1, 2021
• First Submitted That Met QC Criteria: September 27, 2021
• First Posted (Actual): October 6, 2021

Study Record Updates

• Last Update Posted (Estimated): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: A3921395; KIC-START (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No