Clinical trial NCT05069259: Generate Real World Data On Tofacitinib Induction Therapy and Changes In Clinical and Patient Reported Outcomes.
Official title: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Ulcerative Colitis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-10-06
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Who Achieved Clinical Response at Week 8
timeFrame: Week 8
Secondary outcomes:
measure: Percentage of Participants Who Achieved Clinical Remission at Week 8
timeFrame: Week 8
measure: Percentage of Participants Who Achieved Clinical Response at Week 16
timeFrame: Week 16
measure: Percentage of Participants Who Achieved Clinical Remission at Week 16
timeFrame: Week 16
measure: Percentage of Participants Who Achieved Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 8
timeFrame: Week 8
measure: Percentage of Participants Who Achieved IBDQ Remission at Week 16
timeFrame: Week 16
measure: Percentage of Participants Who Achieved IBDQ Response at Week 8
timeFrame: Week 8
measure: Percentage of Participants Who Achieved IBDQ Response at Week 16
timeFrame: Week 16
measure: Percentage of Participants Who Achieved Biochemical Remission at Week 8
timeFrame: Week 8
measure: Percentage of Participants Who Achieved Biochemical Remission at Week 16
timeFrame: Week 16
measure: Median Change From Baseline in Stool Frequency Measured by Mayo Score Stool Frequency Subscore at Weeks 8 and 16
timeFrame: Baseline, Week 8 and Week 16
measure: Median Change From Baseline in Rectal Bleeding Measured by Mayo Score Rectal Bleeding Subscore at Weeks 8 and 16
timeFrame: Baseline, Week 8 and Week 16
measure: Median Change From Baseline in Urgency of Defecation Assessed Using Numeric Rating Scale (NRS) at Weeks 8 and 16
timeFrame: Baseline, Week 8 and Week 16
measure: Median Change From Baseline in Abdominal Pain Assessed Using Pain NRS at Weeks 8 and 16
timeFrame: Baseline, Week 8 and Week 16
measure: Median Change From Baseline in Quality of Sleep Assessed Using NRS at Weeks 8 and 16
timeFrame: Baseline, Week 8 and Week 16
measure: Median Change From Baseline in Daily Fatigue Assessed Using NRS at Weeks 8 and 16
timeFrame: Baseline, Week 8 and Week 16
measure: Median Change From Baseline in Weekly Fatigue Assessed Using FACIT-F at Weeks 8 and 16
timeFrame: Baseline, Week 8 and Week 16
measure: Median Change From Baseline in IBDQ Score (Total) at Weeks 8 and 16
timeFrame: Baseline, Week 8 and Week 16
measure: Median Change From Baseline in fCAL at Weeks 8 and 16
timeFrame: Baseline, Week 8 and Week 16
measure: Correlations Between PMS and IBDQ Score
timeFrame: Baseline, Week 8 and Week 16
measure: Correlations Between PMS and fCAL Concentration
timeFrame: Baseline, Week 8 and Week 16
measure: Correlations Between Stool Frequency and fCAL Concentration
timeFrame: Baseline, Week 8 and Week 16
measure: Correlations Between Rectal Bleeding and fCAL Concentration
timeFrame: Baseline, Week 8 and Week 16
measure: Correlations Between Urgency of Defecation and fCAL Concentration
timeFrame: Baseline, Week 8 and Week 16
measure: Correlations Between Abdominal Pain and fCAL Concentration
timeFrame: Baseline, Week 8 and Week 16
measure: Correlations Between Quality of Sleep and fCAL Concentration
timeFrame: Baseline, Week 8 and Week 16
measure: Correlations Between Daily Fatigue and fCAL Concentration
timeFrame: Baseline, Week 8 and Week 16
measure: Correlations Between Weekly Fatigue and fCAL Concentration
timeFrame: Baseline, Week 8 and Week 16
measure: Correlations Between IBDQ Score and fCAL Concentration
timeFrame: Baseline, Week 8 and Week 16
measure: Correlations Between Stool Frequency and IBDQ Score
timeFrame: Baseline, Week 8 and Week 16
measure: Correlations Between Rectal Bleeding and IBDQ Score
timeFrame: Baseline, Week 8 and Week 16
measure: Correlations Between Urgency of Defecation and IBDQ Score
timeFrame: Baseline, Week 8 and Week 16
measure: Correlations Between Abdominal Pain and IBDQ Score
timeFrame: Baseline, Week 8 and Week 16
measure: Correlations Between Quality of Sleep and IBDQ Score
timeFrame: Baseline, Week 8 and Week 16
measure: Correlations Between Daily Fatigue and IBDQ Score
timeFrame: Baseline, Week 8 and Week 16
measure: Correlations Between Weekly Fatigue and IBDQ Score
timeFrame: Baseline, Week 8 and Week 16
measure: Correlations Between PMS and Stool Frequency
timeFrame: Baseline, Week 8 and Week 16
measure: Correlations Between PMS and Rectal Bleeding
timeFrame: Baseline, Week 8 and Week 16
measure: Correlations Between PMS and Urgency of Defecation
timeFrame: Baseline, Week 8 and Week 16
measure: Correlations Between PMS and Abdominal Pain
timeFrame: Baseline, Week 8 and Week 16
measure: Correlations Between PMS and Quality of Sleep
timeFrame: Baseline, Week 8 and Week 16
measure: Correlations Between PMS and Daily Fatigue
timeFrame: Baseline, Week 8 and Week 16
measure: Correlations Between PMS and Weekly Fatigue
timeFrame: Baseline, Week 8 and Week 16
measure: Median fCAL Concentrations Over Time Stratified by Week 8 Clinical Remission Status
timeFrame: Baseline, Week 8 and Week 16
measure: Median fCAL Concentrations Over Time Stratified by Week 16 Clinical Remission Status
timeFrame: Baseline, Week 8 and Week 16
measure: Median fCAL Concentrations Over Time Stratified by Week 8 Clinical Response Status
timeFrame: Baseline, Week 8 and Week 16
measure: Median fCAL Concentrations Over Time Stratified by Week 16 Clinical Response Status
timeFrame: Baseline, Week 8 and Week 16
Other outcomes:
Locations:
city: St. Gallen
country: Switzerland
facility: Kantonsspital St, Gallen
state: Sankt Gallen
city: Basel
country: Switzerland
facility: Clarunis, Universitätsspital
city: Bern
country: Switzerland
facility: Verein IBD Study Group
city: Fribourg
country: Switzerland
facility: Centre Fribourgeois de Gastroenterologie
city: Liestal
country: Switzerland
facility: Kantonsspital Baselland
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: