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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05069259
Recruitment Status : Recruiting
First Posted : October 6, 2021
Last Update Posted : May 18, 2023
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.


Condition or disease Intervention/treatment
Ulcerative Colitis 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).

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : April 7, 2022
Estimated Primary Completion Date : October 20, 2023
Estimated Study Completion Date : October 20, 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Proportion of participants achieving clinical response [ Time Frame: Week 8 ]

    Clinical response is defined as a reduction in the Partial Mayo Score from baseline of ≥2 points or achieving clinical remission.

    Clinical remission is defined as Partial Mayo Score of ≤ 2 with no subscore >1.



Secondary Outcome Measures :
  1. Proportion of participants achieving clinical remission [ Time Frame: Week 8, Week 16 ]
    Clinical remission is defined as Partial Mayo Score of ≤ 2 with no subscore >1.

  2. Proportion of participants achieving clinical response [ Time Frame: Week 16 ]

    Clinical response is defined as a reduction in the Partial Mayo Score from baseline of ≥2 points or achieving clinical remission.

    Clinical remission is defined as Partial Mayo Score of ≤ 2 with no subscore >1.


  3. Proportion of participants achieving Inflammatory Bowel Disease Questionnaire remission [ Time Frame: Week 8, Week 16 ]

    Inflammatory Bowel Disease Questionnaire remission is defined as an Inflammatory Bowel Disease Questionnaire score ≥ 170.

    The Inflammatory Bowel Disease Questionnaire is a 32-item questionnaire grouped into four dimensions: bowel function, emotional status, systemic symptoms and social function. The total Inflammatory Bowel Disease Questionnaire score ranges from 32 to 224. For the total score and each domain, a higher score indicates better quality of life.


  4. Proportion of participants achieving Inflammatory Bowel Disease Questionnaire response [ Time Frame: Week 8, Week 16 ]
    Inflammatory Bowel Disease Questionnaire response is defined as an Inflammatory Bowel Disease Questionnaire score ≥16 points higher than Inflammatory Bowel Disease Questionnaire baseline score.

  5. Proportion of participants achieving biochemical remission [ Time Frame: Week 8, Week 16 ]

    Biochemical remission is defined as a fecal calprotectin concentration ≤250 mg/g.

    Fecal calprotectin 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, fecal calprotectin serves as a noninvasive biomarker for intestinal inflammation.


  6. Change from baseline in fecal calprotectin concentrations over time. [ Time Frame: Baseline to Week 16 ]
    Median change from baseline in fecal calprotectin concentrations over time. Fecal calprotectin concentration is a continuous outcome.

  7. Fecal calprotectin concentrations over time stratified by Week 8 clinical remission status [ Time Frame: Baseline to Week 16 ]

    Median fecal calprotectin concentrations over time stratified by participants' Week 8 clinical remission status.

    Clinical remission status is either achieved or not achieved. Clinical remission is defined as Partial Mayo Score of ≤ 2 with no subscore >1.


  8. Fecal calprotectin concentrations over time stratified by Week 16 clinical remission status [ Time Frame: Baseline to Week 16 ]

    Median fecal calprotectin concentrations over time stratified by participants' Week 16 clinical remission status.

    Clinical remission status is either achieved or not achieved. Clinical remission is defined as Partial Mayo Score of ≤ 2 with no subscore >1.


  9. Fecal calprotectin concentrations over time stratified by Week 8 clinical response status. [ Time Frame: Baseline to Week 16 ]

    Median fecal calprotectin concentrations over time stratified by participants' Week 8 clinical response status.

    Clinical response status is either achieved or not achieved. Clinical response is defined as a reduction in the Partial Mayo Score from baseline of ≥2 points or achieving clinical remission.

    Clinical remission is defined as Partial Mayo Score of ≤ 2 with no subscore >1.


  10. Fecal calprotectin concentrations over time stratified by Week 16 clinical response status [ Time Frame: Baseline to Week 16 ]

    Median fecal calprotectin concentrations over time stratified by participants' Week 16 clinical response status.

    Clinical response status is either achieved or not achieved. Clinical response is defined as a reduction in the Partial Mayo Score from baseline of ≥2 points or achieving clinical remission.

    Clinical remission is defined as Partial Mayo Score of ≤ 2 with no subscore >1.


  11. Fecal calprotectin concentrations stratified by Week 8 clinical response status [ Time Frame: Week 8 ]

    Median fecal calprotectin concentrations at Week 8 stratified by participants' Week 8 clinical response status. Clinical response status is either achieved or not achieved. Clinical response is defined as a reduction in the Partial Mayo Score from baseline of ≥2 points or achieving clinical remission.

    Clinical remission is defined as Partial Mayo Score of ≤ 2 with no subscore >1.


  12. Correlations between changes in amplitude and timing of Partial Mayo Score and Inflammatory Bowel Disease Questionnaire score [ Time Frame: Baseline to Week 16 ]
    Correlations are assessed by the Spearman correlation coefficient.

  13. Correlations between changes in amplitude and timing of Partial Mayo Score and fecal calprotectin concentration [ Time Frame: Baseline to Week 16 ]
    Correlations are assessed by the Spearman correlation coefficient.

  14. Correlations between changes in amplitude and timing of patient reported outcomes and fecal calprotectin concentration [ Time Frame: Baseline to Week 16 ]
    Correlations are assessed by the Spearman correlation coefficient. There are eight individual patient reported outcomes: stool frequency, rectal bleeding, urgency of defecation, abdominal pain, quality of sleep, daily fatigue, weekly fatigue and quality of life.

  15. Correlations between changes in amplitude and timing of patient reported outcomes and Inflammatory Bowel Disease Questionnaire score [ Time Frame: Baseline to Week 16 ]
    Correlations are assessed by the Spearman correlation coefficient. There are eight individual patient reported outcomes: stool frequency, rectal bleeding, urgency of defecation, abdominal pain, quality of sleep, daily fatigue, weekly fatigue and quality of life.

  16. Correlations between changes in amplitude and timing of Inflammatory Bowel Disease Questionnaire score and fecal calprotectin concentration. [ Time Frame: Baseline to Week 16 ]
    Correlations are assessed by the Spearman correlation coefficient.

  17. Change from baseline in stool frequency patient-reported outcome over time. [ Time Frame: Baseline to Week 16 ]

    Median change from baseline in each stool frequency patient-reported outcome over time.

    The stool frequency patient-reported outcome is assessed with one question about the number of stools on a given day. The Mayo Score stool frequency subscore is used for scoring. Scores range from 0 to 3 and higher scores indicate more severe disease activity. Each participant serves as his or her own control to establish the degree of abnormality of stool frequency.


  18. Change from baseline in rectal bleeding patient-reported outcome over time. [ Time Frame: Baseline to Week 16 ]

    Median change from baseline in each rectal bleeding patient-reported outcome over time.

    The rectal bleeding patient-reported outcome is assessed with one question about most severe rectal bleeding on a given day. The Mayo Score rectal bleeding subscore is used for scoring. Scores range from 0 to 3 and higher scores indicate more severe disease activity. Each participant serves as his or her own control to establish the degree of rectal bleeding.


  19. Change from baseline in urgency of defecation patient-reported outcome over time. [ Time Frame: Baseline to Week 16 ]

    Median change from baseline urgency of defecation patient-reported outcome over time.

    The Urgency of defecation patient-reported outcome is assessed with the Urgency Numeric Rating Scale. Scoring is done on a 11-point numeric rating scale. Participant can input a score from 0 to 10. Higher scores indicate more severe urgency.


  20. Change from baseline in abdominal pain patient-reported outcome over time. [ Time Frame: Baseline to Week 16 ]

    Median change from baseline in abdominal pain patient-reported outcome over time.

    The abdominal pain patient-reported outcome is assessed with the Pain Numeric Rating Scale. Scoring is done on a 10-point horizontal numeric rating scale. Participant can input a score from 1 to 10. Higher scores indicate more severe pain.


  21. Change from baseline in quality of sleep patient-reported outcome over time. [ Time Frame: Baseline to Week 16 ]

    Median change from baseline in quality of sleep patient-reported outcome over time.

    The quality of sleep patient-reported outcome is assessed with a question from the Sleep Quality visual analogue scale survey. Scoring is done on a 11-point numeric rating scale. Participant can input a score from 0 to 10. Higher scores indicate better quality of sleep.


  22. Change from baseline in daily fatigue patient-reported outcome over time. [ Time Frame: Baseline to Week 16 ]

    Median change from baseline in daily fatigue patient-reported outcome over time.

    The daily fatigue patient-reported outcome is assessed with the Fatigue numeric rating scale. Scoring is done on a 11-point numeric rating scale. Participant can input a score from 0 to 10. Higher scores indicate more severe fatigue.


  23. Change from baseline in weekly fatigue patient-reported outcome over time. [ Time Frame: Baseline to Week 16 ]

    Median change from baseline in each weekly fatigue patient-reported outcome over time.

    The weekly fatigue patient-reported outcome is assessed with 13 questions from the ("Additional concerns" section) FACIT-F (Version 4). Scoring is done on a Responses are recorded on a 5-point Likert scale. Scores range from 0 to 52, with higher scores representing greater fatigue.


  24. Change from baseline in Inflammatory Bowel Disease Questionnaire score over time. [ Time Frame: Baseline to Week 16 ]
    The Inflammatory Bowel Disease Questionnaire is a 32-item questionnaire on quality of life. The total Inflammatory Bowel Disease Questionnaire score ranges from 32 to 224. For the total score and each domain, a higher score indicates better quality of life.

  25. Correlations between changes in amplitude and timing of Partial Mayo Score and stool frequency patient-reported outco [ Time Frame: Baseline to Week 16 ]
    Correlations are assessed by the Spearman correlation coefficient. The stool frequency patient-reported outcome is assessed with one question about the number of stools on a given day. The Mayo Score stool frequency subscore is used for scoring. Scores range from 0 to 3 and higher scores indicate more severe disease activity. Each participant serves as his or her own control to establish the degree of abnormality of stool frequency.

  26. Correlations between changes in amplitude and timing of Partial Mayo Score and rectal bleeding patient-reported outcome. [ Time Frame: Baseline to Week 16 ]
    Correlations are assessed by the Spearman correlation coefficient. The rectal bleeding patient-reported outcome is assessed with one question about most severe rectal bleeding on a given day. The Mayo Score rectal bleeding subscore is used for scoring. Scores range from 0 to 3 and higher scores indicate more severe disease activity. Each participant serves as his or her own control to establish the degree of rectal bleeding.

  27. Correlations between changes in amplitude and timing of Partial Mayo Score and urgency of defecation patient-reported outcome. [ Time Frame: Baseline to Week 16 ]
    Correlations are assessed by the Spearman correlation coefficient. The Urgency of defecation patient-reported outcome is assessed with the Urgency Numeric Rating Scale. Scoring is done on a 11-point numeric rating scale. Participant can input a score from 0 to 10. Higher scores indicate more severe urgency.

  28. Correlations between changes in amplitude and timing of Partial Mayo Score and abdominal pain patient-reported outcome. [ Time Frame: Baseline to Week 16 ]

    Correlations are assessed by the Spearman correlation coefficient. The abdominal pain patient-reported outcome is assessed with the Pain Numeric Rating Scale. Scoring is done on a 10-point horizontal numeric rating scale. Participant can input a score from 1 to 10. Higher scores indicate more severe pain.

    Scoring is done on a 10-point horizontal numeric rating scale. Participant can input a score from 1 to 10. Higher scores indicate more severe pain.


  29. Correlations between changes in amplitude and timing of Partial Mayo Score and quality of sleep patient-reported outcome. [ Time Frame: Baseline to Week 16 ]

    Correlations are assessed by the Spearman correlation coefficient. The quality of sleep patient-reported outcome is assessed with a question from the Sleep Quality visual analogue scale survey.

    Scoring is done on a 11-point numeric rating scale. Participant can input a score from 0 to 10. Higher scores indicate better quality of sleep.


  30. Correlations between changes in amplitude and timing of Partial Mayo Score and daily fatigue patient-reported outcome. [ Time Frame: Baseline to Week 16 ]

    Correlations are assessed by the Spearman correlation coefficient. The daily fatigue patient-reported outcome is assessed with the Fatigue numeric rating scale.

    Scoring is done on a 11-point numeric rating scale. Participant can input a score from 0 to 10. Higher scores indicate more severe fatigue.


  31. Correlations between changes in amplitude and timing of Partial Mayo Score and weekly fatigue patient-reported outcome. [ Time Frame: Baseline to Week 16 ]
    Correlations are assessed by the Spearman correlation coefficient. The weekly fatigue patient-reported outcome is assessed with 13 questions from the ("Additional concerns" section) FACIT-F (Version 4). Scoring is done on a Responses are recorded on a 5-point Likert scale. Scores range from 0 to 52, with higher scores representing greater fatigue.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05069259


Contacts
Layout table for location contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Switzerland
Inselspital Bern Not yet recruiting
Bern, Bern (de), Switzerland, 3010
Kantonsspital St, Gallen Not yet recruiting
St. Gallen, Sankt Gallen, Switzerland, 9007
Clarunis, Universitätsspital Recruiting
Basel, Switzerland
Verein IBD Study Group Recruiting
Bern, Switzerland, CH - 3012
Centre Fribourgeois de Gastroenterologie Not yet recruiting
Fribourg, Switzerland
Kantonsspital Baselland Not yet recruiting
Liestal, Switzerland
Zentrum für Gastroenterologie und Hepatologie Not yet recruiting
Zuerich, Switzerland
University Hospital Zurich Not yet recruiting
Zurich, Switzerland, 8091
University Hospital Zurich Not yet recruiting
Zurich, Switzerland
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT05069259    
Other Study ID Numbers: A3921395
KIC-START ( Other Identifier: Alias Study Number )
First Posted: October 6, 2021    Key Record Dates
Last Update Posted: May 18, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases