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This Study is to Describe and Evaluate Patients in Finland Treated With Tofacitinib for the Treatment of Ulcerative Colitis Using Real World Data.

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ClinicalTrials.gov Identifier: NCT05082428
Recruitment Status : Not yet recruiting
First Posted : October 19, 2021
Last Update Posted : April 20, 2022
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
The aim of this study is to describe and evaluate clinical outcomes, treatment lines, and to identify the key characteristics of the patients treated with tofacitinib.

Condition or disease
Ulcerative Colitis

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Retrospective Non-interventional Multicenter Patient Chart Data Study on Tofacitinib Realworld Experience in Ulcerative Colitis in Finland (FinTofUC)
Estimated Study Start Date : May 16, 2022
Estimated Primary Completion Date : November 16, 2022
Estimated Study Completion Date : November 16, 2022

Resource links provided by the National Library of Medicine


Group/Cohort
Patients treated with Tofacitinib
Patients treated with tofacitinib for ulcerative colitis in Finland.



Primary Outcome Measures :
  1. Participant demographics at tofacitinib treatment initiation [ Time Frame: Baseline ]
    Age, gender, weight, height, smoking status, body mass index (BMI), treating hospital

  2. Disease characteristics at tofacitinib treatment initiation [ Time Frame: Baseline ]
    Age at diagnosis, duration of disease and extent of colonic involvement according to the Montreal classification: E1 (ulcerative proctitis), E2 (left sided, distal colitis), E3 (pancolitis)

  3. Disease severity at tofacitinib treatment initiation [ Time Frame: Baseline ]
    Assessed by Mayo score and fecal calprotectin (f-calprotectin)

  4. Laboratory results for biochemical inflammatory markers at tofacitinib treatment initiation [ Time Frame: Baseline ]
    Plasma C-reactive protein (P-CRP), blood thrombocytes (B-thromb), plasma albumin (P-alb), blood leukocytes (B-leuk), blood lymphocytes (B-ly), blood neutrophiles (B-neutr), blood hemoglobin (B-hb) and f-calprotectin

  5. Endoscopic findings including histology at tofacitinib treatment initiation [ Time Frame: Baseline ]

Secondary Outcome Measures :
  1. Proportion of patients who are taking tofacitinib [ Time Frame: Weeks 8, 16, 24, 52 ]
  2. Rate of clinical remission based on full Mayo score [ Time Frame: Weeks 8, 16, 24, 52 ]
    A clinical remission is defined as a full Mayo score of ≤2 points with no individual sub score exceeding 1 point, with rectal bleeding sub-score of 0

  3. Rate of clinical remission based on partial Mayo score [ Time Frame: Weeks 8, 16, 24, 52 ]
    A clinical remission is defined as a partial Mayo score <2 points with rectal bleeding sub-score of 0

  4. Rate of clinical response based on full Mayo score [ Time Frame: Weeks 8, 16, 24, 52 ]
    A clinical response is defined as a full Mayo score decrease of ≥3 points and a decrease of ≥30% from baseline, with a decrease of ≥1 point on the rectal bleeding sub score or an absolute rectal bleeding score of ≤1

  5. Rate of clinical response based on partial Mayo score [ Time Frame: Weeks 8, 16, 24, 52 ]
    A clinical response is defined as a partial Mayo score decrease of ≥2 points and reduction of at least 25% in partial Mayo score from baseline with an accompanying decrease in rectal bleeding sub score of ≥1 point or absolute rectal bleeding sub score of ≤1

  6. Proportion of participants in steroid-free clinical remission [ Time Frame: Weeks 8, 16, 24, 52 ]
    Steroid-free clinical remission is defined by full or partial Mayo who did not require any corticosteroid treatment during the period ≥4 weeks prior to the visit

  7. Proportion of participants reaching clinical response based on full Mayo score [ Time Frame: Weeks 8, 16, 24, 52 ]
    A clinical response is defined as a full Mayo score decrease of ≥3 points and a decrease of ≥30% from baseline, with a decrease of ≥1 point on the rectal bleeding sub score or an absolute rectal bleeding score of ≤1.

  8. Proportion of participants reaching clinical response based on partial Mayo score [ Time Frame: Weeks 8, 16, 24, 52 ]
    A clinical response is defined as a partial Mayo score decrease of ≥2 points and reduction of at least 25% in partial Mayo score from baseline with an accompanying decrease in rectal bleeding sub score of ≥1 point or absolute rectal bleeding sub score of ≤1

  9. Time to response as assessed by a decrease based on full Mayo score. [ Time Frame: Weeks 8, 16, 24, 52 ]
  10. Time to response as assessed by a decrease based on partial Mayo score. [ Time Frame: Weeks 8, 16, 24, 52 ]
  11. Proportion of participants that had f-calprotectin above 250 mg/kg [ Time Frame: Baseline ]
  12. Change from baseline in fecal calprotectin [ Time Frame: Baseline, Weeks 8, 16, 24, 52 ]
  13. Proportion of participants reaching f-calprotectin below 250 mg/kg of those with active disease based on f-calprotectin at baseline [ Time Frame: Weeks 8, 16, 24, 52 ]
    Active disease defined as fecal calprotectin (f-calprotectin) >250mg/kg.

  14. Proportion of participants in sustained remission (full Mayo score) [ Time Frame: Week 8 to week 16, 24 and 52 ]
  15. Proportion of participants in sustained remission (full Mayo score) [ Time Frame: Week 16 to week 24 and 52 ]
  16. Proportion of participants in sustained remission (partial Mayo score) [ Time Frame: Week 8 to week 16, 24 and 52 ]
  17. Proportion of participants in sustained remission (partial Mayo score) [ Time Frame: Week 16 to week 24 and 52 ]
  18. Proportion of participants in sustained steroid free remission (full Mayo score) (for all patients and for those treated with corticosteroids at baseline). [ Time Frame: Week 16 to 24 and 52 ]
  19. Proportion of participants in sustained steroid free remission (partial Mayo score) (for all patients and for those treated with corticosteroids at baseline). [ Time Frame: Week 16 to 24 and 52 ]
  20. Change in full Mayo score [ Time Frame: Baseline, Weeks 8, 16, 24, 52 ]
  21. Change in partial Mayo score [ Time Frame: Baseline, Weeks 8, 16, 24, 52 ]
  22. Proportion of participants in sustained endoscopic remission, mucosal healing or endoscopic response [ Time Frame: Baseline, Week 8 to week 16, 24 and 52 ]
    Endoscopic remission is defined as a sub score = 0. Mucosal healing is defined as a sub score 0-1. Endoscopic response is defined as a sub score reduction from baseline of ≥1.

  23. Proportion of participants in physician assessed histological remission determined as inactive disease, or normal histology, and change from baseline in histology assessment [ Time Frame: Baseline, Weeks 8, 16, 24, 52 ]
    Active disease is defined as an endoscopic Mayo sub-score of ≥2 or fecal-calprotectin (f-calprotectin) >250mg/kg. Histology is assessed as subscore 0= normal histology, 1= inactive disease and 2 = active disease.

  24. Proportion of participants in sustained steroid free remission (partial Mayo score) (for all patients and for those treated with corticosteroids at baseline) and endoscopic remission, mucosal healing or endoscopic response [ Time Frame: Baseline, Week 8 to week 16, 24 and 52 ]
    Endoscopic remission is defined as a sub score = 0. Mucosal healing is defined as a sub score 0-1. Endoscopic response is defined as a sub score reduction from baseline of ≥1.

  25. Proportion of participants in sustained steroid free remission (full Mayo score) (for all patients and for those treated with corticosteroids at baseline) and endoscopic remission, mucosal healing or endoscopic response [ Time Frame: Baseline, Week 8 to week 16, 24 and 52 ]
    Endoscopic remission is defined as a sub score = 0. Mucosal healing is defined as a sub score 0-1. Endoscopic response is defined as a sub score reduction from baseline of ≥1.

  26. Comparison of response and remission (full Mayo score) based on the extent of colonic involvement according to the Montreal classification [ Time Frame: Baseline, Weeks 8, 16, 24, 52 ]
  27. Comparison of response and remission (partial Mayo score) based on the extent of colonic involvement according to the Montreal classification [ Time Frame: Baseline, Weeks 8, 16, 24, 52 ]
  28. Proportion of participants with corticosteroid tapering and their tapering rates and doses [ Time Frame: Baseline, Weeks 8, 16, 24, 52 ]
  29. Proportion of participants with improvement in stool frequency and change from baseline in stool frequency sub score [ Time Frame: Baseline, Weeks 8, 16, 24, 52 ]
    Improvement in stool frequency defined as sub score improvement of 1 or more points

  30. Proportion of patients with improvement in rectal bleeding and change from baseline in rectal bleeding sub score [ Time Frame: Baseline, Weeks 8, 16, 24, 52 ]
    Improvement inrectal bleeding defined as sub score improvement of 1 or more points

  31. Proportion of participants reaching normal plasma C-reactive protein (P-CRP) levels and change from baseline [ Time Frame: Baseline, Weeks 8, 16, 24, 52 ]
    Normal P-CRP levels defined as below 4mg/L

  32. Proportion of participants reaching normal blood hemoglobin (B-hb) levels and change from baseline [ Time Frame: Baseline, Weeks 8, 16, 24, 52 ]
    Normal B-hb levels defined as men=134-167 g/L, women=117-155 g/L

  33. Proportion of participants reaching normal blood leukocyte (B-leuk) levels and change from baseline [ Time Frame: Baseline, Weeks 8, 16, 24, 52 ]
    Normal B-leuk levels defined as 3.4-8.2 x 109/L

  34. Proportion of participants reaching normal blood thrombocytes (B-Thromb) levels and change from baseline [ Time Frame: Baseline, Weeks 8, 16, 24, 52 ]
    Normal B-Thromb levels defined as 150-360 x 109/L

  35. Proportion of participants reaching normal blood lymphocyte (B-ly) levels and change from baseline [ Time Frame: Baseline, Weeks 8, 16, 24, 52 ]
    Normal B-ly levels defined as 1.3-3.6 x 109/L

  36. Proportion of participants reaching normal blood neutrophile (B-neutr) levels and change from baseline [ Time Frame: Baseline, Weeks 8, 16, 24, 52 ]
    Normal B-neutr levels defined as 1.5-6.7 x 109/L

  37. Proportion of participants reaching normal plasma albumin (P-alb) levels and change from baseline [ Time Frame: Baseline, Weeks 8, 16, 24, 52 ]
    Normal P-alb levels defined as 18-39 years=36-48 g/L, 40-69 years=36-45 g/L, 70 years and over=34-45 g/L

  38. Proportion of participants with extended tofacitinib induction dose [ Time Frame: Baseline, Weeks 8, 16, 24, 52 ]
    Participants with induction dose after 8 weeks

  39. Real-world dosing of tofacitinib [ Time Frame: Baseline, Weeks 8, 16, 24, 52 ]
  40. Survival without drug discontinuation, colectomy or UC-related hospitalization [ Time Frame: Baseline, Weeks 8, 16, 24, 52 ]
  41. To Assess Treatment Lines Prior to Tofacitinib Treatment. [ Time Frame: Baseline ]
    Number and type of previous UC treatments.

  42. Proportion of responders defined by a fecal calprotectin (f-calprotectin) reduction of ≥50%, ≥75% or ≥90% compared to baseline [ Time Frame: Baseline, Weeks 8, 16, 24, 52 ]
    Fecal calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Higher values indicate more serious inflammation.



Information from the National Library of Medicine

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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
This is a retrospective non-interventional multicenter patient chart review study, collecting real world data from 21 Finnish hospital district databases and for whom data is available.
Criteria

Inclusion Criteria:

  • Xeljanz (tofacitinib) usage for ulcerative colitis
  • Diagnosis of ulcerative colitis (ICD-10: K51.0, K51.1, K51.2, K51.3, K51.5, K51.8, K51.9) between January 2010 and December 2021 (incident or prevalent).

Exclusion Criteria:

  • Age < 18 years at the start of tofacitinib use
  • Use of tofacitinib before reimbursement (1.3.2019)
  • < 8 weeks of treatment with tofacitinib at the start of data mining
  • History of panproctocolectomy, IPAA or ileostomy.

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): NCT05082428


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Finland
Pfizer
Helsinki, Finland
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT05082428    
Other Study ID Numbers: A3921390
FinTofUC ( Other Identifier: Alias Study Number )
First Posted: October 19, 2021    Key Record Dates
Last Update Posted: April 20, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.
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