AzTrials
AzTrials

Ulcerative ColitisNCT05082428

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

An observational study of Ulcerative Colitis, run by Pfizer at 1 site in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ulcerative Colitis
How many people
252 participants
Where
1 siteFinland
Study dates
30 May 2022to 1 Nov 2022
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Finland1 site
  • Pfizer

    Helsinki

Other trials in Finland

About this study

Official title: Retrospective Non-interventional Multicenter Patient Chart Data Study on Tofacitinib Realworld Experience in Ulcerative Colitis in Finland (FinTofUC)

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.

Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05082428
Study groupRoleWhat they receive
Patients treated with TofacitinibPatients treated with tofacitinib for ulcerative colitis in Finland.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Age at the Time of Diagnosis

    Participant's age at the time of ulcerative colitis diagnosis was presented in this outcome measure. Index was considered as date of initiation of tofacitinib treatment for ulcerative colitis.

    Measured: At diagnosis (anytime between Jan 2010 and Dec-2021, approximately 12 years (from data collected and analyzed retrospectively over 5 months)

  2. Duration of Ulcerative Colitis

    Duration of ulcerative colitis was presented in this outcome measure. Index was considered as date of initiation of tofacitinib treatment for ulcerative colitis.

    Measured: At index (from data collected and analyzed retrospectively over 5 months)

  3. Number of Participants With Extent of Colonic Involvement According to the Montreal Classification

    Montreal classification was used to classify UC based on extent of inflammation. Three subgroups of UC were: E1= ulcerative proctitis: involvement limited to rectum i.e, proximal extent of inflammation is distal to rectosigmoid junction, E2= left sided, distal colitis: involvement limited to portion of colorectum distal to splenic flexure and E3= extensive UC (pancolitis): involvement extends proximal to the splenic flexure. Index was considered as date of initiation of tofacitinib treatment for UC.

    Measured: At index (from data collected and analyzed retrospectively over 5 months)

  4. Mayo Score at Initiation of Tofacitinib

    Mayo score was composed of four components: rectal bleeding, stool frequency, physician (doctors) assessment of disease activity, and endoscopy findings. Each sub score ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 12, where higher scores indicated higher disease severity. Index was considered as date of initiation of tofacitinib treatment for ulcerative colitis. Mayo scores and sub-scores have been collected by doctors independently as part of standard of care.

    Measured: At index (from data collected and analyzed retrospectively over 5 months)

  5. Partial Mayo Score at Initiation of Tofacitinib

    Partial Mayo score consisted of 3 components: rectal bleeding, stool frequency, and physician (doctors) assessment of disease activity. Each sub score ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 9, where higher scores indicated higher disease severity. Index was considered as date of initiation of tofacitinib treatment for ulcerative colitis. Partial Mayo scores and sub-scores have been collected by doctors independently as part of standard of care.

    Measured: At index (from data collected and analyzed retrospectively over 5 months)

  6. Number of Participants According to Endoscopic Findings Based on Histology

    Endoscopic findings were graded from 0 to 3 where 0 = Normal or inactive disease (Normal vascular pattern with arborization of capillaries clearly defined, or with blurring or patchy loss of capillary margins), 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3 = Severe disease (spontaneous bleeding, ulceration). Index was considered as date of initiation of tofacitinib treatment for ulcerative colitis.

    Measured: At index (from data collected and analyzed retrospectively over 5 months)

  7. Number of Participants According to Endoscopic Sub Score Based on Mayo Score

    Endoscopic findings were graded from 0 to 3 where 0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 3 = Severe disease (spontaneous bleeding, ulceration). Mayo score was composed of four components: rectal bleeding, stool frequency, physician assessment of disease activity and endoscopy findings. Each sub score ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 12, where higher scores indicated higher disease severity. Index was considered as date of initiation of tofacitinib treatment for ulcerative colitis.

    Measured: At index (from data collected and analyzed retrospectively over 5 months)

Secondary outcomes (56)
  1. Percentage of Participants Who Received Tofacitinib at Week 8, Week 16, Week 24 and Week 52

    Percentage of participants who received tofacitinib is presented in this outcome measure.

    Measured: Week 8, Week 16, Week 24 and Week 52

  2. Percentage of Participants With Clinical Remission Based on Full Mayo Score at Week 8, Week 16, Week 24 and Week 52

    Clinical remission in participants was defined as a full Mayo score of less than or equal to (<=) 2 points, with no individual sub score exceeding 1 point with rectal bleeding sub-score of 0. Full Mayo score consisted of 4 sub scores: rectal bleeding, stool frequency, physician assessment of disease activity, and endoscopy findings. Each subscore ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score which ranged from 0 to 12, where higher scores indicated higher disease severity.

    Measured: Week 8, Week 16, Week 24 and Week 52

  3. Percentage of Participants With Clinical Remission Based on Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52

    Clinical remission in participants was defined as a partial Mayo score of less than 2 points with rectal bleeding sub-score of 0. Partial Mayo score consisted of 3 sub scores: rectal bleeding, stool frequency, physician assessment of disease activity. Each sub score ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 9, where higher scores indicated higher disease severity.

    Measured: Week 8, Week 16, Week 24 and Week 52

  4. Percentage of Participants With Clinical Response Based on Full Mayo Score at Week 8, Week 16, Week 24 and Week 52

    Clinical response in participants was defined as a full Mayo score decrease of greater than or equal (>=) to 3 points and a decrease of >=30 percent (%) from baseline, with a decrease of >=1 point on the rectal bleeding sub score or an absolute rectal bleeding score of less than equal to (<=)1. Full Mayo score consisted of 4 sub scores: rectal bleeding, stool frequency, physician assessment of disease activity, and endoscopy findings. Each graded from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 12, where higher scores indicated higher disease severity.

    Measured: Week 8, Week 16, Week 24 and Week 52

  5. Percentage of Participants With Clinical Response Based on Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52

    Clinical response in participants was 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. Partial Mayo score consisted of 3 sub scores: rectal bleeding, stool frequency, physician assessment of disease activity. Each graded from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 9, where higher scores indicated higher disease severity.

    Measured: Week 8, Week 16, Week 24 and Week 52

  6. Percentage of Participants With Steroid-free Clinical Remission for All Participants Based on Full Mayo Score at Week 8, Week 16, Week 24 and Week 52

    Clinical remission in participants was defined as a full Mayo score of <=2 points, with no individual sub score exceeding 1 point with rectal bleeding sub-score of 0. Full Mayo score consisted of 4 sub scores: rectal bleeding, stool frequency, physician assessment of disease activity, and endoscopy findings, each graded from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 12, where higher scores indicated higher disease severity.

    Measured: Week 8, Week 16, Week 24 and Week 52

  7. Percentage of Participants With Steroid-free Clinical Remission for All Participants Based on Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52

    Clinical remission in participants was defined as a partial Mayo score of less than 2 points with rectal bleeding sub-score of 0. Partial Mayo score consisted of 3 sub scores: rectal bleeding, stool frequency, physician assessment of disease activity. Each graded from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 9, where higher scores indicated higher disease severity. Steroid-free clinical remission was defined for participants who were treated with corticosteroids at baseline and did not require any corticosteroid treatment during the period >=4 weeks prior to the visit.

    Measured: Week 8, Week 16, Week 24 and Week 52

  8. Percentage of Participants According to Time to Response Based on Full or Partial Mayo Score at 1, 2, 3, 6, 12, 24, 36 Months

    Time to clinical response was analyzed using a competing risk time-to-event model, where clinical response and drug discontinuation were assessed. Clinical response in participants was defined as full Mayo score decrease of >=3 points \& decrease of >=30% from baseline, with decrease of >=1 point on rectal bleeding sub score or absolute rectal bleeding score of <=1. Full Mayo score consisted of 4 sub scores: rectal bleeding, stool frequency, physician assessment of disease activity, \& endoscopy findings. Each graded from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). Sub scores were summed up to give total score range: 0 to 12, Partial Mayo score consisted of 3 components without endoscopy findings. Each graded from 0 to 3, sub scores were summed up to give total score range: 0 to 9.Higher scores indicated higher disease severity.

    Measured: At 1, 2, 3, 6, 12, 24 and 36 months

  9. Percentage of Participants With Fecal (F)-Calprotectin Reduction of >=50% at Week 8, Week 16, Week 24 and Week 52

    F-calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Percentage of participants with F-calprotectin reduction of >=50% from baseline at Week 8, Week 16, Week 24 and Week 52 is presented.

    Measured: Week 8, Week 16, Week 24 and Week 52

  10. Percentage of Participants With F-calprotectin Reduction of >=75% at Week 8, Week 16, Week 24 and Week 52

    F-calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Percentage of participants with F-calprotectin reduction of >=75% compared to baseline at Week 8, Week 16, Week 24 and Week 52 is presented.

    Measured: Week 8, Week 16, Week 24 and Week 52

  11. Percentage of Participants With F-calprotectin Reduction of >=90% at Week 8, Week 16, Week 24 and Week 52

    F-calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Percentage of participants with F-calprotectin reduction of >=90% compared to baseline at Week 8, Week 16, Week 24 and Week 52 is presented.

    Measured: Week 8, Week 16, Week 24 and Week 52

  12. Number of Participants Reaching F-calprotectin Below 250 mg/kg of Those That Had F-calprotectin Above 250 mg/kg at Baseline

    F-calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Percentage of participants reaching F-calprotectin below 250mg/kg at Week 8, Week 16, Week 24 and Week 52 in those participants who had F-calprotectin above 250 mg/kg at Baseline is presented.

    Measured: Week 8, Week 16, Week 24 and Week 52

  13. Change From Baseline in F-calprotectin at Week 8, Week 16, Week 24 and Week 52 With F-Calprotectin Above 250 mg/kg at Baseline

    F-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. Baseline was considered as date of initiation of tofacitinib.

    Measured: Baseline, Week 8, Week 16, Week 24 and Week 52

  14. Percentage of Participants in Sustained Remission Based on Full Mayo Score From Week 8 to Week 16, Week 24, and Week 52

    Sustained remission in participants was defined as a full Mayo score of <=2 points, with no individual sub score exceeding 1 point with rectal bleeding sub-score of 0. Full Mayo score consisted of 4 sub scores: rectal bleeding, stool frequency, physician assessment of disease activity, and endoscopy findings, each ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 12, where higher scores indicated higher disease severity.

    Measured: From Week 8 to Week 16, Week 24, and Week 52

  15. Percentage of Participants in Sustained Remission Based on Partial Mayo Score From Week 8 to Week 16, Week 24, and Week 52

    Sustained remission in participants was defined as a partial score of less than 2 points with rectal bleeding sub-score of 0. Partial Mayo score consisted of 3 sub scores: rectal bleeding, stool frequency, physician assessment of disease activity. Each sub score ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 9, where higher scores indicated higher disease severity.

    Measured: From Week 8 to Week 16, Week 24 and Week 52

  16. Percentage of Participants in Sustained Remission Based on Full Mayo Score From Week 16 to Week 24 and Week 52

    Sustained remission in participants was defined as a full Mayo score of >=2 points, with no individual sub score exceeding 1 point with rectal bleeding sub-score of 0. Full Mayo score consisted of 4 sub scores: rectal bleeding, stool frequency, physician assessment of disease activity, and endoscopy findings, each sub score ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 12, where higher scores indicated higher disease severity.

    Measured: From Week 16 to Week 24 and Week 52

  17. Percentage of Participants in Sustained Remission Based on Partial Mayo Score From Week 16 to Week 24 and Week 52

    Sustained remission in participants was defined as a partial score of less than 2 points with rectal bleeding sub-score of 0. Partial Mayo score consisted of 3 sub scores: rectal bleeding, stool frequency, physician assessment of disease activity. Each sub score ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 9, where higher scores indicated higher disease severity.

    Measured: From Week 16 to Week 24 and Week 52

  18. Percentage of Participants in Sustained Steroid Free Remission Based on Full Mayo Score From Week 16 to Week 24 and Week 52

    Clinical remission in participants was defined as a full Mayo score of <=2 points, with no individual sub score exceeding 1 point with rectal bleeding sub-score of 0. Full Mayo score consisted of 4 sub scores: rectal bleeding, stool frequency, physician assessment of disease activity, and endoscopy findings, each sub score ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 12, where higher scores indicated higher disease severity. Steroid-free clinical remission was defined as clinical remission in participants who were treated with corticosteroids at baseline and did not require any corticosteroid treatment during the period >=4 weeks prior to the visit.

    Measured: From Week 16 to Week 24 and Week 52

  19. Percentage of Participants in Sustained Steroid Free Remission Based on Partial Mayo Score From Week 16 to Week 24 and Week 52

    Clinical remission in participants was defined as a partial score of less than 2 points with rectal bleeding sub-score of 0. Partial Mayo score consisted of 3 sub scores: rectal bleeding, stool frequency, physician assessment of disease activity. Each sub score ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 9, where higher scores indicated higher disease severity. Steroid-free clinical remission was defined as clinical remission in participants who were treated with corticosteroids at baseline and did not require any corticosteroid treatment during the period >=4 weeks prior to the visit.

    Measured: From Week 16 to Week 24 and Week 52

  20. Change From Baseline in Full Mayo Score at Week 8, Week 16, Week 24 and Week 52

    Mayo score was an instrument designed to measure disease activity of UC. Full Mayo score consisted of 4 sub scores: rectal bleeding, stool frequency, physician assessment of disease activity, and endoscopy findings, each graded from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 12, where higher scores indicated higher disease severity. Baseline was considered as date of initiation of tofacitinib.

    Measured: Baseline, Week 8, Week 16, Week 24 and Week 52

  21. Change From Baseline in Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52

    Partial Mayo score consisted of 3 sub scores: rectal bleeding, stool frequency, physician assessment of disease activity. Each sub score ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 9, where higher scores indicated higher disease severity. Baseline was considered as date of initiation of tofacitinib.

    Measured: Baseline, Week 8, Week 16, Week 24 and Week 52

  22. Percentage of Participants in Sustained Endoscopic Remission, Mucosal Healing or Endoscopic Response From Week 8 to Week 16, Week 24 and Week 52

    Sustained endoscopic remission was defined as Mayo endoscopic sub score of 0. Mucosal healing = Mayo endoscopic sub score of 0 or 1. Endoscopic response= sub score reduction from baseline of >=1. The Mayo endoscopic sub score ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). Higher sub scores indicated higher disease severity.

    Measured: From Week 8 to Week 16, Week 24 and Week 52

  23. Percentage of Participants With Physician Assessed Histological Remission at Week 8, Week 16, Week 24 and Week 52

    Physician assessed histological remission was defined as inactive disease or normal histology. Inactive disease was characterized by marked architectural abnormalities in the absence of active inflammation.

    Measured: Week 8, Week 16, Week 24 and Week 52

  24. Change From Baseline in Histology Assessment at Week 8, Week 16, Week 24 and Week 52

    Histology assessment was categorized as, 1= inactive disease or normal histology and 2 = active disease. Inactive disease was characterized by marked architectural abnormalities in the absence of active inflammation. Active disease was characterized by absence of active inflammation. Baseline was considered as date of initiation of tofacitinib.

    Measured: Baseline, Week 8, Week 16, Week 24 and Week 52

  25. Percentage of Participants in Sustained Steroid Free Remission for All Participants Based on Full Mayo Score and Endoscopic Remission, Mucosal Healing or Endoscopic Response From Week 8 to Week 16, Week 24 and Week 52

    Sustained endoscopic remission was defined as Mayo endoscopic sub score of 0. Mucosal healing was defined by Mayo endoscopic sub score of 0 or 1. Endoscopic response was defined as sub score reduction from baseline of >=1. Full Mayo score consisted of 4 sub scores: rectal bleeding, stool frequency, physician assessment of disease activity, and endoscopy findings, each graded from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 12, where higher scores indicated higher disease severity. Steroid-free clinical remission was defined as clinical remission in participants who were treated with corticosteroids at baseline and did not require any corticosteroid treatment during the period >=4 weeks prior to the visit.

    Measured: From Week 8 to Week 16, Week 24 and Week 52

  26. Percentage of Participants in Sustained Steroid Free Remission for All Participants Based on Partial Mayo Score and Endoscopic Remission, Mucosal Healing or Endoscopic Response From Week 8 to Week 16, Week 24 and Week 52

    Sustained endoscopic remission was defined as Mayo endoscopic sub score of 0. Mucosal healing was defined by Mayo endoscopic sub score of 0 or 1. Endoscopic response was defined as sub score reduction from baseline of >=1. Partial Mayo score consisted of 3 sub scores: rectal bleeding, stool frequency, physician assessment of disease activity. Each graded from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 9, where higher scores indicated higher disease severity. Steroid-free clinical remission was defined as participants who were treated with corticosteroids at baseline and did not require any corticosteroid treatment during the period >=4 weeks prior to the visit.

    Measured: From Week 8 to Week 16, Week 24 and Week 52

  27. Number of Participants With Clinical Remission Based on Full Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52

    Montreal classification was system used to classify UC based on the extent of inflammation. Three subgroups of UC were defined by extent of colonic involvement: E1= ulcerative proctitis: involvement limited to the rectum i.e, proximal extent of inflammation is distal to rectosigmoid junction, E2= left sided UC also known as distal colitis: involvement limited to portion of colorectum distal to the splenic flexure, E3= extensive UC (pancolitis): involvement extents proximal to splenic flexure. Clinical remission: full Mayo score of <=2 points, with no individual sub score exceeding 1 point with rectal bleeding sub-score of 0. Full Mayo score consisted of 4 sub scores: rectal bleeding, stool frequency, physician assessment of disease activity, \& endoscopy findings, each sub score ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give total score range of 0 to 12. Higher scores indicated higher disease severity.

    Measured: Week 8, Week 16, Week 24, and Week 52

  28. Number of Participants With Clinical Remission Based on Partial Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52

    Montreal Classification was system used to classify UC based on the extent of inflammation. Three subgroups of UC were defined by extent of colonic involvement: E1= ulcerative proctitis: involvement limited to the rectum i.e, proximal extent of inflammation is distal to rectosigmoid junction, E2= left sided UC also known as distal colitis: involvement limited to portion of colorectum distal to the splenic flexure, E3= extensive UC (pancolitis): involvement extents proximal to splenic flexure. Clinical remission: partial score of less than 2 points with rectal bleeding sub-score of 0. Partial Mayo score consisted of 3 sub scores: rectal bleeding, stool frequency, physician assessment of disease activity. Each graded from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 9, where higher scores indicated higher disease severity.

    Measured: Week 8, Week 16, Week 24, and Week 52

  29. Number of Participants With Clinical Response Based on Full Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52

    Montreal Classification was used to classify ulcerative colitis (UC) based on extent of inflammation. Three subgroups of UC were: E1= ulcerative proctitis: involvement limited to rectum i.e, proximal extent of inflammation is distal to rectosigmoid junction, E2= left sided, distal colitis: involvement limited to portion of colorectum distal to splenic flexure and E3= extensive UC (pancolitis): involvement extends proximal to the splenic flexure. Clinical response: full Mayo score decrease of >= 3 points \& decrease of >=30% from baseline, with decrease of >=1 point on rectal bleeding sub score or an absolute rectal bleeding score of less than equal to (<=)1. Full Mayo score consisted of 4 sub scores: rectal bleeding, stool frequency, physician assessment of disease activity, and endoscopy findings, each graded from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 12. Higher scores indicated higher disease severity.

    Measured: Week 8, Week 16, Week 24, and Week 52

  30. Number of Participants With Clinical Response Based on Partial Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52

    Montreal Classification was used to classify ulcerative colitis (UC) based on extent of inflammation. Three subgroups of UC were: E1= ulcerative proctitis: involvement limited to rectum i.e, proximal extent of inflammation is distal to rectosigmoid junction, E2= left sided, distal colitis: involvement limited to portion of colorectum distal to splenic flexure and E3= extensive UC (pancolitis): involvement extends proximal to the splenic flexure. Clinical response: full Mayo score decrease of >=3 points and decrease of >=30% from baseline, with a decrease of >=1 point on rectal bleeding sub score or an absolute rectal bleeding score of less than equal to (<=)1. Partial Mayo score consisted of 3 sub scores: rectal bleeding, stool frequency, physician assessment of disease activity. Each graded from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 9, where higher scores indicated higher disease severity.

    Measured: Week 8, Week 16, Week 24, and Week 52

  31. Percentage of Participants With Corticosteroid Tapering at Week 8, Week 16, Week 24 and Week 52

    Percentage of participants with corticosteroid tapering response was collected as Yes or No based on latest available data.

    Measured: Week 8, Week 16, Week 24 and Week 52

  32. Tapering Rate

    Corticosteroid tapering rate is reported in this outcome measure.

    Measured: Up to Week 52

  33. Corticosteroid Tapering Dose

    Measured: Up to Week 52

  34. Percentage of Participants With Improvement in Stool Frequency Sub Score of 1 or More Points at Week 8, Week 16, Week 24 and Week 52

    Stool frequency sub score ranged from 0 to 3, where, 0 = Normal, 1 = 1 to 2 stools per day more than normal, 2 = 3 to 4 stools per day more than normal, 3 = 5 or more stools per day than normal. Percentage of participants with improvement in stool frequency sub score of 1 or more points is presented.

    Measured: Week 8, Week 16, Week 24 and Week 52

  35. Change From Baseline in Stool Frequency Sub Score at Week 8, Week 16, Week 24 and Week 52

    Stool frequency sub score ranged from 0 to 3, where, 0 = Normal, 1 = 1 to 2 stools per day more than normal, 2 = 3 to 4 stools per day more than normal, 3 = 5 or more stools per day than normal.

    Measured: Baseline, Week 8, Week 16, Week 24 and Week 52

  36. Percentage of Participants With Improvement in Rectal Bleeding Sub Score of 1 or More Points at Week 8, Week 16, Week 24 and Week 52

    Rectal bleeding sub scores ranged from 0 to 3, where, 0 = None, 1 = Visible blood with stool less than half the time, 2 = Visible blood with stool half of the time or more, 3 = Passing blood alone. Percentage of participants with improvement in rectal bleeding sub score of 1 or more points are presented.

    Measured: Week 8, Week 16, Week 24 and Week 52

  37. Change From Baseline in Rectal Bleeding Sub Score at Week 8, Week 16, Week 24 and Week 52

    Rectal bleeding sub scores ranged from 0 to 3, where, 0 = None, 1 = Visible blood with stool less than half the time, 2 = Visible blood with stool half of the time or more, 3 = Passing blood alone. Baseline was considered as initiation of tofacitinib.

    Measured: Baseline, Week 8, Week 16, Week 24 and Week 52

  38. Percentage of Participants Reaching Normal P-CRP, B-hb, B-leuk, B-Thromb, B-ly, B-Neutr and P-alb Levels at Week 8, Week 16, Week 24 and Week 52

    Normal values for the parameters were as follows: P-CRP: below 4 milligrams per liter (mg/L), B-hb: men: 134 to 167 grams per liter (g/L), women: 117-155 g/L, B-leuk: 3.4 to 8.2*10^9 cells/L, B-Thromb: 150 to 360*10^9 cells/L, B-ly: 1.3 to3.6*10^9 cells/L, B-Neutr: 1.5 to6.7*10^9 cells/L, P-alb: 18 to 39 years: 36 to 48 g/L, 40 to 69 years: 36 to 45 g/L, 70 years and over: 34 to 45 g/L.

    Measured: Week 8, Week 16, Week 24 and Week 52

  39. Change From Baseline in P-CRP Levels at Week 8, Week 16, Week 24 and Week 52

    Baseline was considered as date of initiation of tofacitinib.

    Measured: Baseline, Week 8, Week 16, Week 24 and Week 52

  40. Change From Baseline in B-hb and P-alb Levels at Week 8, Week 16, Week 24 and Week 52

    Baseline was considered as date of initiation of tofacitinib.

    Measured: Baseline, Week 8, Week 16, Week 24 and Week 52

  41. Change From Baseline in B-leuk, B-ly, B-neutr and B-Thromb Levels at Week 8, Week 16, Week 24 and Week 52

    Baseline was considered as date of initiation of tofacitinib.

    Measured: Baseline, Week 8, Week 16, Week 24 and Week 52

  42. Percentage of Participants With Extended Tofacitinib Induction Dose at Week 8, Week 16

    Percentage of participants with extended tofacitinib induction dose (additional 8 weeks with 10 mg) is presented in this outcome measure.

    Measured: Week 8 and Week 16

  43. Percentage of Participants With Higher Dose (10 mg) of Tofacitinib For All Participants at Week 8, Week 16, Week 24 and Week 52

    Percentage of participants with higher dose (10 mg) of tofacitinib (for all participants) is presented in this outcome measure.

    Measured: Week 8, Week 16, Week 24 and Week 52

  44. Number of Participants With Higher Dose (10mg) of Tofacitinib of Those on Treatment at Week 8, Week 16, Week 24 and Week 52

    Percentage of participants with higher (10 mg) dose of tofacitinib in participants who received treatment at different timepoints is presented in this outcome measure.

    Measured: Week 8, Week 16, Week 24 and Week 52

  45. Time to Drug Discontinuation, Colectomy or UC-related Hospitalization

    Time to survival without drug discontinuation, colectomy or UC-related hospitalization was calculated using time to event analysis.

    Measured: Up to Week 52

  46. Number of Previous Treatments

    Number of previous treatments received by participants is presented in this outcome measure.

    Measured: Up to Week 52

  47. Number of Participants According to Type of Previous Treatment

    Number of participants according to type of their previous treatment received is presented.

    Measured: Up to Week 52

  48. Number of Participants With Steroid-free Clinical Remission of Those Treated With Corticosteroids at Baseline Based on Full Mayo Score at Week 8, Week 16, Week 24 and Week 52

    Clinical remission in participants was defined as a full Mayo score of <=2 points, with no individual sub score exceeding 1 point with rectal bleeding sub-score of 0. Full Mayo score consisted of 4 sub scores: rectal bleeding, stool frequency, physician assessment of disease activity, and endoscopy findings, each graded from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 12, where higher scores indicated higher disease severity. Steroid-free clinical remission was defined as participants who were treated with corticosteroids at baseline and did not require any corticosteroid treatment during the period >=4 weeks prior to the visit.

    Measured: Week 8, Week 16, Week 24 and Week 52

  49. Number of Participants With Steroid-free Clinical Remission of Those Treated With Corticosteroids at Baseline Based on Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52

    Clinical remission in participants was defined as a partial Mayo score of less than 2 points with rectal bleeding sub-score of 0. Partial Mayo score consisted of 3 sub scores: rectal bleeding, stool frequency, physician assessment of disease activity. Each graded from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 9, where higher scores indicated higher disease severity. Steroid-free clinical remission was defined for participants who were treated with corticosteroids at baseline and did not require any corticosteroid treatment during the period >=4 weeks prior to the visit.

    Measured: Week 8, Week 16, Week 24 and Week 52

  50. Percentage of Participants That Had f-Calprotectin Above 250 mg/kg at Baseline

    F-calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Percentage of Participants That had f-Calprotectin Above 250 mg/kg at Baseline is presented.

    Measured: At index (date of initiation of tofacitinib treatment for ulcerative colitis)

  51. Change From Baseline in F-calprotectin at Week 8, Week 16, Week 24 and Week 52

    F-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. Baseline was considered as date of initiation of tofacitinib.

    Measured: Baseline, Week 8, Week 16, Week 24 and Week 52

  52. Percentage of Participants in Sustained Steroid Free Remission for Those Treated With Corticosteroids at Baseline Based on Full Mayo Score From Week 16 to Week 24 and Week 52

    Clinical remission in participants was defined as a full Mayo score of <=2 points, with no individual sub score exceeding 1 point with rectal bleeding sub-score of 0. Full Mayo score consisted of 4 sub scores: rectal bleeding, stool frequency, physician assessment of disease activity, and endoscopy findings, each sub score ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 12, where higher scores indicated higher disease severity. Steroid-free clinical remission was defined as clinical remission in participants who were treated with corticosteroids at baseline and did not require any corticosteroid treatment during the period >=4 weeks prior to the visit.

    Measured: From Week 16 to Week 24 and Week 52

  53. Percentage of Participants in Sustained Steroid Free Remission for Those Treated With Corticosteroids at Baseline Based on Partial Mayo Score From Week 16 to Week 24 and Week 52

    Clinical remission in participants was defined as a partial score of less than 2 points with rectal bleeding sub-score of 0. Partial Mayo score consisted of 3 sub scores: rectal bleeding, stool frequency, physician assessment of disease activity. Each sub score ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 9, where higher scores indicated higher disease severity. Steroid-free clinical remission was defined as clinical remission in participants who were treated with corticosteroids at baseline and did not require any corticosteroid treatment during the period >=4 weeks prior to the visit.

    Measured: From Week 16 to Week 24 and Week 52

  54. Percentage of Participants in Sustained Steroid Free Remission for Those Treated With Corticosteroids at Baseline Based on Partial Mayo Score and Endoscopic Remission, Mucosal Healing or Endoscopic Response From Week 8 to Week 16, Week 24 and Week 52

    Sustained endoscopic remission was defined as Mayo endoscopic sub score of 0. Mucosal healing was defined by Mayo endoscopic sub score of 0 or 1. Endoscopic response was defined as sub score reduction from baseline of >=1. Partial Mayo score consisted of 3 sub scores: rectal bleeding, stool frequency, physician assessment of disease activity. Each graded from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 9, where higher scores indicated higher disease severity. Steroid-free clinical remission was defined as participants who were treated with corticosteroids at baseline and did not require any corticosteroid treatment during the period >=4 weeks prior to the visit.

    Measured: From Week 8 to Week 16, Week 24 and Week 52

  55. Percentage of Participants in Sustained Steroid Free Remission for Those Treated With Corticosteroids at Baseline Based on Full Mayo Score and Endoscopic Remission, Mucosal Healing or Endoscopic Response From Week 8 to Week 16, Week 24 and Week 52

    Sustained endoscopic remission was defined as Mayo endoscopic sub score of 0. Mucosal healing was defined by Mayo endoscopic sub score of 0 or 1. Endoscopic response was defined as sub score reduction from baseline of >=1. Full Mayo score consisted of 4 sub scores: rectal bleeding, stool frequency, physician assessment of disease activity, and endoscopy findings, each graded from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 12, where higher scores indicated higher disease severity. Steroid-free clinical remission was defined as clinical remission in participants who were treated with corticosteroids at baseline and did not require any corticosteroid treatment during the period >=4 weeks prior to the visit.

    Measured: From Week 8 to Week 16, Week 24 and Week 52

  56. Absolute Values of Blood Hemoglobin and Plasma Albumin at Baseline

    Absolute Values of Blood Hemoglobin and Plasma Albumin at Baseline are presented in this outcome measure.

    Measured: At index (from data collected and analyzed retrospectively over 5 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2021
  2. Study start30 May 2022
  3. Primary completion1 Nov 2022
  4. Study completion1 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Retrospective
Enrolment
252 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05082428
Sponsor's protocol ID
A3921390
Other IDs
FinTofUC
Status last verified
Jun 2024
First submitted
5 Oct 2021
Last updated
23 Sep 2024
Data monitoring committee
No
Individual data sharing
No: 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.

Publications

  • Molander P, Kosunen M, Eronen H, Tillonen J, Karajamaki A, Heikkinen M, Punkkinen J, Mattila R, Toppila I, Holsa O, Kalpala K, Henrohn D, Af Bjorkesten CG. Tofacitinib real-world experience in ulcerative colitis in Finland (FinTofUC): a retrospective non-interventional multicenter patient chart data study. Scand J Gastroenterol. 2024 Apr;59(4):425-432. doi: 10.1080/00365521.2023.2298361. Epub 2023 Dec 29.

    PubMed 38156792

Questions about this trial

What is this clinical trial studying?

An observational study of Ulcerative Colitis, run by Pfizer at 1 site in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Age at the Time of Diagnosis (time frame: At diagnosis (anytime between Jan 2010 and Dec-2021, approximately 12 years (from data collected and analyzed retrospectively over 5 months)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05082428, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.

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