Clinical trial NCT05082428: This Study is to Describe and Evaluate Patients in Finland Treated With Tofacitinib for the Treatment of Ulcerative Colitis Using Real World Data.
Official title: Retrospective Non-interventional Multicenter Patient Chart Data Study on Tofacitinib Realworld Experience in Ulcerative Colitis in Finland (FinTofUC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ulcerative Colitis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-10-19
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: Age at the Time of Diagnosis
timeFrame: At diagnosis (anytime between Jan 2010 and Dec-2021, approximately 12 years (from data collected and analyzed retrospectively over 5 months)
measure: Duration of Ulcerative Colitis
timeFrame: At index (from data collected and analyzed retrospectively over 5 months)
measure: Number of Participants With Extent of Colonic Involvement According to the Montreal Classification
timeFrame: At index (from data collected and analyzed retrospectively over 5 months)
measure: Mayo Score at Initiation of Tofacitinib
timeFrame: At index (from data collected and analyzed retrospectively over 5 months)
measure: Partial Mayo Score at Initiation of Tofacitinib
timeFrame: At index (from data collected and analyzed retrospectively over 5 months)
measure: Number of Participants According to Endoscopic Findings Based on Histology
timeFrame: At index (from data collected and analyzed retrospectively over 5 months)
measure: Number of Participants According to Endoscopic Sub Score Based on Mayo Score
timeFrame: At index (from data collected and analyzed retrospectively over 5 months)
Secondary outcomes:
measure: Percentage of Participants Who Received Tofacitinib at Week 8, Week 16, Week 24 and Week 52
timeFrame: Week 8, Week 16, Week 24 and Week 52
measure: Percentage of Participants With Clinical Remission Based on Full Mayo Score at Week 8, Week 16, Week 24 and Week 52
timeFrame: Week 8, Week 16, Week 24 and Week 52
measure: Percentage of Participants With Clinical Remission Based on Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52
timeFrame: Week 8, Week 16, Week 24 and Week 52
measure: Percentage of Participants With Clinical Response Based on Full Mayo Score at Week 8, Week 16, Week 24 and Week 52
timeFrame: Week 8, Week 16, Week 24 and Week 52
measure: Percentage of Participants With Clinical Response Based on Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52
timeFrame: Week 8, Week 16, Week 24 and Week 52
measure: 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
timeFrame: Week 8, Week 16, Week 24 and Week 52
measure: 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
timeFrame: Week 8, Week 16, Week 24 and Week 52
measure: Percentage of Participants According to Time to Response Based on Full or Partial Mayo Score at 1, 2, 3, 6, 12, 24, 36 Months
timeFrame: At 1, 2, 3, 6, 12, 24 and 36 months
measure: Percentage of Participants With Fecal (F)-Calprotectin Reduction of >=50% at Week 8, Week 16, Week 24 and Week 52
timeFrame: Week 8, Week 16, Week 24 and Week 52
measure: Percentage of Participants With F-calprotectin Reduction of >=75% at Week 8, Week 16, Week 24 and Week 52
timeFrame: Week 8, Week 16, Week 24 and Week 52
measure: Percentage of Participants With F-calprotectin Reduction of >=90% at Week 8, Week 16, Week 24 and Week 52
timeFrame: Week 8, Week 16, Week 24 and Week 52
measure: Number of Participants Reaching F-calprotectin Below 250 mg/kg of Those That Had F-calprotectin Above 250 mg/kg at Baseline
timeFrame: Week 8, Week 16, Week 24 and Week 52
measure: 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
timeFrame: Baseline, Week 8, Week 16, Week 24 and Week 52
measure: Percentage of Participants in Sustained Remission Based on Full Mayo Score From Week 8 to Week 16, Week 24, and Week 52
timeFrame: From Week 8 to Week 16, Week 24, and Week 52
measure: Percentage of Participants in Sustained Remission Based on Partial Mayo Score From Week 8 to Week 16, Week 24, and Week 52
timeFrame: From Week 8 to Week 16, Week 24 and Week 52
measure: Percentage of Participants in Sustained Remission Based on Full Mayo Score From Week 16 to Week 24 and Week 52
timeFrame: From Week 16 to Week 24 and Week 52
measure: Percentage of Participants in Sustained Remission Based on Partial Mayo Score From Week 16 to Week 24 and Week 52
timeFrame: From Week 16 to Week 24 and Week 52
measure: Percentage of Participants in Sustained Steroid Free Remission Based on Full Mayo Score From Week 16 to Week 24 and Week 52
timeFrame: From Week 16 to Week 24 and Week 52
measure: Percentage of Participants in Sustained Steroid Free Remission Based on Partial Mayo Score From Week 16 to Week 24 and Week 52
timeFrame: From Week 16 to Week 24 and Week 52
measure: Change From Baseline in Full Mayo Score at Week 8, Week 16, Week 24 and Week 52
timeFrame: Baseline, Week 8, Week 16, Week 24 and Week 52
measure: Change From Baseline in Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52
timeFrame: Baseline, Week 8, Week 16, Week 24 and Week 52
measure: Percentage of Participants in Sustained Endoscopic Remission, Mucosal Healing or Endoscopic Response From Week 8 to Week 16, Week 24 and Week 52
timeFrame: From Week 8 to Week 16, Week 24 and Week 52
measure: Percentage of Participants With Physician Assessed Histological Remission at Week 8, Week 16, Week 24 and Week 52
timeFrame: Week 8, Week 16, Week 24 and Week 52
measure: Change From Baseline in Histology Assessment at Week 8, Week 16, Week 24 and Week 52
timeFrame: Baseline, Week 8, Week 16, Week 24 and Week 52
measure: 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
timeFrame: From Week 8 to Week 16, Week 24 and Week 52
measure: 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
timeFrame: From Week 8 to Week 16, Week 24 and Week 52
measure: 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
timeFrame: Week 8, Week 16, Week 24, and Week 52
measure: 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
timeFrame: Week 8, Week 16, Week 24, and Week 52
measure: 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
timeFrame: Week 8, Week 16, Week 24, and Week 52
measure: 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
timeFrame: Week 8, Week 16, Week 24, and Week 52
measure: Percentage of Participants With Corticosteroid Tapering at Week 8, Week 16, Week 24 and Week 52
timeFrame: Week 8, Week 16, Week 24 and Week 52
measure: Tapering Rate
timeFrame: Up to Week 52
measure: Corticosteroid Tapering Dose
timeFrame: Up to Week 52
measure: 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
timeFrame: Week 8, Week 16, Week 24 and Week 52
measure: Change From Baseline in Stool Frequency Sub Score at Week 8, Week 16, Week 24 and Week 52
timeFrame: Baseline, Week 8, Week 16, Week 24 and Week 52
measure: 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
timeFrame: Week 8, Week 16, Week 24 and Week 52
measure: Change From Baseline in Rectal Bleeding Sub Score at Week 8, Week 16, Week 24 and Week 52
timeFrame: Baseline, Week 8, Week 16, Week 24 and Week 52
measure: 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
timeFrame: Week 8, Week 16, Week 24 and Week 52
measure: Change From Baseline in P-CRP Levels at Week 8, Week 16, Week 24 and Week 52
timeFrame: Baseline, Week 8, Week 16, Week 24 and Week 52
measure: Change From Baseline in B-hb and P-alb Levels at Week 8, Week 16, Week 24 and Week 52
timeFrame: Baseline, Week 8, Week 16, Week 24 and Week 52
measure: Change From Baseline in B-leuk, B-ly, B-neutr and B-Thromb Levels at Week 8, Week 16, Week 24 and Week 52
timeFrame: Baseline, Week 8, Week 16, Week 24 and Week 52
measure: Percentage of Participants With Extended Tofacitinib Induction Dose at Week 8, Week 16
timeFrame: Week 8 and Week 16
measure: Percentage of Participants With Higher Dose (10 mg) of Tofacitinib For All Participants at Week 8, Week 16, Week 24 and Week 52
timeFrame: Week 8, Week 16, Week 24 and Week 52
measure: Number of Participants With Higher Dose (10mg) of Tofacitinib of Those on Treatment at Week 8, Week 16, Week 24 and Week 52
timeFrame: Week 8, Week 16, Week 24 and Week 52
measure: Time to Drug Discontinuation, Colectomy or UC-related Hospitalization
timeFrame: Up to Week 52
measure: Number of Previous Treatments
timeFrame: Up to Week 52
measure: Number of Participants According to Type of Previous Treatment
timeFrame: Up to Week 52
measure: 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
timeFrame: Week 8, Week 16, Week 24 and Week 52
measure: 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
timeFrame: Week 8, Week 16, Week 24 and Week 52
measure: Percentage of Participants That Had f-Calprotectin Above 250 mg/kg at Baseline
timeFrame: At index (date of initiation of tofacitinib treatment for ulcerative colitis)
measure: Change From Baseline in F-calprotectin at Week 8, Week 16, Week 24 and Week 52
timeFrame: Baseline, Week 8, Week 16, Week 24 and Week 52
measure: 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
timeFrame: From Week 16 to Week 24 and Week 52
measure: 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
timeFrame: From Week 16 to Week 24 and Week 52
measure: 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
timeFrame: From Week 8 to Week 16, Week 24 and Week 52
measure: 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
timeFrame: From Week 8 to Week 16, Week 24 and Week 52
measure: Absolute Values of Blood Hemoglobin and Plasma Albumin at Baseline
timeFrame: At index (from data collected and analyzed retrospectively over 5 months)
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Pfizer
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: