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

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05082428
• Other study ID #: A3921390
• Secondary ID: FinTofUC
• Status: Completed
• Start date: May 30, 2022
• Est. completion date: November 1, 2022

Study information

• Verified date: March 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Locations

Country	Name	City	State
Finland	Pfizer	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant demographics at tofacitinib treatment initiation	Age, gender, weight, height, smoking status, body mass index (BMI), treating hospital	Baseline
Primary	Disease characteristics at tofacitinib treatment initiation	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)	Baseline
Primary	Disease severity at tofacitinib treatment initiation	Assessed by Mayo score and fecal calprotectin (f-calprotectin)	Baseline
Primary	Laboratory results for biochemical inflammatory markers at tofacitinib treatment initiation	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	Baseline
Primary	Endoscopic findings including histology at tofacitinib treatment initiation		Baseline
Secondary	Proportion of patients who are taking tofacitinib		Weeks 8, 16, 24, 52
Secondary	Rate of clinical remission based on full Mayo score	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	Weeks 8, 16, 24, 52
Secondary	Rate of clinical remission based on partial Mayo score	A clinical remission is defined as a partial Mayo score <2 points with rectal bleeding sub-score of 0	Weeks 8, 16, 24, 52
Secondary	Rate of clinical response based on full Mayo score	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	Weeks 8, 16, 24, 52
Secondary	Rate of clinical response based on partial Mayo score	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	Weeks 8, 16, 24, 52
Secondary	Proportion of participants in steroid-free clinical remission	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	Weeks 8, 16, 24, 52
Secondary	Proportion of participants reaching clinical response based on full Mayo score	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.	Weeks 8, 16, 24, 52
Secondary	Proportion of participants reaching clinical response based on partial Mayo score	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	Weeks 8, 16, 24, 52
Secondary	Time to response as assessed by a decrease based on full Mayo score.		Weeks 8, 16, 24, 52
Secondary	Time to response as assessed by a decrease based on partial Mayo score.		Weeks 8, 16, 24, 52
Secondary	Proportion of participants that had f-calprotectin above 250 mg/kg		Baseline
Secondary	Change from baseline in fecal calprotectin		Baseline, Weeks 8, 16, 24, 52
Secondary	Proportion of participants reaching f-calprotectin below 250 mg/kg of those with active disease based on f-calprotectin at baseline	Active disease defined as fecal calprotectin (f-calprotectin) >250mg/kg.	Weeks 8, 16, 24, 52
Secondary	Proportion of participants in sustained remission (full Mayo score)		Week 8 to week 16, 24 and 52
Secondary	Proportion of participants in sustained remission (full Mayo score)		Week 16 to week 24 and 52
Secondary	Proportion of participants in sustained remission (partial Mayo score)		Week 8 to week 16, 24 and 52
Secondary	Proportion of participants in sustained remission (partial Mayo score)		Week 16 to week 24 and 52
Secondary	Proportion of participants in sustained steroid free remission (full Mayo score) (for all patients and for those treated with corticosteroids at baseline).		Week 16 to 24 and 52
Secondary	Proportion of participants in sustained steroid free remission (partial Mayo score) (for all patients and for those treated with corticosteroids at baseline).		Week 16 to 24 and 52
Secondary	Change in full Mayo score		Baseline, Weeks 8, 16, 24, 52
Secondary	Change in partial Mayo score		Baseline, Weeks 8, 16, 24, 52
Secondary	Proportion of participants in sustained endoscopic remission, mucosal healing or endoscopic response	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.	Baseline, Week 8 to week 16, 24 and 52
Secondary	Proportion of participants in physician assessed histological remission determined as inactive disease, or normal histology, and change from baseline in histology assessment	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.	Baseline, Weeks 8, 16, 24, 52
Secondary	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	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.	Baseline, Week 8 to week 16, 24 and 52
Secondary	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	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.	Baseline, Week 8 to week 16, 24 and 52
Secondary	Comparison of response and remission (full Mayo score) based on the extent of colonic involvement according to the Montreal classification		Baseline, Weeks 8, 16, 24, 52
Secondary	Comparison of response and remission (partial Mayo score) based on the extent of colonic involvement according to the Montreal classification		Baseline, Weeks 8, 16, 24, 52
Secondary	Proportion of participants with corticosteroid tapering and their tapering rates and doses		Baseline, Weeks 8, 16, 24, 52
Secondary	Proportion of participants with improvement in stool frequency and change from baseline in stool frequency sub score	Improvement in stool frequency defined as sub score improvement of 1 or more points	Baseline, Weeks 8, 16, 24, 52
Secondary	Proportion of patients with improvement in rectal bleeding and change from baseline in rectal bleeding sub score	Improvement inrectal bleeding defined as sub score improvement of 1 or more points	Baseline, Weeks 8, 16, 24, 52
Secondary	Proportion of participants reaching normal plasma C-reactive protein (P-CRP) levels and change from baseline	Normal P-CRP levels defined as below 4mg/L	Baseline, Weeks 8, 16, 24, 52
Secondary	Proportion of participants reaching normal blood hemoglobin (B-hb) levels and change from baseline	Normal B-hb levels defined as men=134-167 g/L, women=117-155 g/L	Baseline, Weeks 8, 16, 24, 52
Secondary	Proportion of participants reaching normal blood leukocyte (B-leuk) levels and change from baseline	Normal B-leuk levels defined as 3.4-8.2 x 109/L	Baseline, Weeks 8, 16, 24, 52
Secondary	Proportion of participants reaching normal blood thrombocytes (B-Thromb) levels and change from baseline	Normal B-Thromb levels defined as 150-360 x 109/L	Baseline, Weeks 8, 16, 24, 52
Secondary	Proportion of participants reaching normal blood lymphocyte (B-ly) levels and change from baseline	Normal B-ly levels defined as 1.3-3.6 x 109/L	Baseline, Weeks 8, 16, 24, 52
Secondary	Proportion of participants reaching normal blood neutrophile (B-neutr) levels and change from baseline	Normal B-neutr levels defined as 1.5-6.7 x 109/L	Baseline, Weeks 8, 16, 24, 52
Secondary	Proportion of participants reaching normal plasma albumin (P-alb) levels and change from baseline	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	Baseline, Weeks 8, 16, 24, 52
Secondary	Proportion of participants with extended tofacitinib induction dose	Participants with induction dose after 8 weeks	Baseline, Weeks 8, 16, 24, 52
Secondary	Real-world dosing of tofacitinib		Baseline, Weeks 8, 16, 24, 52
Secondary	Survival without drug discontinuation, colectomy or UC-related hospitalization		Baseline, Weeks 8, 16, 24, 52
Secondary	To Assess Treatment Lines Prior to Tofacitinib Treatment.	Number and type of previous UC treatments.	Baseline
Secondary	Proportion of responders defined by a fecal calprotectin (f-calprotectin) reduction of =50%, =75% or =90% compared to baseline	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.	Baseline, Weeks 8, 16, 24, 52

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