Ulcerative Colitis
Conditions
Interventions
investigational material(s)
Generic name etc : Vedolizumab
INN of investigational material : Vedolizumab
Therapeutic category code : 239 Other agents affecting digestive organs
Dosage and Administrat
Sponsors
Takeda Pharmaceutical Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient initiated VDZ IV treatment (at least one infusion) as per label indication in Japan between December 1st, 2018 and February 29th, 2020 2. Female or male patient with a confirmed diagnosis of moderately to severely active UC 3. Patient aged 20 years or older at index event 4. Patient has medical information available from the date of UC diagnosis
Exclusion criteria
Exclusion criteria: 1. Patient that received VDZ IV as part of clinical trial or interventional clinical study at index event 2. Patient enrolled in another Inflammatory Bowel Disease (IBD) clinical trial or interventional clinical study at index event 3. Partial Mayo score is missing at baseline 4. Patient initiated VDZ IV treatment as combination therapy with another biologic agent 5. Patient initiated VDZ IV treatment at another institution (patient's medical information is not precisely accessible) 6. Patient requested to opt-out of his or her medical information
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Clinical effectiveness along the induction phase in biologic naive patients Time Frame: 54 weeks Examples of individual components of scores; clinical response, clinical remission, mucosal healing efficacy Time-to-event Analysis Time Frame: 54 weeks efficacy Sustained Clinical effectiveness along the induction phase in biologic naive patients Time Frame: 54 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Clinical effectiveness along the induction and maintenance phases in all treated patients (biologic naive and non-naive), and in biologic non-naive patients Time Frame: 54 weeks Examples of individual components of scores; clinical response, clinical remission, mucosal healing efficacy Clinical effectiveness according to corticosteroid use (naive, dependent and refractory at index event) as concomitant therapy along the induction and the maintenance phases in all treated patients, in biologic naive patients and in biologic non-naive patients Time Frame: 54 weeks efficacy Clinical effectiveness in the non-elderly patients (< 65years) compared to the elderly patients along the induction and the maintenance phases in all treated patients, in biologic naive patients and in biologic non-naive patients Time Frame: 54 weeks efficacy Clinical effectiveness according to the disease severity based upon the partial Mayo score (e.g., moderate as partial Mayo score 5 to 7, severe as partial Mayo score 8 to 9) along the induction and the maintenance phases in all treated patients, in biologic naive patients and in biologic non-naive patients Time Frame: 54 weeks efficacy Clinical effectiveness according to disease duration along the VDZ induction and the maintenance phases in all treated patients, in biologic naive patients and in biologic non-naive patients Time Frame: 54 weeks efficacy Clinical effectiveness according to concomitant therapies including corticosteroids and immunomodulators along the VDZ induction and the maintenance phases in all treated patients, in biologic naive patients and in biologic non-naive patients Time Frame: 54 weeks efficacy Patient populations Time Frame: Baseline Patient demographics (including age, age group, sex, smoking status, body mass index), treatment histories (including time from UC diagnosis to index event, prior non-biologic use, surgery) and laboratory measures (including CRP, fecal calprotectin, ESR, hemoglobin, platelet | — |
Countries
Japan
Outcome results
None listed