Crohn'
Conditions
Interventions
None listed
Sponsors
Takeda Pharmaceutical Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subjects are capable of understanding the study and questionnaire and complying with the protocol in the opinion of the investigator or subinvestigator.In the opinion of the investigator or sub-investigator, the subject is capable of understanding the study and questionnaire and complying with protocol requirements. 2. The subject signs and dates a written, informed consent form prior to the initiation of any study procedures. 3. The subject is aged 18 years or older at the time of informed consent. 4. At baseline, Tthe subject has a definite diagnosis of Crohn's disease and anal fistulas as a complication of Crohn's disease assessed by a specialist. The subject has a symptomatic* fistula(s) at baseline *Symptomatic: anal fistulas with any level of perianal symptoms. All patients with seton will be eligible. 5. The subject is a native speaker of Japanese or has a comparable language ability of a native speaker based on the judgement of the physician.
Exclusion criteria
Exclusion criteria: 1. The subject with completely closed fistulas at baseline
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CAF-QoL, PDAI, HBI, SIBDQ, QDIS, HADS scores | — |
Secondary
| Measure | Time frame |
|---|---|
| Longitudinal CAF-QoL, PDAI, HBI, SIBDQ, QDIS, HADS scores Physician-report and patient reported changes CAF-QoL, PDAI, HBI, SIBDQ, QDIS, HADS, Van-Assche Index scores (as for Van-Assche scores, only when MRI data was obtained as part of clinical practice during 1 month before baseline or the study period) Patient demographic and medical history data Patient-reported disease related information | — |
Countries
Japan
Contacts
Public ContactMasahiro Mizoguchi
A2 Healthcare Corporation Clinical Development Division Clinical Development Department 4
Outcome results
None listed