MedPath

Inception Cohort Registry Study of Patients with Crohn's disease

Not Applicable
Recruiting
Conditions
Crohn&#39
s disease(CD)
Registration Number
JPRN-UMIN000032237
Lead Sponsor
Janssen Pharma K.K.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
900
Inclusion Criteria

Not provided

Exclusion Criteria

1.Patients who have used a biological drug having an indication for auto-immune diseases before diagnosis of CD 2.Patients with unknown dates (month and year) of CD diagnosis. 3.Patients currently enrolled or expected to be enrolled in other registration trial(s) at the registry entry.

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
umber of proportion(%)of patients using each CD treatment after CD diagnosis.
Secondary Outcome Measures
NameTimeMethod
1.Time to start using a biological drug from CD diagnosis 2.Duration of each CD treatment, Time to next CD treatment 3.Time to CD-related surgery from CD diagnosis 4.Change in HBI score in 4 years 5.Change in QOL indices (FACIT-Fatigue, short inflammatory bowel disease questionnaire[SIBDQ], and work productivity and activity impairment questionnaire: General Health[WPAI:GH])in 4 years. 6.Adverse events in each drug therapy for CD
© Copyright 2025. All Rights Reserved by MedPath