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Inception Cohort Registry Study of Patients with Crohn's disease

Inception Cohort Registry Study of Patients with Crohn's disease - CD Registry Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000032237
Enrollment
900
Registered
2018-04-13
Start date
2018-07-23
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn&#39

Interventions

None listed

Sponsors

Janssen Pharma K.K.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Men and women aged over 16 years. 2.Pstients newly given a CD diagnosis according to MHLW criteria on or after June 1,2016. 3.Each subject must sign an Informed Consent Form(ICF) indicating that subject understands the purpose of and procedures required for the study and are willing to participate in the study.(if the subject is minor, informed assent might be obtained from each study subject according to the regulation of institution/hospital and their legally acceptable representative must sign an ICF).

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Number of proportion(%)of patients using each CD treatment after CD diagnosis.

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactYutaro Kawagoe

EP-CRSU Co., Ltd Project Management Promotion Department

kawagoe226@eps.co.jp03-6759-9904

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026