Adalimumab multicenter cohort study of the effectiveness for patients with Ulcerative colitis

Adalimumab multicenter cohort study of the effectiveness for patients with Ulcerative colitis - ADVENTURE study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000029030

Enrollment

100

Registered

2017-10-01

Start date

2017-11-01

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

ulcerative colitis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with ulcerative colitis were treated adalimumab between July 2013 and March 2017

Exclusion criteria

Exclusion criteria: 1) 2)Parial Mayo score 2 or less at baseline. 3)Not conforming to the packege insert of adalimumab until 4 weeks. 4)Patients who underwent colectomy. 5)The patints who treated with anti-TNF antibody excepted Infliximab.

Design outcomes

Primary

Measure	Time frame
proportion of patients achieving clinical response at week 8.	—

Secondary

Measure	Time frame
i)overall 1)Rate of clinical remission at week 2,4,8,12. 2)Rate of clinical response at week 2,4,8,12 and 24,36,52. 3)Rate of operation at week 12. 4)Rate of ongoing adalimumab treatment at week 12. 5)Rate of corticosteroid discontinuation at week 12. ii)The patients who were injected adalimumab from 24 August 2013 to 30 July 2016. 1)Rate of clinical remission at week 2,4,8,12 and 24,36,52. 2)Rate of clinical response at week 2,4,8,12 and 24,36,52. 3)Cumulative operation rate at week 52. 4)Cumulative ongoing adalimumab treatment rate at week 52. 5)Cumulative response rate at week 52. 6)Cumulative remission rate at week 52. 7)Rate of corticosteroid discontinuation at week 52. 8)Adverse event. etc	—

Measure

Time frame

i)overall 1)Rate of clinical remission at week 2,4,8,12. 2)Rate of clinical response at week 2,4,8,12 and 24,36,52. 3)Rate of operation at week 12. 4)Rate of ongoing adalimumab treatment at week 12. 5)Rate of corticosteroid discontinuation at week 12. ii)The patients who were injected adalimumab from 24 August 2013 to 30 July 2016. 1)Rate of clinical remission at week 2,4,8,12 and 24,36,52. 2)Rate of clinical response at week 2,4,8,12 and 24,36,52. 3)Cumulative operation rate at week 52. 4)Cumulative ongoing adalimumab treatment rate at week 52. 5)Cumulative response rate at week 52. 6)Cumulative remission rate at week 52. 7)Rate of corticosteroid discontinuation at week 52. 8)Adverse event. etc

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Countries

Japan

Contacts

Public ContactSakemi Ryosuke

Tobatakyoritu hospital Department of Gastroenterology

ryosuke.s.1980@gmail.com093-871-5422

Outcome results