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Study on the selection of appropriate patients for the dose escalation of adalimumab in Crohn's disease therapy.

Study on the selection of appropriate patients for the dose escalation of adalimumab in Crohn's disease therapy. - Study on the selection of appropriate patients for the dose escalation of adalimumab.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000024566
Enrollment
60
Registered
2016-11-01
Start date
2016-11-01
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

Crohn&#39

Interventions

Dose escalation group Administration of Adalimumab 80 mg every other week Non-dose escalation group Administration of Adalimumab 40 mg every other week

Sponsors

Toho University Medical Center Sakura Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Japanese individuals with Crohn's disease who received induction treatment with adalimumab (160/80 mg at Weeks 0/2), achieved CDAI<=150 AND a decrease in CDAI of >=70 at 4 weeks after initial dose and then lost response. The lost response is defined as "CRP>0.3 more than 2 times and CRP<3 all the time" or "175<=CDAI<300".

Exclusion criteria

Exclusion criteria: 1.Patients who correspond to the warning or contraindication of the package insert of adalimumab 2.Patients under breast-feeding 3.Patients who do not agree to join the study 4.Patients with previous use of anti-TNF therapy 5.Patients who has neoplasm 6.Patients who had intestinal resection within 6 months 7.Patients with short bowel syndrome 8.When the doctor in charge determines that the patients are not suitable for the study

Design outcomes

Primary

MeasureTime frame
Comparison of clinical remission rates at 1 year after randomization between dose escalation group and non-dose escalation group.—

Secondary

MeasureTime frame
Comparison of CDAI/CRP, trough/AAA concentration in blood, and endoscopic remission rate at 24, 48 weeks after randomization. Predictive factors for effectiveness of adalimumab dose escalation.—

Countries

Japan

Contacts

Public ContactYasuo Suzuki

Toho University Medical Center Sakura Hospital Department of Internal Medicine

yasuo-suzuki@sakura.med.toho-u.ac.jp043-462-8811

Outcome results

None listed

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