Effect of adalimumab dose escalation in patients with Crohn's disease

Effect of adalimumab dose escalation in patients with Crohn's disease - Effect of adalimumab dose escalation in patients with Crohn's disease

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000023719

Enrollment

Registered

2016-08-22

Start date

2016-08-23

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients who are treated with 40mg of adalimumab biweekly 2. CDAI more than 150, massive intestinal lesion, or refractory perianal disease 3. Patients who do not correspond to the warning or contraindication of the package insert of adalimumab 4. Dose escalation of adalimumab is possible under health insurance 5. Aged 15 and over

Exclusion criteria

Exclusion criteria: 1. Patients without intestinal mucosal lesion 2. Patients with active tuberculosis 3. Patients with demyelinating disease 4. Patients with chronic heart failure 5. Serum creatinine more than 2 mg/dl 6. Total bilirubin more than 2 mg/dl 7. AST or ALT more than 50 IU/l 8. Patients under pregnancy or breast-feeding 9. Patients who wishes to become pregnant 10. Less than 15 years old 11. Patients who has neoplasm 12. Patients who have psychoneurotic disorder 13. Patients who do not agree to join this study 14. When the doctor in charge feel that the patients are not suitable for this study

Design outcomes

Primary

Measure	Time frame
The relationships between adalimumab trough levels before dose escalation and clinical remission rate at 12 weeks or mucosal healing in 24 weeks	—

Countries

Japan

Contacts

Public ContactShigeki Bamba

Shiga University of Medical Science Division of Gastroenterology

sb@belle.shiga-med.ac.jp077-548-2217

Outcome results