The Study for Efficacy and Safety of Adalimumab for Crohn's Disease with Loss of Response to Infliximab

The Study for Efficacy and Safety of Adalimumab for Crohn's Disease with Loss of Response to Infliximab - The Efficacy of Adalimumab

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005761

Enrollment

Registered

2011-06-13

Start date

2010-10-27

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

Adalimumab (HUMIRA 40mg for SC Injection) Inject SC 160mg on Day 1, then inject SC 80 mg on Day 15, and inject SC 40 mg every other week, beginning on Day 29.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Crohn's Disease patient as following 1)or 2) 1)the patient who treated with IFX infusion of interval every 4-6 weeks. 2)the patient who could not keep to treat with IFX due to side effect or ineffectiveness.

Exclusion criteria

Exclusion criteria: 1)The patient of contraindication for adalimumab as following a.serious infections b.active tuberculosis c.hypersensitivity d.neurologic reactions (peripheral demyelinating disease) e.congestive heart failure 2)The case which is hard to get the patient's consent 3)The patient who was judged for unsuitable by responsibility doctor

Design outcomes

Primary

Measure	Time frame
CDAI score in the 28th week (the rate of remission, CR70, CR100), SF-36, IBDQ	—

Countries

Japan

Outcome results

None listed

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

The Study for Efficacy and Safety of Adalimumab for Crohn&#39;s Disease with Loss of Response to Infliximab