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The Study for Efficacy of Adalimumab Conbined Elemental Diet Therapy for Crohn's Disease

The Study for Efficacy of Adalimumab Conbined Elemental Diet Therapy for Crohn's Disease - The Efficacy of Adalimumab

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000005762
Enrollment
40
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

1)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. 2)Elental(1 kcal/ml
80g/300ml)

Sponsors

Kenji Watanabe
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Crohn's Disease patient who was ineffective for present therapy and who has not been treated with anti TNF alpha antibody.

Exclusion criteria

Exclusion criteria: 1)The patient who has internal fistula 2)The patient who is planning to have an operation 3)The patient who is short bowel syndorome 4)The patient of contraindication for adalimumab or Elental 5)The case which is hard to get the patient's consent 6)The patient who was judged for unsuitable by responsibility doctor

Design outcomes

Primary

MeasureTime 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