A Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects with Crohn's Disease

A Multi-Center, Randomized, Double-blind, Placebo-controlled Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects with Crohn's Disease

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080220357

Enrollment

Registered

2007-03-12

Start date

2007-03-12

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's disease

Interventions

investigational material(s) Generic name etc : adalimumab INN of investigational material : adalimumab Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: - CDAI score of >=220 and =<450 - If subjects have previously been administered infliximab, subjects who discontinued use due to a loss of response or intolerance to infliximab therapy Exclusion criteria: - Ulcerative colitis or indeterminate colitis - History of cancer, lymphoma, leukemia or lymphoproliferative disease, active TB, HIV - Body weight is below 30 kg - Surgical bowel resections within the past 6 months - Females who are pregnant or breast-feeding or considering becoming pregnant during the study

Exclusion criteria

Exclusion criteria: Exclusion Criteria: - Subject with a current diagnosis of ulcerative colitis or indeterminate colitis as determined by the investigator - Subject has a history of cancer, lymphoma, leukemia or lymphoproliferative disease, active TB, HIV - Subject's body weight is below 30 kg - Subject who has had surgical bowel resections within the past 6 months - Pregnant women

Design outcomes

Primary

Measure	Time frame
Crohn's Disease Activity Index (CDAI)	—

Outcome results

None listed

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