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Exploratory study of relation between efficacy and serum infliximab level, and predictors of response to infliximab dose escalation in patients with crohn's disease

Exploratory study of relation between efficacy and serum infliximab level, and predictors of response to infliximab dose escalation in patients with crohn's disease - Exploratory study of relation between efficacy and serum infliximab level, and predictors of response to infliximab dose escalation in patients with crohn's disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000014006
Enrollment
20
Registered
2014-07-31
Start date
2014-08-01
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 of infliximab

Sponsors

IBD Center, Sapporo Kosei General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with active crohn's disease ( CDAI>= 150 and CRP >= 0.3mg/dL ) on 5mg/kg infliximab

Exclusion criteria

Exclusion criteria: 1)Patients whose age below 18 years old 2)Patients with serious infection (sepsis,etc) 3)Patients with active tuberculosis 4)Patients with history of allergy to ingredients of infliximab or to proteins derived from mouse 5)Patients with demyelinating diseases and its past history 6)Patients with congestive heart failure 7)Patients who are inadequate to enter this trial due to the other reasons by physician's judgments

Design outcomes

Primary

MeasureTime frame
Relationship between CDAI change and serum infliximab level from week 0 to week 16 and 40 in increased dose period—

Countries

Japan

Contacts

Public ContactHiroki Tanaka

Sapporo Kosei General Hospital IBD Center

hirokit@mtc.biglobe.ne.jp011-261-5331

Outcome results

None listed

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