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Evaluation of efficacy of high dose infliximab with azathiopurine add-on therapy for patients with Crohn's disease refractory to low dose infliximab

Evaluation of efficacy of high dose infliximab with azathiopurine add-on therapy for patients with Crohn's disease refractory to low dose infliximab - High dose infliximab with azathiopurine add-on therapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000006232
Enrollment
40
Registered
2011-09-01
Start date
2011-10-01
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

treatment with high dose infliximab and azathiopurine(6MP can be used in case of refractory patients to azatioupurine) treatment with only high dose infliximab

Sponsors

Saitama Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The patients who had not been treated with immunomodulators and was not in remission state with low dose infliximab (CDAI<150)

Exclusion criteria

Exclusion criteria: patients who cannot been kept in the treatment with infliximab and who cannot been treated with azathiopurine patients in lactate state patient whose age below 15 years old and above 70 years old patients who cannot agree with this study patients who had been treated with open surgery within 6 months patients with short bowel syndrome patients who was determined not to be appropriate in participation in this study

Design outcomes

Primary

MeasureTime frame
Remission rate in 24 week

Secondary

MeasureTime frame
Remission rates in each state CR70, CR100 Mucosal healing rates in 24, 48 week Loss of response rate Relapse rate Safety

Countries

Japan

Contacts

Public ContactShingo Kato

Saitama Medical Center, Saitama Medical University Department of Gastroenterology and Hepatology

skato@saitama-med.ac.jp049-228-3564

Outcome results

None listed

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