UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of efficacy of high dose infliximab with azathiopurine add-on therapy for patients with Crohn's disease refractory to low dose infliximab
Title of the study (Brief title)	High dose infliximab with azathiopurine add-on therapy
Region	Japan

Condition
Condition	Crohn's disease
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Additional effects of azathiopurine in the treatment of high dose infliximab
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Remission rate in 24 week
Key secondary outcomes	Remission rates in each state CR70, CR100 Mucosal healing rates in 24, 48 week Loss of response rate Relapse rate Safety

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	treatment with high dose infliximab and azathiopurine(6MP can be used in case of refractory patients to azatioupurine)
Interventions/Control_2	treatment with only high dose infliximab
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	15 years-old <=
Age-upper limit	70 years-old >
Gender	Male and Female
Key inclusion criteria	The patients who had not been treated with immunomodulators and was not in remission state with low dose infliximab (CDAI<150)
Key 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
Target sample size	40

Research contact person
Name of lead principal investigator	Shingo Kato
Organization	Saitama Medical Center, Saitama Medical University
Division name	Department of Gastroenterology and Hepatology
Address	1981 Kamoda, Kawagoe City, Saitama
TEL	049-228-3564
Email	skato@saitama-med.ac.jp

Public contact
Name of contact person	Shingo Kato
Organization	Saitama Medical Center, Saitama Medical University
Division name	Department of Gastroenterology and Hepatology
Address	1981 Kamoda, Kawagoe City, Saitama
TEL	049-228-3564
Homepage URL
Email	skato@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical University
Institute
Department

Funding Source
Organization	Saitama Medical University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2011 Year 09 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 09 Month 22 Day
Anticipated trial start date	2011 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2017 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 08 Month 25 Day
Last modified on	2018 Year 01 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007377