UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Withdrawal of immunomodulator in Crohn's disease treated with adalimumab and immnomodulator : a multicenter randomized trial(Diamond2 study).
Title of the study (Brief title)	Withdrawal of immunomodulator in Crohn's disease treated with adalimumab and immnomodulator : a multicenter randomized trial.
Region	Japan

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

Objectives
Narrative objectives1	To clarify the pros and cons of immunomodulator withdrawal by a comparative investigation of an immunomodulator withdrawal group and non-withdrawal group in CD patients whose condition was stabilized by concomitant treatment of adalimumab and an immunomodulator.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Remission maintenance rate (nonclinical relapse rate) following a steroid-free period of 52 weeks. *Clinical relapse: The condition where CDAI increased at least 70%, and is at least 150.
Key secondary outcomes	Endoscopic relapse rate *Endoscopic relapse: ulcer findings present CRP negative rate *CRP positive: CRP is at least 0.3 mg/dL Steroid-free remission maintenance rate by factor (duration of illness, IFX treatment history, CRP, endoscopic findings etc.) Incidence of adverse events etc.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Withdrawal of the concomitant immunomodulator (azathioprine or 6-mercaptoprine) while under adalimumab 40 mg/every other week continued treatment.
Interventions/Control_2	Non-withdrawal of the concomitant immunomodulator (azathioprine or 6-mercaptoprine) while under adalimumab 40 mg/every other week continued treatment.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	CD patient on concomitant treatment of adalimumab and an immunomodulator (azathioprine;25 mg/day or 6-mercaptoprine;15 mg/day) for at least 6 month, and the steroid-free remission (CDAI is below 150 without the use of steroids) period has continued for at least 6 months.
Key exclusion criteria	1. The patient is below 15 years of age 2. The patient is pregnant or lactating 3. The patient has an artificial anus 4. The period after the patient underwent gastrointestinal surgery is within 6 months 5. The patient has short-bowel syndrome 6. The patient has an imminent CD-related surgery 7. The patient has malignant tumor 8. The patient was judged not eligible by the investigator.
Target sample size	200

Research contact person
Name of lead principal investigator	Toshifumi Hibi
Organization	School of Medicine, Keio University
Division name	Gastroenterology
Address	Shinanomachi 35, Shinjyuku-ku, Tokyo
TEL	03-3353-1211
Email	thibi@z5.keio.jp

Public contact
Name of contact person	Tadakazu Hisamatsu
Organization	School of Medicine, Keio University
Division name	Gastroenterology
Address	Shinanomachi 35, Shinjyuku-ku, Tokyo
TEL	03-3353-1211
Homepage URL
Email	hisamachi@a7.keio.jp

Sponsor
Institute	Department of Internal Medicine, School of Medicine, Keio University
Institute
Department

Funding Source
Organization	Department of Internal Medicine(Gastroenterology), School of Medicine, Keio University and Self funding of each Institusions
Organization
Division
Category of Funding Organization	Self funding
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	慶應義塾大学（東京都）、東京医科歯科大学（東京都）、京都大学（京都府）、大阪市立大学（大阪府）、九州大学（福岡県）、札幌厚生病院（北海道）、福岡大学筑紫病院（福岡県）、東邦大学医療センター佐倉病院（千葉県）、社会保険中央総合病院（東京都）、獨協医科大学（栃木県）、東北大学（宮城県）、広島大学（広島県）、札幌東徳洲会病院（北海道）、松山赤十字病院（愛媛県）、長崎大学（長崎県）、佐賀大学（佐賀県）、岩手医科大学（岩手県）、医療法人錦秀会インフュージョンクリニック（大阪府）、琉球大学（沖縄県）、岡山大学（岡山県）、愛知医科大学（愛知県）、守口敬任会病院（大阪府）、千葉大学（千葉県）、町田市民病院（東京都）

Other administrative information
Date of disclosure of the study information	2012 Year 12 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 07 Month 25 Day
Anticipated trial start date	2013 Year 01 Month 01 Day
Last follow-up date	2015 Year 12 Month 31 Day
Date of closure to data entry	2016 Year 03 Month 01 Day
Date trial data considered complete	2016 Year 03 Month 31 Day
Date analysis concluded	2016 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 12 Month 20 Day
Last modified on	2019 Year 02 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011255