UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009596 |
|---|---|
| Receipt number | R000011255 |
| Scientific Title | Withdrawal of immunomodulator in Crohn's disease treated with adalimumab and immnomodulator : a multicenter randomized trial(Diamond2 study). |
| Date of disclosure of the study information | 2012/12/21 |
| Last modified on | 2019/02/24 14:15:51 |
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Basic information
Public title
Withdrawal of immunomodulator in Crohn's disease treated with adalimumab and immnomodulator : a multicenter randomized trial(Diamond2 study).
Acronym
Withdrawal of immunomodulator in Crohn's disease treated with adalimumab and immnomodulator : a multicenter randomized trial.
Scientific Title
Withdrawal of immunomodulator in Crohn's disease treated with adalimumab and immnomodulator : a multicenter randomized trial(Diamond2 study).
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Toshifumi Hibi |
Organization
School of Medicine, Keio University
Division name
Gastroenterology
Zip code
Address
Shinanomachi 35, Shinjyuku-ku, Tokyo
TEL
03-3353-1211
thibi@z5.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tadakazu Hisamatsu |
Organization
School of Medicine, Keio University
Division name
Gastroenterology
Zip code
Address
Shinanomachi 35, Shinjyuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
hisamachi@a7.keio.jp
Sponsor or person
Institute
Department of Internal Medicine, School of Medicine, Keio University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 07 | Month | 25 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011255
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
