UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005146 |
|---|---|
| Receipt number | R000006111 |
| Scientific Title | Study of Combination Therapy of Adalimumab and an Immunomodulator for Crohn's Disease(Diamond study) |
| Date of disclosure of the study information | 2011/02/25 |
| Last modified on | 2016/02/25 09:47:12 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Study of Combination Therapy of Adalimumab and an Immunomodulator for Crohn's Disease(Diamond study)
Acronym
Study of Combination Therapy of Adalimumab and an Immunomodulator for Crohn's Disease(Diamond study)
Scientific Title
Study of Combination Therapy of Adalimumab and an Immunomodulator for Crohn's Disease(Diamond study)
Scientific Title:Acronym
Study of Combination Therapy of Adalimumab and an Immunomodulator for Crohn's Disease(Diamond study)
Region
| Japan |
Condition
Condition
Crohn's disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy and safety of combination of Adalimumab and Azathioprine
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Remission(CDAI<150) rate at 26 weeks.
Key secondary outcomes
Remission rate at each observational period, Clinical Response70 (CR70) and Clinical Response100 (CR100).
Mucosal healing rate at 26 weeks and 52 weeks.
Deep remission rate at 26 weeks and 52 weeks
Loss of response(Exacerbation) rate
Adalimumab blood concentration and AAA Incidence rate at 26 weeks.
Incidence of adverse events.
Others.
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
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of Adalimumab 160 mg at baseline, 80 mg at 2 weeks and 40 mg every 2 weeks.
Interventions/Control_2
In addition to Adalimumab Therapy, co-administration of 25-100mg Azathioprine once a day.Fixed dosage of Azathioprine up to 4 weeks and not increase in dosage later
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
Moderate or severe (CDAI220-450) patients with CD who has not ever received anti-TNF antibodies or immunomodulators before.
Key exclusion criteria
(1)Adalimumab contraindication
1)Patients with severe infection (Sepsis, etc)
2)Patients with active tuberculosis
3)Patients with history of hypersensitivity to any of the other ingredients of Adalimumab
4)Patients with demyelinating disease (Multiple sclerosis, etc) or with history of demyelinating disease
5)Patients with congestive heart failure
(2)Azathioprine contraindication
1)Patients with history of hypersensitivity to any of the other ingredients of Azathioprine
2)Patients with the number of leukocytes ≤ 3000/mm3
3)Pregnant or likely to be pregnant women
(3)Pregnant or lactating women
(4)Patients < 20 years of age
(5)Patients not approving the study consent
(6)Patients who have ever received anti-TNF antibodies before
(7)Patients who have received immunomodulators like Azathioprine, 6-mercaptopurine, Tacrolimus and Methotrexate
(8)Patients with malignancy
(9)Patients in 6 months after surgery
(10)Patients with short bowel syndrome
(11)Patients judged as inadequate at the discretion of physicians
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
Internal Medicine(Gastroenterology)
Zip code
Address
Shinanomachi 35, Shinjyuku-ku, Tokyo
TEL
0334446161
thibi@instikitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takayuki Matsumoto |
Organization
Iwate Medial University
Division name
Division of Gastroenterology, Department of Medicine
Zip code
Address
Uchimaru 19-1, Morioka City, Iwate 020-8505, Japan
TEL
019-651-5111
Homepage URL
tmatsumo@iwate-med.ac.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
札幌厚生病院（北海道）、札幌東徳州会病院（北海道）、北海道大学（北海道）、旭川医科大学（北海道）、弘前大学（青森県）、東北大学（宮城県）、筑波大学（茨城県）、獨協医科大学（栃木県）、東邦大学医療センター佐倉病院（千葉県）、千葉大学（千葉県）、埼玉医科大学医療センター（埼玉県）、慶應義塾大学医学部（東京都）、東京医科歯科大学（東京都）、社会保険中央総合病院（東京都）、東京女子医科大学、北里大学東病院（神奈川県）、横浜市立大学市民総合医療センター（神奈川県）、大船中央病院（神奈川）、昭和大学藤が丘病院（神奈川）、新潟市民病院（新潟県）、信州大学（長野）、藤田保健衛生大学（愛知県）、愛知医科大学（愛知県）、名古屋市立大学（愛知県）、静岡県立総合病院（静岡県）、浜松南病院（静岡県）、金沢大学（石川県）、富山大学（富山）、富山県立中央病院（富山）、京都大学（京都府）、京都府立医科大学（京都）、滋賀医科大学（滋賀県）、大阪市立大学（大阪府）、錦秀会インフュージョンクリニック（大阪府）、大阪大学（大阪府）、大阪医科大学（大阪府）、関西医科大学（大阪府）、ベルランド病院（大阪）、兵庫医科大学（兵庫県）、和歌山医科大学（和歌山県）、岡山大学（岡山県）、倉敷中央病院（岡山県）、広島大学（広島）、島根大学（島根県）、松山赤十字病院（愛媛県）、九州大学（福岡県）、福岡大学筑紫病院（福岡県）、久留米大学（福岡県）、長崎大学（長崎県）、大分赤十字病院（大分県）、宮崎大学（宮崎県）、宮崎医療センター（宮崎県）、鹿児島大学（鹿児島県）、琉球大学（沖縄県）、大阪市立総合医療センター（大阪府）、杏林大学（東京都）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 02 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2011 | Year | 02 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2015 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 02 | Month | 25 | Day |
Last modified on
| 2016 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006111
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
