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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005146
Receipt No. 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

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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 &#8804; 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
Email 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
Email tmatsumo@iwate-med.ac.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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
URL(English) https://upload.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


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