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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019958
Receipt No. R000023044
Scientific Title Research for biomarkers of inflammatory bowel disease. - Investigation of the usefulness of LRG for evaluation of disease condition after adalimumab treatments
Date of disclosure of the study information 2015/11/27
Last modified on 2019/03/13

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Basic information
Public title Research for biomarkers of inflammatory bowel disease. - Investigation of the usefulness of LRG for evaluation of disease condition after adalimumab treatments
Acronym Investigation of the usefulness of LRG for evaluation of disease condition after adalimumab treatments
Scientific Title Research for biomarkers of inflammatory bowel disease. - Investigation of the usefulness of LRG for evaluation of disease condition after adalimumab treatments
Scientific Title:Acronym Investigation of the usefulness of LRG for evaluation of disease condition after adalimumab treatments
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the correlation between disease activity/endoscopic findings and biomarkers after 52 weeks adalimumab treatments in patients with IBD.
Basic objectives2 Others
Basic objectives -Others To evaluate the correlation between disease activity/endoscopic findings and biomarkers at the following points.
- start of the treatment
- 12 weeks after treatment starting
- 24 weeks after treatment starting
- 52 weeks after treatments starting
(or discontinuance of administration)
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes -Correlation between biomarkers and disease activity/endoscopic findings
Key secondary outcomes - Change of biomarkers (LRG, fCal, CRP) and disease activity
- Correlations between several biomarkers.
- Cutoff value, sensitivity and specificity of biomarkers in the stage of disease activity (remission)/endscopic findings(healing)
- Usefulness of biomarkers for predicting prognosis of IBD
- Effects on adalimumab concentration and anti-drug antibody titer for disease activity/endoscopic findings and biomarker.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver Other
Interventions/Control_1 Patients with Crohn's disease or ulcerative colitis

Adalimumab administration subcutaneously for 52 weeks using the recommended dosing regimens.
Interventions/Control_2
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 1. Patients diagnosed with moderate to severe CD or moderate to severe UC (except proctitis type),and should meet the following criteria;
CD : CDAI;220 or more
UC : Mayo Score;6 or more
2. Of this study after having received enough explanation on participating, a document agreement by the free will of the patient person is provided after enough understanding.
3. Patients aged 15 or older (Need agreement for deputy for patients under 20 years old)
4. Patients with inadequate response to existing therapies
Key exclusion criteria 1. Patients with history of following intestinal surgery. Patients who are scheduled for following surgery.
CD : enterectomy within 12 weeks prior to enrollment
pouch or stoma (except rectostomy)
UC : subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Kock pouch and ileostomy
2. Patients with history of adalimumab treatment
3. Patients who had not showed initial response to infliximab before and patients with secondary failure to infliximab 10 mg/kg
4. Patients with serious infections
5. Patients with active tuberculosis
6. Patients with a history of hypersensitivity toadalimumab
7. Patients with demyelinating disease (Multiple sclerosis, etc) or with history of demyelinating disease
8. Patients with congestive heart failure
9. Patients who is determined inappropriate to participate to this study by the investigator.
Target sample size 100

Research contact person
Last name of lead principal investigator
1st name Takayuki
Middle name
Last name Matsumoto
Organization Iwate Medical University
Division name Internal Medicine, The center for Immune Intractable Disease
Zip code 020-8505
Address 19-1, Uchimaru, Morioka, Iwate/185-1 Kohasu,Oko-cho,Nankoku-shi,Kochi/35, Shinanomachi, Shinjuku-ku, Tokyo
TEL 019-651-5111
Email adalrg-project@umin.ac.jp

Public contact
1st name of contact person
1st name Yukimi
Middle name
Last name Kokubun
Organization RPM Co., Ltd.
Division name Clinical Development Div.
Zip code 160-0023
Address 5F Shinwa-building, 3-2-4, Nishi-shinjuku, Shinjuku-ku, Tokyo
TEL 03-5325-5821
Homepage URL
Email adalrg-project@umin.ac.jp

Sponsor
Institute Iwate Medical University
Kochi Medical School Hospital
Keio University School of Medicine
Institute
Department

Funding Source
Organization Eisai Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Iwate Medical University School of Medicine Ethics Committee
Address 19-1, Uchimaru, Morioka, Iwate
Tel 019-651-5111
Email kenkyu@j.iwate-med.ac.jp

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)、岩手医科大学(岩手県)、千葉大学(千葉県)、東邦大学医療センター佐倉病院(千葉県)、埼玉医科大学総合医療センター(千葉県)、慶應義塾大学(東京都)、東京医科歯科大学(東京都)、北里大学北里研究所病院(東京都)、東京山手メディカルセンター(東京都)、杏林大学(東京都)、横浜市立大学附属市民総合医療センター(神奈川県)、北里大学(神奈川県)、京都大学(京都府)、大阪大学(大阪府)、兵庫医科大学(兵庫県)、岡山大学(岡山県)、川崎医科大学(岡山県)、九州大学(福岡県)、福岡大学筑紫病院(福岡県)、長崎大学(長崎県)

Other administrative information
Date of disclosure of the study information
2015 Year 11 Month 27 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 80
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
2016 Year 06 Month 27 Day
Date of IRB
2016 Year 01 Month 27 Day
Anticipated trial start date
2016 Year 07 Month 02 Day
Last follow-up date
2018 Year 11 Month 20 Day
Date of closure to data entry
2018 Year 12 Month 14 Day
Date trial data considered complete
2018 Year 12 Month 31 Day
Date analysis concluded
2019 Year 01 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 11 Month 27 Day
Last modified on
2019 Year 03 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023044

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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