UMIN-CTR Clinical Trial

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