UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019958 |
|---|---|
| Receipt number | 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 12:11:05 |
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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
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
adalrg-project@umin.ac.jp
Public contact
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
adalrg-project@umin.ac.jp
Sponsor or person
Institute
Iwate Medical University
Kochi Medical School Hospital
Keio University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023044
