UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007341 |
|---|---|
| Receipt number | R000008653 |
| Scientific Title | The study of the effectiveness of maintenance treatment with infliximab for ulcerative colitis patients who respond to induction treatment with infliximab |
| Date of disclosure of the study information | 2012/02/21 |
| Last modified on | 2019/09/04 17:48:02 |
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Basic information
Public title
The study of the effectiveness of maintenance treatment with infliximab for ulcerative colitis patients who respond to induction treatment with infliximab
Acronym
The study of the effectiveness of maintenance treatment with infliximab for ulcerative colitis patients who respond to induction treatment with infliximab
Scientific Title
The study of the effectiveness of maintenance treatment with infliximab for ulcerative colitis patients who respond to induction treatment with infliximab
Scientific Title:Acronym
The study of the effectiveness of maintenance treatment with infliximab for ulcerative colitis patients who respond to induction treatment with infliximab
Region
| Japan |
Condition
Condition
ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of maintenance treatment with infliximab for ulcerative colitis patients who respond to induction treatment with infliximab. To find predictive factors of discontinuation of infliximab after attaining low disease activity.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Remission rate at week 54
Key secondary outcomes
1) The rate of remission (Mayo score of 0-2, with each individual subscore of 0-1) at week 8 and 30
2) The rate of clinical response (a decrease in the total Mayo score of at least 3 points and at least 30%, with a decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1) at week 8, 30 and 54
3) The rate of mucosal healing at week 8, 30 and 54
4) Safety assessment
etc.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients in maintenance group receive intravenous infusion of infliximab (5mg/kg) at week 0, 2, and 6 and then every 8 weeks (up to week 54).
Interventions/Control_2
Patients in discontinuation group receive intravenous infusion of infliximab (5mg/kg) at week 0, 2, and 6 (not receiving infliximab at week 14, 22, 30, 38, 46 and 54).
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Eligible patients have active ulcerative colitis with a Mayo score of 6 to 12 points and moderate-to-severe active disease on sigmoidoscopy (Mayo endoscopic subscore of at least 2) despite concurrent treatment with 5-aminosalicylates, corticosteroids, azathioprine or 6-mercaptopurine at week 0, and have a clinical response to infliximab at week 8.
Key exclusion criteria
(1) Infliximab contraindication
1) Patients with severe infection (Sepsis, etc)
2) Patients with active tuberculosis
3) Patients with history of hypersensitivity to the ingredient of infliximab, or the protein of mouse origin
4) Patients with demyelinating disease (Multiple sclerosis, etc) or with history of demyelinating disease
5) Patients with congestive heart failure
(2) 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 severe obstructive strictures or abdominal abscess assessed by X-ray, abdominal computed tomography, or endoscopy
(8) Patients with active hepatitis B or C
(9) Patients with human immunodeficiency virus
(10) Patients with malignancy
(11) Patients in 6 months after surgery
(12) Patients judged as inadequate at the discretion of physicians
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuya Endo |
Organization
Tohoku University Graduate School of Medicine (Tohoku University Hospital)
Division name
Division of Gastroenterology
Zip code
Address
1-1 Seiryo, Aoba, Sendai 980-8574, Japan
TEL
022-717-7171
kendo@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hisashi Shiga |
Organization
Tohoku University Graduate School of Medicine (Tohoku University Hospital)
Division name
Division of Gastroenterology
Zip code
Address
1-1 Seiryo, Aoba, Sendai 980-8574, Japan
TEL
022-717-7171
Homepage URL
shiga@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine (Tohoku University Hospital)
Institute
Department
Personal name
Funding Source
Organization
none
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 02 | Month | 21 | 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 | 07 | Month | 25 | Day |
Date of IRB
| 2011 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 21 | Day |
Last modified on
| 2019 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008653
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