UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006141 |
|---|---|
| Receipt number | R000007262 |
| Scientific Title | Comparative study of Infliximab monotherapy vs combined therapy with azathiopurine for inducing and maintaining clinical remission in steroid-dependent or -resistant ulcerative colitis |
| Date of disclosure of the study information | 2011/08/12 |
| Last modified on | 2016/02/11 10:34:54 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Comparative study of Infliximab monotherapy vs combined therapy with azathiopurine for inducing and maintaining clinical remission in steroid-dependent or -resistant ulcerative colitis
Acronym
Comparative study of Infliximab monotherapy vs combined therapy with azathiopurine for inducing and maintaining clinical remission in steroid-dependent or -resistant ulcerative colitis
Scientific Title
Comparative study of Infliximab monotherapy vs combined therapy with azathiopurine for inducing and maintaining clinical remission in steroid-dependent or -resistant ulcerative colitis
Scientific Title:Acronym
Comparative study of Infliximab monotherapy vs combined therapy with azathiopurine for inducing and maintaining clinical remission in steroid-dependent or -resistant ulcerative colitis
Region
| Japan |
Condition
Condition
ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of Infliximab monotherapy and combined therapy with azathiopurine for inducing and maintaining clinical remission in steroid-dependent or -resistant ulcerative colitis, in a multicenter, open labeled, randomized, controlled study
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Remission and clinical response rate at week 30
Key secondary outcomes
1) Remission rate (CAI 0-4) at week 8, 30, and 54
2) Clinical response (more than 50 percent reduction from baseline in their CAI) at week 8 and 54
3) Mucosal healing at week 8 and 54
4) Steroid sparing effect
5) Safety assessment
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 not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients in Infliximab monotherapy receive intravenous infusion of IFX at week 0, 2, and 6, and then every 8 weeks (up to week 54).
Interventions/Control_2
Patients in the combination therapy of Infliximab and azathiopurine receive intravenous infusion of IFX (at week 0, 2, 6, and then every 8 weeks) and oral azathiopurine (up to week 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
| 16 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients with moderately active ulcerative colitis (CAI; 7-11)
2) Patients treated with corticosteroid (PSL; less or equal to 30mg/day, within 2 weeks)
3) Immunomodulators (azathiopurine, methotrexate, tacrolimus, cyclosporine
) naive patients
4) Anti-TNF biologic agent naive patients
Key exclusion criteria
1) Patients who are required total colectomy or subtotal colectomy
2) Patients with severe active ulcerative colitis (CAI; more than 12)
3) Patients with malignancy
4) Patients with intestinal stenosis to cause intestinal obstruction
5) Patients with serious extraintestinal complication
6) Patients who are pregnant or desire pregnancy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Nakase |
Organization
Kyoto University Hospital
Division name
Division of Endoscopic Medicine
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, 606-8507, Japan
TEL
075-751-4319
hiropy_n@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Minoru Matsuura |
Organization
Kyoto University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, 606-8507, Japan
TEL
075-751-4319
Homepage URL
minomats@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Kyoto 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
京都大学医学部附属病院（京都府）
京都桂病院（京都府）
北野病院（大阪府）
大阪府済生会中津病院（大阪府）
日本赤十字社 大津赤十字病院（滋賀県）
神戸市立医療センター中央市民病院（兵庫県）
神戸市立医療センター西市民病院（兵庫県）
西神戸医療センター（兵庫県）
天理よろづ相談所病院（奈良県）
滋賀県立成人病センター（滋賀県）
日本赤十字社 和歌山医療センター（和歌山県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 08 | Month | 12 | 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
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
| 2015 | Year | 12 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 08 | Month | 09 | Day |
Last modified on
| 2016 | Year | 02 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007262
