UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032485 |
|---|---|
| Receipt number | R000037045 |
| Scientific Title | efficacy of early adalimumab or immunomodulator on postoperative remission maintenance in patients with Crohn's disease |
| Date of disclosure of the study information | 2018/05/08 |
| Last modified on | 2020/05/13 22:41:14 |
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Basic information
Public title
efficacy of early adalimumab or immunomodulator on postoperative remission maintenance in patients with Crohn's disease
Acronym
postoperative early adalimumab or immunomodulator in CD study
Scientific Title
efficacy of early adalimumab or immunomodulator on postoperative remission maintenance in patients with Crohn's disease
Scientific Title:Acronym
postoperative early adalimumab or immunomodulator in CD study
Region
| Japan |
Condition
Condition
Cron's disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
the comparison of long-term efficacy with postoperative early adalimumab or immunoregulatory in Crohn disease
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
endoscopic remission rate of 18 months after surgery
Key secondary outcomes
clinical remission rate, negative CRP, trough level of anti-TNF agents, maintenance rate of the therapy, re-surgery rate of 18 months after surgery
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
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
adalimumab
Interventions/Control_2
azathiopurine
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
CD patients with intestinal resection for active CD lesion within 3 months
Key exclusion criteria
stoma
without intestinal resection
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Akihiro |
| Middle name | |
| Last name | Yamada |
Organization
Sakura medical center, Toho university
Division name
gastroenterology
Zip code
285-0841
Address
564-1,shimoshizu, sakura,chiba
TEL
043-462-8811
taro-dog@sakura.med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Akihiro |
| Middle name | |
| Last name | Yamada |
Organization
Sakura medical center, Toho university
Division name
gastroenterology
Zip code
285-0841
Address
564-1,shimoshizu, sakura,chiba
TEL
043-462-8811
Homepage URL
taro-dog@sakura.med.toho-u.ac.jp
Sponsor or person
Institute
Sakura medical center, Toho university
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
Sakura medical center, Toho university
Address
564-1,shimoshizu, sakura, chiba
Tel
043-462-8811
taro-dog@sakura.med.toho-u.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 08 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037045
Publication of results
Published
Result
URL related to results and publications
https://www.longdom.org/open-access/efficacy-of-early-adalimumab-or-immunomodulator-on-postoperative
Number of participants that the trial has enrolled
47
Results
At 78 weeks, endoscopic remission was confirmed in 5/16 patients in the AZA group (31.2%) and 7/12 patients in the ADA group (58.3%) (p=0.24) in the intention-to-treat population. In the per-protocol population (19 patients with evaluable images), remission was recorded in 3/9 (33.3%) patients in the AZA and 7/10 (70.0%) in the ADA group.
Results date posted
| 2020 | Year | 05 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
There were no statistical difference between groups regarding baseline including sm- oking status, previous resections, CD phenotype, previous perianal disease, and previous drug exposure
Participant flow
Atotal 47 patients were entered into the study.Eight patients (17.1%) were excluded during screening (five did not fulfill
the selection criteria, and three patients were lost to follow-up), leaving 39 eligible patients; 20 patients were randomized to the AZA group and 19 to the ADA group.
Adverse events
Sixteen (41.0%) patients withdrew from the trial before the 78-month end point, although 4 (10.2%) of these patients withdrew only after clinical recurrence. The reasons for withdrawal are detailed in Table 3. A total of 12 adverse events were observed, the adverse event rates were similar across treatment groups (p=1.00). Six patients were withdrawn due to severe adverse events (AZA; 5, vs ADA; 0, p=0.04).
Outcome measures
The primary endpoint was the rate of remission of CD in the endoscopy performed at Week 78, the evidence based on the Rutgeerts score.
The secondary endpoints included the percentages of clinical remission (Crohn's Disease Activity Index, CDAI less than 150) after 78 weeks of therapy, as well as negative titer in activity markers such as fecal calprotectin less than 300 mg/g, serum C-reactive protein less than 0.3 mg/dl at Weeks 78. Adverse events and surgical requirements were evaluated until Weeks 78.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | 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
| 2018 | Year | 05 | Month | 07 | Day |
Last modified on
| 2020 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037045
| Research Plan | |
|---|---|
| Registered date | File name |
| 2020/05/13 | ADA AZA(様式3)研究実施計画書.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2020/05/13 | ADA AZA(様式2)研究実施計画の概要.xls |
| Research case data | |
|---|---|
| Registered date | File name |
| 2020/05/13 | CD ADA IM randomize.xls |
