UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026195 |
|---|---|
| Receipt number | R000030091 |
| Scientific Title | Evaluation of the structual remission and its sustainment after discontinuation of infliximab in patients with rheumatoid arthritis who receive "programmed" treatment in randomized controlled trial |
| Date of disclosure of the study information | 2017/02/17 |
| Last modified on | 2018/12/18 15:09:38 |
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Basic information
Public title
Evaluation of the structual remission and its sustainment after discontinuation of infliximab in patients with rheumatoid arthritis who receive "programmed" treatment in randomized controlled trial
Acronym
RRRR-XP Study
Scientific Title
Evaluation of the structual remission and its sustainment after discontinuation of infliximab in patients with rheumatoid arthritis who receive "programmed" treatment in randomized controlled trial
Scientific Title:Acronym
RRRR-XP Study
Region
| Japan |
Condition
Condition
Rheumatoid Arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the frequency of structual remission and its sustainment after discontinuation of infliximab (IFX) in methotrexate-refractory patients with rheumatoid arthritis who receive "programmed" treatment (programmed treatment arm), whose dose of IFX for each patient is determined by the baseline tumor necrosis factor-alpha (TNF-alpha) level, compared with patients who receive a "standard" treatment (standard treatment arm), whose dose was fixed as 3mg/kg every 8 weeks, as a control in a prospective randomized controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Proportion of patients maintaining discontinuation of IFX at 1 year after a discontinuation of IFX at the time of 54 weeks after the first administration of IFX
Proportion of structual remission 1 yer after enrolloing in RRRR-EX study
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
"programmed" treatment (Programmed treatment arm), whose dose of IFX for each patient is determined by the baseline TNF-alpha level
IFX 3mg/kg is administered on week 0, 2 and 6. After week 14, dose of IFX for each patient is determined by the baseline TNF-alpha level as follows;
TNF-alpha < 0.55pg/mL: IFX 3mg/kg is continued every 8 weeks.
0.55pg/mL =< TNF-alpha < 1.65pg/mL: IFX 6mg/kg is administered on week 14. IFX 6mg/kg is continued every 8 weeks.
TNF-alpha >= 1.65pg/mL: IFX 6mg/kg is administered on week 14 and IFX 10mg/kg is administered on week 22. IFX 10mg/kg is continued every 8 weeks.
In all cases, IFX is discontinued at the time of 54 weeks after the first administration of IFX.
Key exclusion criteria
"standard" treatment (standard treatment arm), whose dose was fixed as 3mg/kg every 8 weeks
IFX 3mg/kg is administered on week 0, 2 and 6. After week 14, IFX 3mg/kg is continued every 8 weeks. IFX is discontinued at the time of 54 weeks after the first administration of IFX.
Target sample size
405
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiya Tanaka |
Organization
University of Occupational and Environmental Health, Japan
Division name
The First Department of Internal Medicine, School of Medicine
Zip code
Address
1-1, Iseigaoka, Yahata-nishi-ku, Kitakyushu, Japan
TEL
093-603-1611
tanaka@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nao Horie |
Organization
Hokkaido University Hospital
Division name
Translational Research and Clinical Trial Center
Zip code
Address
Nishi-5, Kita-14, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-7735
Homepage URL
nhorie@med.hokudai.ac.jp
Sponsor or person
Institute
University of Occupational and Environmental Health, Japan
Institute
Department
Personal name
Funding Source
Organization
MitsubishiTanabe Pharma
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
| 2017 | Year | 02 | Month | 17 | 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
| 2016 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 31 | Day |
Other
Other related information
retrospective study
Management information
Registered date
| 2017 | Year | 02 | Month | 17 | Day |
Last modified on
| 2018 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030091
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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