UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018848 |
|---|---|
| Receipt number | R000021800 |
| Scientific Title | Tapering and withdrawal of methotrexate and biologics in patients with rheumatoid arthritis |
| Date of disclosure of the study information | 2015/08/29 |
| Last modified on | 2019/10/09 19:14:19 |
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Basic information
Public title
Tapering and withdrawal of methotrexate and biologics in patients with rheumatoid arthritis
Acronym
Tapering and withdrawal of methotrexate and biologics in patients with rheumatoid arthritis
Scientific Title
Tapering and withdrawal of methotrexate and biologics in patients with rheumatoid arthritis
Scientific Title:Acronym
Tapering and withdrawal of methotrexate and biologics in patients with rheumatoid arthritis
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assess the feasibility of tapering and withdrawal of methotrexate and biologics to find the appropriate dosage and interval of anti-rheumatic drugs
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Rate of sustaining remission in patients who have continued the present therapy, tapered and discontinued methotrexate, and extended the interval of biologics 52 weeks after starting tapering.
Key secondary outcomes
Disease activity, clinical characteristics, serological markers, rate of adverse events, FACS analysis, blood concentration of each drugs and antibodies against each drugs, serological concentration of cytokines and chemokines in patients who could successfully taper and discontinue anti-rheumatic drugs and who could not at the point anti-rheumatic drugs are started to be tapered, anti-rheumatic drugs are discontinued, and 52 weeks after anti-rheumatic drugs are started to be tapered.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
control: continue the present treatment
Interventions/Control_2
intervention: reduce the dosage of methotrexate by half every 3 months and discontinue
Interventions/Control_3
intervention: extend the interval of biologics to one and a half times every 3 months and discontinue
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients of rheumatoid arthritis treated with methotrexate and/or biologics who have sustained remission(DAS28<2.6) for 6 months
Key exclusion criteria
Patients who do not agree with the study
Patients who are judged inappropriate in medical aspect by the doctor
Target sample size
900
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kunihiro Yamaoka |
Organization
Keio University Hospital
Division name
Division of Rheumatology
Zip code
Address
35 Shinanomachi, Shinjyuku-Ku, Tokyo
TEL
81-3-5363-3786
yamaokak@a6.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kunihiro Yamaoka |
Organization
Keio University Hospital
Division name
Division of Rheumatology
Zip code
Address
35 Shinanomachi, Shinjyuku-Ku, Tokyo
TEL
81-3-5363-3786
Homepage URL
yamaokak@a6.keio.jp
Sponsor or person
Institute
Keio 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
| 2015 | Year | 08 | Month | 29 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 11 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 29 | Day |
Last modified on
| 2019 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021800
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
