UMIN-CTR Clinical Trial

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
Email	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
Email	yamaokak@a6.keio.jp

Sponsor
Institute	Keio University Hospital
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021800