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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000021247
Receipt No. R000024483
Scientific Title Tocilizumab treatment with reducing and stopping methotrexate in patients with rheumatoid arthritis in stable low disease activity-state
Date of disclosure of the study information 2016/07/22
Last modified on 2019/09/06

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Basic information
Public title Tocilizumab treatment with reducing and stopping methotrexate in patients with rheumatoid arthritis in stable low disease activity-state
Acronym Tocilizumab treatment with reducing and stopping methotrexate (T-ReX study)
Scientific Title Tocilizumab treatment with reducing and stopping methotrexate in patients with rheumatoid arthritis in stable low disease activity-state
Scientific Title:Acronym Tocilizumab treatment with reducing and stopping methotrexate (T-ReX study)
Region
Japan

Condition
Condition Rheumatoid arthritis
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess whether low disease activity would be sustained with reducing and stopping methotrexate (MTX) in patients with rheumatoid arthritis (RA) treated with tocilizumab (TCZ)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Proportion of patients maintaining CDAI<=10 at 36 weeks (24weeks after stopping MTX)
Key secondary outcomes 1) Proportion of patients maintaining CDAI<=10 at 12 weeks (after reducing MTX) and 64 weeks (52weeks after stopping MTX)
2) Disease activity, serum concentration of TNF-alpha and IL-6, FSSG score, and EQ-5Dat each visit
3) Proportion of patients regaining CDAI<=10
4) Predictors of maintaining CDAI<=10
5) Adverse events

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Double the time between applications of MTX without changing dose for the first 12 weeks, and then stop MTX if CDAI<=10 is maintained.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients with RA fulfilled the ACR 1987 classification criteria or ACR/EULAR 2010 classification criteria
2) Patients who had a CRP concentration of >=0.6mg/dl at initiation of TCZ
3) Patients maintaining low disease activity with a CDAI of <=10 with TCZ and MTX for at least 12 weeks
4) Patients receiving stable treatment without alteration in dosage and administration for at least 12 weeks
Key exclusion criteria 1) Patients receiving TCZ and/or MTX for any disease other than RA
2) Patients judged as inadequate at the discretion of physicians
Target sample size 51

Research contact person
Name of lead principal investigator
1st name Toshihisa
Middle name
Last name Kojima
Organization Nagoya University Hospital
Division name Orthopedic Surgery
Zip code 466-8560
Address 65 Tsurumai-cho, Showa-ku, Nagoya
TEL 052-744-1908
Email toshik@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Shuji
Middle name
Last name Asai
Organization Nagoya University Hospital
Division name Center for Advanced Medicine and Clinical Research
Zip code 466-8560
Address 65 Tsurumai-cho, Showa-ku, Nagoya
TEL 052-744-1957
Homepage URL
Email asai@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Hospital
Institute
Department

Funding Source
Organization Chugai Pharmaceutical Co.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nagoya University Certified Review Board
Address 65 Tsurumai-cho, Showa-ku, Nag oya, Aichi 466-8550, Japan Aichi
Tel 0 5 2 -7 4 4 -2 4 7 9
Email ethics@med.nagoya-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
2016 Year 07 Month 22 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled 53
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 Main results already published
Date of protocol fixation
2016 Year 07 Month 22 Day
Date of IRB
2016 Year 06 Month 28 Day
Anticipated trial start date
2016 Year 07 Month 22 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
2016 Year 02 Month 29 Day
Last modified on
2019 Year 09 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024483

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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