UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021247 |
|---|---|
| Receipt number | 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 14:07:52 |
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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
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
asai@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024483
