UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017440 |
|---|---|
| Receipt number | R000019412 |
| Scientific Title | In methotrexate resistant rheumatoid arthritis, switching methotrexate to tofacitinib versus adding tofacitinib to methotrexate, open labeled, multicenter randomized non-inferiority study. |
| Date of disclosure of the study information | 2015/05/07 |
| Last modified on | 2020/11/20 14:04:46 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
In methotrexate resistant rheumatoid arthritis, switching methotrexate to tofacitinib versus adding tofacitinib to methotrexate, open labeled, multicenter randomized non-inferiority study.
Acronym
RAXEL study
Scientific Title
In methotrexate resistant rheumatoid arthritis, switching methotrexate to tofacitinib versus adding tofacitinib to methotrexate, open labeled, multicenter randomized non-inferiority study.
Scientific Title:Acronym
RAXEL study
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In MTX resistant RA, it is an object to verify that group of switching MTX to tofacitinib is not inferior to group of adding tofacitinib to MTX in achievement rate of ACR 20 in three months time.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Achievement rate of ACR20 at 12 weeks
Key secondary outcomes
Achievement rate of ACR20 at 4 and 8 weeks
Achievement rate of ACR50 and 70 at 4, 8 and 12 weeks
Achievement rate of remission at 4, 8 and 12 weeks
DAS28-ESR and DAS28-CRP at 4, 8 and 12 weeks
HAQ score at 4, 8 and 12weeks
Tender joint counts and swollen joint counts at 4, 8 and 12 weeks
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
for 3 months Tofacitinib 5mg BID everyday
Interventions/Control_2
for 3 months Tofacitinib 5mg BID everyday
for 3 months Methotrexate6mg-16mg/week
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
(2) Patients must be at least 18 years of age or older.
(3) Patients must meet the ACR/EULAR classification criteria for the diagnosis of rheumatoid arthritis.
(4) Disease duration of RA is more than or equal to 6 months.
(5) Patients must have a positive IgM rheumatoid factor (RF+), as determined by an acceptable laboratory method, or antibodies to cyclic citrullinated peptide , as determined by an acceptable laboratory method.
(6) Patients must have active disease at the time of enrollment as indicated by a DAS28-ESR>3.2 or DAS28-CRP>2.7.
(7) The patients musut have oral the medicine for more than 12 weeks and more than 6mg/w.
(8) Oral amount of PSL is 10mg or less.
Key exclusion criteria
(1)The patient suffering from autoimmune disease With the exception of the Sjogren's syndrome and thyroid disease.
(2)Active tuberculosis, HIV, HBV or HCV infection has coexist.
(3)There is a pregnancy hope.
(4)There is a history of malignancy within the past 5 years.
(5)There is a history of tuberculosis infection within the past one year.
(6)There is a potential comorbidities requiring Intravenous glucocorticoid, Oral glucocorticoid, Immunosuppressant, biologics, Plasma exchange or IVIG during the study period.
(7)Other, who is investigator or test sharing doctor was judged unsuitable to safely carry out the present study.
Target sample size
134
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Nakajima |
Organization
Graduate School of Medicine and School of Medicine, Chiba University
Division name
the department of allergy and clinical immunology
Zip code
260-0856
Address
1-8-1, Inohana, Chuo-ku Chiba-shi, Chiba, 260-0856, Japan
TEL
043-222-7171
nakajimh@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Sohei |
| Middle name | |
| Last name | Makita |
Organization
Graduate School of Medicine and School of Medicine, Chiba University
Division name
the department of allergy and clinical immunology
Zip code
2620856
Address
1-8-1, Inohana, Chuo-ku Chiba-shi, Chiba, 260-0856, Japan
TEL
043-222-7171
Homepage URL
makitasohei@chiba-u.jp
Sponsor or person
Institute
Graduate School of Medicine and School of Medicine, Chiba University
the department of allergy and clinical immunology
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
industrial revenue bond of Chiba university
Address
1-8-1, Inohana, Chuo-ku Chiba-shi, Chiba, 260-0856, Japan
Tel
043-226-2616
shiken@office.chiba-u.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
千葉大学病院（千葉県）、国保旭中央病院（千葉県）、国立病院機構下志津病院（千葉県）、成田赤十字病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 07 | 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
| 2015 | Year | 02 | Month | 22 | Day |
Date of IRB
| 2015 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2015 | Year | 05 | Month | 18 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 18 | Day |
Date of closure to data entry
| 2019 | Year | 06 | Month | 18 | Day |
Date trial data considered complete
| 2020 | Year | 01 | Month | 16 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 07 | Day |
Last modified on
| 2020 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019412
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
