UMIN-CTR Clinical Trial

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
Email	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
Email	makitasohei@chiba-u.jp

Sponsor
Institute	Graduate School of Medicine and School of Medicine, Chiba University the department of allergy and clinical immunology
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	industrial revenue bond of Chiba university
Address	1-8-1, Inohana, Chuo-ku Chiba-shi, Chiba, 260-0856, Japan
Tel	043-226-2616
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019412