UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A clinical study to evaluate the correlation between the efficacy and the immunological markers in patients with rheumatoid arthritis treated with Tofacitinib.
Title of the study (Brief title)	A clinical study to evaluate the correlation between the efficacy and the immunological markers in patients with rheumatoid arthritis treated with Tofacitinib.
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the correlation between the efficacy and immunological markers, such as the cytokine concentration in the serum, immunophenotype of peripheral blood, or the activity of intracellular signaling of lymphocytes in patients with rheumatoid arthritis treated with Tofacitinib.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Remission rate at 3.6.9.12 months by DAS, SDAI, CDAI and Boolean index.
Key secondary outcomes	HAQ-DI improvement rate at 3,6,9,12 months. Ultrasonography, the rate and number of subset of lymphocyte, serum cytokine concentration, phosphorylation level of intracellular signaling molecules at 6,12 months modified Total Sharp Score (mTSS) at 12months

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	Period :12 months Patients take Tofacitinib 5mg twice a day.
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. A patient who fulfills the 1987 ACR classification or the 2010 ACR/EULAR classification criteria for RA 2. A patient who has understood adequately about this study and given informed consent personally and voluntarily. 3. A patient who is 20 years of age and older. 4. A patient who has active arthritis despite adequate treatment with MTX (over 8mg/week, over 3 months) The definition of active arthritis: 1) A patient who meets all of the followings (a-c). a. Equal or more than 6 swollen joints b. Equal or more than 6 tender joints c. Equal or more than CRP 2.0mg/dL or ESR 28mm/hr 2) A patient who has moderate activity; equal or more than DAS28-ESR 3.2 or SDAI 26 or CDAI 22. 5. A patient who meets all of followings: equal or more than 4000/mm3 peripheral WBC, 1000/mm3 periphera Lymphocyte and negative for beta-D-glucan.
Key exclusion criteria	1.A patient with tuberculosis or non-tuberculous mycobacteria. 2 .A patient who is positive for HBs antigen or HBV DNA not receiving nucleotide analogue. 3. A patient who has an active infectious disease. 4. A patient who has concurrent malignancy or its previous history. 5. A patient with reduced renal function less than CLcr15/min. 6. A patient with reduced hepatic function more than 10 points of Child-Pugh score (grade C) 7. A patient with interstitial pneumonia. 8. A pregnant or breastfeeding women or a women who may be pregnant. 9. A patient who has hypersensitivity reaction to ingredients in this drug. 10. A patient who meets any of followings: less than 1000/mm3 peripheral neutrophils or less than 8g/dL hemoglobin. 11. A patient who is regarded as inappropriate to participate in the study by a doctor.
Target sample size	20

Research contact person
Name of lead principal investigator	Koichi Akashi
Organization	Kyusyu University Hospital
Division name	Medicine and biosystemic science
Address	1-1 Maidashi 3-chome, Higashi-ku, Fukuoka-city, Fukuoka, Japan
TEL	092-642-5233
Email	akashi@med.kyushu-u.ac.jp

Public contact
Name of contact person	Yojiro Arinobu
Organization	Kyusyu University Hospital
Division name	Medicine and biosystemic science
Address	1-1 Maidashi 3-chome, Higashi-ku, Fukuoka-city, Fukuoka, Japan
TEL	092-642-5233
Homepage URL
Email	yarinobu@cancer.med.kyushu-u.ac.jp

Sponsor
Institute	Kyusyu University Hospital Medicine and biosystemic science
Institute
Department

Funding Source
Organization	Takeda Pharmaceutical Company
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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

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

飯塚病院（福岡県）、北九州市立医療センター（福岡県）、国立病院機構　福岡病院（福岡県）、JR九州病院（福岡県）、浜の町病院（福岡県）、福岡赤十字病院（福岡県）、福岡大学病院（福岡県）、宗像医師会病院（福岡県）、九州大学病院別府病院（大分県）、佐賀大学医学部附属病院（佐賀県） Iizuka Hospital(Fukuoka),Kitakyushu Municipal Medical Center(Fukuoka),Fukuoka Hospital(Fukuoka),JR kyushu Hospital(Fukuoka),Hamanomachi Hospital(Fukuoka),Japanese Red Cross Fukuoka Hospital(Fukuoka),Fukuoka University Hospital(Fukuoka),Munakata Medical Association Hospital(Fukuoka),Kyushu University Beppu Hospital(Oita),Saga University Hospital(Saga)

Other administrative information
Date of disclosure of the study information	2016 Year 01 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 14 Day
Anticipated trial start date	2014 Year 12 Month 16 Day
Last follow-up date	2016 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 01 Month 20 Day
Last modified on	2019 Year 01 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023849