UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020663 |
|---|---|
| Receipt number | R000023849 |
| Scientific Title | A clinical study to evaluate the correlation between the efficacy and the immunological markers in patients with rheumatoid arthritis treated with Tofacitinib. |
| Date of disclosure of the study information | 2016/01/21 |
| Last modified on | 2019/01/23 17:37:00 |
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Basic information
Public title
A clinical study to evaluate the correlation between the efficacy and the immunological markers in patients with rheumatoid arthritis treated with Tofacitinib.
Acronym
A clinical study to evaluate the correlation between the efficacy and the immunological markers in patients with rheumatoid arthritis treated with Tofacitinib.
Scientific Title
A clinical study to evaluate the correlation between the efficacy and the immunological markers in patients with rheumatoid arthritis treated with Tofacitinib.
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Koichi Akashi |
Organization
Kyusyu University Hospital
Division name
Medicine and biosystemic science
Zip code
Address
1-1 Maidashi 3-chome, Higashi-ku, Fukuoka-city, Fukuoka, Japan
TEL
092-642-5233
akashi@med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yojiro Arinobu |
Organization
Kyusyu University Hospital
Division name
Medicine and biosystemic science
Zip code
Address
1-1 Maidashi 3-chome, Higashi-ku, Fukuoka-city, Fukuoka, Japan
TEL
092-642-5233
Homepage URL
yarinobu@cancer.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyusyu University Hospital
Medicine and biosystemic science
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
| 2014 | Year | 07 | Month | 14 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023849
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