UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035854 |
|---|---|
| Receipt number | R000029024 |
| Scientific Title | Tofacitinib therapy for rheumatoid arthritis : a direct comparison study between biologic-naive and experienced patients. |
| Date of disclosure of the study information | 2019/02/12 |
| Last modified on | 2019/02/12 17:53:32 |
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Basic information
Public title
Tofacitinib therapy for rheumatoid arthritis : a direct comparison study between biologic-naive and experienced patients.
Acronym
Efficacy of tofacitinib for rheumatoid arthritis patients in Japan.
Scientific Title
Tofacitinib therapy for rheumatoid arthritis : a direct comparison study between biologic-naive and experienced patients.
Scientific Title:Acronym
Efficacy of tofacitinib for rheumatoid arthritis patients in Japan.
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To directly compare the outcome of tofacitinib therapy for methotrexate-refractory rheumatoid arthritis (RA) between biologics-naive patients and patients who had experienced in inadequate response to biological agents.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CDAI Index
Key secondary outcomes
Safety
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who met RA classification criteria (1987 ACR, 2010 ACR/EULAR).
Patients have a disease activity score assesing 28 joints (CDAI) of more than 10.
Patients agreed with tofacitinib therapy.
Key exclusion criteria
Patients who have previously recieved tofacitinib therapy.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shunsuke Mori |
Organization
NHO Kumamoto Saishunsou National Hospital
Division name
Dept of Rheumatology
Zip code
Address
2659 Kohshi, Kumamoto Japan
TEL
81-96-242-1000
moris@saisyunsou1.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsunori Kokubu |
Organization
NHO Kumamoto Saishunsou National Hospital
Division name
secretariat
Zip code
Address
2659 Kohshi, Kumamoto Japan
TEL
81-96-242-1000
Homepage URL
8211sy01@hosp.go.jp
Sponsor or person
Institute
National Hospital Organization
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Although tofacitinib can provide an effective treatment option for intractable RA patients. its impact on outcomes in lowere in patinets with previous failure.
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
| 2014 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
At month 6, 65 patients reached CDAI50, which is defined as achieving more than 50% improvement. The number of previous biological agents was twice as high in CDAI50 non-responders as in responders (2.2 versus 1.1, p<0.001), but there was no significant difference in the type of previous agents or the reason for discontinuation. According to a multivariate logistic regression analysis, the previous use of the biologic agents [odds ratio (OR) 4.48, p=0.002) and the concomitant use of predonisolone (OR 2.40, p=0.047) were associated with afailure to achieve a CDAI50 response. Biologic-naive patinets were more likely to achieve CDAI50 than biologic-experienced patients (80.6% versus 46.8%.p=0.001). Mean CDAI values were higher in biologic-naive patients (41.7% versus 11.7%, p=0.001). Biologic-naive patiets more rapidly achieved remission. Rates of discontinuation resulting from adverse events were similar in both group.
Management information
Registered date
| 2019 | Year | 02 | Month | 12 | Day |
Last modified on
| 2019 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029024
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
