UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000035854
Receipt No. 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

* 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 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
Last 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
Email moris@saisyunsou1.hosp.go.jp

Public contact
1st 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
Email 8211sy01@hosp.go.jp

Sponsor
Institute National Hospital Organization
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029024

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.