UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Tofacitinib therapy for rheumatoid arthritis : a direct comparison study between biologic-naive and experienced patients.
Title of the study (Brief title)	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	Shunsuke Mori
Organization	NHO Kumamoto Saishunsou National Hospital
Division name	Dept of Rheumatology
Address	2659 Kohshi, Kumamoto Japan
TEL	81-96-242-1000
Email	moris@saisyunsou1.hosp.go.jp

Public contact
Name of contact person	Katsunori Kokubu
Organization	NHO Kumamoto Saishunsou National Hospital
Division name	secretariat
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 08 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results	Although tofacitinib can provide an effective treatment option for intractable RA patients. its impact on outcomes in lowere in patinets with previous failure.
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