UMIN-CTR Clinical Trial

Basic information
Public title	Corticosteroid-sparing effect of Actemra in patients with Rheumatoid Arthritis refractory to anti-TNF agents, methotrexate and corticosteroid
Acronym	CARAT study
Scientific Title	Corticosteroid-sparing effect of Actemra in patients with Rheumatoid Arthritis refractory to anti-TNF agents, methotrexate and corticosteroid
Scientific Title:Acronym	CARAT study
Region	Japan

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

Objectives
Narrative objectives1	To test the possibility to reduce dosage of prednisolone (PSL) of less than 5mg/day with low disease activity in DAS28 by switching anti-TNF agents to tocilizumab in RA patients refractory to anti-TNF agents, MTX and PSL of more than 5mg/day with moderate or high diseae activity in DAS28.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Proportion of patients with less than 5mg/day in observation period.
Key secondary outcomes	In observation period, 1. proportion of patients free from PSL 2. proportion of patients with recurrent RA after tapering PSL dosage 3. proporiton of patients with less than 2.6 of DAS28 4. proportion of patients with less than 5mg/day of PSL to be maintained 5. proportion of improvement of mHAQ 6. severe adverse events

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	tocilizumab
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	16 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Fulfill the RA classification criteria of American College of Rheumatology 1987. 2. More than 3.2 of DAS28-ESR. 3. Aged 16 to 80 years at registration. 4. PSL of 5 to 15mg/day in average is given and PSL of more 1mg/day in average has not been tapered for three months. 5. Both an anti-TNF agent and methotrexate of 4mg/week are given for more than 14weeks. 6. Written informed consent.
Key exclusion criteria	1. Be against the guideline of tocilizumab use by Japanese College of Rheumatology. 2. Infliximab dosage is more than 6mg/kg or administration interval of infliximab is within 6weeks. 3. Be true of class 4 in Steinblocker functional class within four weeks before tocilizumab administration. 4. Has been treated with tocilizumab so far. 5. PSL is increased in its dosage or newly administered within 2weeks before administration of tocilizumab. 6. Patients to whom the following treatments are administered within 4weeks before tocilizumab administration: Newly use or increase in dose of DMARDs or immunosuppressive agents except for methotrexate. Plasma exchange including leukocytapheresis. Surgery such as total knee joint replacement which seems to have an influence on the evaluation of efficacy of tocilizumab. 7. Be pregnant or possible to be pregnant. 8. Have a past medical history of malignancy within 5years. 9. More than three times of ALT levels as high as standard in our institution.
Target sample size	25

Research contact person
Name of lead principal investigator	1st name Middle name Last name Teruhisa AZUMA
Organization	Tenri Hospital
Division name	General Internal Medicine
Zip code
Address	200, Mishima-cho, Tenri, Nara
TEL	0743-63-5611
Email

Public contact
Name of contact person	1st name Middle name Last name Teruhisa AZUMA
Organization	Tenri Hospital
Division name	General Internal Medicine
Zip code
Address	200, Mishima-cho, Tenri, Nara
TEL	+81-743-63-5611
Homepage URL
Email	tazuma@tenriyorozu.jp

Sponsor
Institute	General Internal Medicine, Tenri Hospital
Institute
Department

Funding Source
Organization	Tenri Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
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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	天理よろづ相談所病院（奈良県）

Other administrative information
Date of disclosure of the study information	2010 Year 10 Month 20 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
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Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2010 Year 07 Month 16 Day
Date of IRB
Anticipated trial start date	2010 Year 11 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

Management information
Registered date	2010 Year 10 Month 19 Day
Last modified on	2010 Year 10 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005270

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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