UMIN-CTR Clinical Trial

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

rheumatoid arthritis

Classification by specialty

Clinical immunology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

General Internal Medicine, Tenri Hospital

Institute

Department

Personal name

Organization

Tenri Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

天理よろづ相談所病院（奈良県）

Date of disclosure of the study information

2010

Year

10

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2010

Year

10

Month

19

Day

Last modified on

2010

Year

10

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005270