UMIN-CTR Clinical Trial

Public title

Effects of Subcutaneous Actemura and MTX Blending in RA

Acronym

eSCRAMBLE

Scientific Title

Effects of Subcutaneous Actemura and MTX Blending in RA

Scientific Title:Acronym

eSCRAMBLE

Region

Japan

Condition

rheumatoid arthritis

Classification by specialty

Clinical immunology

Orthopedics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

In patients with active rheumatoid arthritis despite methotrexate use, we compare the effi cacy of adding tocilizumab (sc) to that of switching to tocilizumab (sc) monotherapy, as found in tocilizumab (iv).

Basic objectives2

Bio-equivalence

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV

Primary outcomes

disease activity measurement in rheumatoid arthritis

Key secondary outcomes

radiological evaluation by modified total sharp score, evaluation of synovitis by ultrasound, measurements stratified by body weight

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Adults with active RA (DAS28 >3.2) despite methotrexate prescription were randomly assigned to continue methotrexate with the addition of tocilizumab (MTX+TCZ) 162mg/body every other week for 52 weeks.

Interventions/Control_2

Adults with active RA (DAS28 >3.2) despite methotrexate prescription were randomly assigned to switch to tocilizumab (TCZ) 162mg/body every other week for 52 weeks.

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

20

years-old

<=

Age-upper limit

85

years-old

>=

Gender

Male and Female

Key inclusion criteria

1) Those who had confirmed RA according to the ACR/EULAR criteria with active
disease defined as disease activity score based on 28 joints-erythrocyte sedimentation rate (DAS28-ESR) greater than 3.2 at baseline.
2) Those who had been receiving methotrexate for at least 3 months
3) Those who had been receiving methotrexate for at least 3 months, with a stable dose.
4) Those who are able to comply with the study procedures and provide written informed consent

Key exclusion criteria

1) Those whose joint damage was too severe to evaluate
2) Those who receiving tacrolims or tofacitinib
3) Those with allergy for tocilizumab
4) Those who had received treatment listed below within 4 weeks starting study treatment: Start taking prednisone or increasing dose of prednisone, leukocytapheresis, surgical procedures
5) lymphocyte count was below 1000/microL
6) Those who has suffered from infection disease
7) Those who was in pregnancy or possible pregnancy
8) Those that was judged to be inappropriate by the responsible physician

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Kentaro Inui

Organization

Graduate School of Medicine,
Osaka City University Medical School

Division name

Department of Orthopaedic Surgery

Zip code

Address

1-4-3 Asahi-Machi Abeno-Ku, Osaka

TEL

06-6645-3851

Email

inuken@med.osaka-cu.ac.jp

Name of contact person

1st name
Middle name
Last name	Kentaro Inui

Organization

Graduate School of Medicine, Osaka City University Medical School

Division name

Department of Orthopaedic Surgery

Zip code

Address

1-4-3 Asahi-Machi Abeno-Ku, Osaka

TEL

06-6645-3851

Homepage URL

Email

inuken@med.osaka-cu.ac.jp

Institute

Department of Orthopaedic Surgery,
Graduate School of Medicine, Osaka City University Medical School

Institute

Department

Personal name

Organization

none

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

Date of disclosure of the study information

2013

Year

10

Month

21

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

Terminated

Date of protocol fixation

2013

Year

11

Month

21

Day

Date of IRB

Anticipated trial start date

2013

Year

12

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

2013

Year

10

Month

18

Day

Last modified on

2015

Year

08

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014102