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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000012073
Receipt No. R000014102
Scientific Title Effects of Subcutaneous Actemura and MTX Blending in RA
Date of disclosure of the study information 2013/10/21
Last modified on 2015/08/03

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

Objectives
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

Assessment
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

Base
Study type Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

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

Funding Source
Organization none
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
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
2013 Year 10 Month 21 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
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
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
Other related information

Management information
Registered date
2013 Year 10 Month 18 Day
Last modified on
2015 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014102

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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