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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000010033
Receipt No. R000011736
Scientific Title To investigate the efficacy of tocilizumab in RA patients with moderate disease activity under biologic therapy
Date of disclosure of the study information 2013/02/14
Last modified on 2018/09/13

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Basic information
Public title To investigate the efficacy of tocilizumab in RA patients with moderate disease activity under biologic therapy
Acronym To investigate the efficacy of tocilizumab in RA patients with moderate disease activity
Scientific Title To investigate the efficacy of tocilizumab in RA patients with moderate disease activity under biologic therapy
Scientific Title:Acronym To investigate the efficacy of tocilizumab in RA patients with moderate disease activity
Region
Japan

Condition
Condition Rheumatoid Arthritis
Classification by specialty
Clinical immunology Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the remission or low disease activity of tocilizumab therapy in RA patients with moderate disease activity under biologic therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Low disease activity rate at 24 weeks (SDAI)
Key secondary outcomes

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 (8 mg/kg of body weight) is to be infused every 4 weeks.
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
20 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria 1)Patients between 20 and 75 years old
2)Patients with rheumatoid arthritis
3)Patients with low to moderate activity activity under more than 24 weeks of anti-tumour necrosis factor biologic therapy
4)Moderate disease activity by SDAI
5)The patient by whom consent is got in written form about participation of the final examination
Key exclusion criteria 1)Patients who have serious infection
2)Patients who have history of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies
3)Patients who have history of a malignant tumor, or who have malignant tumor
4)Patients who have serious cardiac disease or liver disease, renal damage
5)Pregnant women or women trying to get pregnant
6)Patients considered inappropriate judged by attending physicians
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Daihei Kida
Organization Nagoya Medical Center, National Hospital Organization in Japan
Division name Department of Orthopaedic Surgery and Rheumatology
Zip code
Address 4-1-1 Sannomaru,Naka-ku Nagoya Aichi 460-0001, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Nagoya Medical Center, National Hospital Organization in Japan
Division name Department of Orthopaedic Surgery and Rheumatology
Zip code
Address 4-1-1 Sannomaru,Naka-ku Nagoya Aichi 460-0001, Japan
TEL
Homepage URL
Email

Sponsor
Institute Daihei Kida
Institute
Department

Funding Source
Organization Nagoya Medical Center, National Hospital Organization in Japan
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 02 Month 14 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 01 Month 28 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 14 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 02 Month 14 Day
Last modified on
2018 Year 09 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011736

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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