UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002744 |
|---|---|
| Receipt number | R000003337 |
| Scientific Title | Success of tocilizumab in RA patients with remission induction and sustained efficacy after discontinuation |
| Date of disclosure of the study information | 2009/11/10 |
| Last modified on | 2018/03/13 22:16:54 |
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Basic information
Public title
Success of tocilizumab in RA patients with remission induction and sustained efficacy after discontinuation
Acronym
Surprise study
Scientific Title
Success of tocilizumab in RA patients with remission induction and sustained efficacy after discontinuation
Scientific Title:Acronym
Surprise study
Region
| Japan |
Condition
Condition
rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety of tocilizumab with methotrexate in rheumatoid arthritis, and sustained efficacy after discontinuation of tocilizumab
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
remission rate at 24 weeks (DAS28-ESR)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
tocilizumab plus methotrexate
Interventions/Control_2
tocilizumab
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 with rheumatoid arthritis diagnosed according to the criteria of the American College of Rheumatology (ACR)
2) Patients treated with more than 6mg/week dose of methotrexate for more than 8 weeks
3) Patients whose disease duration are less than 10 years
4) DAS28-ESR score less than 3.2 at the time of entry
Key exclusion criteria
1) Patients whose Steinbrocker functional classification are class 4
2) Patients treated with leflunomide, disease modifying anti-rhuematic disease drugs without methotrexate, or tacrolimus
3) Patients who have ever treated with any of biologic agents
4) Patients treated with 10mg/day of predonisolone
5) Patients whose WBC is less than 4000 or lymphocytes is less than 1000
6) Patients with infection of HBV or EBV
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsutomu Takeuchi |
Organization
Department of Internal Medicine, Keio University School of Medicine
Division name
Division of Rheumatology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, JAPAN
TEL
0333531211
tsutake@z5.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuko Kaneko |
Organization
Department of Internal Medicine, Keio University School of Medicine
Division name
Division of Rheumatology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, JAPAN
TEL
0333531211
Homepage URL
http://www.keio-rheum.jp/
ykaneko@z6.keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
nonprofit organization ACRO
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2009 | Year | 11 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2009 | Year | 10 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 11 | Month | 10 | Day |
Last modified on
| 2018 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003337
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
