UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015441 |
|---|---|
| Receipt number | R000017953 |
| Scientific Title | The effectiveness and safety of certolizumab pegol in clinical practice |
| Date of disclosure of the study information | 2014/11/01 |
| Last modified on | 2018/03/15 14:47:38 |
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Basic information
Public title
The effectiveness and safety of certolizumab pegol in clinical practice
Acronym
The effectiveness and safety of certolizumab pegol in clinical practice
Scientific Title
The effectiveness and safety of certolizumab pegol in clinical practice
Scientific Title:Acronym
The effectiveness and safety of certolizumab pegol in clinical practice
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Medicine in general | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the effectiveness and safety of certolizumab pegol in clinical practice in Japanese patients with rheumatoid arthritis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Remission (SDAI<= 3.3) rate at week 52
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients with rheumatoid arthritis diagnosed with 1987 ACR or 2010 ACR/EULAR classification criteria
2.Patients with rheumatoid arthritis who meet the guideline about the usage of TNF inhibitors by JCR
3.Patients who will receive CZP treatment
4.Patients who submit the written informed consent to participate in this study
Key exclusion criteria
1.Patients complicated with serious infection
2.Patients with active tuberculosis
3.Patients allergic to the drug
4.Patients complicated with demyelinating disease or have a history of i
5.Patients with congestive heart failure
6.Patients contraindicated to the treatment with TNF inhibitors by the guideline about the usage by JCR
7.Patients their doctors find not appropriate for this study
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsutomu Takeuchi |
Organization
Keio University School of Medicine
Division name
Division of Rheumatology, Department of Internal Medicine
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, JAPAN
TEL
03-3353-1211
tsutake@z5.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuko Kaneko |
Organization
Keio University School of Medicine
Division name
Division of Rheumatology, Department of Internal Medicine
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, JAPAN
TEL
03-3353-1211
Homepage URL
ykaneko@z6.keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
UCB Japan Co. Ltd.
Astellas
Organization
Division
Category of Funding Organization
Profit organization
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
慶應義塾大学（東京都）、北海道大学（北海道）、埼玉医科大学総合医療センター（埼玉県）、東京女子医科大学（東京都）、産業医科大学（福岡）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The SDAI remission rates, the primary endpoint, was 36.7% (95% confidential interval 26.8-47.5). The rates of CDC achievment was 32.5% at week 52, 48.4% at week 104, and 100.0% at week 156. No new signal for safety was not observed.
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
| 2014 | Year | 06 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2018 | Year | 01 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Primary endmoint
Remission (SDAI<=3.3) rate at week 52
Secondary endopoint
1.Comprehensive disease control rate at every visit
2.Remission rate (CDAI<=2.8,DAS28<=2.6) rate at every visit
3.ACR20/50/70 achievement rate at every visit
4.Remission (SDAI<=3.3) rate at every visit except for week 52
5. Radiological remission (delta mTSS<=0.5) rate at every visit
6.Functional remission (HAQ-DI<=0.5) rate at every visit
7.Time course changes in disease activity index(DAS28,SDAI,CDAI,mTSS,HAQ,EQ5D,pain-VAS,etc
8.Safety
Management information
Registered date
| 2014 | Year | 10 | Month | 15 | Day |
Last modified on
| 2018 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017953
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| Registered date | File name |
| Research case data | |
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