UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015441
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email ykaneko@z6.keio.jp

Sponsor
Institute Keio University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017953

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.