UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014486 |
|---|---|
| Receipt number | R000016445 |
| Scientific Title | Efficacy and security of certolizumab pegol treatment in patients with reumatoid arthritis |
| Date of disclosure of the study information | 2014/12/01 |
| Last modified on | 2020/07/10 10:18:35 |
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Basic information
Public title
Efficacy and security of certolizumab pegol treatment in patients with reumatoid arthritis
Acronym
Saitama East Study
Scientific Title
Efficacy and security of certolizumab pegol treatment in patients with reumatoid arthritis
Scientific Title:Acronym
Saitama East Study
Region
| Japan |
Condition
Condition
rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy and safty of certolizumab pegoltratment for patients with rheumatoid arthritis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number(%) of patients who developed in low disease activity from 12 to 52 weeks
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
RA patients with medium disease activity are treated with 200mg of CZP (loading dose method is ommited)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients are fulfilled ACR(1987) or ACR/EULAR classification criteria for rheumatoid arthritis and are diagnosed as RA.
2.Patients have never treated with any biologics.
3.Before CPZ treatment,the dose and method of DMARD have not changed at leaset 8 weeks.
4.Before CPZ treatment,the dose and method of NSAIDs have not changed at leaset 4 weeks.
5.Before CPZ treatment,the dose and method of glucocorticoid have not changed at leaset 4 weeks.Patiennts are treated with prednisolone of 10mg/day or thess than 10mg/day.
6.The patients have swollen joints of 6 or less than 6 joints and have tender joints of 6 or less than 6 joints.
Key exclusion criteria
1.Patients have other rheumatic diseases.
2. Patients have malignant disorders in recent 5 years.
3.Patients have a risk for tuberculosis.
4.Patients who develpoprd bacterial infection and antibiotics were administrated within 30 days after first CPZ treatment.
5.Drug or alcohol addiction or abusers.
6.Patients who are not able to be adequately evaluated in this study.
7.Patients who have Type B viral hepatitis.
8.Patients who have nontuberculous mycobacteril infection.
9.Patients who have congestive heart failure(>II).
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeto Kobayashi |
Organization
Juntendo University, Juntendo Koshigaya Hopspital
Division name
Rheumatology, Internal Medicine
Zip code
Address
560 Fukuroyama Koshigaya Saitama
TEL
048-975-0321
shigeto@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeto Kobayashi |
Organization
Juntendo University, Juntendo Koshigaya Hopspital
Division name
Rheumatology, Internal Medicine
Zip code
Address
560 Fukuroyama Koshigaya Saitama
TEL
048-975-0321
Homepage URL
shigeto@juntendo.ac.jp
Sponsor or person
Institute
Saitama East Study Group
Institute
Department
Personal name
Funding Source
Organization
Dept.Internal Medicine, Juntendo Koshigaya Hospital
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
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
| 2014 | Year | 12 | Month | 01 | 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
| 2014 | Year | 05 | Month | 21 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 21 | Day |
Last follow-up date
| 2016 | Year | 06 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 06 | Day |
Last modified on
| 2020 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016445
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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