UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027387 |
|---|---|
| Receipt number | R000031386 |
| Scientific Title | Effectiveness and Safety of Certolizumab Pegol in Treating Rheumatoid Arthritis Patients with Persistent Inflamed Residual Mono- or Oligo-synovitis Resistant to Prior TNF-alpha Inhibitors |
| Date of disclosure of the study information | 2017/05/25 |
| Last modified on | 2021/05/21 10:48:31 |
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Basic information
Public title
Effectiveness and Safety of Certolizumab Pegol in Treating Rheumatoid Arthritis Patients with Persistent Inflamed Residual Mono- or Oligo-synovitis Resistant to Prior TNF-alpha Inhibitors
Acronym
Effectiveness and Safety of CZP in RA with Persistent Inflamed Residual Synovitis
Scientific Title
Effectiveness and Safety of Certolizumab Pegol in Treating Rheumatoid Arthritis Patients with Persistent Inflamed Residual Mono- or Oligo-synovitis Resistant to Prior TNF-alpha Inhibitors
Scientific Title:Acronym
Effectiveness and Safety of CZP in RA with Persistent Inflamed Residual Synovitis
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Because potentially effective, safe, and long-lasting treatment for persistent and residual mono- or oligo-arthritis is required in clinical practice of RA, in this study we examine the efficacy, especially using ultrasound findings and biomakers, and safety in a prospective and multi-center study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessment of efficacy of CZP: 6 months follow-up with US
Key secondary outcomes
Assessment of efficacy with biomakers and side effects of CZP
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
RA patients with mono- or oligo-arthritis (1-5 joints) after treatment with bDMARD(s) who will be treated with CZP
Key exclusion criteria
Patients with the reasons for inadequate toparticipate in this study, due to contraindication of CZP and judeged by attending rheumatologist
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Tada |
Organization
Faculty of Medicine, Saga University
Division name
Division of Rheumatology
Zip code
849-8501
Address
5-1-1, Nabeshima, Saga, Japan
TEL
0952-31-6511
taday@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Syuichi |
| Middle name | |
| Last name | Koarada |
Organization
Faculty of Medicine, Saga University
Division name
Division of Rheumatology
Zip code
849-8501
Address
5-1-1, Nabeshima, Saga, Japan
TEL
0952-31-6511
Homepage URL
koarada@cc.saga-u.ac.jp
Sponsor or person
Institute
Faculty of Medicine, Saga University
Institute
Department
Personal name
Funding Source
Organization
Saga University
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
Saga University
Address
Nabeshima, Saga, Japan
Tel
0952316511
koarada@cc.saga-u.ac.jp
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
九州大学病院（福岡県）
浜の町病院（福岡県）
医療法人相生会ピーエスクリニック（福岡県）
広島赤十字・原爆病院（広島県）
飯塚病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 25 | Day |
Related information
URL releasing protocol
http://www.intmed.med.saga-u.ac.jp/kenkyuugroup/group/collagen/kenkyu.html
Publication of results
Unpublished
Result
URL related to results and publications
no publications
Number of participants that the trial has enrolled
9
Results
The number of registered cases was small and no significant difference was obtained.
Results date posted
| 2021 | Year | 05 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients who can change to CZP in cases where other biologics are ineffective
Participant flow
Musculoskeletal echography was performed in participating patients
Adverse events
None
Outcome measures
Outcome measures are not possible due to the small number of registrations
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2015 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2015 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
US findings
Management information
Registered date
| 2017 | Year | 05 | Month | 18 | Day |
Last modified on
| 2021 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031386
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
