UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020154 |
|---|---|
| Receipt number | R000023277 |
| Scientific Title | Efficacy and safety of certolizumab pegol in patients with rheumatoid arthritis who failed to respond to a single previous TNF inhibitor |
| Date of disclosure of the study information | 2015/12/11 |
| Last modified on | 2017/12/12 11:14:36 |
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Basic information
Public title
Efficacy and safety of certolizumab pegol in patients with rheumatoid arthritis who failed to respond to a single previous TNF inhibitor
Acronym
Efficacy and safety of certolizumab pegol in patients with rheumatoid arthritis who failed to respond to a single previous TNF inhibitor
Scientific Title
Efficacy and safety of certolizumab pegol in patients with rheumatoid arthritis who failed to respond to a single previous TNF inhibitor
Scientific Title:Acronym
Efficacy and safety of certolizumab pegol in patients with rheumatoid arthritis who failed to respond to a single previous TNF inhibitor
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the efficacy and safety of certolizumab pegol in patients with rheumatoid arthritis who failed to respond to a single previous TNF inhibitor
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Disease activity (DAS28, SDAI, CDAI), disability (HAQ-DI), Joint destruction (modified total Sharp score), adverse effects at week 0, 12, 24, 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Eligible patients were diagnosed with RA, as defined by the ACR 1987 criteria or ACR/EULAR 2010 criteria. Patients had previous secondary inadequate response or were intolerant to a TNF antagonist other than certolizumab pegol.
Key exclusion criteria
Patients were excluded if they had history of demyelinating or convulsive disease of the central nervous system (e.g., multiple sclerosis and epilepsy), New York Heart Association Class III or IV congestive heart failure, infectious disease, hepatitis B or hepatitis C, malignant tumor or lymphoproliferative disorder, including lymphoma or signs and symptoms suggestive of lymphoproliferative disease. Patients with any indication of current or past tuberculosis as shown by clinical history, chest X-ray and/or positive tuberculin reaction test were also excluded unless preventive therapy by isoniazid was first taken.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihide Mimura |
Organization
Saitama Medical University
Division name
Department of Rheumatology and Applied Immunology
Zip code
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
TEL
049-276-1462
toshim@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fumie Iino |
Organization
Saitama Medical University Hospital
Division name
Clinical trial
Zip code
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
TEL
049-276-2019
Homepage URL
f_yamamo@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University, Department of Rheumatology and Applied Immunology
Institute
Department
Personal name
Funding Source
Organization
UCB Japan Co. Ltd. , Astellas Pharma Inc
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
| 2015 | Year | 12 | Month | 11 | 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
| 2015 | Year | 12 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 11 | Day |
Date of closure to data entry
| 2017 | Year | 09 | Month | 11 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective study
Management information
Registered date
| 2015 | Year | 12 | Month | 10 | Day |
Last modified on
| 2017 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023277
