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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000020154
Receipt No. 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

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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
Email 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
Email f_yamamo@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University, Department of Rheumatology and Applied Immunology
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023277

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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