UMIN-CTR Clinical Trial

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
Email	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
Email	shigeto@juntendo.ac.jp

Sponsor
Institute	Saitama East Study Group
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016445