UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of certolizumab pegol in patients with rheumatoid arthritis who failed to respond to a single previous TNF inhibitor
Title of the study (Brief title)	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	Toshihide Mimura
Organization	Saitama Medical University
Division name	Department of Rheumatology and Applied Immunology
Address	38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
TEL	049-276-1462
Email	toshim@saitama-med.ac.jp

Public contact
Name of contact person	Fumie Iino
Organization	Saitama Medical University Hospital
Division name	Clinical trial
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 12 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000023277