UMIN-CTR Clinical Trial

Basic information
Public title	Effect of diease-modifying and biological drugs on intestinal immunity in patients with rheumatoid arthritis.
Acronym	Anti-rheumatic drugs, biologicals and intestinal immunity.
Scientific Title	Effect of diease-modifying and biological drugs on intestinal immunity in patients with rheumatoid arthritis.
Scientific Title:Acronym	Anti-rheumatic drugs, biologicals and intestinal immunity.
Region	Japan

Condition
Condition	Rheumatoid arthritis
Classification by specialty	Clinical immunology Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to revieal the effects of DMARDs and biological drugs on intestinal immunity of pateients with RA for further improving therapeutic strategies.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	a) Therapeutic effects of DMARDs and biologicals will be evaluated by EULAR and ACR criteria. b) Antibody response to E. coli and LPS will be assayed to determine intestinal immune function of individual pateints, whereas serum LPS levels will be determined to measure intestinal barrier function. In addition, serum TNF, IL-6 and anti-CCP antibody levels will be assayed to study the potential linkage between intestinal immune function and inflamation. c) Effect of RMARDs and biologicals on intestinal immune function will be evaluated in individual patients for a 6-month period as well as for their their therapeutic effect.
Key secondary outcomes	This study will provide basic data to study a new concept that lowered immune function may be the fundamental common disorder in autoimmune diseases.

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Three groups of RA patients of each consisting of 20 and more persons will be studied for at least 6 months. A group ofhealthy persons will be addopted as a control. 1) Untreated RA patients, before and after treatment with DMARDs. 2) RA patients during treatment with DMARs. 3) DMARDs resistant RA patient, before and after treatement with biologicals. 4) Normal adults
Key exclusion criteria	RA patients having complication other than rheumatoid arthritis
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Kou Middle name Last name Katayama
Organization	Katayama Orthopedic Rheumatology Clinic
Division name	Department of orthopedic surgery
Zip code	078-8243
Address	Toyooka 13-4-5-17 Asahikawa Hokkaido Japan
TEL	0166-39-1155
Email	kou@kata-rheum.or.jp

Public contact
Name of contact person	1st name Kou Middle name Last name Katayama
Organization	Katayama Orthopedic Rheumatology Clinic
Division name	Department of orthopedic surgery
Zip code	078-8243
Address	Toyooka 13-4-5-17 Asahikawa Hokkaido Japan
TEL	0166-39-1155
Homepage URL	http://www.kata-rheum.or.jp/dr_info.html
Email	kou@kata-rheum.or.jp

Sponsor
Institute	Katayama Orthopadic Rheumatology Clinic
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Chondrex Inc. Asama-chemical Co. Ltd. Seien Drugs Compounding Co. Ltd
Name of secondary funder(s)	None

IRB Contact (For public release)
Organization	Asahikawa Medical University Research Ethics Committee
Address	1-1-1 Higashi 2 jou midorigaoka Asahikawa Japan
Tel	0166-68-2187
Email	sho-kenkyu@jimu asahikawa-med.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	片山整形外科リウマチ科クリニック（北海道）、Katayama Orthopadic Rheumatology Clinic (Hokkaido) コンドレックスインク（レッドモンド,WA,USA), Chondrex Inc (Redmond, WA,USA) アサマ化成株式会社（東京都）、Asama-chemical Co.Ltd (Tokyo) 株式会社深井薬局（北海道）、Seien Drugs Compounding (Hokkaido)

Other administrative information
Date of disclosure of the study information	2013 Year 11 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	Patients of Rheumatoid arthritis(RA), dividing into two pathogenisis of rapid rediographic progression(RRP) and non-RRP, were assyed for their IgA and IgG antibody activity to E coli-LPS, Gingivalis LPS and St. pyogenes PG-PS and compared with those of normal person. No significant differenses was obserbed between RA and normal. Correlation between RA disease markers,RF, ESR, CRP and also DAS28-ESR to an anti IgA/IgG ratio of Pg-LPS correlated in RRP. In contrast,the ratio to E. coli-LPS and also PG-PS correlated with the disease markers in non-RRP. Results shwed that multiple embironmental pathogen, which overwhelm the host antibody defense function, cotribute independently or concomitantly to evoking disease markers and aggravationg disease activity, and affect disease outcomes.
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	Open public recruiting
Date of protocol fixation	2013 Year 10 Month 31 Day
Date of IRB
Anticipated trial start date	2013 Year 11 Month 01 Day
Last follow-up date	2017 Year 05 Month 09 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2017 Year 12 Month 31 Day

Other
Other related information	The present study is designed on the hypothesis that increased mucosal permeability associated with low immune function at gut lymphoid tissue may be the fundamental, common disorder in autoimmune diseases. In parallel with the treatment of rheumatoid arthritis, a search is performed with a focus on gastrointestinal immune function and gut permeability and to test the hypothesis.

Management information
Registered date	2013 Year 11 Month 01 Day
Last modified on	2019 Year 11 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014218

Research Plan
Registered date	File name
2021/05/08	pone.0190588.s006.pdf

Research case data specifications
Registered date	File name

Research case data
Registered date	File name
2021/05/08	pone.0190588.s006.pdf

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