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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000012200 |
Receipt No. | R000014218 |
Scientific Title | Effect of diease-modifying and biological drugs on intestinal immunity in patients with rheumatoid arthritis. |
Date of disclosure of the study information | 2013/11/01 |
Last modified on | 2019/11/07 |
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 |
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Condition | |||
Condition | Rheumatoid arthritis | ||
Classification by specialty |
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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.
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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 |
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Age-upper limit |
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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 |
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Key exclusion criteria | RA patients having complication other than rheumatoid arthritis | |||
Target sample size | 80 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
kou@kata-rheum.or.jp |
Public contact | |||||||
Name of contact person |
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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 | ||||||
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 |
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 |
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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 |
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Anticipated trial start date |
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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 |
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Last modified on |
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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 |