UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024507 |
|---|---|
| Receipt number | R000028200 |
| Scientific Title | Drug interaction between methotrexate and salazosulfapyridine in Japanese patients with rheumatoid arthritis |
| Date of disclosure of the study information | 2016/10/21 |
| Last modified on | 2016/10/20 16:32:44 |
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Basic information
Public title
Drug interaction between methotrexate and salazosulfapyridine in Japanese patients with rheumatoid arthritis
Acronym
Drug interaction between methotrexate and salazosulfapyridine in Japanese patients with rheumatoid arthritis
Scientific Title
Drug interaction between methotrexate and salazosulfapyridine in Japanese patients with rheumatoid arthritis
Scientific Title:Acronym
Drug interaction between methotrexate and salazosulfapyridine in Japanese patients with rheumatoid arthritis
Region
| Japan |
Condition
Condition
rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study was designed to examine the interaction between MTX and SASP from the viewpoint of serum MTX concentration in Japanese RA patients, who were receiving combination therapy with relatively low doses of MTX and SASP.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
change of serum MTX concentration
Key secondary outcomes
simplified disease activity index (SDAI) and disease activity score-C reactive protein (DAS28-CRP),levels of matrix metalloproteinase-3 (MMP-3),inflammatory cytokines,questionnaire
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
In these patients, who had received SASP/MTX combination therapy for at least 12 weeks, SASP was discontinued, and the patients received MTX monotherapy for the next 24 weeks.
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The main inclusion criteria were age 20 years and over, treatment with SASP/MTX combination therapy for at least 12 weeks before entry into this study, and low disease activity
Key exclusion criteria
patients who showed poor compliance
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Morihiro Okada |
Organization
Japan Community Healthcare Organization Kanazawa Hospital
Division name
Department of Pharmacy
Zip code
Address
Ha-15 Oki-machi, Kanazawa 920-8610, Japan
TEL
+81-76-252-2200
okada-knz@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Morihiro Okada |
Organization
Japan Community Healthcare Organization Kanazawa Hospital
Division name
Department of Pharmacy
Zip code
Address
Ha-15 Oki-machi, Kanazawa 920-8610, Japan
TEL
+81-76-252-2200
Homepage URL
okada-knz@umin.ac.jp
Sponsor or person
Institute
Japan Community Healthcare Organization
Institute
Department
Personal name
Funding Source
Organization
There are no funding sources for this study.
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
Secondary IDs
Secondary IDs
YES
Study ID_1
1228-2
Org. issuing International ID_1
University Hospital, Kanazawa University
Study ID_2
2012-002
Org. issuing International ID_2
Social Welfare Organization Saiseikai Kanazawa Hospital
IND to MHLW
Institutions
Institutions
金沢大学病院（石川県）、済生会金沢病院（石川県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 21 | 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
The MTX concentration increased about 2-fold upon discontinuation of SASP, with no apparent change of efficacy or side effects.
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
Completed
Date of protocol fixation
| 2011 | Year | 03 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 12 | Day |
Last follow-up date
| 2015 | Year | 02 | Month | 13 | Day |
Date of closure to data entry
| 2015 | Year | 02 | Month | 13 | Day |
Date trial data considered complete
| 2015 | Year | 02 | Month | 13 | Day |
Date analysis concluded
| 2015 | Year | 02 | Month | 13 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 20 | Day |
Last modified on
| 2016 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028200
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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