UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003643 |
|---|---|
| Receipt number | R000004404 |
| Scientific Title | Therapeutic efficacy and safety of chronotherapy of methotrexate in patients with rheumatic arthritis: double-blind randomized trial |
| Date of disclosure of the study information | 2010/06/30 |
| Last modified on | 2018/05/26 13:23:38 |
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Basic information
Public title
Therapeutic efficacy and safety of chronotherapy of methotrexate in patients with rheumatic arthritis: double-blind randomized trial
Acronym
Chronotherapy of MTX in RA patients
Scientific Title
Therapeutic efficacy and safety of chronotherapy of methotrexate in patients with rheumatic arthritis: double-blind randomized trial
Scientific Title:Acronym
Chronotherapy of MTX in RA patients
Region
| Japan |
Condition
Condition
rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We study to estimate dosing time dependency for toxicity and efficacy of methotrexate in patients with rheumatoid arthritis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Disease Activity Score (DAS) 28
adverse effects
mHAQ
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
the dosing schedule used commonly in clinical practice
Interventions/Control_2
chronotherapy
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
Patients who satisfied the following inclusion criteria were selected for enrollment in the study: Patients (1) RA patients , (2) patients have received methotrexate and (3) 20- years of age, and (4) DAS 28 > 3.2,(5) patients have notreceived biological products,
each patient included in the study gave a written informed consent.
Key exclusion criteria
Patients were excluded from the study if any of the following criteria applied: (1) concurrent pregnancy, (2) the presence of serious complications in the heart, lung, kidney, etc., (3) perform of surgical operation for rheumatoid arthritis within a period of 6 months before administration (4) use of glucocorticoids(10.1 mg/day) within a period of one month before administration or (5) any other reason for which the investigator judged the patient to be unfit for study.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideto To |
Organization
Graduate School of Medicine and Pharmaceutical Sciences for Research, University of Toyama
Division name
Department of Medical Pharmaceutics
Zip code
Address
2630 Sugitani, Toyama
TEL
076-415-8811
hide-to@umin.net
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideto To |
Organization
Graduate School of Medicine and Pharmaceutical Sciences for Research, University of Toyama
Division name
Department of Medical Pharmaceutics
Zip code
Address
2630 Sugitani, Toyama
TEL
076-415-8811
Homepage URL
hide-to@umin.net
Sponsor or person
Institute
Department of Medical Pharmaceutics, Graduate School of Medicine and Pharmaceutical Sciences for Research, University of Toyama
Institute
Department
Personal name
Funding Source
Organization
Health and Labour Sciences Research Grants
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
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
| 2010 | Year | 06 | Month | 30 | 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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 04 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 05 | Month | 20 | Day |
Last modified on
| 2018 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004404
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
