UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006701 |
|---|---|
| Receipt number | R000007921 |
| Scientific Title | An epidemiological study for treat-to-target strategy in rheumatoid arthritis patients with moderate or high disease activity |
| Date of disclosure of the study information | 2011/11/11 |
| Last modified on | 2015/05/19 16:04:11 |
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Basic information
Public title
An epidemiological study for treat-to-target strategy in rheumatoid arthritis patients with moderate or high disease activity
Acronym
An epidemiological study for T2T
Scientific Title
An epidemiological study for treat-to-target strategy in rheumatoid arthritis patients with moderate or high disease activity
Scientific Title:Acronym
An epidemiological study for T2T
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary purpose of this study is to clarify the effects of induction and maintenance of clinical remission or low disease activity status on structural damage of joints or physical function in RA patients with moderate or high disease activity. Secondary purposes are to evaluate achievement rates for clinical remission or low disease activity status and implementation rate of treat-to-target (T2T) strategy, and to identify obstacles for implementation of T2T strategy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcome for our study is to identify prognostic factors for physical function and structural damage at week 72 in RA patient with moderate or high disease activity who receive treatment with T2T strategy. The main outcome measures are SDAI, CDAI, HAQ, EQ-5D and vdH-modified Total Sharp Score. We compare these outcome measures between the T2T-achieved group and not-achieved group.
Key secondary outcomes
1.Remission or Low disease activity status achievement rates in clinical practice
2.Implementation rate of T2T
3.Obstacles for implementation of T2T strategy
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
A Patient of rheumatoid arthritis (RA) who meets all of the following will be eligible to our study.
1.A patient who fulfills the 2010 ACR/EULAR classification criteria of RA (SDAI>11 or CDAI>10)
2.A patient who have equal or more than 2 swollen joints and equal or more than 2 tender joints
3.A patient who is older than 20 years old and provides a written informed consent to join in this study
4.A patient who have never received biological disease-modifying anti-rheumatic drugs (DMARDs)
5.A patient who starts, adds, or changes a DMARD or biological DMARD
6.A patient who can be followed regularly in the outpatient clinic
Key exclusion criteria
A patient who has any of the following will be excluded from our study.
1.When a patient withdraws his or her consent.
2.When a doctor judges a patient is not appropriate to join the study.
3.When a patient is under breastfeeding or pregnant.
4.When a doctor judges a patient cannot be followed regularly in the outpatient clinic for 72 weeks.
Target sample size
366
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayoshi Harigai |
Organization
Tokyo Medical and Dental University
Division name
Department of Pharmacovigilance, Department of Medicine and Rheumatology
Zip code
Address
1-5-45,Yushima 1-chome, Bunkyo-ku, Tokyo
TEL
03-5803-4677
mharigai.mpha@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Marie Yajima |
Organization
Tokyo Medical and Dental University
Division name
Department of Pharmacovigilance
Zip code
Address
1-5-45,Yushima 1-chome, Bunkyo-ku, Tokyo
TEL
03-5803-4677
Homepage URL
yajima.phv@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
ministry of health, labour, and welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Pharmacovigilance
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
東京医科歯科大学・埼玉医科大学総合医療センター・慶應義塾大学・長崎大学・国立病院機構相模原病院・北海道大学・新潟県立リウマチセンター・宇多津浜クリニック・横浜市立大学・東広島記念病院・日立製作所多賀総合病院・道後温泉病院・草加市立病院・産業医科大学・東京都健康長寿医療センター・順天堂大学・香川大学・青梅市立総合病院・国家公務員東京共済病院・横浜市立みなと赤十字病院・筑波大学・宮崎市民の森病院・熊本大学・京都大学
Tokyo medical and dental university, Saitama medical center, Keio university, Nagasaki university, NHO Sagamihara national hospital, Hokkaido university, Niigata rheumatic center, Utazuhama clinic, Yokohama city university, Higashi hiroshima memorial hospital, Taga general hospital, Dohgo spa hospital, Soka municipal hospital, University of occupational and environmental health, Tokyo metropolitan geriatric hospital, Juntendo university, Kagawa university, Ome municipal general hospital, Tokyo kyosai Hospital, Yokohama city minato red cross hospital, Tsukuba university, Shiminnomori hospital, Kumamoto university, Kyoto university.
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 11 | Month | 11 | 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
Completed
Date of protocol fixation
| 2011 | Year | 08 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 01 | Month | 15 | Day |
Date of closure to data entry
| 2015 | Year | 01 | Month | 15 | Day |
Date trial data considered complete
| 2015 | Year | 01 | Month | 15 | Day |
Date analysis concluded
Other
Other related information
The main outcome measures are SDAI, CDAI, HAQ, EQ-5D and vdH-modified Total Sharp Score. We compare these outcome measures between the T2T-achieved group and not-achieved group.
Management information
Registered date
| 2011 | Year | 11 | Month | 11 | Day |
Last modified on
| 2015 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007921
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| Registered date | File name |
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| Registered date | File name |
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