UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043547 |
|---|---|
| Receipt number | R000049730 |
| Scientific Title | Examination of structural remission and reduction of drug free of filgotinib in rheumatoid arthritis patients whose MTX alone or MTX combined with biologics are non responsive. |
| Date of disclosure of the study information | 2021/03/08 |
| Last modified on | 2021/03/08 09:01:21 |
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Basic information
Public title
Examination of structural remission and reduction of drug free of filgotinib in rheumatoid arthritis patients whose MTX alone or MTX combined with biologics are non responsive.
Acronym
Examination of structural remission and reduction of drug free of filgotinib in rheumatoid arthritis patients whose MTX alone or MTX combined with biologics are non responsive.
Scientific Title
Examination of structural remission and reduction of drug free of filgotinib in rheumatoid arthritis patients whose MTX alone or MTX combined with biologics are non responsive.
Scientific Title:Acronym
Examination of structural remission and reduction of drug free of filgotinib in rheumatoid arthritis patients whose MTX alone or MTX combined with biologics are non responsive.
Region
| Japan |
Condition
Condition
Rheumatoid Arthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine the maintenance rate and QOL including structural remission in rheumatoid arthritis patients whose MTX alone or MTX combined with biologics is non response, especially in which a certain paeriod of filgotinib therapy with MTX reduction or drug free will be performed.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Less than 0.5 of mTSS at 24 weeks after the start of this study
2.Less than 0.5 of mTSS at 60 weeks after the start of this study
3.Less than 2.6 of DAS28CRP at 24 weeks after the start of this study
4.Less than 2.6 of DAS28CRP at 60 weeks after the start of this study
Key secondary outcomes
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
60 weeks
Oral administration of 200mg filgotinib daily
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
1.Patients who agree with participation of this study
2.Patients who are more than 20-years-old
3.Patients with filg0tinib administerable
Key exclusion criteria
1.Patients with administration contraindication of JAK inhibitor
2.Patients with sensitivity for filgotinib
3.Patients prior to serious infection
4.Patients with active tuberculosis
5.Patients with end-stage renal failure
6.Patients with severe liver function
7.Patients with less than 1000/mm3 of neutrofils
8.Patients with less than 500/mm3 of lymphocytes
9.Patients with less than 8g/dL of hemoglobin
10.Patients with possibilities of pregnancy or feeding
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yukio |
| Middle name | |
| Last name | Nakamura |
Organization
Shinshu University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
390-8621
Address
Asahi3-1-1, Matsumoto 3908621, Japan
TEL
0263372659
yxn14@aol.jp
Public contact
Name of contact person
| 1st name | Yukio |
| Middle name | |
| Last name | Nakamura |
Organization
Shinshu University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
390-8621
Address
Asahi3-1-1, Matsumoto 3908621, Japan
TEL
0263372659
Homepage URL
yxn14@aol.jp
Sponsor or person
Institute
DeparShinshu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Shinshu University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University School of Medicine
Address
Asahi3-1-1, Matsumoto3908621, Japan
Tel
0263-37-2572
mdrinri@shinshu-u.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 03 | Month | 04 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 04 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 08 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 03 | Month | 08 | Day |
Last modified on
| 2021 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049730
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| Registered date | File name |
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