UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020833 |
|---|---|
| Receipt number | R000024050 |
| Scientific Title | The efficacy of Iguratimod, and adding Adalimumab in patients with active rheumatoid arthritis: an open label multicenter randomized parallel study. |
| Date of disclosure of the study information | 2016/02/01 |
| Last modified on | 2017/12/22 02:46:59 |
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Basic information
Public title
The efficacy of Iguratimod, and adding Adalimumab in patients with active rheumatoid arthritis: an open label multicenter randomized parallel study.
Acronym
The efficacy of Iguratimod, and adding Adalimumab in patients with active rheumatoid arthritis.
Scientific Title
The efficacy of Iguratimod, and adding Adalimumab in patients with active rheumatoid arthritis: an open label multicenter randomized parallel study.
Scientific Title:Acronym
The efficacy of Iguratimod, and adding Adalimumab in patients with active rheumatoid arthritis.
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In daily practice,
(1) To directly compare the efficacy between Iguratimod and Tacrolimus.
(2) To directly compare the efficacy of adding Adalimumab between Iguratimod and Tacrolimus.
(3) To directly compare the efficacy of adalimumab discontinuation between Iguratimod and Tacrolimus.
In each group, to indirectly compare the efficacy between Methotrexate and Iguratimod or Tacrolimus.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
DAS28-CRP remission rate at 12weeks, 36weeks and 108weeks
Key secondary outcomes
1) DAS28-CRP LDA rate at 12weeks, 36weeks and 108weeks
2) Change of ADL(Delta HAQ-DI)
3) Adverse event
4) The factors for each outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administer MTX 6-16mg/week for 12 weeks to patients with MDA-RA.
If patients can't take MTX, administer IGU 25-50mg/day or Tac 1.5-3.0mg/day for 12 weeks.
Interventions/Control_2
Administer ADA 40mg/2weeks for 24weeks additionally, in case of MDA taking MTX or IGU, Tac for 12 weeks.
Interventions/Control_3
If patients maintain remission for 24weeks, discontinue ADA by their own will, after 48 weeks administering ADA.
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 with MDA-RA who take other csDMARDs and Steroid more than 3months.
Key exclusion criteria
Patients who contraindicate for IGU, Tac or ADA.
In case of MTX group, patients who contraindicate for MTX.
Patients who can't provide informed concent.
Patients who have malignancy.
Patients who judged to be disqualified by the physician.
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihiko Hidaka MD. PhD. |
Organization
Zenjinkai Shimin-no-mori Hospital
Division name
Insutitution of Rheumatology
Zip code
Address
2783-37, Ohaza Shioji, Miyazaki city, MIYAZAKI
TEL
+81-985-39-7630
tosirin@d4.dion.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshihiko Hidaka MD. PhD. |
Organization
Zenjinkai Shimin-no-mori Hospital
Division name
Insutitution of Rheumatology
Zip code
Address
2783-37, Ohaza Shioji, Miyazaki city, MIYAZAKI
TEL
+81-985-39-7630
Homepage URL
tosirin@d4.dion.ne.jp
Sponsor or person
Institute
Zenjinkai Shimin-no-mori Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
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
| 2016 | Year | 02 | Month | 01 | 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
It has difficulty with case registration.
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
Terminated
Date of protocol fixation
| 2015 | Year | 10 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 09 | 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
| 2016 | Year | 02 | Month | 01 | Day |
Last modified on
| 2017 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024050
| Research Plan | |
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| 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 |
