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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000020833
Receipt No. 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

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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
Email 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
Email tosirin@d4.dion.ne.jp

Sponsor
Institute Zenjinkai Shimin-no-mori Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024050

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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