UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy of Iguratimod, and adding Adalimumab in patients with active rheumatoid arthritis: an open label multicenter randomized parallel study.
Title of the study (Brief title)	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	Toshihiko Hidaka MD. PhD.
Organization	Zenjinkai Shimin-no-mori Hospital
Division name	Insutitution of Rheumatology
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	Toshihiko Hidaka MD. PhD.
Organization	Zenjinkai Shimin-no-mori Hospital
Division name	Insutitution of Rheumatology
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 10 Month 08 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	It has difficulty with case registration.
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