UMIN-CTR Clinical Trial

Basic information
Public title	The clinical impact of methotrexate dose reduction at combination therapy with adalimumab plus methotrexate in rheumatoid arthritis; ALIBABA study
Acronym	ALIBABA study
Scientific Title	The clinical impact of methotrexate dose reduction at combination therapy with adalimumab plus methotrexate in rheumatoid arthritis; ALIBABA study
Scientific Title:Acronym	ALIBABA study
Region	Japan

Condition
Condition	Rheumatoid Arthritis
Classification by specialty	Clinical immunology Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the clinical, functional and structural outcomes of reducing methotrexate (MTX) dosage upon initiating adalimumab (ADA) in MTX-inadequate responders with moderately to severely active rheumatoid arthritis (RA) in Japan.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Mean DAS28(CRP) at week 26
Key secondary outcomes	CDAI, SDAI, HAQ-DI, delta mTSS, total score of gray and power Doppler at week 26

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Dose comparison
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	receiving 40 mg open-label ADA every other week for 26 weeks with low dose MTX (6mg/week)
Interventions/Control_2	receiving 40 mg open-label ADA every other week for 26 weeks with high dose MTX (12mg/week)
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	1. Diagnosed with RA by the 2010 ACR/EULAR classification criteria. 2. Patients should be above 20 years old. 3. Duration of disease should be below 10 years. 4. Patients should be treated with MTX above12 mg a week for above 12 weeks before baseline. 5. Up to 10% of the patients could be treated within one prior biological DMARD; otherwise , patients are biologic-naive. 6. Patients exposed to ADA were excluded. 7. Patients must have 28-joint count Disease Activity Score (DAS) based on C-reactive protein (CRP) above 3.2 at baseline 8. Requirement for above 5 tender joints out of 68 and above 5 swollen joints out of 66.
Key exclusion criteria	1. An autoimmune disease patient except RA which can affect the inflammatory views 2. The patient receiving the following treatments within four weeks before baseline The increase of glucocorticoid (GC) dosage or newly administration of GC 3. Plasma pheresis 4. The surgical management that it is thought to affect the efficacy evaluation 5. The patient who uses GC more than 5 mg a day 6. A patient with a history of administration of ADA 7. A patient (less than two weeks before therapeutic drug dosage start) less than number of the lymphocytes 1,000 per micro litter 8. The patient with severe infectious diseases 9. A pregnant or nursing woman, the woman who may be pregnant, the woman in hope of the pregnancy and the partner 10. The patient who participates in the clinical trials such as similar effect therapeutic drugs now
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Middle name Last name Tatsuya Koike
Organization	Shirahama Foundation for Health and Welfare
Division name	Search Institute for Bone and Arthritis Disease (SINBAD)
Zip code
Address	Nishimurogun Shirahamacho 1447, Wakayama, Japan
TEL	+81-739-43-6200
Email	tatsuya@med.osaka-cu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Atsuko Kamiyama
Organization	Shirahama Foundation for Health and Welfare
Division name	Search Institute for Bone and Arthritis Disease (SINBAD)
Zip code
Address	Nishimurogun Shirahamacho 1447, Wakayama, Japan
TEL	+81-739-43-6200
Homepage URL
Email	kamiyama@hamayu-hp.or.jp

Sponsor
Institute	Search Institute for Bone and Arthritis Disease (SINBAD), Shirahama Foundation for Health and Welfare
Institute
Department

Funding Source
Organization	Self funding
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
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	1.　　白浜はまゆう病院（和歌山） 2. 大阪市立大学（大阪） 3. 北出病院（和歌山） 4. 大阪市立総合医療センター（大阪） 5. 奈良県立医科大学RAセンター（奈良） 6. 和歌山県立医科大学（和歌山） 7. 市民の森病院（宮崎） 8. 片山整形外科（北海道） 9. 北播磨総合医療センター（兵庫） 10. 豊橋市民病院（愛知） 11. 永田整形外科（福岡県） 12. 岸和田市民（大阪） 13. 八木病院（福岡） 14. 兵庫医大（兵庫） 15.　神戸大学（兵庫）

Other administrative information
Date of disclosure of the study information	2016 Year 10 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
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	2016 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date	2016 Year 10 Month 01 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2020 Year 03 Month 31 Day
Date analysis concluded	2020 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date	2016 Year 09 Month 12 Day
Last modified on	2018 Year 01 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027666

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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