UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024025
Receipt No. R000027666
Scientific Title The clinical impact of methotrexate dose reduction at combination therapy with adalimumab plus methotrexate in rheumatoid arthritis; ALIBABA study
Date of disclosure of the study information 2016/10/01
Last modified on 2018/01/02

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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


Contact us.