UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024025 |
|---|---|
| Receipt number | 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 | 2021/04/17 13:42:27 |
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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 | Tatsuya |
| Middle name | |
| Last name | koike |
Organization
Shirahama Foundation for Health and Welfare
Division name
Search Institute for Bone and Arthritis Disease (SINBAD)
Zip code
649-2211
Address
Nishimurogun Shirahamacho 1447, Wakayama, Japan
TEL
+81-739-43-6200
tatsuya@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | Atsuko |
| Middle name | |
| Last name | Kamiyama |
Organization
Shirahama Foundation for Health and Welfare
Division name
Search Institute for Bone and Arthritis Disease (SINBAD)
Zip code
649-2211
Address
Nishimurogun Shirahamacho 1447, Wakayama, Japan
TEL
+81-739-43-6200
Homepage URL
kamiyama@hamayu-hp.or.jp
Sponsor or person
Institute
Search Institute for Bone and Arthritis Disease (SINBAD), Shirahama Foundation for Health and Welfare
Institute
Department
Personal name
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
IRB Shirahama Foundation for Health and Welfare
Address
Nishimurogun Shirahamacho 1447, Wakayama, Japan
Tel
+81-739-43-6200
s_ozaki@hamayu-hp.or.jp
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
| 2021 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027666
