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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | |||
Condition | Rheumatoid Arthritis | ||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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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 |
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Target sample size | 80 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
tatsuya@med.osaka-cu.ac.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 | |
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IRB Contact (For public release) | |
Organization | |
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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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Recruitment status | Open public recruiting | ||||||
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Last modified on |
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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 |