Efficacy and Safety of Adalimumab 80 mg Every Other Week With Methotrexate
1 other identifier
interventional
40
1 country
2
Brief Summary
In Japan, as well as in other countries, the dose of adalimumab (ADA) is limited to 40 mg every other week when used in combination with methotrexate (MTX) for patients with rheumatoid arthritis (RA). However, ADA 80 mg with MTX may be required for some RA patients, especially for those with high disease activity. Therefore, we tried to increase the ADA dose to 80 mg every other week with concomitant MTX, only if the disease activity did not decrease below moderate activity defined by DAS28 \< 3.2. The primary endpoint was the rate of patients who achieved disease remission (DAS28 \< 2.6) at 30 weeks with this predifined treatment strategy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 rheumatoid-arthritis
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 4, 2011
CompletedFirst Posted
Study publicly available on registry
January 5, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedJune 27, 2011
December 1, 2010
3 years
January 4, 2011
June 23, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
The rate of achieving remission at week 30
30 weeks
Study Arms (1)
ADA 80 mg eow + MTX
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- patients with rheumatoid arthritis receiving MTX ≧ 6 mg/week for at least 3 months disease activity : DAS28 \> 5.1
You may not qualify if:
- allergy to ADA present active infection including TB history of demyelinating disease, HBV infection and malignancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Keio Universitylead
- Saitama Medical Universitycollaborator
Study Sites (2)
Saitama Medical Center
Kawagoe, Saitama, 350-8550, Japan
Keio University Hospital
Shinanomachi, Tokyo, 160-8582, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 4, 2011
First Posted
January 5, 2011
Study Start
January 1, 2011
Primary Completion
January 1, 2014
Last Updated
June 27, 2011
Record last verified: 2010-12