Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis
Open-Label Continuous Administration Study With Adalimumab (D2E7) in Subjects With Rheumatoid Arthritis
1 other identifier
interventional
309
1 country
25
Brief Summary
The purpose of the study is to assess the long-term safety and tolerability of repeated administration of adalimumab in Japanese subjects with rheumatoid arthritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 rheumatoid-arthritis
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 7, 2005
CompletedFirst Posted
Study publicly available on registry
October 12, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2006
CompletedResults Posted
Study results publicly available
January 13, 2010
CompletedApril 11, 2011
April 1, 2011
1.9 years
October 7, 2005
December 9, 2009
April 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Number of responders with ACR criteria improvement consisting of 20%, 50%, and 70% (ACR20/50/70, respectively) reduction in tender or swollen joint counts (TJC or SJC, respectively) and 20%, 50%, and 70% improvement, respectively, in 3 of the following 5 criteria: 1) physician's global assessment of disease activity (PGA), 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire (DI-HAQ), and 5) C-reactive protein (CRP) at each visit.
Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)
Secondary Outcomes (11)
Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit
Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)
Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit
Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)
Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit
Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value).
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value).
Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value).
- +6 more secondary outcomes
Study Arms (1)
Adalimumab 40 mg every other week (eow)
EXPERIMENTALInterventions
40 mg eow, sc
Eligibility Criteria
You may qualify if:
- Participation and completion until Week 24 of the prior adalimumab dose-ranging study.
- Females must be postmenopausal for at least 1 year, surgically sterile, or practicing birth control throughout the study and for 90 days after study completion.
- Female subjects tested negative in pregnancy test (serum test) at Week 24 in prior adalimumab study, if capable of pregnancy.
You may not qualify if:
- A subject who experienced any of the following during prior study:
- Advanced or poorly controlled diabetes
- Joint surgery (joint evaluated in this study)
- A subject who has been prescribed excluded medications during prior study.
- History of following during prior study:
- Clinically significant drug or alcohol abuse
- Intravenous (iv) drug abuse
- Active infection with listeria or tuberculosis (TB)
- Lymphoma, leukemia
- And, any malignancy with the exception of successfully treated non-metastatic basal cell carcinoma of the skin.
- A subject who has been administered a live vaccine during prior study, or subject scheduled to complete the administration of a live vaccine during the study period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
- Abbott Japan Co.,Ltdcollaborator
- Eisai Co., Ltd.collaborator
Study Sites (25)
Unknown Facility
Tokyo, Metropolis, Japan
Unknown Facility
Aichi, Prefecture, Japan
Unknown Facility
Chiba, Prefecture, Japan
Unknown Facility
Ehime, Prefecture, Japan
Unknown Facility
Fukui, Prefecture, Japan
Unknown Facility
Fukuoka, Prefecture, Japan
Unknown Facility
Gunma, Prefecture, Japan
Unknown Facility
Hokkaido, Prefecture, Japan
Unknown Facility
Hyōgo, Prefecture, Japan
Unknown Facility
Ibaraki, Prefecture, Japan
Unknown Facility
Ishikawa, Prefecture, Japan
Unknown Facility
Kagoshima, Prefecture, Japan
Unknown Facility
Kanagawa, Prefecture, Japan
Unknown Facility
Kyoto, Prefecture, Japan
Unknown Facility
Miyagi, Prefecture, Japan
Unknown Facility
Nagano, Prefecture, Japan
Unknown Facility
Nagasaki, Prefecture, Japan
Unknown Facility
Niigata, Prefecture, Japan
Unknown Facility
Okayama, Prefecture, Japan
Unknown Facility
Osaka, Prefecture, Japan
Unknown Facility
Saitama, Prefecture, Japan
Unknown Facility
Shizuoka, Prefecture, Japan
Unknown Facility
Tochigi, Prefecture, Japan
Unknown Facility
Tokushima, Prefecture, Japan
Unknown Facility
Toyama, Prefecture, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- Abbott
Study Officials
- STUDY DIRECTOR
Shigeki Hashimoto, Ph.D.
Abbott
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 7, 2005
First Posted
October 12, 2005
Study Start
August 1, 2004
Primary Completion
July 1, 2006
Last Updated
April 11, 2011
Results First Posted
January 13, 2010
Record last verified: 2011-04