Phase 3
N=309
Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT00235872 ↗Enrolled (actual)
309
Serious AEs
35.9%
Results posted
Jan 2010
Primary outcome: Primary: Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) — 104; 52; 22; 157 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- adalimumab (Biological)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Abbott
- Primary completion
- Jul 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) |
104; 52; 22; 157; 74; 30 | — |
| SECONDARY Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit |
22.3; -7.2; -10.0; -10.6; -11.0; -11.5 | — |
| SECONDARY Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit |
17.6; -6.1; -8.5; -8.6; -9.0; -9.0 | — |
| SECONDARY Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit |
67.2; -20.0; -27.9; -28.1; -28.3; -29.9 | — |
| SECONDARY 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 |
63.5; -14.2; -19.4; -19.8; -21.1; -21.0 | — |
| SECONDARY Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit |
61.3; -12.3; -17.0; -17.7; -19.1; -19.6 | — |
| SECONDARY Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit |
1.5; -0.2; -0.3; -0.3; -0.3; -0.3 | — |
| SECONDARY Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit |
4.7; -1.2; -1.7; -1.6; -1.5; -1.6 | — |
| SECONDARY Presence of Morning Stiffness |
182; 173; 168; 167; 154; 148 | — |
| SECONDARY Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit |
221.8; -48.9; -64.2; -69.4; -79.7; -64.0 | — |
| SECONDARY Presence of Rheumatoid Factor (RF) |
248; 191; 142; 92; 69; 66 | — |
| SECONDARY Mean Change From Baseline in Rheumatoid Factor (IU/ML) by Visit |
293.7; -37.6; -82.1; -104.2; -59.7; -101.0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00235872). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.