Phase 2
N=25
Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT00235833 ↗Enrolled (actual)
25
Serious AEs
40.0%
Results posted
Jan 2010
Primary outcome: Primary: Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) — 12; 7; 5; 15 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- adalimumab (Biological)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Abbott
- Primary completion
- Oct 2004
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) |
12; 7; 5; 15; 12; 5 | — |
| SECONDARY Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit |
-11.2; -13.4; -16.0; -17.5; -16.3; -17.0 | — |
| SECONDARY Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit |
-8.8; -11.3; -12.0; -14.4; -13.8; -12.4 | — |
| SECONDARY Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit |
-27.0; -34.5; -40.7; -42.2; -41.3; -34.3 | — |
| SECONDARY Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit |
-21.7; -29.5; -33.3; -35.1; -35.6; -33.0 | — |
| SECONDARY Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit |
-13.7; -23.1; -27.2; -29.1; -30.6; -26.2 | — |
| SECONDARY Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit |
-0.41; -0.48; -0.47; -0.50; -0.49; -0.43 | — |
| SECONDARY Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit. |
-0.92; -2.30; -2.49; -2.11; -2.62; -2.42 | — |
| SECONDARY Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response) |
3.2; 7.0; 11.0; 15.1; 22.6; 29.3 | — |
| SECONDARY Number of Subjects With Morning Stiffness at Each Visit |
16; 15; 11; 11; 9; 10 | — |
Summary
The purpose of the study is to assess the long-term safety, tolerability, and efficacy of repeated administration of adalimumab in adult Japanese subjects with rheumatoid arthritis.
Eligibility Criteria
Inclusion Criteria
- Participation in the prior adalimumab study
- Body weight less than 100 kg.
- Subject's who wished to continue the study drug administration
- 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.
Exclusion Criteria
- A subject who experienced any of the following during the prior adalimumab sc dosing study:
- Advanced or poorly controlled diabetes
- Any poorly controlled medical condition
- Intra-articular, intramuscular or iv administration of corticosteroids
- Joint surgery.
- A subject who has been prescribed excluded medications during previous adalimumab study.
- History of clinically significant drug or alcohol abuse, intravenous (iv) drug abuse, active infection with listeria or tuberculosis (TB), lymphoma, leukemia, or any malignancy with the exception of successfully treated non- metastatic basal cell carcinoma of the skin.
- A subject who experienced chronic or active infection or any major episode of infection requiring hospitalization or treatment with intravenous (iv) antibiotics within 30 days of entry into study or chronic use of oral antibiotics within 14 days of entry into study.
- Preexisting or recent onset of central nervous system (CNS) demyelinating disorders.
Data sourced from ClinicalTrials.gov (NCT00235833). 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.