Phase 3
N=88
Self-injection of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT00603993 ↗Enrolled (actual)
88
Serious AEs
22.7%
Results posted
Feb 2010
Primary outcome: Primary: Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) — 66; 48; 28; 64 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
- Nov 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) |
66; 48; 28; 64; 44; 27 | — |
| SECONDARY Mean Change From Baseline in Tender Joint Count (TJC; Max = 68), a Component of the ACR Criteria, by Visit |
20.5; -15.3; -14.9; -15.3; -14.8; -14.7 | — |
| SECONDARY Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria by Visit |
15.8; -11.9; -11.9; -12.3; -11.9; -12.1 | — |
| 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 Assessment), a Component of the ACR Criteria, by Visit |
63.2; -41.0; -39.5; -43.3; -41.6; -42.1 | — |
| 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 Assessment), a Component of the ACR Criteria, by Visit |
58.4; -34.0; -32.2; -33.4; -33.9; -33.2 | — |
| SECONDARY Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Pain), a Component of the ACR Criteria, by Visit |
57.8; -33.6; -31.8; -33.7; -33.3; -32.5 | — |
| SECONDARY Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ), a Component of the ACR Criteria, by Visit |
1.4; -0.5; -0.5; -0.6; -0.6; -0.6 | — |
| SECONDARY Mean Change From Baseline in C-reactive Protein (CRP), a Component of the ACR Criteria by Visit |
4.0; -2.5; -2.4; -2.5; -2.6; -2.6 | — |
| SECONDARY Presence of Morning Stiffness by Visit |
24; 29; 26; 25; 24; 23 | — |
| SECONDARY Duration (Minutes) of the Presence of Morning Stiffness by Visit |
164.7; -119.1; -98.5; -122.3; -100.3; -120.1 | — |
Summary
The purpose of this study is to evaluate the long-term safety of subcutaneous (SC) self-injections (by the subject or subject's family member) of adalimumab in adult Japanese subjects with Rheumatoid Arthritis in an open-label study.
Eligibility Criteria
Inclusion Criteria
- Completed Week 36 of Study M03-651 [NCT 00235872]
- Wish to participate in self-injection study
- Give written informed consent
- Comply with protocol requirements
Exclusion Criteria
- Subject develops serious adverse events at time of eligibility confirmation
- Subject develops severe infections requiring hospitalization or IV injection of antibiotics within 28 days before eligibility confirmation
- Subject develops infections requiring oral administration of antibiotics within 14 days before eligibility confirmation
- The investigator considers the subject inappropriate for participation
Data sourced from ClinicalTrials.gov (NCT00603993). 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.