Phase 3
N=41
A Study of Adalimumab in Japanese Subjects With Active Ankylosing Spondylitis
Ankylosing Spondylitis
Bottom Line
View on ClinicalTrials.gov: NCT00667355 ↗Enrolled (actual)
41
Serious AEs
14.6%
Results posted
Aug 2010
Primary outcome: Primary: Number of Subjects Achieving Assessment in Ankylosing Spondylitis 20 (ASAS 20) at Week 12 — 30; 30; 30 Subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- adalimumab (Biological)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- Abbott
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Achieving Assessment in Ankylosing Spondylitis 20 (ASAS 20) at Week 12 |
30; 30; 30 | — |
| SECONDARY Number of Subjects Achieving ASAS 20 |
30; 30; 32; 32; 27; 21 | — |
| SECONDARY Number of Subjects Achieving ASAS 50 |
23; 26; 26; 25; 19; 17 | — |
| SECONDARY Number of Subjects Achieving ASAS 70 |
13; 16; 18; 17; 15; 13 | — |
| SECONDARY Number of Subjects Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI 50) |
27; 26; 25; 28; 22; 18 | — |
| SECONDARY Mean Change From Baseline in Patient's Global Assessment of Disease Activity |
-34.6; -37.3; -39.5; -39.7; -37.1; -40.1 | — |
| SECONDARY Mean Change From Baseline in Total Back Pain |
-35.6; -37.0; -38.6; -39.3; -36.4; -39.2 | — |
| SECONDARY Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) |
-19.4; -20.5; -21.9; -22.2; -22.1; -21.8 | — |
| SECONDARY Mean Change From Baseline in C-Reactive Protein (CRP) |
-1.2; -1.3; -1.4; -1.3; -1.4; -1.3 | — |
| SECONDARY Number of Subjects Achieving Assessment in Ankylosing Spondylitis (ASAS) 5/6. |
28; 29; 31; 28; 25; 20 | — |
| SECONDARY Number of Subjects Achieving Assessment in Ankylosing Spondylitis 40 (ASAS 40) |
26; 26; 27; 28; 24; 18 | — |
| SECONDARY Number of Subjects Achieving Assessment in Ankylosing Spondylitis Partial Remission |
15; 16; 17; 20; 15; 13 | — |
| SECONDARY Mean Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) |
-0.4; -0.5; -0.6; -0.5; -0.6; -0.7 | — |
| SECONDARY Mean Change From Baseline in Chest Expansion |
0.7; 0.4; 0.8; 1.0; 0.6; 1.1 | — |
| SECONDARY Mean Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) |
-1.0; -1.1; -1.3; -1.1; -1.4; -1.4 | — |
| SECONDARY Mean Change From Baseline in Nocturnal Pain |
-30.0; -31.7; -35.8; -34.6; -33.4; -35.0 | — |
| SECONDARY Mean Change From Baseline in Swollen Joint Count for 44 Joints (SJC 44) |
-1.1; -1.1; -1.1; -1.3; -1.2; -1.2 | — |
| SECONDARY Mean Change From Baseline in Tender Joint Count for 46 Joints (TJC 46) |
-1.5; -1.4; -1.3; -1.6; -1.6; -1.6 | — |
| SECONDARY Mean Change From Baseline in 36-Item Short Form (SF-36) Questionnaire |
9.6; 10.6; 11.4; 11.3; 12.3; 12.1 | — |
Summary
To evaluate efficacy, safety and pharmacokinetics of adalimumab in Japanese subjects with active ankylosing spondylitis
Eligibility Criteria
Inclusion Criteria
- Subject who meets the definition of Ankylosing Spondylitis based on the Modified New York Criteria, has a diagnosis of active Ankylosing Spondylitis and has had an inadequate response to or intolerance to one or more nonsteroidal anti-inflammatory drugs
Exclusion Criteria
- History of cancer, lymphoma, leukemia or lymphoproliferative disease, active TB, HIV
- Previously received anti-TNF therapy
- Spinal surgery or joint surgery involving joints to be assessed within 2 months prior to the Screening
Data sourced from ClinicalTrials.gov (NCT00667355). 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.