Phase 3
N=344
Efficacy and Safety of Adalimumab in Adult Chinese Subjects With Active Ankylosing Spondylitis
Ankylosing Spondylitis
Bottom Line
View on ClinicalTrials.gov: NCT01114880 ↗Enrolled (actual)
344
Serious AEs
0.9%
Results posted
Nov 2011
Primary outcome: Primary: Number of Participants Meeting the Assessment of Spondyloarthritis International Society (ASAS) ASAS20 Response Criteria — 154; 35 participants — p=< 0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- adalimumab (Biological); placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Meeting the Assessment of Spondyloarthritis International Society (ASAS) ASAS20 Response Criteria |
154; 35 | < 0.001 sig |
| SECONDARY Number of Participants Meeting the ASAS20 Response Criteria |
180; 85 | — |
| SECONDARY Number of Participants Meeting the ASAS40 Response Criteria |
134; 63 | — |
| SECONDARY Number of Participants Meeting the ASAS40 Response Criteria |
134; 63 | — |
| SECONDARY Number of Participants Meeting the ASAS5/6 Response Criteria |
150; 69 | — |
| SECONDARY Number of Participants Meeting the ASAS5/6 Response Criteria |
150; 69 | — |
| SECONDARY Number of Participants With ASAS Partial Remission |
85; 33 | — |
| SECONDARY Number of Participants With ASAS Partial Remission |
85; 33 | — |
| SECONDARY Change From Baseline in Patient Global Assessment of Disease Activity |
-37.8; -35.5 | — |
| SECONDARY Change From Baseline in Patient Global Assessment of Disease Activity |
-37.8; -35.5 | — |
| SECONDARY Change From Baseline in Total Back Pain Score |
-42.1; -37.8 | — |
| SECONDARY Change From Baseline in Total Back Pain Score |
-42.1; -37.8 | — |
| SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score |
-23.2; -20.9 | — |
| SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score |
-23.2; -20.9 | — |
| SECONDARY Change From Baseline in Inflammation Score |
-3.6; -3.6 | — |
| SECONDARY Change From Baseline in Inflammation Score |
-3.6; -3.6 | — |
| SECONDARY Number of Participants Meeting the Bath Ankylosing Spondyloarthritis Disease Activity Index (BASDAI) BASDAI50 Response Criteria |
156; 71 | — |
| SECONDARY Number of Participants Meeting the Bath Ankylosing Spondyloarthritis Disease Activity Index (BASDAI) BASDAI50 Response Criteria |
156; 71 | — |
| SECONDARY Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP) |
-18.2; -20.1 | — |
| SECONDARY Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP) |
-18.2; -20.1 | — |
| SECONDARY Change From Baseline in 36-item Short Form Questionnaire Version 2 (SF-36v2) Physical Component Summary Score |
8.6; 9.2 | — |
| SECONDARY Change From Baseline in 36-item Short Form Questionnaire Version 2 (SF-36v2) Physical Component Summary Score |
8.6; 9.2 | — |
Summary
Study of the efficacy and safety of adalimumab compared with placebo in adult Chinese participants with ankylosing spondylitis (AS) who have had an inadequate response to or who are intolerant to one or more nonsteroidal anti-inflammatory drugs (NSAIDs)
Eligibility Criteria
Inclusion Criteria
- Age 18 through 65 years
- Has a diagnosis of ankylosing spondylitis (AS) based on the Modified New York Criteria
- Has active AS, as defined by fulfillment of at least 2 of the following 3 conditions at both Screening and Baseline visits:
- BASDAI score at least 4 cm
- Total back pain on a visual analog scale (VAS) at least 40 mm
- Morning stiffness at least 1 hr
- Has inadequate response to or intolerance to one or more non-steroidal anti-inflammatory drugs (NSAIDs) as defined by the Investigator
Exclusion Criteria
- Has total spinal ankylosis (bamboo spine)
- Has undergone spinal surgery or joint surgery involving joints assessed within 2 months prior to Baseline
- Has extra-articular manifestations (i.e., psoriasis, uveitis, inflammatory bowel disease) that is not clinically stable, as defined by the Investigator's best clinical judgment, for at least 28 days prior to Baseline
- Has received intra-articular joint injection(s), spinal or paraspinal injection(s) with corticosteroids within 28 days prior to Baseline
- Has prior exposure to any biologic therapy with potential therapeutic impact on AS, including anti-TNF (tumor necrosis factor) therapy
Data sourced from ClinicalTrials.gov (NCT01114880). 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.