N/A
N=201
Observe the Frequency of Extra-Axial Symptoms in Korean Ankylosing Spondylitis (AS) Patients
Ankylosing Spondylitis
Bottom Line
View on ClinicalTrials.gov: NCT02333383 ↗Enrolled (actual)
201
Serious AEs
4.0%
Results posted
Jan 2019
Primary outcome: Primary: Frequency of Extra-Axial Manifestations (EAMs) of Interest — 46.27; 33.33; 2.99 Percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Adalimumab (Drug)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- AbbVie
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of Extra-Axial Manifestations (EAMs) of Interest |
46.27; 33.33; 2.99 | — |
| SECONDARY Proportion of Participants Achieving a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response |
142; 128; 142; 130 | — |
| SECONDARY Mean Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Participants With Enthesitis at Baseline |
-1.85; -2.31; -2.31; -2.50 | — |
| SECONDARY Proportion of Participants With Enthesitis of the Plantar Fascia |
19; 10; 2; 4; 7 | — |
| SECONDARY Mean Change in Dactylitis Score in Participants With Dactylitis at Baseline |
-3.83; -4.40; -5.00; -5.00 | — |
| SECONDARY Mean Change in Tender Joint Counts (TJC) in Participants With Peripheral Arthritis (≥1 Swollen Joint) at Baseline |
-1.82; -2.05; -2.38; -2.60 | — |
| SECONDARY Mean Change in Change in Swollen Joint Counts (SJC) in Participants With Peripheral Arthritis (≥1 Swollen Joint) at Baseline |
-1.80; -1.98; -2.04; -2.40 | — |
Summary
This was a prospective mono-country, multi-center study of the frequency of extra-axial manifestations (EAMs) in Ankylosing Spondylitis (AS) participants treated with adalimumab in routine clinical practice.
Eligibility Criteria
Inclusion Criteria
- Participant must be ≥19 years of age
- Participant has been diagnosed with ankylosing spondylitis (AS) according to the 1984 modified New York criteria for at least 3 months
- Participant has active disease defined by a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥4, despite treatment with at least 2 nonsteroidal anti-inflammatory drugs (NSAIDs) or with disease-modifying antirheumatic drugs (DMARDs) for more than 3 months based on Korea AS reimbursement guideline
- Participant is eligible for adalimumab in daily rheumatologic practice
- Participant must provide written authorization form to use personal and/or health data prior to the entry into the study
Exclusion Criteria
- Female participants who are pregnant or breastfeeding
- Participants who are contraindicated to any anti-tumor necrosis factor (TNF) agent
- Participant is enrolled in other clinical trials
Data sourced from ClinicalTrials.gov (NCT02333383). 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.