Clinical trial NCT02333383: Observe the Frequency of Extra-Axial Symptoms in Korean Ankylosing Spondylitis (AS) Patients
Official title: A Prospective, Mono-Country, Multi-Center Study to Observe the Frequency of Extra-Axial Symptoms in Korean Ankylosing Spondylitis Patients on Adalimumab Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankylosing Spondylitis
Keywords: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score
EAMs
Adalimumab
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2015-01-07
Enrollment: 201
Sex: ALL
Minimum age (years): 19
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General Hospital

Brief 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.

Detailed description: A baseline assessment was performed prior to the first dose of adalimumab. Participants received 40 mg of adalimumab every other week for one year. Study visits were conducted at 12, 28, 36 and 52 weeks. All participants were to have one follow-up approximately 70 days after the last dose of adalimumab.

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

Primary outcomes:
measure: Frequency of Extra-Axial Manifestations (EAMs) of Interest
timeFrame: Baseline
Secondary outcomes:
measure: Proportion of Participants Achieving a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response
timeFrame: Baseline, Week 12, Week 28, Week 36, Week 52
measure: Mean Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Participants With Enthesitis at Baseline
timeFrame: Baseline, Week 12, Week 28, Week 36, Week 52
measure: Proportion of Participants With Enthesitis of the Plantar Fascia
timeFrame: Baseline, Week 12, Week 28, Week 36, Week 52
measure: Mean Change in Dactylitis Score in Participants With Dactylitis at Baseline
timeFrame: Baseline, Week 12, Week 28, Week 36, Week 52
measure: Mean Change in Tender Joint Counts (TJC) in Participants With Peripheral Arthritis (≥1 Swollen Joint) at Baseline
timeFrame: Baseline, Week 12, Week 28, Week 36, Week 52
measure: Mean Change in Change in Swollen Joint Counts (SJC) in Participants With Peripheral Arthritis (≥1 Swollen Joint) at Baseline
timeFrame: Baseline, Week 12, Week 28, Week 36, Week 52
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie Korea
name: EunJung Gu
role: STUDY_DIRECTOR
References: