Observe the Frequency of Extra-Axial Symptoms in Korean Ankylosing Spondylitis (AS) Patients (AS PMOS)

AbbVie

Status

Completed

Conditions

Ankylosing Spondylitis

Treatments

Drug: Adalimumab

Study type

Observational

Funder types

Industry

Identifiers

NCT02333383

P15-238

Details and patient eligibility

About

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.

Full 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.

Enrollment

201 patients

Sex

All

Ages

19 to 100 years old

Volunteers

No Healthy Volunteers

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