Overview

This trial is active, not recruiting.

Condition ankylosing spondylitis
Sponsor AbbVie
Start date December 2014
End date July 2017
Trial size 200 participants
Trial identifier NCT02333383, P15-238

Summary

This is a prospective mono-country, multi-center study in Ankylosing Spondylitis (AS) subjects treated with Adalimumab. At least 200 subjects will be enrolled at approximately 10 sites. The baseline assessment should be performed prior to the first dose of Adalimumab. Study visit will be conducted at 12, 28, 36 and 52 week after baseline. All subjects will have one follow-up approximately 70 days after last dose of Adalimumab.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
Subjects who have been diagnosed with active ankylosing spondylitis according to the 1984 modified New York criteria.

Primary Outcomes

Measure
Frequency of Extra-Axial Manifestations (EAMs) of interest in Korean AS patients
time frame: At Week 0

Secondary Outcomes

Measure
Percentage of subjects with 50% improvement of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score
time frame: Up to Week 52
Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)
time frame: From Week 0 to Week 52
Percentage of subjects with enthesitis of the plantar fascia
time frame: Up to week 52
Change of dactylitis score
time frame: From Week 0 to Week 52
Change in tender joint counts (TJC)
time frame: From Week 0 to Week 52
Change in swollen tender joints
time frame: From Week 0 to Week 52

Eligibility Criteria

Male or female participants from 19 years up to 100 years old.

Inclusion Criteria: - Subject must be an adult ≥19 years. - Subject has been diagnosed with ankylosing spondylitis (AS) according to the 1984 modified New York criteria for at least 3 months. - Subject 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 DMARDs for more than 3 months based on Korea AS reimbursement guideline. - Subject is eligible for adalimumab in daily rheumatologic practice. - Subject must provide written authorization form to use personal and/or health data prior to the entry into the study. Exclusion Criteria: - Female subjects who are pregnant or breast feeding. - Subject applies contraindication to any anti-TNF agent. - Subject is participating in other clinical trials.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by AbbVie.