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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02333383
Date of registration: 06/01/2015
Prospective Registration: No
Primary sponsor: AbbVie
Public title: Observe the Frequency of Extra-Axial Symptoms in Korean Ankylosing Spondylitis (AS) Patients AS PMOS
Scientific title: A Prospective, Mono-Country, Multi-Center Study to Observe the Frequency of Extra-Axial Symptoms in Korean Ankylosing Spondylitis Patients on Adalimumab Therapy
Date of first enrolment: December 31, 2014
Target sample size: 201
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02333383
Study type:  Observational
Study design:   
Phase: 
Countries of recruitment
Korea, Republic of
Contacts
Name:     EunJung Gu
Address: 
Telephone:
Email:
Affiliation:  AbbVie Korea
Key inclusion & exclusion 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



Age minimum: 19 Years
Age maximum: 100 Years
Gender: All
Health Condition(s) or Problem(s) studied
Ankylosing Spondylitis
Intervention(s)
Drug: Adalimumab
Primary Outcome(s)
Frequency of Extra-Axial Manifestations (EAMs) of Interest [Time Frame: Baseline]
Secondary Outcome(s)
Mean Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Participants With Enthesitis at Baseline [Time Frame: Baseline, Week 12, Week 28, Week 36, Week 52]
Mean Change in Change in Swollen Joint Counts (SJC) in Participants With Peripheral Arthritis (=1 Swollen Joint) at Baseline [Time Frame: Baseline, Week 12, Week 28, Week 36, Week 52]
Mean Change in Dactylitis Score in Participants With Dactylitis at Baseline [Time Frame: Baseline, Week 12, Week 28, Week 36, Week 52]
Mean Change in Tender Joint Counts (TJC) in Participants With Peripheral Arthritis (=1 Swollen Joint) at Baseline [Time Frame: Baseline, Week 12, Week 28, Week 36, Week 52]
Proportion of Participants Achieving a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response [Time Frame: Baseline, Week 12, Week 28, Week 36, Week 52]
Proportion of Participants With Enthesitis of the Plantar Fascia [Time Frame: Baseline, Week 12, Week 28, Week 36, Week 52]
Secondary ID(s)
P15-238
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 15/01/2019
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT02333383
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