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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

201 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2017-08-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of Adalimumab in Patients With Axial Spondyloarthritis

NCT00939003

Axial Spondyloarthritis

COMPLETED PHASE3

Adalimumab Administered in Korean Rheumatoid Arthritis Subjects Treated With Methotrexate

NCT00235859

Rheumatoid Arthritis

COMPLETED PHASE3

An Observational, Prospective Study to Assess the Efficacy and Safety of Adalloce in Patients With RA and AS

NCT05835518

Rheumatoid Arthritis Ankylosing Spondylitis

RECRUITING

Special Investigation in Patients With Ankylosing Spondylitis (All Patients Investigation)

NCT01329380

Ankylosing Spondylitis

COMPLETED

Safety and Efficacy of Adalimumab in Patients With Active Ankylosing Spondylitis

NCT00195819

Ankylosing Spondylitis

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ankylosing Spondylitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Participants with Ankylosing Spondylitis

Adalimumab 40 mg every other week by subcutaneous (SC) injection for 52 weeks

Adalimumab

Intervention Type DRUG

Adalimumab pre-filled syringe, administered by subcutaneous injection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Adalimumab

Adalimumab pre-filled syringe, administered by subcutaneous injection

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Humira ABT-D2E7

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

19 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No