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

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ClinicalTrials.gov Identifier: NCT02333383
Recruitment Status : Completed
First Posted : January 7, 2015
Last Update Posted : August 15, 2017
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief 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.

Condition or disease
Ankylosing Spondylitis

Study Type : Observational
Actual Enrollment : 201 participants
Observational Model: Case-Only
Time Perspective: Prospective
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 Start Date : December 31, 2014
Actual Primary Completion Date : August 8, 2017
Actual Study Completion Date : August 8, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Group/Cohort
Subjects with Ankylosing Spondylitis
Subjects who have been diagnosed with active ankylosing spondylitis according to the 1984 modified New York criteria.



Primary Outcome Measures :
  1. Frequency of Extra-Axial Manifestations (EAMs) of interest in Korean AS patients [ Time Frame: At Week 0 ]
    The frequency of EAMs of interest at baseline are peripheral arthritis, enthesitis and dactylitis.


Secondary Outcome Measures :
  1. Percentage of subjects with 50% improvement of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score [ Time Frame: Up to Week 52 ]
    BASDAI score will be checked by physician, and the score range is from 0 to 10. The percentage of patients with 50% improvement of baseline BASDAI (BASDAI 50) at week 12, 28, 36, and 52 is assessed.

  2. Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) [ Time Frame: From Week 0 to Week 52 ]
    MASES (Maastricht Ankylosing Spondylitis Enthesitis Score) will be checked by physician, and the score range is from 0 to 13. The change of MASES from week 0 to week 12, 28, 36, and 52 is assessed.

  3. Percentage of subjects with enthesitis of the plantar fascia [ Time Frame: Up to week 52 ]
    Physician will assess presence or absence of plantar facia. The percentage of patients who have enthesitis of the plantar fascia from Week 0 to week 12, 28, 36 and 52 is assessed.

  4. Change of dactylitis score [ Time Frame: From Week 0 to Week 52 ]
    Physician will assess dactylitis with counts of dactylitic digit (0 to 20). The change of dactylitis score from week 0 to week 12, 28, 36 and 52 is assessed.

  5. Change in tender joint counts (TJC) [ Time Frame: From Week 0 to Week 52 ]
    Physician will assess tender joint count by physical exam. The change in tender joint counts (TJC: 0-46) is assessed.

  6. Change in swollen tender joints [ Time Frame: From Week 0 to Week 52 ]
    Physician will assess swollen joint count by physical exam excluding hip joint. The change in swollen joint counts (SJC: 0-44) is assessed.



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Ages Eligible for Study:   19 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
General Hospital
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02333383


Locations
Korea, Republic of
Hallym University Sacred Heart Hospital /ID# 135329
Anyang-si, Korea, Republic of, 431-070
Dong-A University Hospital /ID# 135232
Busan, Korea, Republic of, 49201
Daegu Catholic University Medical Center /ID# 135349
Daegu, Korea, Republic of, 42472
Eulji University Hospital /ID# 141792
Daejeon, Korea, Republic of, 302-799
Hanyang University Guri Hospital /ID# 148287
Guri, Korea, Republic of, 471-701
Chonnam National University Hospital /ID# 135351
Gwangju, Korea, Republic of, 61469
Inha University Hospital /ID# 135231
Incheon, Korea, Republic of, 22332
Gangnam Severance Hospital /ID# 138001
Seoul, Korea, Republic of, 06273
The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 135868
Seoul, Korea, Republic of, 06591
Kyung Hee University Medical Center /ID# 148288
Seoul, Korea, Republic of, 130-872
Hanyang University Seoul Hospital /ID# 135229
Seoul, Korea, Republic of, 133-792
Kyung Hee University Medical Center /ID# 135233
Seoul, Korea, Republic of, 134-727
Konkuk University Medical Center /ID# 135350
Seoul, Korea, Republic of
Sponsors and Collaborators
AbbVie
Investigators
Study Director: EunJung Gu AbbVie Korea

Additional Information:
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02333383     History of Changes
Other Study ID Numbers: P15-238
First Posted: January 7, 2015    Key Record Dates
Last Update Posted: August 15, 2017
Last Verified: August 2017

Keywords provided by AbbVie:
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score
EAMs
Adalimumab

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents