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

NCT02333383 | Completed Results

• 1 other identifier: P15-238
• Study Type: observational
• Target: 201
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Ankylosing Spondylitis

Keywords

Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score; EAMs; Adalimumab

Outcome Measures

Primary Outcomes (1)

• Frequency of Extra-Axial Manifestations (EAMs) of Interest

  The baseline assessment was performed prior to the first dose of adalimumab. The presence of peripheral arthritis (arthritis affecting shoulders, elbows, wrists, hands, knees, ankles, feet), enthesitis (inflammation of the areas where ligaments or tendons insert into bone) and dactylitis (inflammation of finger and/or toe joints) was noted. Peripheral arthritis was defined as ≥1 swollen joint on the Swollen Joint Count scale (SJC; range, 0 to 44, excluding hip joints). Enthesitis was defined as at least one inflamed enthesis in the Maastricht Ankylosing Spondylitis Enthesitis Score (MASES, 0 to 13, with higher scores representing more severe disease) or of the plantar fascia of the foot. Dactylitis was measured by a simple count of dactylitic digits.

  Baseline

Secondary Outcomes (6)

• Proportion of Participants Achieving a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response

  Baseline, Week 12, Week 28, Week 36, Week 52

• Mean Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Participants With Enthesitis at Baseline

  Baseline, Week 12, Week 28, Week 36, Week 52

• Proportion of Participants With Enthesitis of the Plantar Fascia

  Baseline, Week 12, Week 28, Week 36, Week 52

• Mean Change in Dactylitis Score in Participants With Dactylitis at Baseline

  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

  Baseline, Week 12, Week 28, Week 36, Week 52

Study Arms (1)

Participants with Ankylosing Spondylitis

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

Drug: Adalimumab

Interventions

Adalimumab DRUG

Adalimumab pre-filled syringe, administered by subcutaneous injection

Also known as: Humira, ABT-D2E7

Participants with Ankylosing Spondylitis

Eligibility Criteria

• Age: 19 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

General Hospital

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie: lead

Related Links

• Related Info

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• EunJung Gu

  AbbVie Korea

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2015
• First Posted: January 7, 2015
• Study Start: December 31, 2014
• Primary Completion: August 8, 2017
• Study Completion: August 8, 2017
• Last Updated: January 15, 2019
• Results First Posted: January 15, 2019

Record last verified: 2018-07