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

Ankylosing Spondylitis Clinical Trial

— AS PMOS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02333383
• Other study ID #: P15-238
• Status: Completed
• Start date: December 31, 2014
• Est. completion date: August 8, 2017

Study information

• Verified date: July 2018
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: August 8, 2017
• Est. primary completion date: August 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Drug:
• Adalimumab
Adalimumab pre-filled syringe, administered by subcutaneous injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of Participants Achieving a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response	The Bath Ankylosing Spondylitis (AS) Disease Activity Index assesses disease activity by asking the participant to answer 6 questions (each on a 10 point numeric rating scale [NRS]) pertaining to symptoms experienced for the past week. For 5 questions (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (= 2 hours). The overall BASDAI score ranges from 0 to 10. Lower scores indicate less disease activity. BASDAI 50 is a 50% improvement from baseline in BASDAI score.	Baseline, Week 12, Week 28, Week 36, Week 52
Secondary	Mean Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Participants With Enthesitis at Baseline	Assessment of enthesitis was performed in the following 7 domains: 1) 1st costochondral joint left and right, 2) 7th costochondral joint left and right, 3) posterior superior iliac spine left and right, 4) anterior superior iliac spine left and right, 5) iliac crest left and right, 6) 5th lumbar spinous process and 7) proximal insertion of Achilles tendon left and right. Each domain was graded for the presence (1) or absence (0) of tenderness yielding total MASES ranging from 0 (0 sites with tenderness) to 13 (worst possible score; 13 sites with tenderness). Negative values indicate improvement from baseline.	Baseline, Week 12, Week 28, Week 36, Week 52
Secondary	Proportion of Participants With Enthesitis of the Plantar Fascia	The plantar fascia is a ligament that runs along the bottom of each foot. The percentage of participants who had enthesitis of the plantar fascia was documented at each study visit.	Baseline, Week 12, Week 28, Week 36, Week 52
Secondary	Mean Change in Dactylitis Score in Participants With Dactylitis at Baseline	Assessment of the presence or absence of dactylitis (inflammation of finger and/or toe joints) as well as grading of tenderness and swelling in all 20 of the participants' digits was performed. Tenderness at each site was quantified from absent to severe. Swelling was quantified from mild to severe. Total Dactylitis Assessment scores ranged from 0 (no digits with dactylitis) to 20 (worst possible score; 20 digits with dactylitis). Negative values indicate improvement from baseline.	Baseline, Week 12, Week 28, Week 36, Week 52
Secondary	Mean Change in Tender Joint Counts (TJC) in Participants With Peripheral Arthritis (=1 Swollen Joint) at Baseline	Forty-six joints were assessed for tenderness by physical examination. Tenderness of each joint was classified as present (1) or absent (0), for a total possible TJC score of 0 (0 joints with tenderness) to 46 (worst possible score/46 joints with tenderness). Negative values indicate improvement from baseline.	Baseline, Week 12, Week 28, Week 36, Week 52
Secondary	Mean Change in Change in Swollen Joint Counts (SJC) in Participants With Peripheral Arthritis (=1 Swollen Joint) at Baseline	Forty-four joints, excluding hip joints, were assessed for swelling by physical examination. Swelling of each joint was classified as present (1) or absent (0), for a total possible score SJC of 0 (0 joints with swelling) to 44 (worst possible score/44 joints with swelling). Negative values indicate improvement from baseline.	Baseline, Week 12, Week 28, Week 36, Week 52

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