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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
Results First Posted : January 15, 2019
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Ankylosing Spondylitis
Intervention Drug: Adalimumab
Enrollment 201
Recruitment Details  
Pre-assignment Details Intention-to-Treat (ITT) population: Participants who received at least one dose of adalimumab and had extra-axial manifestations (EAMs) assessed at baseline
Arm/Group Title Participants With Ankylosing Spondylitis
Hide Arm/Group Description Adalimumab 40 mg every other week by subcutaneous (SC) injection for 52 weeks
Period Title: Overall Study
Started 201
Completed 160
Not Completed 41
Reason Not Completed
Adalimumab discontinuation             21
Lost to Follow-up             15
Withdrawal by Subject             3
Transfer to another hospital             2
Arm/Group Title Participants With Ankylosing Spondylitis
Hide Arm/Group Description Adalimumab 40 mg every other week by subcutaneous (SC) injection for 52 weeks
Overall Number of Baseline Participants 201
Hide Baseline Analysis Population Description
Intention-to-Treat (ITT) population: Participants who received at least one dose of adalimumab and had extra-axial manifestations (EAM) assessed at baseline
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 201 participants
39.84  (12.34)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 201 participants
Female
39
  19.4%
Male
162
  80.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 201 participants
American Indian or Alaska Native
0
   0.0%
Asian
201
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
0
   0.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Frequency of Extra-Axial Manifestations (EAMs) of Interest
Hide Description 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.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat (ITT) population: Participants who received at least one dose of adalimumab and had extra-axial manifestations (EAMs) assessed at baseline
Arm/Group Title Participants With Ankylosing Spondylitis
Hide Arm/Group Description:
Adalimumab 40 mg every other week by subcutaneous (SC) injection for 52 weeks
Overall Number of Participants Analyzed 201
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Enthesitis
46.27
(39.23 to 53.42)
Peripheral arthritis
33.33
(26.86 to 40.31)
Dactylitis
2.99
(1.10 to 6.38)
2.Secondary Outcome
Title Proportion of Participants Achieving a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response
Hide Description 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.
Time Frame Baseline, Week 12, Week 28, Week 36, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat (ITT) population: Participants with available data who received at least one dose of adalimumab and had extra-axial manifestations (EAMs) assessed at baseline
Arm/Group Title Participants With Ankylosing Spondylitis
Hide Arm/Group Description:
Adalimumab 40 mg every other week by subcutaneous (SC) injection for 52 weeks
Overall Number of Participants Analyzed 189
Measure Type: Count of Participants
Unit of Measure: Participants
Week 12 Number Analyzed 189 participants
142
  75.1%
Week 28 Number Analyzed 155 participants
128
  82.6%
Week 36 Number Analyzed 162 participants
142
  87.7%
Week 52 Number Analyzed 144 participants
130
  90.3%
3.Secondary Outcome
Title Mean Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Participants With Enthesitis at Baseline
Hide Description 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.
Time Frame Baseline, Week 12, Week 28, Week 36, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat (ITT) population: Participants with available data who received at least one dose of adalimumab and had enthesitis at baseline
Arm/Group Title Participants With Ankylosing Spondylitis
Hide Arm/Group Description:
Adalimumab 40 mg every other week by subcutaneous (SC) injection for 52 weeks
Overall Number of Participants Analyzed 86
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 12 Number Analyzed 84 participants
-1.85  (2.50)
Week 28 Number Analyzed 72 participants
-2.31  (2.03)
Week 36 Number Analyzed 71 participants
-2.31  (1.78)
Week 52 Number Analyzed 68 participants
-2.50  (1.90)
4.Secondary Outcome
Title Proportion of Participants With Enthesitis of the Plantar Fascia
Hide Description 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.
Time Frame Baseline, Week 12, Week 28, Week 36, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat (ITT) population: Participants with available data who received at least one dose of adalimumab and had extra-axial manifestations (EAMs) assessed at baseline
Arm/Group Title Participants With Ankylosing Spondylitis
Hide Arm/Group Description:
Adalimumab 40 mg every other week by subcutaneous (SC) injection for 52 weeks
Overall Number of Participants Analyzed 201
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Number Analyzed 201 participants
19
   9.5%
Week 12 Number Analyzed 193 participants
10
   5.2%
Week 28 Number Analyzed 173 participants
2
   1.2%
Week 36 Number Analyzed 169 participants
4
   2.4%
Week 52 Number Analyzed 160 participants
7
   4.4%
5.Secondary Outcome
Title Mean Change in Dactylitis Score in Participants With Dactylitis at Baseline
Hide Description 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.
Time Frame Baseline, Week 12, Week 28, Week 36, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat (ITT) population: Participants with available data who received at least one dose of adalimumab and had dactylitis at baseline
Arm/Group Title Participants With Ankylosing Spondylitis
Hide Arm/Group Description:
Adalimumab 40 mg every other week by subcutaneous (SC) injection for 52 weeks
Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 12 Number Analyzed 6 participants
-3.83  (3.66)
Week 28 Number Analyzed 5 participants
-4.40  (3.78)
Week 36 Number Analyzed 4 participants
-5.00  (4.08)
Week 52 Number Analyzed 4 participants
-5.00  (4.08)
6.Secondary Outcome
Title Mean Change in Tender Joint Counts (TJC) in Participants With Peripheral Arthritis (≥1 Swollen Joint) at Baseline
Hide Description 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.
Time Frame Baseline, Week 12, Week 28, Week 36, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat (ITT) population: Participants with available data who received at least one dose of adalimumab and had peripheral arthritis (≥1 swollen joint) at baseline
Arm/Group Title Participants With Ankylosing Spondylitis
Hide Arm/Group Description:
Adalimumab 40 mg every other week by subcutaneous (SC) injection for 52 weeks
Overall Number of Participants Analyzed 67
Mean (Standard Deviation)
Unit of Measure: Tender joint counts
Week 12 Number Analyzed 66 participants
-1.82  (3.43)
Week 28 Number Analyzed 56 participants
-2.05  (3.03)
Week 36 Number Analyzed 53 participants
-2.38  (3.13)
Week 52 Number Analyzed 50 participants
-2.60  (2.87)
7.Secondary Outcome
Title Mean Change in Change in Swollen Joint Counts (SJC) in Participants With Peripheral Arthritis (≥1 Swollen Joint) at Baseline
Hide Description 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.
Time Frame Baseline, Week 12, Week 28, Week 36, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat (ITT) population: Participants with available data who received at least one dose of adalimumab and had peripheral arthritis (≥1 swollen joint) at baseline
Arm/Group Title Participants With Ankylosing Spondylitis
Hide Arm/Group Description:
Adalimumab 40 mg every other week by subcutaneous (SC) injection for 52 weeks
Overall Number of Participants Analyzed 67
Mean (Standard Deviation)
Unit of Measure: Swollen joint counts
Week 12 Number Analyzed 66 participants
-1.80  (2.25)
Week 28 Number Analyzed 56 participants
-1.98  (2.79)
Week 36 Number Analyzed 53 participants
-2.04  (2.86)
Week 52 Number Analyzed 50 participants
-2.40  (2.30)
Time Frame Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks).
Adverse Event Reporting Description TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
 
Arm/Group Title Participants With Ankylosing Spondylitis
Hide Arm/Group Description Adalimumab 40 mg every other week by subcutaneous (SC) injection for 52 weeks
All-Cause Mortality
Participants With Ankylosing Spondylitis
Affected / at Risk (%)
Total   0/201 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Participants With Ankylosing Spondylitis
Affected / at Risk (%)
Total   8/201 (3.98%) 
Blood and lymphatic system disorders   
Lymphadenopathy  1  1/201 (0.50%) 
Gastrointestinal disorders   
Diarrhoea  1  1/201 (0.50%) 
Pancreatitis  1  1/201 (0.50%) 
General disorders   
Pain  1  1/201 (0.50%) 
Infections and infestations   
Cellulitis  1  1/201 (0.50%) 
Pneumonia  1  1/201 (0.50%) 
Injury, poisoning and procedural complications   
Road traffic accident  1  1/201 (0.50%) 
Musculoskeletal and connective tissue disorders   
Fibromyalgia  1  1/201 (0.50%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Chronic myelomonocytic leukaemia  1  1/201 (0.50%) 
Skin and subcutaneous tissue disorders   
Toxic skin eruption  1  1/201 (0.50%) 
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Participants With Ankylosing Spondylitis
Affected / at Risk (%)
Total   18/201 (8.96%) 
Blood and lymphatic system disorders   
Lymphadenopathy  1  1/201 (0.50%) 
Eye disorders   
Uveitis  1  1/201 (0.50%) 
Gastrointestinal disorders   
Diarrhoea  1  1/201 (0.50%) 
Pancreatitis  1  1/201 (0.50%) 
General disorders   
Pain  1  1/201 (0.50%) 
Pyrexia  1  1/201 (0.50%) 
Infections and infestations   
Cellulitis  1  1/201 (0.50%) 
Latent tuberculosis  1  1/201 (0.50%) 
Pneumonia  1  1/201 (0.50%) 
Injury, poisoning and procedural complications   
Road traffic accident  1  1/201 (0.50%) 
Investigations   
Alanine aminotransferase increased  1  1/201 (0.50%) 
Aspartate aminotransferase increased  1  1/201 (0.50%) 
Musculoskeletal and connective tissue disorders   
Ankylosing spondylitis  1  2/201 (1.00%) 
Fibromyalgia  1  1/201 (0.50%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Chronic myelomonocytic leukaemia  1  1/201 (0.50%) 
Skin and subcutaneous tissue disorders   
Pruritus  1  1/201 (0.50%) 
Rash  1  1/201 (0.50%) 
Toxic skin eruption  1  1/201 (0.50%) 
Urticaria  1  1/201 (0.50%) 
Vascular disorders   
Hypertension  1  1/201 (0.50%) 
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Results Point of Contact
Name/Title: Global Medical Services
Organization: AbbVie
Phone: 800-633-9110
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02333383     History of Changes
Other Study ID Numbers: P15-238
First Submitted: January 6, 2015
First Posted: January 7, 2015
Results First Submitted: July 23, 2018
Results First Posted: January 15, 2019
Last Update Posted: January 15, 2019