- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00939003
Study of Adalimumab in Patients With Axial Spondyloarthritis
A Multicenter Study of the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Axial Spondyloarthritis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Brisbane, Australia, 4102
- Site Reference ID/Investigator# 22342
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Kogarah, Australia, 2217
- Site Reference ID/Investigator# 21223
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Maroochydore, Australia, 4558
- Site Reference ID/Investigator# 21222
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Genk, Belgium, 3600
- Site Reference ID/Investigator# 21225
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Ghent, Belgium, 9000
- Site Reference ID/Investigator# 21224
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Gilly, Belgium, 6060
- Site Reference ID/Investigator# 26544
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Merksem, Belgium, 2170
- Site Reference ID/Investigator# 27382
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Edmonton, Canada, T6G 2S2
- Site Reference ID/Investigator# 21229
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Sainte-Foy, Quebec, Canada, G1W 4R4
- Site Reference ID/Investigator# 21226
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St. John's, Canada, A1C 5B8
- Site Reference ID/Investigator# 21227
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Toronto, Canada, M5T 2S8
- Site Reference ID/Investigator# 21228
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Brno, Czech Republic, 65691
- Site Reference ID/Investigator# 21231
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Pardubice, Czech Republic, 530 02
- Site Reference ID/Investigator# 26882
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Prague 2, Czech Republic, 128 50
- Site Reference ID/Investigator# 21230
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Uherske Hradiste, Czech Republic, 686 01
- Site Reference ID/Investigator# 26883
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Boulogne Billancourt, France, 92100
- Site Reference ID/Investigator# 21263
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Chambray-les-Tour, France, 37170
- Site Reference ID/Investigator# 21262
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Orleans, France, 45067
- Site Reference ID/Investigator# 21261
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Paris Cedex 14, France, 75679
- Site Reference ID/Investigator# 22343
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Berlin, Germany, 12200
- Site Reference ID/Investigator# 21266
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Erlangen, Germany, 91054
- Site Reference ID/Investigator# 21267
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Herne, Germany, 44652
- Site Reference ID/Investigator# 21264
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Munich, Germany, 80336
- Site Reference ID/Investigator# 21265
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Amsterdam, Netherlands, 1105 AZ
- Site Reference ID/Investigator# 21285
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Leiden, Netherlands, 2333 ZA
- Site Reference ID/Investigator# 21284
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A Coruna, Spain, 15006
- Site Reference ID/Investigator# 21282
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Barcelona, Spain, 08907
- Site Reference ID/Investigator# 21283
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Cordoba, Spain, 14004
- Site Reference ID/Investigator# 21281
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Newcastle upon Tyne, United Kingdom, NE7 7DN
- Site Reference ID/Investigator# 21289
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Alabama
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Birmingham, Alabama, United States, 35205
- Site Reference ID/Investigator# 21250
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Colorado
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Colorado Springs, Colorado, United States, 80910
- Site Reference ID/Investigator# 21249
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Denver, Colorado, United States, 80230
- Site Reference ID/Investigator# 21245
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Maryland
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Wheaton, Maryland, United States, 20902
- Site Reference ID/Investigator# 21246
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Pennsylvania
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Duncansville, Pennsylvania, United States, 16635
- Site Reference ID/Investigator# 26582
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Wyomissing, Pennsylvania, United States, 19610
- Site Reference ID/Investigator# 21241
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Texas
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Dallas, Texas, United States, 75231
- Site Reference ID/Investigator# 21243
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Houston, Texas, United States, 77030
- Site Reference ID/Investigator# 21248
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Washington
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Seattle, Washington, United States, 98122
- Site Reference ID/Investigator# 21247
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult patients with inadequate response to >/= 1 non-steroidal anti-inflammatory drugs (NSAIDs)
- Chronic back pain with onset < 45 years of age
- Magnetic resonance imaging (MRI) indicating active sacroiliitis or positive human leukocyte antigen-B27 (HLA-B27) blood test in addition to meeting spondyloarthritis clinical criteria
- Negative purified protein derivative (PPD) test and chest x-ray performed at Baseline visit must be negative
- Ability to administer subcutaneous injections
- General good health otherwise
Exclusion Criteria:
- Prior anti-tumor necrosis factor (TNF) therapy
- Psoriasis or psoriatic arthritis
- Fulfillment of modified New York criteria for ankylosing spondylitis
- Recent infection requiring treatment
- Significant medical events or conditions that may put patients at risk for participation
- Females who are pregnant or breast-feeding or considering becoming pregnant during the study
- History of cancer, except successfully treated skin cancer
- Recent history of drug or alcohol abuse
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo
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Placebo every other week up to Week 12
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Experimental: Adalimumab
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40 mg every other week up to Week 12
Other Names:
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Experimental: Open-label Adalimumab
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40 mg every other week, Week 12 through Week 156
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 40 Response
Time Frame: Baseline and Week 12
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ASAS40 response was defined as improvement of ≥ 40% relative to Baseline and absolute improvement of ≥ 20 units (on a scale from 0 to 100) in ≥ 3 of the following 4 domains with no deterioration (defined as a net worsening of > 0 units on a scale from 0 to 100) in the potential remaining domain:
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Baseline and Week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 20 Response
Time Frame: Baseline and Week 12
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ASAS20 response was defined as improvement of ≥ 20% relative to Baseline and absolute improvement of ≥ 10 units (on a scale from 0 to 100) in ≥ 3 of the following 4 domains with no deterioration (defined as a change for the worse of ≥ 20% and net worsening of ≥ 10 units) in the potential remaining domain:
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Baseline and Week 12
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Number of Participants Achieving a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response
Time Frame: Baseline and Week 12
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The Bath Ankylosing Spondylitis (AS) Disease Activity Index assesses disease activity by asking the participant to answer 6 questions (each on a 10 cm VAS) 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 cm.
Lower scores indicate less disease activity.
BASDAI50 is a 50% improvement from Baseline in BASDAI score.
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Baseline and Week 12
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Change From Baseline in Short Form-36 (SF-36) Physical Component Summary Score
Time Frame: Baseline and Week 12
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The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life.
The SF-36 consists of 36 questions in 8 domains (limitations in physical functioning due to health problems; limitations in usual role because of physical health problems; bodily pain; general health perceptions; vitality; limitations in social functioning because of physical or emotional problems; limitations in usual role due to emotional problems; and general mental health).
Two component scores can be summarized: physical and mental; domains 1-4 comprise the physical component summary of the SF-36.
A transformed summary score is calculated ranging from 0 to 100 where higher scores indicate a higher level of functioning.
A positive change from Baseline score indicates an improvement.
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Baseline and Week 12
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Number of Participants Achieving ASAS Partial Remission
Time Frame: Week 12
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ASAS partial remission is an absolute score of < 20 units on a 0 to 100 scale for each of the four following domains:
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Week 12
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Number of Participants Achieving an ASAS5/6 Response
Time Frame: Baseline and Week 12
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ASAS5/6 response is a 20% improvement in five out of the following six domains:
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Baseline and Week 12
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Change From Baseline in Disability Index of Health Assessment Questionnaire Modified for the Spondyloarthropathies (HAQ-S)
Time Frame: Baseline and Week 12
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Health Assessment Questionnaire modified for spondyloarthropathies (HAQ-S) is a self-reported measure to assess the physical function and health-related quality of life.
The Disability Index (DI) of HAQ-S is calculated as the mean of the following 8 category scores (range: 0 [without any difficulty] to 3 [unable to do]): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities.
Five additional items in the functional status measure were included in the HAQ-S, including carrying heavy packages, sitting for long periods, able to work at a flat topped table, and (if the participant had a driver's license or a car) able to look in the rear view mirror and able to turn head to drive in reverse.
The overall score ranges from 0 (no disability) to 3 (three very severe, high-dependency disability).
Negative mean changes from Baseline in the overall score indicate improvement.
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Baseline and Week 12
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Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP)
Time Frame: Baseline and Week 12
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C-reactive protein (CRP) is considered an efficacy variable for the axial spondyloarthritis indication.
It is a general marker of inflammation that is sensitive to acute changes in inflammatory response.
Higher levels indicate more inflammation.
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Baseline and Week 12
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Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Score for Sacroiliac Joints
Time Frame: Baseline and Week 12
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Six consecutive sacroiliac (SI) joint image coronal slices representing the largest proportion of the synovial compartment of the SI joints were assessed for edema, intensity and depth of edema using SPARCC scoring. Each SI joint (left and right) was divided into quadrants for a total of 8 SI scoring locations. Each quadrant was scored for the presence (1) or absence (0) of edema; the maximum score is 8 per slice and maximum score for 6 SI joint slices is 48. Intensity of edema: A score of 1 was assigned for each SI joint (left and right) if an intense signal was seen in any quadrant of that joint for each slice. The maximum score is 2 per slice and 12 for 6 slices. A lesion was graded as deep (score of 1) if there was homogeneous and unequivocal increase in signal extending over a depth of at least 1 cm from the articular surface of the SI joint in any quadrant. The maximum score per slice is 2 and for 6 slices 12. The total maximum score for all SI joints across 6 slices is 72. |
Baseline and Week 12
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Change From Baseline in SPARCC MRI Score for the Spine
Time Frame: Baseline and Week 12
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Six discovertebral units (DVU) representing the 6 most abnormal DVUs, and 3 consecutive sagittal slices at each DVU representing the most abnormal slices for that DVU were selected for scoring. Each DVU was divided into 4 quadrants and scored for the presence (1) or absence (0) of edema. The maximum score is 12 per DVU. The maximum score is 72 for 6 DVUs. If edema was present in at least 1 quadrant of a DVU slice, it was scored for intensity and depth of the edema representing that slice: A score of 1 was assigned if an intense signal was seen in any quadrant on a DVU slice. The maximum score for intensity per slice is 1, per DVU is 3 and for 6 DVUs is 18. A lesion was graded as deep (score of 1) if there was homogeneous and unequivocal increase in signal extending over a depth of at least 1 cm from the surface of the endplate in any quadrant. The maximum score per slice is 1, for a DVU is 3 and for 6 DVUs is 18. The total maximum SPARCC score for all 6 DVUs is 108. |
Baseline and Week 12
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Participants Reporting Adverse Events
Time Frame: Through Week 12
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Adverse events were collected at designated study visits for all participants who received at least 1 dose of study drug.
The number of participants experiencing any adverse event (serious and non-serious) is summarized.
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Through Week 12
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Number of Participants With Blood Hematology or Chemistry Values Common Toxicity Criteria Grade ≥ 3
Time Frame: Through Week 12
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Blood was collected for analysis at designated study visits; hematology and chemistry results were provided by a central laboratory.
The number of participants with an abnormal laboratory result (higher then upper normal limit or lower than lower normal limit) meeting Common Toxicity Criteria (CTC) of Grade 3 or higher is summarized.
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Through Week 12
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Number of Participants Achieving an ASAS20 Response During the Open-label Period
Time Frame: Baseline and Weeks 52, 104, and 156
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ASAS20 response was defined as improvement of ≥ 20% relative to Baseline and absolute improvement of ≥ 10 units (on a scale from 0 to 100) in ≥ 3 of the following 4 domains with no deterioration (defined as a change for the worse of ≥ 20% and net worsening of ≥ 10 units) in the potential remaining domain:
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Baseline and Weeks 52, 104, and 156
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Number of Participants Achieving an ASAS40 Response During the Open-label Period
Time Frame: Baseline and Weeks 52, 104, and 156
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ASAS40 response was defined as improvement of ≥ 40% relative to Baseline and absolute improvement of ≥ 20 units (on a scale from 0 to 100) in ≥ 3 of the following 4 domains with no deterioration (defined as a net worsening of > 0 units on a scale of 0 to 100) in the potential remaining domain:
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Baseline and Weeks 52, 104, and 156
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Number of Participants Achieving a BASDAI50 Response During the Open-label Period
Time Frame: Baseline and Weeks 52, 104, and 156
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The Bath Ankylosing Spondylitis (AS) Disease Activity Index assesses disease activity by asking the participant to answer 6 questions (each on a 10 cm VAS) 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 cm.
Lower scores indicate less disease activity.
BASDAI50 is a 50% improvement from Baseline in BASDAI score.
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Baseline and Weeks 52, 104, and 156
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Aileen L Pangan, MD, AbbVie
Publications and helpful links
General Publications
- van der Heijde D, Sieper J, Maksymowych WP, Lambert RG, Chen S, Hojnik M, Anderson JK, Pangan AL. Clinical and MRI remission in patients with nonradiographic axial spondyloarthritis who received long-term open-label adalimumab treatment: 3-year results of the ABILITY-1 trial. Arthritis Res Ther. 2018 Mar 27;20(1):61. doi: 10.1186/s13075-018-1556-5.
- van der Heijde D, Sieper J, Maksymowych WP, Brown MA, Lambert RG, Rathmann SS, Pangan AL. Spinal inflammation in the absence of sacroiliac joint inflammation on magnetic resonance imaging in patients with active nonradiographic axial spondyloarthritis. Arthritis Rheumatol. 2014 Mar;66(3):667-73. doi: 10.1002/art.38283.
- Sieper J, van der Heijde D, Dougados M, Mease PJ, Maksymowych WP, Brown MA, Arora V, Pangan AL. Efficacy and safety of adalimumab in patients with non-radiographic axial spondyloarthritis: results of a randomised placebo-controlled trial (ABILITY-1). Ann Rheum Dis. 2013 Jun;72(6):815-22. doi: 10.1136/annrheumdis-2012-201766. Epub 2012 Jul 7.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M10-791
- 2009-010643-14 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Axial Spondyloarthritis
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UCB Biopharma SRLCompletedNonradiographic Axial SpondyloarthritisUnited States, Belgium, Bulgaria, China, Czechia, France, Germany, Hungary, Japan, Poland, Spain, Turkey, United Kingdom
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Novartis PharmaceuticalsRecruitingNon-radiographic Axial SpondyloarthritisBelgium, Netherlands, Italy, Thailand, Hungary, Malaysia, Germany, Israel, France, Czechia, Colombia, Romania, Poland, Turkey, Vietnam, Brazil, Mexico, Philippines
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Sunshine Guojian Pharmaceutical (Shanghai) Co.,...Not yet recruitingAxial SpondyloarthritisChina
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Merck Sharp & Dohme LLCCompletedSpondyloarthritisCzechia, Germany, Netherlands, Poland, Romania, Russian Federation, Spain, Turkey, Ukraine
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Novartis PharmaceuticalsActive, not recruitingNon-radiographic Axial SpondyloarthritisChina
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UCB Biopharma SRLActive, not recruitingAnkylosing Spondylitis | Axial Spondyloarthritis | r-axSpa | Nr-axSpaUnited States, Belgium, Bulgaria, China, Czechia, France, Germany, Hungary, Japan, Netherlands, Poland, Spain, Turkey, United Kingdom
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Bangabandhu Sheikh Mujib Medical University, Dhaka...Healthcare PharmaceuticalsRecruitingSpondyloarthritis, AxialBangladesh
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Fondazione Policlinico Universitario Agostino Gemelli...Not yet recruitingSpondyloarthritis | Spondyloarthritis, AxialItaly
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UCB BIOSCIENCES GmbHCompletedAxial Spondyloarthritis | Nonradiographic Axial Spondyloarthritis | Nr-axSpAUnited States, Australia, Bulgaria, Canada, Czechia, Hungary, Poland, Russian Federation, Taiwan
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Centre Hospitalier Universitaire de BesanconNot yet recruitingSpondyloarthritis, AxialFrance
Clinical Trials on Adalimumab
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PfizerCompletedHealthyUnited States, Belgium
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PfizerCompletedHealthy SubjectsUnited States
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AbbottCompletedArthritis, Juvenile IdiopathicUnited States, Belgium, Czech Republic, France, Germany, Italy, Slovakia, Spain
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Shanghai Henlius BiotechCompleted
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AbbottCompleted
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Turgut İlaçları A.Ş.CompletedHealthy ParticipantsGermany
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Mylan Inc.Mylan GmbHCompletedPsoriasis | Arthritis, PsoriaticBulgaria, Estonia, Hungary, Poland, Russian Federation, Ukraine
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AbbottCompletedRheumatoid ArthritisSpain
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AbbVie (prior sponsor, Abbott)CompletedRheumatoid ArthritisUnited States