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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00939003




Registration number
NCT00939003
Ethics application status
Date submitted
10/07/2009
Date registered
13/07/2009
Date last updated
4/09/2014

Titles & IDs
Public title
Study of Adalimumab in Patients With Axial Spondyloarthritis
Scientific title
A Multicenter Study of the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Axial Spondyloarthritis
Secondary ID [1] 0 0
2009-010643-14
Secondary ID [2] 0 0
M10-791
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Axial Spondyloarthritis 0 0
Axial Spondyloarthritis 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Adalimumab
Other interventions - Placebo
Other interventions - Open-label Adalimumab
Other interventions - Adalimumab
Other interventions - Placebo
Other interventions - Open-label Adalimumab

Experimental: Adalimumab -

Placebo Comparator: Placebo -

Experimental: Open-label Adalimumab -

Experimental: Adalimumab -

Placebo Comparator: Placebo -

Experimental: Open-label Adalimumab -


Other interventions: Adalimumab
40 mg every other week up to Week 12

Other interventions: Placebo
Placebo every other week up to Week 12

Other interventions: Open-label Adalimumab
40 mg every other week, Week 12 through Week 156

Other interventions: Adalimumab
40 mg every other week up to Week 12

Other interventions: Placebo
Placebo every other week up to Week 12

Other interventions: Open-label Adalimumab
40 mg every other week, Week 12 through Week 156

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 40 Response - 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:
Patient's Global Assessment of disease activity, measured on a visual analog scale (VAS) from 0 (none) to 100 (severe);
Pain, measured by the total back pain VAS from 0 (no pain) to 100 (most severe);
Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on a VAS ranging from 0 (easy) to 100 (impossible);
Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) VAS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).
Timepoint [1] 0 0
Baseline and Week 12
Primary outcome [2] 0 0
Number of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 40 Response - 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:
Patient's Global Assessment of disease activity, measured on a visual analog scale (VAS) from 0 (none) to 100 (severe);
Pain, measured by the total back pain VAS from 0 (no pain) to 100 (most severe);
Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on a VAS ranging from 0 (easy) to 100 (impossible);
Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) VAS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).
Timepoint [2] 0 0
Baseline and Week 12
Secondary outcome [1] 0 0
Number of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 20 Response - 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:
Patient's Global Assessment of disease activity, measured on a visual analog scale (VAS) from 0 (none) to 100 (severe);
Pain, measured by the total back pain VAS from 0 (no pain) to 100 (most severe);
Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on a VAS ranging from 0 (easy) to 100 (impossible);
Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) VAS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).
Timepoint [1] 0 0
Baseline and Week 12
Secondary outcome [2] 0 0
Number 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 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.
Timepoint [2] 0 0
Baseline and Week 12
Secondary outcome [3] 0 0
Change From Baseline in Short Form-36 (SF-36) Physical Component Summary Score - 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.
Timepoint [3] 0 0
Baseline and Week 12
Secondary outcome [4] 0 0
Number of Participants Achieving ASAS Partial Remission - ASAS partial remission is an absolute score of < 20 units on a 0 to 100 scale for each of the four following domains:
Patient's Global Assessment of disease activity, measured on a visual analog scale (VAS) from 0 (none) to 100 (severe);
Pain, measured by the total back pain VAS from 0 (no pain) to 100 (most severe);
Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on a VAS ranging from 0 (easy) to 100 (impossible);
Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) VAS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Number of Participants Achieving an ASAS5/6 Response - ASAS5/6 response is a 20% improvement in five out of the following six domains:
Patient's Global Assessment of disease activity, measured on a visual analog scale (VAS) from 0 (none) to 100 (severe);
Pain, measured by the total back pain VAS from 0 (no pain) to 100 (most severe);
Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on a VAS ranging from 0 (easy) to 100 (impossible);
Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) VAS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none) to 10 (very severe/2 hours or more duration).
Spinal mobility, measured from the lateral lumbar flexion score of the Bath AS Metrology Index (BASMI) on a scale from 0 (best mobility) to 10 (worst mobility);
C-reactive protein level (lower levels indicate less inflammation).
Timepoint [5] 0 0
Baseline and Week 12
Secondary outcome [6] 0 0
Change From Baseline in Disability Index of Health Assessment Questionnaire Modified for the Spondyloarthropathies (HAQ-S) - 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.
Timepoint [6] 0 0
Baseline and Week 12
Secondary outcome [7] 0 0
Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) - 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.
Timepoint [7] 0 0
Baseline and Week 12
Secondary outcome [8] 0 0
Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Score for Sacroiliac Joints - 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.
Timepoint [8] 0 0
Baseline and Week 12
Secondary outcome [9] 0 0
Change From Baseline in SPARCC MRI Score for the Spine - 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.
Timepoint [9] 0 0
Baseline and Week 12
Secondary outcome [10] 0 0
Number of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 20 Response - 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:
Patient's Global Assessment of disease activity, measured on a visual analog scale (VAS) from 0 (none) to 100 (severe);
Pain, measured by the total back pain VAS from 0 (no pain) to 100 (most severe);
Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on a VAS ranging from 0 (easy) to 100 (impossible);
Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) VAS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).
Timepoint [10] 0 0
Baseline and Week 12
Secondary outcome [11] 0 0
Number 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 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.
Timepoint [11] 0 0
Baseline and Week 12
Secondary outcome [12] 0 0
Change From Baseline in Short Form-36 (SF-36) Physical Component Summary Score - 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.
Timepoint [12] 0 0
Baseline and Week 12
Secondary outcome [13] 0 0
Number of Participants Achieving ASAS Partial Remission - ASAS partial remission is an absolute score of < 20 units on a 0 to 100 scale for each of the four following domains:
Patient's Global Assessment of disease activity, measured on a visual analog scale (VAS) from 0 (none) to 100 (severe);
Pain, measured by the total back pain VAS from 0 (no pain) to 100 (most severe);
Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on a VAS ranging from 0 (easy) to 100 (impossible);
Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) VAS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).
Timepoint [13] 0 0
Week 12
Secondary outcome [14] 0 0
Number of Participants Achieving an ASAS5/6 Response - ASAS5/6 response is a 20% improvement in five out of the following six domains:
Patient's Global Assessment of disease activity, measured on a visual analog scale (VAS) from 0 (none) to 100 (severe);
Pain, measured by the total back pain VAS from 0 (no pain) to 100 (most severe);
Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on a VAS ranging from 0 (easy) to 100 (impossible);
Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) VAS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none) to 10 (very severe/2 hours or more duration).
Spinal mobility, measured from the lateral lumbar flexion score of the Bath AS Metrology Index (BASMI) on a scale from 0 (best mobility) to 10 (worst mobility);
C-reactive protein level (lower levels indicate less inflammation).
Timepoint [14] 0 0
Baseline and Week 12
Secondary outcome [15] 0 0
Change From Baseline in Disability Index of Health Assessment Questionnaire Modified for the Spondyloarthropathies (HAQ-S) - 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.
Timepoint [15] 0 0
Baseline and Week 12
Secondary outcome [16] 0 0
Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) - 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.
Timepoint [16] 0 0
Baseline and Week 12
Secondary outcome [17] 0 0
Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Score for Sacroiliac Joints - 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.
Timepoint [17] 0 0
Baseline and Week 12
Secondary outcome [18] 0 0
Change From Baseline in SPARCC MRI Score for the Spine - 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.
Timepoint [18] 0 0
Baseline and Week 12

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Site Reference ID/Investigator# 22342 - Brisbane
Recruitment hospital [2] 0 0
Site Reference ID/Investigator# 21223 - Kogarah
Recruitment hospital [3] 0 0
Site Reference ID/Investigator# 21222 - Maroochydore
Recruitment postcode(s) [1] 0 0
4102 - Brisbane
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
4558 - Maroochydore
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
United States of America
State/province [6] 0 0
Washington
Country [7] 0 0
Belgium
State/province [7] 0 0
Genk
Country [8] 0 0
Belgium
State/province [8] 0 0
Ghent
Country [9] 0 0
Belgium
State/province [9] 0 0
Gilly
Country [10] 0 0
Belgium
State/province [10] 0 0
Merksem
Country [11] 0 0
Canada
State/province [11] 0 0
Edmonton
Country [12] 0 0
Canada
State/province [12] 0 0
Sainte-Foy, Quebec
Country [13] 0 0
Canada
State/province [13] 0 0
St. John's
Country [14] 0 0
Canada
State/province [14] 0 0
Toronto
Country [15] 0 0
Czech Republic
State/province [15] 0 0
Brno
Country [16] 0 0
Czech Republic
State/province [16] 0 0
Pardubice
Country [17] 0 0
Czech Republic
State/province [17] 0 0
Prague 2
Country [18] 0 0
Czech Republic
State/province [18] 0 0
Uherske Hradiste
Country [19] 0 0
France
State/province [19] 0 0
Boulogne Billancourt
Country [20] 0 0
France
State/province [20] 0 0
Chambray-les-Tour
Country [21] 0 0
France
State/province [21] 0 0
Orleans
Country [22] 0 0
France
State/province [22] 0 0
Paris Cedex 14
Country [23] 0 0
Germany
State/province [23] 0 0
Berlin
Country [24] 0 0
Germany
State/province [24] 0 0
Erlangen
Country [25] 0 0
Germany
State/province [25] 0 0
Herne
Country [26] 0 0
Germany
State/province [26] 0 0
Munich
Country [27] 0 0
Netherlands
State/province [27] 0 0
Amsterdam
Country [28] 0 0
Netherlands
State/province [28] 0 0
Leiden
Country [29] 0 0
Spain
State/province [29] 0 0
A Coruna
Country [30] 0 0
Spain
State/province [30] 0 0
Barcelona
Country [31] 0 0
Spain
State/province [31] 0 0
Cordoba
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Newcastle upon Tyne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie (prior sponsor, Abbott)
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate how well adalimumab works in the short and long term in patients
with axial spondyloarthritis who are not diagnosed as having either ankylosing spondylitis or
psoriatic arthritis.
Trial website
https://clinicaltrials.gov/show/NCT00939003
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Aileen L Pangan, MD
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications