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Study of the efficacy and safety of adalimumab compared with placebo in adult Chinese participants with ankylosing spondylitis (AS) who have had an inadequate response to or who are intolerant to one or more nonsteroidal anti-inflammatory drugs (NSAIDs)
Adults with active ankylosing spondylitis (AS) were randomized in a 2:1 ratio to receive treatment with adalimumab 40 mg every other week (eow) or matching placebo, given subcutaneously (SC), in the 12-week double-blind (DB) phase. Randomized participants received one SC injection of the appropriate DB study medication (adalimumab 40 mg or matching placebo) at Week 0 and then eow until Week 10. Participants who completed the DB phase could enter the 12-week open-label (OL) phase, during which all participants received treatment with adalimumab 40 mg eow, starting at Weeks 12 through 22. No study drug was administered or injected at the final study visit (Week 24). A follow-up visit occurred 70 days after the last dose of study drug (in DB or OL phases) to obtain information on any ongoing or new adverse events (AEs).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Blinded placebo from Week 0 to Week 10, open-label adalimumab from Week 12 to Week 24. |
|
| Adalimumab | Experimental | Blinded adalimumab from Week 0 to Week 10, open-label adalimumab from Week 12 to Week 24. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adalimumab | Biological | Prefilled syringe, 40 mg/0.8 mL administered subcutaneously every other week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Meeting the Assessment of Spondyloarthritis International Society (ASAS) ASAS20 Response Criteria | ASAS20 responder had improvement of 20% or more and absolute improvement of at least 10 units (on a scale of 0 [least] to 100 [worst]) from Baseline in at least 3 of the following 4 domains, with absence of deterioration (change for worse of at least 20% and net worsening of at least 10 units) in the potential remaining domain: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Bath Ankylosing Spondylitis Functional Index (BASFI); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores). | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Meeting the ASAS20 Response Criteria | ASAS20 responder had improvement of 20% or more and absolute improvement of at least 10 units (on a scale of 0 [least] to 100 [worst]) from Baseline in at least 3 of the following 4 domains, with absence of deterioration (change for worse of at least 20% and net worsening of at least 10 units) in the potential remaining domain: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Bath Ankylosing Spondylitis Functional Index (BASFI); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores). |
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Inclusion Criteria:
Age 18 through 65 years
Has a diagnosis of ankylosing spondylitis (AS) based on the Modified New York Criteria
Has active AS, as defined by fulfillment of at least 2 of the following 3 conditions at both Screening and Baseline visits:
Has inadequate response to or intolerance to one or more non-steroidal anti-inflammatory drugs (NSAIDs) as defined by the Investigator
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aileen Pangan | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 24054 | Hefei | AN | 230022 | China | ||
| Site Reference ID/Investigator# 25522 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Adalimumab | Blinded adalimumab from Week 0 to Week 10, open-label adalimumab from Week 12 to Week 22 |
| FG001 | Placebo | Blinded placebo from Week 0 to Week 10, open-label adalimumab from Week 12 to Week 22 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (Week 0 to Week 12) |
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| |||||||||||||||||||||
| Period 2 (Week 12 to Week 24) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Adalimumab | Blinded adalimumab from Week 0 to Week 10, open-label adalimumab from Week 12 to Week 22 |
| BG001 | Placebo | Blinded placebo from Week 0 to Week 10, open-label adalimumab from Week 12 to Week 22 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Meeting the Assessment of Spondyloarthritis International Society (ASAS) ASAS20 Response Criteria | ASAS20 responder had improvement of 20% or more and absolute improvement of at least 10 units (on a scale of 0 [least] to 100 [worst]) from Baseline in at least 3 of the following 4 domains, with absence of deterioration (change for worse of at least 20% and net worsening of at least 10 units) in the potential remaining domain: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Bath Ankylosing Spondylitis Functional Index (BASFI); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores). | Analysis was performed on the Intent-to-Treat (ITT) analysis set, which included all subjects who were randomized and received at least 1 dose of double-blind study drug. A non-responder (NRI) imputation was used in which a missing response was imputed as non-response. | Posted | Number | participants | Week 12 |
|
All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adalimumab (Period 1) | Blinded adalimumab from Week 0 to Week 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hepatitis viral | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | Abbott | 1-800-633-9110 |
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| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
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| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| placebo | Other | Prefilled syringe, matching placebo administered subcutaneously every other week |
|
| Week 24 |
| Number of Participants Meeting the ASAS40 Response Criteria | An ASAS40 responder had improvement of 40% or more and absolute improvement of 20 units or more (on a scale of 0 [least] to 100 [worst]) from Baseline in at least 3 of the 4 domains identified above for the ASAS20. In addition, there must have been an absence of deterioration in the potential remaining domain, where deterioration was defined as a net worsening of greater than 0 units (on a scale of 0 to 100). | Week 12 |
| Number of Participants Meeting the ASAS40 Response Criteria | An ASAS40 responder had improvement of 40% or more and absolute improvement of 20 units or more (on a scale of 0 [least] to 100 [worst]) from Baseline in at least 3 of the 4 domains identified above for the ASAS20. In addition, there must have been an absence of deterioration in the potential remaining domain, where deterioration was defined as a net worsening of greater than 0 units (on a scale of 0 to 100). | Week 24 |
| Number of Participants Meeting the ASAS5/6 Response Criteria | An ASAS5/6 responder had an improvement from Baseline of 20% or more in 5 of the following 6 domains: Patient's Global Assessment of Disease Activity; pain as measured by the Total Back Pain visual analog scale (VAS); function as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI); inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores); spinal mobility (lateral lumbar flexion from Bath Ankylosing Spondylitis Metrology Index [BASMI]); and acute phase reactant (high-sensitivity C-reactive protein). | Week 12 |
| Number of Participants Meeting the ASAS5/6 Response Criteria | An ASAS5/6 responder had an improvement from Baseline of 20% or more in 5 of the following 6 domains: Patient's Global Assessment of Disease Activity; pain as measured by the Total Back Pain visual analog scale (VAS); function as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI); inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores); spinal mobility (lateral lumbar flexion from Bath Ankylosing Spondylitis Metrology Index [BASMI]); and acute phase reactant (high-sensitivity C-reactive protein). | Week 24 |
| Number of Participants With ASAS Partial Remission | Participants were classified as having achieved ASAS partial remission if they had a value of less than 20 on a scale from 0 (normal/none) to 100 (most severe) in each of 4 domains: Patient's Global Assessment of Disease Activity; pain as measured by the Total Back Pain visual analog scale (VAS); function as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI); and inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores). | Week 12 |
| Number of Participants With ASAS Partial Remission | Participants were classified as having achieved ASAS partial remission if they had a value of less than 20 on a scale from 0 (normal/none) to 100 (most severe) in each of 4 domains: Patient's Global Assessment of Disease Activity; pain as measured by the Total Back Pain visual analog scale (VAS); function as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI); and inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores). | Week 24 |
| Change From Baseline in Patient Global Assessment of Disease Activity | Participants assessed their disease activity during the preceding week using a 100 millimeter (mm) visual analog scale, with responses ranging from no activity (0) to severe activity (100). | Baseline and Week 12 |
| Change From Baseline in Patient Global Assessment of Disease Activity | Participants assessed their disease activity during the preceding week using a 100 millimeter (mm) visual analog scale, with responses ranging from no activity (0) to severe activity (100). | Baseline and Week 24 |
| Change From Baseline in Total Back Pain Score | Participants assessed their total back pain within the preceding week using a total back pain 100 mm visual analog scale, with responses ranging from no pain (0) to most severe pain (100). | Baseline and Week 12 |
| Change From Baseline in Total Back Pain Score | Participants assessed their total back pain within the preceding week using a total back pain 100 mm visual analog scale, with responses ranging from no pain (0) to most severe pain (100). | Baseline and Week 24 |
| Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score | Participants assessed their ability to perform 10 selected activities (e.g., putting on socks or tights without help or aids, bending forward from the waist to pick up a pen from the floor without an aid) during the preceding week. Responses ranged from 0 (easy) to 100 (impossible). The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 100. | Baseline and Week 12 |
| Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score | Participants assessed their ability to perform 10 selected activities (e.g., putting on socks or tights without help or aids, bending forward from the waist to pick up a pen from the floor without an aid) during the preceding week. Responses ranged from 0 (easy) to 100 (impossible). The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 100. | Baseline and Week 24 |
| Change From Baseline in Inflammation Score | The Inflammation score is the mean of the 10-cm visual analog scale scores from the 2 morning stiffness-related BASDAI questions: "How would you describe the overall level of morning stiffness you have had from the time you wake up?", with response ranging from none to very severe; and "How long does your morning stiffness last from the time you wake up?", with response ranging from 0 hours to 2 or more hours. | Baseline and Week 12 |
| Change From Baseline in Inflammation Score | The Inflammation score is the mean of the 10-cm visual analog scale scores from the 2 morning stiffness-related BASDAI questions: "How would you describe the overall level of morning stiffness you have had from the time you wake up?", with response ranging from none to very severe; and "How long does your morning stiffness last from the time you wake up?", with response ranging from 0 hours to 2 or more hours. | Baseline and Week 24 |
| Number of Participants Meeting the Bath Ankylosing Spondyloarthritis Disease Activity Index (BASDAI) BASDAI50 Response Criteria | A BASDAI50 responder had at least a 50% improvement from Baseline in BASDAI score. In the BASDAI, participants use a 10-centimeter visual analog scale to answer 6 questions pertaining to symptoms experienced in the preceding week (e.g., How would you describe the overall level of fatigue/tiredness you have experienced? How long does your morning stiffness last from the time you wake up?) Responses range from "none" to "very severe" or from 0 hours to 2 or more hours for morning stiffness. The score is calculated as 0.2 (Q1 + Q2 + Q3 + Q4 + Q5/2 + Q6/2). | Week 12 |
| Number of Participants Meeting the Bath Ankylosing Spondyloarthritis Disease Activity Index (BASDAI) BASDAI50 Response Criteria | A BASDAI50 responder had at least a 50% improvement from Baseline in BASDAI score. In the BASDAI, participants use a 10-centimeter visual analog scale to answer 6 questions pertaining to symptoms experienced in the preceding week (e.g., How would you describe the overall level of fatigue/tiredness you have experienced? How long does your morning stiffness last from the time you wake up?) Responses range from "none" to "very severe" or from 0 hours to 2 or more hours for morning stiffness. The score is calculated as 0.2 (Q1 + Q2 + Q3 + Q4 + Q5/2 + Q6/2). | Week 24 |
| Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP) | Elevation of hs-CRP is a nonspecific marker of inflammation. Values above 5 milligrams/liter (mg/L) were considered abnormally high. Decrease in level of hs-CRP indicates reduction in inflammation. | Baseline and Week 12 |
| Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP) | Elevation of hs-CRP is a nonspecific marker of inflammation. Values above 5 milligrams/liter (mg/L) were considered abnormally high. Decrease in level of hs-CRP indicates reduction in inflammation. | Baseline and Week 24 |
| Change From Baseline in 36-item Short Form Questionnaire Version 2 (SF-36v2) Physical Component Summary Score | The SF-36 questionnaire, version 2, consists of 36 general health questions with 2 components, physical and mental. For each component, a transformed summary score is calculated using 8 sub-domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100. Higher scores indicate a better health state. | Baseline and Week 12 |
| Change From Baseline in 36-item Short Form Questionnaire Version 2 (SF-36v2) Physical Component Summary Score | The SF-36 questionnaire, version 2, consists of 36 general health questions with 2 components, physical and mental. For each component, a transformed summary score is calculated using 8 sub-domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100. Higher scores indicate a better health state. | Baseline and Week 24 |
| Beijing |
| 100029 |
| China |
| Site Reference ID/Investigator# 24055 | Beijing | 100032 | China |
| Site Reference ID/Investigator# 24052 | Beijing | 100853 | China |
| Site Reference ID/Investigator# 24056 | Guangzhou | 510630 | China |
| Site Reference ID/Investigator# 24243 | Hangzhou | 310009 | China |
| Site Reference ID/Investigator# 24053 | Shanghai | 200001 | China |
| Site Reference ID/Investigator# 24058 | Shanghai | 200003 | China |
| Site Reference ID/Investigator# 24057 | Xi'an | 710032 | China |
| Lost to Follow-up |
|
| Poor subject compliance |
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| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Adalimumab/Adalimumab |
Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22 |
| OG001 | Placebo/Adalimumab | Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22 |
|
|
|
| Secondary | Number of Participants Meeting the ASAS20 Response Criteria | ASAS20 responder had improvement of 20% or more and absolute improvement of at least 10 units (on a scale of 0 [least] to 100 [worst]) from Baseline in at least 3 of the following 4 domains, with absence of deterioration (change for worse of at least 20% and net worsening of at least 10 units) in the potential remaining domain: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Bath Ankylosing Spondylitis Functional Index (BASFI); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores). | ITT analysis set, missing data imputed by NRI | Posted | Number | participants | Week 24 |
|
|
|
| Secondary | Number of Participants Meeting the ASAS40 Response Criteria | An ASAS40 responder had improvement of 40% or more and absolute improvement of 20 units or more (on a scale of 0 [least] to 100 [worst]) from Baseline in at least 3 of the 4 domains identified above for the ASAS20. In addition, there must have been an absence of deterioration in the potential remaining domain, where deterioration was defined as a net worsening of greater than 0 units (on a scale of 0 to 100). | ITT analysis set, missing data imputed by NRI | Posted | Number | participants | Week 12 |
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|
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| Secondary | Number of Participants Meeting the ASAS40 Response Criteria | An ASAS40 responder had improvement of 40% or more and absolute improvement of 20 units or more (on a scale of 0 [least] to 100 [worst]) from Baseline in at least 3 of the 4 domains identified above for the ASAS20. In addition, there must have been an absence of deterioration in the potential remaining domain, where deterioration was defined as a net worsening of greater than 0 units (on a scale of 0 to 100). | ITT analysis set, missing data imputed by NRI | Posted | Number | participants | Week 24 |
|
|
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| Secondary | Number of Participants Meeting the ASAS5/6 Response Criteria | An ASAS5/6 responder had an improvement from Baseline of 20% or more in 5 of the following 6 domains: Patient's Global Assessment of Disease Activity; pain as measured by the Total Back Pain visual analog scale (VAS); function as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI); inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores); spinal mobility (lateral lumbar flexion from Bath Ankylosing Spondylitis Metrology Index [BASMI]); and acute phase reactant (high-sensitivity C-reactive protein). | ITT analysis set, missing data imputed by NRI | Posted | Number | participants | Week 12 |
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| Secondary | Number of Participants Meeting the ASAS5/6 Response Criteria | An ASAS5/6 responder had an improvement from Baseline of 20% or more in 5 of the following 6 domains: Patient's Global Assessment of Disease Activity; pain as measured by the Total Back Pain visual analog scale (VAS); function as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI); inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores); spinal mobility (lateral lumbar flexion from Bath Ankylosing Spondylitis Metrology Index [BASMI]); and acute phase reactant (high-sensitivity C-reactive protein). | ITT analysis set, missing data imputed by NRI | Posted | Number | participants | Week 24 |
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|
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| Secondary | Number of Participants With ASAS Partial Remission | Participants were classified as having achieved ASAS partial remission if they had a value of less than 20 on a scale from 0 (normal/none) to 100 (most severe) in each of 4 domains: Patient's Global Assessment of Disease Activity; pain as measured by the Total Back Pain visual analog scale (VAS); function as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI); and inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores). | ITT analysis set, missing data imputed by NRI | Posted | Number | participants | Week 12 |
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| Secondary | Number of Participants With ASAS Partial Remission | Participants were classified as having achieved ASAS partial remission if they had a value of less than 20 on a scale from 0 (normal/none) to 100 (most severe) in each of 4 domains: Patient's Global Assessment of Disease Activity; pain as measured by the Total Back Pain visual analog scale (VAS); function as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI); and inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores). | ITT analysis set, missing data imputed by NRI | Posted | Number | participants | Week 24 |
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| Secondary | Change From Baseline in Patient Global Assessment of Disease Activity | Participants assessed their disease activity during the preceding week using a 100 millimeter (mm) visual analog scale, with responses ranging from no activity (0) to severe activity (100). | ITT analysis set, missing data imputed by last observation carried forward (LOCF) | Posted | Mean | Standard Deviation | millimeters | Baseline and Week 12 |
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| Secondary | Change From Baseline in Patient Global Assessment of Disease Activity | Participants assessed their disease activity during the preceding week using a 100 millimeter (mm) visual analog scale, with responses ranging from no activity (0) to severe activity (100). | ITT analysis set, missing data imputed by last observation carried forward (LOCF) | Posted | Mean | Standard Deviation | millimeters | Baseline and Week 24 |
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| Secondary | Change From Baseline in Total Back Pain Score | Participants assessed their total back pain within the preceding week using a total back pain 100 mm visual analog scale, with responses ranging from no pain (0) to most severe pain (100). | ITT analysis set, LOCF | Posted | Mean | Standard Deviation | millimeters | Baseline and Week 12 |
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| Secondary | Change From Baseline in Total Back Pain Score | Participants assessed their total back pain within the preceding week using a total back pain 100 mm visual analog scale, with responses ranging from no pain (0) to most severe pain (100). | ITT analysis set, LOCF | Posted | Mean | Standard Deviation | millimeters | Baseline and Week 24 |
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| Secondary | Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score | Participants assessed their ability to perform 10 selected activities (e.g., putting on socks or tights without help or aids, bending forward from the waist to pick up a pen from the floor without an aid) during the preceding week. Responses ranged from 0 (easy) to 100 (impossible). The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 100. | ITT analysis set, LOCF | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 12 |
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| Secondary | Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score | Participants assessed their ability to perform 10 selected activities (e.g., putting on socks or tights without help or aids, bending forward from the waist to pick up a pen from the floor without an aid) during the preceding week. Responses ranged from 0 (easy) to 100 (impossible). The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 100. | ITT analysis set, LOCF | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 24 |
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| Secondary | Change From Baseline in Inflammation Score | The Inflammation score is the mean of the 10-cm visual analog scale scores from the 2 morning stiffness-related BASDAI questions: "How would you describe the overall level of morning stiffness you have had from the time you wake up?", with response ranging from none to very severe; and "How long does your morning stiffness last from the time you wake up?", with response ranging from 0 hours to 2 or more hours. | ITT analysis set, LOCF | Posted | Mean | Standard Deviation | centimeters | Baseline and Week 12 |
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| Secondary | Change From Baseline in Inflammation Score | The Inflammation score is the mean of the 10-cm visual analog scale scores from the 2 morning stiffness-related BASDAI questions: "How would you describe the overall level of morning stiffness you have had from the time you wake up?", with response ranging from none to very severe; and "How long does your morning stiffness last from the time you wake up?", with response ranging from 0 hours to 2 or more hours. | ITT analysis set, LOCF | Posted | Mean | Standard Deviation | centimeters | Baseline and Week 24 |
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| Secondary | Number of Participants Meeting the Bath Ankylosing Spondyloarthritis Disease Activity Index (BASDAI) BASDAI50 Response Criteria | A BASDAI50 responder had at least a 50% improvement from Baseline in BASDAI score. In the BASDAI, participants use a 10-centimeter visual analog scale to answer 6 questions pertaining to symptoms experienced in the preceding week (e.g., How would you describe the overall level of fatigue/tiredness you have experienced? How long does your morning stiffness last from the time you wake up?) Responses range from "none" to "very severe" or from 0 hours to 2 or more hours for morning stiffness. The score is calculated as 0.2 (Q1 + Q2 + Q3 + Q4 + Q5/2 + Q6/2). | ITT analysis set, missing data imputed by NRI | Posted | Number | participants | Week 12 |
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| Secondary | Number of Participants Meeting the Bath Ankylosing Spondyloarthritis Disease Activity Index (BASDAI) BASDAI50 Response Criteria | A BASDAI50 responder had at least a 50% improvement from Baseline in BASDAI score. In the BASDAI, participants use a 10-centimeter visual analog scale to answer 6 questions pertaining to symptoms experienced in the preceding week (e.g., How would you describe the overall level of fatigue/tiredness you have experienced? How long does your morning stiffness last from the time you wake up?) Responses range from "none" to "very severe" or from 0 hours to 2 or more hours for morning stiffness. The score is calculated as 0.2 (Q1 + Q2 + Q3 + Q4 + Q5/2 + Q6/2). | ITT analysis set, missing data imputed by NRI | Posted | Number | participants | Week 24 |
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| Secondary | Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP) | Elevation of hs-CRP is a nonspecific marker of inflammation. Values above 5 milligrams/liter (mg/L) were considered abnormally high. Decrease in level of hs-CRP indicates reduction in inflammation. | ITT analysis set, LOCF | Posted | Mean | Standard Deviation | milligrams/liter | Baseline and Week 12 |
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| Secondary | Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP) | Elevation of hs-CRP is a nonspecific marker of inflammation. Values above 5 milligrams/liter (mg/L) were considered abnormally high. Decrease in level of hs-CRP indicates reduction in inflammation. | ITT analysis set, LOCF | Posted | Mean | Standard Deviation | milligrams/liter | Baseline and Week 24 |
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| Secondary | Change From Baseline in 36-item Short Form Questionnaire Version 2 (SF-36v2) Physical Component Summary Score | The SF-36 questionnaire, version 2, consists of 36 general health questions with 2 components, physical and mental. For each component, a transformed summary score is calculated using 8 sub-domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100. Higher scores indicate a better health state. | ITT analysis set, observed cases | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 12 |
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| Secondary | Change From Baseline in 36-item Short Form Questionnaire Version 2 (SF-36v2) Physical Component Summary Score | The SF-36 questionnaire, version 2, consists of 36 general health questions with 2 components, physical and mental. For each component, a transformed summary score is calculated using 8 sub-domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100. Higher scores indicate a better health state. | ITT analysis set, observed cases | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 24 |
|
|
|
| 1 |
| 229 |
| 55 |
| 229 |
| EG001 | Placebo (Period 1) | Blinded placebo from Week 0 to Week 10 | 1 | 115 | 16 | 115 |
| EG002 | Adalimumab/Adalimumab (Period 2) | Open-label adalimumab from Week 12 to Week 22 in participants previously on blinded adalimumab from Week 0 to Week 10 | 3 | 224 | 32 | 224 |
| EG003 | Placebo/Adalimumab (Period 2) | Open-label adalimumab from Week 12 to Week 22 in participants previously on blinded placebo from Week 0 to Week 10 | 1 | 113 | 22 | 113 |
| Pelvic inflammatory disease | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Peritoneal tuberculosis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment | Note: One subject had 3 tuberculosis-related adverse events (peritoneal tuberculosis, pulmonary tuberculosis, and tuberculous pleurisy). |
|
| Pulmonary tuberculosis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Tuberculosis pleurisy | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment | Note: One subject had 3 injury-related adverse events (concussion, contusion, and skin laceration). |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
|
| Fibroadenoma of breast | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Non-systematic Assessment |
|
| Intraductal papilloma of breast | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Non-systematic Assessment |
|
| Abortion induced | Surgical and medical procedures | MedDRA 13.1 | Non-systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
Abbott 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. Abbott 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 Abbott needs to secure patent or proprietary protection.
| D013122 |
| Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |