Ankylosing Spondylitis
Conditions
Keywords
ankylosing spondylitis, China
Brief summary
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)
Detailed description
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).
Interventions
BIOLOGICALadalimumab
Prefilled syringe, 40 mg/0.8 mL administered subcutaneously every other week
OTHERplacebo
Prefilled syringe, matching placebo administered subcutaneously every other week
Sponsors
Abbott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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: * BASDAI score at least 4 cm * Total back pain on a visual analog scale (VAS) at least 40 mm * Morning stiffness at least 1 hr * Has inadequate response to or intolerance to one or more non-steroidal anti-inflammatory drugs (NSAIDs) as defined by the Investigator
Exclusion criteria
* Has total spinal ankylosis (bamboo spine) * Has undergone spinal surgery or joint surgery involving joints assessed within 2 months prior to Baseline * Has extra-articular manifestations (i.e., psoriasis, uveitis, inflammatory bowel disease) that is not clinically stable, as defined by the Investigator's best clinical judgment, for at least 28 days prior to Baseline * Has received intra-articular joint injection(s), spinal or paraspinal injection(s) with corticosteroids within 28 days prior to Baseline * Has prior exposure to any biologic therapy with potential therapeutic impact on AS, including anti-TNF (tumor necrosis factor) therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Meeting the Assessment of Spondyloarthritis International Society (ASAS) ASAS20 Response Criteria | Week 12 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Meeting the ASAS40 Response Criteria | Week 12 | 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). |
| Number of Participants Meeting the ASAS5/6 Response Criteria | Week 12 | 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). |
| Number of Participants With ASAS Partial Remission | Week 12 | 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). |
| Change From Baseline in Patient Global Assessment of Disease Activity | Baseline and Week 12 | 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). |
| Change From Baseline in Total Back Pain Score | Baseline and Week 12 | 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). |
| Number of Participants Meeting the ASAS20 Response Criteria | Week 24 | 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). |
| Change From Baseline in Inflammation Score | Baseline and Week 12 | 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. |
| Number of Participants Meeting the Bath Ankylosing Spondyloarthritis Disease Activity Index (BASDAI) BASDAI50 Response Criteria | Week 12 | 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). |
| Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP) | Baseline and Week 12 | 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. |
| Change From Baseline in 36-item Short Form Questionnaire Version 2 (SF-36v2) Physical Component Summary Score | Baseline and Week 12 | 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. |
| Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score | Baseline and Week 12 | 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. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Adalimumab Blinded adalimumab from Week 0 to Week 10, open-label adalimumab from Week 12 to Week 22 | 229 |
| Placebo Blinded placebo from Week 0 to Week 10, open-label adalimumab from Week 12 to Week 22 | 115 |
| Total | 344 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 (Week 0 to Week 12) | Adverse Event | 4 | 0 |
| Period 1 (Week 0 to Week 12) | Lost to Follow-up | 0 | 1 |
| Period 1 (Week 0 to Week 12) | Poor subject compliance | 0 | 1 |
| Period 1 (Week 0 to Week 12) | Withdrawal by Subject | 1 | 0 |
| Period 2 (Week 12 to Week 24) | Adverse Event | 3 | 0 |
| Period 2 (Week 12 to Week 24) | Lost to Follow-up | 0 | 2 |
Baseline characteristics
| Characteristic | Adalimumab | Placebo | Total |
|---|---|---|---|
| Age Continuous | 30.1 years STANDARD_DEVIATION 8.73 | 29.6 years STANDARD_DEVIATION 7.49 | 29.9 years STANDARD_DEVIATION 8.33 |
| Region of Enrollment China | 229 participants | 115 participants | 344 participants |
| Sex: Female, Male Female | 44 Participants | 20 Participants | 64 Participants |
| Sex: Female, Male Male | 185 Participants | 95 Participants | 280 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 55 / 229 | 16 / 115 | 32 / 224 | 22 / 113 |
| serious Total, serious adverse events | 1 / 229 | 1 / 115 | 3 / 224 | 1 / 113 |
Outcome results
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).
Time frame: Week 12
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab/Adalimumab | Number of Participants Meeting the Assessment of Spondyloarthritis International Society (ASAS) ASAS20 Response Criteria | 154 participants |
| Placebo/Adalimumab | Number of Participants Meeting the Assessment of Spondyloarthritis International Society (ASAS) ASAS20 Response Criteria | 35 participants |
p-value: <0.001Chi-squared
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.
Time frame: Baseline and Week 12
Population: ITT analysis set, observed cases
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adalimumab/Adalimumab | Change From Baseline in 36-item Short Form Questionnaire Version 2 (SF-36v2) Physical Component Summary Score | 6.6 units on a scale | Standard Deviation 6.43 |
| Placebo/Adalimumab | Change From Baseline in 36-item Short Form Questionnaire Version 2 (SF-36v2) Physical Component Summary Score | 4.0 units on a scale | Standard Deviation 6.31 |
p-value: <0.001ANCOVA
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.
Time frame: Baseline and Week 24
Population: ITT analysis set, observed cases
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adalimumab/Adalimumab | Change From Baseline in 36-item Short Form Questionnaire Version 2 (SF-36v2) Physical Component Summary Score | 8.6 units on a scale | Standard Deviation 7.44 |
| Placebo/Adalimumab | Change From Baseline in 36-item Short Form Questionnaire Version 2 (SF-36v2) Physical Component Summary Score | 9.2 units on a scale | Standard Deviation 7.25 |
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.
Time frame: Baseline and Week 12
Population: ITT analysis set, LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adalimumab/Adalimumab | Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score | -17.5 units on a scale | Standard Deviation 20.18 |
| Placebo/Adalimumab | Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score | -4.7 units on a scale | Standard Deviation 16.4 |
p-value: <0.001ANCOVA
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.
Time frame: Baseline and Week 24
Population: ITT analysis set, LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adalimumab/Adalimumab | Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score | -23.2 units on a scale | Standard Deviation 21.03 |
| Placebo/Adalimumab | Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score | -20.9 units on a scale | Standard Deviation 21.51 |
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.
Time frame: Baseline and Week 12
Population: ITT analysis set, LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adalimumab/Adalimumab | Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP) | -17.8 milligrams/liter | Standard Deviation 23.76 |
| Placebo/Adalimumab | Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP) | -4.2 milligrams/liter | Standard Deviation 21.23 |
p-value: <0.001ANCOVA
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.
Time frame: Baseline and Week 24
Population: ITT analysis set, LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adalimumab/Adalimumab | Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP) | -18.2 milligrams/liter | Standard Deviation 24.27 |
| Placebo/Adalimumab | Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP) | -20.1 milligrams/liter | Standard Deviation 30.63 |
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.
Time frame: Baseline and Week 24
Population: ITT analysis set, LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adalimumab/Adalimumab | Change From Baseline in Inflammation Score | -3.6 centimeters | Standard Deviation 2.21 |
| Placebo/Adalimumab | Change From Baseline in Inflammation Score | -3.6 centimeters | Standard Deviation 2.24 |
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.
Time frame: Baseline and Week 12
Population: ITT analysis set, LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adalimumab/Adalimumab | Change From Baseline in Inflammation Score | -2.9 centimeters | Standard Deviation 2.01 |
| Placebo/Adalimumab | Change From Baseline in Inflammation Score | -1.5 centimeters | Standard Deviation 2.16 |
p-value: <0.001ANCOVA
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).
Time frame: Baseline and Week 24
Population: ITT analysis set, missing data imputed by last observation carried forward (LOCF)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adalimumab/Adalimumab | Change From Baseline in Patient Global Assessment of Disease Activity | -37.8 millimeters | Standard Deviation 24.47 |
| Placebo/Adalimumab | Change From Baseline in Patient Global Assessment of Disease Activity | -35.5 millimeters | Standard Deviation 25.03 |
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).
Time frame: Baseline and Week 12
Population: ITT analysis set, missing data imputed by last observation carried forward (LOCF)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adalimumab/Adalimumab | Change From Baseline in Patient Global Assessment of Disease Activity | -28.8 millimeters | Standard Deviation 24.16 |
| Placebo/Adalimumab | Change From Baseline in Patient Global Assessment of Disease Activity | -11.7 millimeters | Standard Deviation 21.77 |
p-value: <0.001ANCOVA
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).
Time frame: Baseline and Week 24
Population: ITT analysis set, LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adalimumab/Adalimumab | Change From Baseline in Total Back Pain Score | -42.1 millimeters | Standard Deviation 23.29 |
| Placebo/Adalimumab | Change From Baseline in Total Back Pain Score | -37.8 millimeters | Standard Deviation 24.2 |
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).
Time frame: Baseline and Week 12
Population: ITT analysis set, LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adalimumab/Adalimumab | Change From Baseline in Total Back Pain Score | -32.0 millimeters | Standard Deviation 23.55 |
| Placebo/Adalimumab | Change From Baseline in Total Back Pain Score | -13.7 millimeters | Standard Deviation 22.88 |
p-value: <0.001Chi-squared, Corrected
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).
Time frame: Week 24
Population: ITT analysis set, missing data imputed by NRI
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab/Adalimumab | Number of Participants Meeting the ASAS20 Response Criteria | 180 participants |
| Placebo/Adalimumab | Number of Participants Meeting the ASAS20 Response Criteria | 85 participants |
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).
Time frame: Week 24
Population: ITT analysis set, missing data imputed by NRI
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab/Adalimumab | Number of Participants Meeting the ASAS40 Response Criteria | 134 participants |
| Placebo/Adalimumab | Number of Participants Meeting the ASAS40 Response Criteria | 63 participants |
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).
Time frame: Week 12
Population: ITT analysis set, missing data imputed by NRI
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab/Adalimumab | Number of Participants Meeting the ASAS40 Response Criteria | 102 participants |
| Placebo/Adalimumab | Number of Participants Meeting the ASAS40 Response Criteria | 11 participants |
p-value: <0.001Chi-squared
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).
Time frame: Week 12
Population: ITT analysis set, missing data imputed by NRI
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab/Adalimumab | Number of Participants Meeting the ASAS5/6 Response Criteria | 128 participants |
| Placebo/Adalimumab | Number of Participants Meeting the ASAS5/6 Response Criteria | 14 participants |
p-value: <0.001Chi-squared
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).
Time frame: Week 24
Population: ITT analysis set, missing data imputed by NRI
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab/Adalimumab | Number of Participants Meeting the ASAS5/6 Response Criteria | 150 participants |
| Placebo/Adalimumab | Number of Participants Meeting the ASAS5/6 Response Criteria | 69 participants |
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).
Time frame: Week 12
Population: ITT analysis set, missing data imputed by NRI
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab/Adalimumab | Number of Participants Meeting the Bath Ankylosing Spondyloarthritis Disease Activity Index (BASDAI) BASDAI50 Response Criteria | 114 participants |
| Placebo/Adalimumab | Number of Participants Meeting the Bath Ankylosing Spondyloarthritis Disease Activity Index (BASDAI) BASDAI50 Response Criteria | 19 participants |
p-value: <0.001Chi-squared
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).
Time frame: Week 24
Population: ITT analysis set, missing data imputed by NRI
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab/Adalimumab | Number of Participants Meeting the Bath Ankylosing Spondyloarthritis Disease Activity Index (BASDAI) BASDAI50 Response Criteria | 156 participants |
| Placebo/Adalimumab | Number of Participants Meeting the Bath Ankylosing Spondyloarthritis Disease Activity Index (BASDAI) BASDAI50 Response Criteria | 71 participants |
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).
Time frame: Week 24
Population: ITT analysis set, missing data imputed by NRI
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab/Adalimumab | Number of Participants With ASAS Partial Remission | 85 participants |
| Placebo/Adalimumab | Number of Participants With ASAS Partial Remission | 33 participants |
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).
Time frame: Week 12
Population: ITT analysis set, missing data imputed by NRI
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab/Adalimumab | Number of Participants With ASAS Partial Remission | 50 participants |
| Placebo/Adalimumab | Number of Participants With ASAS Partial Remission | 4 participants |
p-value: <0.001Chi-squared