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This 12-month postmarketing observational study (PMOS) was a prospective, single-arm, multicenter, multi-country study, with follow-up visits at 3, 6, 9, and 12 months after the initial baseline visit. The study was conducted to determine the long-term effectiveness of treatment with adalimumab in routine clinical use in participants with Ankylosing Spondylitis (AS) and Psoriatic Arthritis (PsA) in Central and Eastern European Countries.
Additional study objectives were to evaluate AS and PsA with regard to extra-articular manifestations (EAMs), functional status, the use of concomitant nonsteroidal anti-inflammatory medication, and work productivity impairment. In addition, the Ankylosing Spondylitis Disease Activity Score (ASDAS), a new disease activity index in AS, was measured in parallel with the standard Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score to assess the effectiveness of adalimumab in treating axial symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ankylosing Spondylitis | Participants with a diagnosis of ankylosing spondylitis | ||
| Psoriatic Arthritis | Participants with a diagnosis of psoriatic arthritis |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a 50% or More Decrease in Bath Ankylosing Spondylitis Daily Activity Index (BASDAI) Score at 12 Months Relative to Baseline | The BASDAI score was calculated using a questionnaire with 6 questions that the participants completed by marking responses on a 10-centimeter visual analog scale ranging from 0 (none) to 10 (very severe) regarding severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. A positive response was defined as a 50% or more decrease in the BASDAI score at 12 months as compared to baseline. | Baseline (Visit 0) to 12 months |
| Percentage of Participants With a Disease Activity Score 28 (DAS28) Decrease ≥1.2 at 12 Months Relative to Baseline | The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. | Baseline (Visit 0) to 12 months |
| Percentage of Participants With Active Axial Symptoms in Remission | The Ankylosing Spondylitis Disease Score (ASDAS) tool is a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, duration of morning stiffness and peripheral pain/swelling assessed on a visual analogue scale (from 0 to 10 cm) or on a numerical rating scale (from 0 to 10). The laboratory parameter is a measurement of C-reactive protein (mg/L) or erythrocyte sedimentation rate (mm/h). Remission was defined as ASDAS <1.3 at 12 months. | Baseline (Visit 0) to 12 months |
| Percentage of Participants With Peripheral Symptoms in Remission | The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. Remission was defined as DAS28 ≤2.6 at 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (in Case of Axial Symptoms) and/or Disease Activity Score/28 Joints (DAS28) (in Case of Peripheral Symptoms) in Participants With Ankylosing Spondylitis | The BASDAI score was calculated using a questionnaire with 6 questions that the participants completed by marking responses on a 10-centimeter visual analog scale ranging from 0 (none) to 10 (very severe) regarding severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. A positive response was defined as a 50% or more decrease in the BASDAI score at 12 months as compared to baseline. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C- reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. |
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Inclusion Criteria:
Patients will be enrolled in this Postmarketing observational study PMOS if they fulfill all of the below criteria:
Exclusion Criteria:
Patients fulfilling below exclusion criteria will not be eligible for this Postmarketing study (PMOS):
1. Meet contraindications for treatment with adalimumab as outlined in the latest version of the local Summary of Product Characteristics (SmPC)
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This study is a post-marketing observational study (PMOS) where adalimumab is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication. Study population will consist of adult aged (>18 years) with Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA) that can be administered adalimumab as per locally approved Summary of Product Characteristics (SmPC) and reimbursement criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Isidro Villanueva Torrecillas, MD | AbbVie | Study Director |
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 566 participants were enrolled, and 11 participants were lost to follow-up after the baseline visit. According to the pre-specified analysis strategy in the statistical analysis plan, these participants were excluded from the full analysis set, which consisted of 555 participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ankylosing Spondylitis | Participants with a diagnosis of ankylosing spondylitis |
| FG001 | Psoriatic Arthritis | Participants with a diagnosis of psoriatic arthritis |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Baseline (Visit 0) to 12 months |
| Baseline (Visit 0) to 12 months |
| Mean Change in Ankylosing Spondylitis Disease Activity Score (ASDAS) | The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, and peripheral pain/swelling assessed on a visual analogue scale (from 0 (normal) to 10 (extreme pain or disability) cm) and duration of morning stiffness on a numerical rating scale (from 0 to 10, with 0 being none and 10 representing a duration of 2 hours or longer). The laboratory parameter is a measurement of C-reactive protein (mg/L) (CRP) or erythrocyte sedimentation rate (mm/h) (ESR). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and either CRP or ESR values) are combined to yield a score ranging from 0 to no defined upper limit. Remission is defined as ASDAS score <1.3. Clinically important improvement is defined as a change ≥ 1.1 units, and major improvement is defined as a change ≥ 2.0 units. | Baseline (Visit 0) to 12 months |
| Correlation Between Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Ankylosing Spondylitis | BASDAI score (ranging from 0 to 10) was calculated using a questionnaire. Participants marked responses on a 10 cm visual analog scale ranging from 0 (none) to 10 (very severe) regarding fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. A positive response was defined as a 50% or more decrease in the BASDAI score at 12 months as compared to baseline. ASDAS is a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, duration of morning stiffness and peripheral pain/swelling assessed on a visual analogue scale (from 0 to 10 cm) or on a numerical rating scale (from 0 to 10). The laboratory parameter is a measurement of C-reactive protein (mg/L) or erythrocyte sedimentation rate (mm/h). Spearman's rank correlation coefficient (CC) was calculated for BASDAI vs. ASDAS(subscript)CRP(subscript) and BASDAI vs. ASDAS(subscript)ESR(subscript ). | Baseline (Visit 0) to 12 months |
| Predictors of Maintained Treatment Response and Remission in Participants With Ankylosing Spondylitis | A mathematical technique called logistic regression was performed to identify factors that could be used to predict maintained treatment response and remission. The following baseline variables were used in the logistic regression analyses: age, gender, disease of interest, result of tuberculosis screening, time since diagnosis and extra-articular manifestations (symptoms and diseases that occur in parts of the body other than joints) at baseline. The BASDAI score at baseline was forced to serve as a predictor in each model. | Baseline (Visit 0) to 12 months |
| Mean Change in Health Assessment Questionnaire Disability Index (HAQ-DI) Score (in Case of Peripheral Symptoms) or Bath Ankylosing Spondylitis Functional Index (BASFI) Score (in Case of Axial Symptoms) in Participants With Ankylosing Spondylitis | HAQ-DI consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, with a higher score representing a high-dependency disability. The minimal clinically important difference defined for the HAQ-DI is ≥0.22. HAQ-DI remission, indicating normal physical function, is defined as HAQ-DI < 0.5. The BASFI is a set of 10 questions designed to determine the degree of functional limitation in those with AS. A visual analogue scale (with 0 being "easy" and 10 "impossible") is used. The BASFI score ranges from 0 to 10 and is derived as the mean of the single items. A higher score indicates a higher impairment of functioning. | Baseline (Visit 0) to 12 months |
| Mean Frequency of Extra-articular Manifestations (EAMs) | Extra-articular manifestations (EAMs) are symptoms and diseases that occur in parts of the body other than joints. The number of EAMs was determined at each study visit. These included the presence of enthesitis (inflammation of ligaments and/or tendons at the site of insertion into bones), uveitis (inflammation of the middle layer of the eye), psoriasis (a skin condition that causes itchy or sore patches of thick, red skin with silvery scales), and Inflammatory bowel disease (Crohn's disease or ulcerative colitis). | Baseline (Visit 0) to 12 months |
| Duration of Treatment With Adalimumab | The duration of treatment with adalimumab was calculated separately for participants who discontinued the medication during the study and for those who did not. | Baseline (Visit 0) to 12 months |
| Percentage of Participants Whose Co-medication With Nonsteroidal Anti-inflammatory Drugs (NSAIDs) Was Stopped During the Study | Participants were surveyed at each study visit for their use of NSAID medication. | Baseline (Visit 0) to 12 months |
| Mean Change in Individual Components of the Work Productivity and Activity Impairment Specific Health Problem Questionnaire in Participants With Ankylosing Spondylitis | Work Productivity and Activity Impairment (WPAI) Questionnaire is a quantitative assessment of the amount of absenteeism, presenteeism, total work productivity impairment, and total activity impairment attributable to a specific health problem (WPAI-SHP), expressed as a percentage. Participants were queried regarding their current employment status, hours missed from work because of problems associated with their AS, hours missed from work because of any other reason, number of hours worked, how much AS affected work productivity (0=AS had no effect,10= AS completely prevented me from working), and how much AS affected ability to do regular daily activities, other than work at a job (0= AS had no effect, 10= AS completely prevented me from doing my daily activities) in the past 7 days. | Baseline (Visit 0) to 12 months |
| Change in the Percentage of Ankylosing Spondylitis Participants Who Have Paid Work | Working status (Working full-time, working part-time, working at home, unemployed but seeking work, work disabled, retired, student) was documented at each study visit. | Baseline (Visit 0) to 12 months |
| Mean Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (in Case of Axial Symptoms) and/or Disease Activity Score/28 Joints (DAS28) (in Case of Peripheral Symptoms) in Participants With Psoriatic Arthritis | The BASDAI score was calculated using a questionnaire with 6 questions that the participants completed by marking responses on a 10-centimeter visual analog scale ranging from 0 (none) to 10 (very severe) regarding severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. A positive response was defined as a 50% or more decrease in the BASDAI score at 12 months as compared to baseline. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C- reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. | Baseline (Visit 0) to 12 months |
| Correlation Between Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Psoriatic Arthritis | BASDAI score (ranging from 0 to 10) was calculated using a questionnaire. Participants marked responses on a 10 cm visual analog scale ranging from 0 (none) to 10 (very severe) regarding fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. A positive response was defined as a 50% or more decrease in the BASDAI score at 12 months as compared to baseline. ASDAS score consists of a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, duration of morning stiffness and peripheral pain/swelling assessed on a visual analogue scale (from 0 to 10 cm) or on a numerical rating scale (from 0 to 10). The laboratory parameter is a measurement of C-reactive protein (mg/L) or erythrocyte sedimentation rate (mm/h). Spearman's rank correlation coefficient (CC) was calculated for BASDAI vs. ASDAS(subscript)CRP(subscript) and BASDAI vs. ASDAS(subscript)ESR(subscript). | Baseline (Visit 0) to 12 months |
| Predictors of Maintained Treatment Response and Remission in Participants With Psoriatic Arthritis | A mathematical technique called logistic regression was performed to identify factors that could be used to predict maintained treatment response and remission. The following baseline variables were used in the logistic regression analyses: age, gender, disease of interest, result of tuberculosis screening, time since diagnosis and extra-articular manifestations (symptoms and diseases that occur in parts of the body other than joints) at baseline. The BASDAI score at baseline was forced to serve as a predictor in each model. | Baseline (Visit 0) to 12 months |
| Mean Change in Health Assessment Questionnaire Disability Index ( HAQ-DI) Score (in Case of Peripheral Symptoms) or Bath Ankylosing Spondylitis Functional Index (BASFI) Score (in Case of Axial Symptoms) in Participants With Psoriatic Arthritis | HAQ-DI consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, with a higher score representing a high-dependency disability. The minimal clinically important difference defined for the HAQ-DI is ≥0.22. HAQ-DI remission, indicating normal physical function, is defined as HAQ-DI < 0.5. The BASFI is a set of 10 questions designed to determine the degree of functional limitation in those with AS. A visual analogue scale (with 0 being "easy" and 10 "impossible") is used. The BASFI score ranges from 0 to 10 and is derived as the mean of the single items. A higher score indicates a higher impairment of functioning. | Baseline (Visit 0) to 12 months |
| Mean Change in Individual Components of the Work Productivity and Activity Impairment Specific Health Problem Questionnaire in Participants With Psoriatic Arthritis | The Work Productivity and Activity Impairment (WPAI) Questionnaire is a quantitative assessment of the amount of absenteeism, presenteeism, total work productivity impairment, and total activity impairment attributable to a specific health problem (WPAI-SHP), expressed as a percentage. Participants were queried regarding their current employment status, hours missed from work because of problems associated with their PsA, hours missed from work because of any other reason, number of hours worked, how much PsA affected work productivity (0= PsA had no effect,10= PsA completely prevented me from working), and how much PsA affected ability to do regular daily activities, other than work at a job (0= PsA had no effect, 10= PsA completely prevented me from doing my daily activities) in the past 7 days. | Baseline (Visit 0) to 12 months |
| Change in the Percentage of Psoriatic Arthritis Participants Who Have Paid Work | Working status (Working full-time, working part-time, working at home, unemployed but seeking work, work disabled, retired, student) was documented at each study visit. | Baseline (Visit 0) to 12 months |
| FG002 | Disease State Unknown | For one participant, information regarding the underlying disease was not available |
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| NOT COMPLETED |
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Participants who received adalimumab treatment
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| ID | Title | Description |
|---|---|---|
| BG000 | Ankylosing Spondylitis | Participants with a diagnosis of ankylosing spondylitis |
| BG001 | Psoriatic Arthritis | Participants with a diagnosis of psoriatic arthritis |
| BG002 | Disease State Unknown | For one participant, information regarding the underlying disease was not available |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||
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| Primary | Percentage of Participants With a 50% or More Decrease in Bath Ankylosing Spondylitis Daily Activity Index (BASDAI) Score at 12 Months Relative to Baseline | The BASDAI score was calculated using a questionnaire with 6 questions that the participants completed by marking responses on a 10-centimeter visual analog scale ranging from 0 (none) to 10 (very severe) regarding severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. A positive response was defined as a 50% or more decrease in the BASDAI score at 12 months as compared to baseline. | Participants with active axial symptoms (a baseline value of the BASDAI > 4). | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline (Visit 0) to 12 months |
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| Primary | Percentage of Participants With a Disease Activity Score 28 (DAS28) Decrease ≥1.2 at 12 Months Relative to Baseline | The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. | Participants with peripheral symptoms (DAS28 > 5.1 at baseline) | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline (Visit 0) to 12 months |
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| Primary | Percentage of Participants With Active Axial Symptoms in Remission | The Ankylosing Spondylitis Disease Score (ASDAS) tool is a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, duration of morning stiffness and peripheral pain/swelling assessed on a visual analogue scale (from 0 to 10 cm) or on a numerical rating scale (from 0 to 10). The laboratory parameter is a measurement of C-reactive protein (mg/L) or erythrocyte sedimentation rate (mm/h). Remission was defined as ASDAS <1.3 at 12 months. | Participants with active axial symptoms (a baseline value of BASDAI > 4) | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline (Visit 0) to 12 months |
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| Secondary | Mean Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (in Case of Axial Symptoms) and/or Disease Activity Score/28 Joints (DAS28) (in Case of Peripheral Symptoms) in Participants With Ankylosing Spondylitis | The BASDAI score was calculated using a questionnaire with 6 questions that the participants completed by marking responses on a 10-centimeter visual analog scale ranging from 0 (none) to 10 (very severe) regarding severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. A positive response was defined as a 50% or more decrease in the BASDAI score at 12 months as compared to baseline. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C- reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. | Participants with ankylosing spondylitis with peripheral symptoms (DAS28 > 5.1 at baseline) and/or active axial symptoms (a baseline value of BASDAI > 4) | Posted | Mean | Standard Deviation | Units on a scale | Baseline (Visit 0) to 12 months |
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| Secondary | Mean Change in Ankylosing Spondylitis Disease Activity Score (ASDAS) | The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, and peripheral pain/swelling assessed on a visual analogue scale (from 0 (normal) to 10 (extreme pain or disability) cm) and duration of morning stiffness on a numerical rating scale (from 0 to 10, with 0 being none and 10 representing a duration of 2 hours or longer). The laboratory parameter is a measurement of C-reactive protein (mg/L) (CRP) or erythrocyte sedimentation rate (mm/h) (ESR). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and either CRP or ESR values) are combined to yield a score ranging from 0 to no defined upper limit. Remission is defined as ASDAS score <1.3. Clinically important improvement is defined as a change ≥ 1.1 units, and major improvement is defined as a change ≥ 2.0 units. | Participants with active axial symptoms (a baseline value of BASDAI > 4) | Posted | Mean | Standard Deviation | Units on a scale | Baseline (Visit 0) to 12 months |
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| Secondary | Correlation Between Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Ankylosing Spondylitis | BASDAI score (ranging from 0 to 10) was calculated using a questionnaire. Participants marked responses on a 10 cm visual analog scale ranging from 0 (none) to 10 (very severe) regarding fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. A positive response was defined as a 50% or more decrease in the BASDAI score at 12 months as compared to baseline. ASDAS is a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, duration of morning stiffness and peripheral pain/swelling assessed on a visual analogue scale (from 0 to 10 cm) or on a numerical rating scale (from 0 to 10). The laboratory parameter is a measurement of C-reactive protein (mg/L) or erythrocyte sedimentation rate (mm/h). Spearman's rank correlation coefficient (CC) was calculated for BASDAI vs. ASDAS(subscript)CRP(subscript) and BASDAI vs. ASDAS(subscript)ESR(subscript ). | Participants with ankylosing spondylitis and active axial symptoms (a baseline value of BASDAI > 4) | Posted | Number | Correlation coefficient | Baseline (Visit 0) to 12 months |
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| Secondary | Predictors of Maintained Treatment Response and Remission in Participants With Ankylosing Spondylitis | A mathematical technique called logistic regression was performed to identify factors that could be used to predict maintained treatment response and remission. The following baseline variables were used in the logistic regression analyses: age, gender, disease of interest, result of tuberculosis screening, time since diagnosis and extra-articular manifestations (symptoms and diseases that occur in parts of the body other than joints) at baseline. The BASDAI score at baseline was forced to serve as a predictor in each model. | Participants with ankylosing spondylitis and active axial symptoms (a baseline value of BASDAI > 4) | Posted | Number | 95% Confidence Interval | Odds Ratio | Baseline (Visit 0) to 12 months |
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| Secondary | Mean Change in Health Assessment Questionnaire Disability Index (HAQ-DI) Score (in Case of Peripheral Symptoms) or Bath Ankylosing Spondylitis Functional Index (BASFI) Score (in Case of Axial Symptoms) in Participants With Ankylosing Spondylitis | HAQ-DI consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, with a higher score representing a high-dependency disability. The minimal clinically important difference defined for the HAQ-DI is ≥0.22. HAQ-DI remission, indicating normal physical function, is defined as HAQ-DI < 0.5. The BASFI is a set of 10 questions designed to determine the degree of functional limitation in those with AS. A visual analogue scale (with 0 being "easy" and 10 "impossible") is used. The BASFI score ranges from 0 to 10 and is derived as the mean of the single items. A higher score indicates a higher impairment of functioning. | Participants with ankylosing spondylitis with peripheral symptoms (DAS28 > 5.1 at baseline) and/or active axial symptoms (a baseline value of BASDAI > 4) | Posted | Mean | Standard Deviation | Units on a scale | Baseline (Visit 0) to 12 months |
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| Secondary | Mean Frequency of Extra-articular Manifestations (EAMs) | Extra-articular manifestations (EAMs) are symptoms and diseases that occur in parts of the body other than joints. The number of EAMs was determined at each study visit. These included the presence of enthesitis (inflammation of ligaments and/or tendons at the site of insertion into bones), uveitis (inflammation of the middle layer of the eye), psoriasis (a skin condition that causes itchy or sore patches of thick, red skin with silvery scales), and Inflammatory bowel disease (Crohn's disease or ulcerative colitis). | Participants who received adalimumab treatment | Posted | Mean | Standard Deviation | Mean EAMs per participant | Baseline (Visit 0) to 12 months |
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| Secondary | Duration of Treatment With Adalimumab | The duration of treatment with adalimumab was calculated separately for participants who discontinued the medication during the study and for those who did not. | Participants who received adalimumab treatment | Posted | Mean | Standard Deviation | Months | Baseline (Visit 0) to 12 months |
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| Secondary | Percentage of Participants Whose Co-medication With Nonsteroidal Anti-inflammatory Drugs (NSAIDs) Was Stopped During the Study | Participants were surveyed at each study visit for their use of NSAID medication. | Participants who were receiving NSAID medication at baseline | Posted | Number | Percentage of participants | Baseline (Visit 0) to 12 months |
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| Secondary | Mean Change in Individual Components of the Work Productivity and Activity Impairment Specific Health Problem Questionnaire in Participants With Ankylosing Spondylitis | Work Productivity and Activity Impairment (WPAI) Questionnaire is a quantitative assessment of the amount of absenteeism, presenteeism, total work productivity impairment, and total activity impairment attributable to a specific health problem (WPAI-SHP), expressed as a percentage. Participants were queried regarding their current employment status, hours missed from work because of problems associated with their AS, hours missed from work because of any other reason, number of hours worked, how much AS affected work productivity (0=AS had no effect,10= AS completely prevented me from working), and how much AS affected ability to do regular daily activities, other than work at a job (0= AS had no effect, 10= AS completely prevented me from doing my daily activities) in the past 7 days. | For presenteeism, absenteeism, and total work productivity impairment endpoints: participants with ankylosing spondylitis who were employed at the time of the documentation. For the total activity impairment endpoint: participants with ankylosing spondylitis who received adalimumab treatment. | Posted | Mean | Standard Deviation | Percentage change | Baseline (Visit 0) to 12 months |
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| Secondary | Change in the Percentage of Ankylosing Spondylitis Participants Who Have Paid Work | Working status (Working full-time, working part-time, working at home, unemployed but seeking work, work disabled, retired, student) was documented at each study visit. | Participants with ankylosing spondylitis who received adalimumab treatment | Posted | Number | Percentage of participants | Baseline (Visit 0) to 12 months |
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| Secondary | Mean Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (in Case of Axial Symptoms) and/or Disease Activity Score/28 Joints (DAS28) (in Case of Peripheral Symptoms) in Participants With Psoriatic Arthritis | The BASDAI score was calculated using a questionnaire with 6 questions that the participants completed by marking responses on a 10-centimeter visual analog scale ranging from 0 (none) to 10 (very severe) regarding severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. A positive response was defined as a 50% or more decrease in the BASDAI score at 12 months as compared to baseline. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C- reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. | Participants with psoriatic arthritis with peripheral symptoms (DAS28 > 5.1 at baseline) and/or active axial symptoms (a baseline value of BASDAI > 4) | Posted | Mean | Standard Deviation | Units on a scale | Baseline (Visit 0) to 12 months |
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| Secondary | Correlation Between Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Psoriatic Arthritis | BASDAI score (ranging from 0 to 10) was calculated using a questionnaire. Participants marked responses on a 10 cm visual analog scale ranging from 0 (none) to 10 (very severe) regarding fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. A positive response was defined as a 50% or more decrease in the BASDAI score at 12 months as compared to baseline. ASDAS score consists of a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, duration of morning stiffness and peripheral pain/swelling assessed on a visual analogue scale (from 0 to 10 cm) or on a numerical rating scale (from 0 to 10). The laboratory parameter is a measurement of C-reactive protein (mg/L) or erythrocyte sedimentation rate (mm/h). Spearman's rank correlation coefficient (CC) was calculated for BASDAI vs. ASDAS(subscript)CRP(subscript) and BASDAI vs. ASDAS(subscript)ESR(subscript). | Participants with psoriatic arthritis and active axial symptoms (a baseline value of BASDAI > 4) | Posted | Number | Correlation coefficient | Baseline (Visit 0) to 12 months |
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| Secondary | Predictors of Maintained Treatment Response and Remission in Participants With Psoriatic Arthritis | A mathematical technique called logistic regression was performed to identify factors that could be used to predict maintained treatment response and remission. The following baseline variables were used in the logistic regression analyses: age, gender, disease of interest, result of tuberculosis screening, time since diagnosis and extra-articular manifestations (symptoms and diseases that occur in parts of the body other than joints) at baseline. The BASDAI score at baseline was forced to serve as a predictor in each model. | Participants with psoriatic arthritis and active axial symptoms (a baseline value of BASDAI > 4) | Posted | Number | 95% Confidence Interval | Odds Ratio | Baseline (Visit 0) to 12 months |
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| Secondary | Mean Change in Health Assessment Questionnaire Disability Index ( HAQ-DI) Score (in Case of Peripheral Symptoms) or Bath Ankylosing Spondylitis Functional Index (BASFI) Score (in Case of Axial Symptoms) in Participants With Psoriatic Arthritis | HAQ-DI consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, with a higher score representing a high-dependency disability. The minimal clinically important difference defined for the HAQ-DI is ≥0.22. HAQ-DI remission, indicating normal physical function, is defined as HAQ-DI < 0.5. The BASFI is a set of 10 questions designed to determine the degree of functional limitation in those with AS. A visual analogue scale (with 0 being "easy" and 10 "impossible") is used. The BASFI score ranges from 0 to 10 and is derived as the mean of the single items. A higher score indicates a higher impairment of functioning. | Participants with psoriatic arthritis with peripheral symptoms (DAS28 > 5.1 at baseline) and/or active axial symptoms (a baseline value of BASDAI > 4) | Posted | Mean | Standard Deviation | Units on a scale | Baseline (Visit 0) to 12 months |
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| Secondary | Mean Change in Individual Components of the Work Productivity and Activity Impairment Specific Health Problem Questionnaire in Participants With Psoriatic Arthritis | The Work Productivity and Activity Impairment (WPAI) Questionnaire is a quantitative assessment of the amount of absenteeism, presenteeism, total work productivity impairment, and total activity impairment attributable to a specific health problem (WPAI-SHP), expressed as a percentage. Participants were queried regarding their current employment status, hours missed from work because of problems associated with their PsA, hours missed from work because of any other reason, number of hours worked, how much PsA affected work productivity (0= PsA had no effect,10= PsA completely prevented me from working), and how much PsA affected ability to do regular daily activities, other than work at a job (0= PsA had no effect, 10= PsA completely prevented me from doing my daily activities) in the past 7 days. | For presenteeism, absenteeism, and total work productivity impairment endpoints: participants with psoriatic arthritis who were employed at the time of the documentation. For the total activity impairment endpoint: participants with psoriatic arthritis who received adalimumab treatment. | Posted | Mean | Standard Deviation | Percentage change | Baseline (Visit 0) to 12 months |
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| Primary | Percentage of Participants With Peripheral Symptoms in Remission | The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. Remission was defined as DAS28 ≤2.6 at 12 months. | Participants with peripheral symptoms (DAS28 > 5.1 at baseline) | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline (Visit 0) to 12 months |
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| Secondary | Change in the Percentage of Psoriatic Arthritis Participants Who Have Paid Work | Working status (Working full-time, working part-time, working at home, unemployed but seeking work, work disabled, retired, student) was documented at each study visit. | Participants with psoriatic arthritis who received adalimumab treatment | Posted | Number | Percentage of participants | Baseline (Visit 0) to 12 months |
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Serious adverse events were collected from the time of adalimumab administration until the completion of the study, up to 52 weeks.
In case of premature discontinuation, participants were followed for 70 days (5 half-lives) following the intake of the last dose of adalimumab.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Overall Study Population | Participants who received adalimumab treatment | 26 | 555 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoacusis | Ear and labyrinth disorders | MedDRA 17.0 | Systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | MedDRA 17.0 | Systematic Assessment |
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| Cataract | Eye disorders | MedDRA 17.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Hyperchlorhydria | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Oral mucosal blistering | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Feeling abnormal | General disorders | MedDRA 17.0 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 17.0 | Systematic Assessment |
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| Injection site induration | General disorders | MedDRA 17.0 | Systematic Assessment |
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| Injection site rash | General disorders | MedDRA 17.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 17.0 | Systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA 17.0 | Systematic Assessment |
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| Erysipelas | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Lymphadenitis bacterial | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 17.0 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 17.0 | Systematic Assessment |
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| C-reactive protein increased | Investigations | MedDRA 17.0 | Systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA 17.0 | Systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA 17.0 | Systematic Assessment |
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| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| Morphoea | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| Chronic lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
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| Carpal tunnel syndrome | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| Guillain-Barre syndrome | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| Skin hypopigmentation | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| Carpal tunnel decompression | Surgical and medical procedures | MedDRA 17.0 | Systematic Assessment |
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| Cataract operation | Surgical and medical procedures | MedDRA 17.0 | Systematic Assessment |
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| Hip surgery | Surgical and medical procedures | MedDRA 17.0 | Systematic Assessment |
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| Lymphadenectomy | Surgical and medical procedures | MedDRA 17.0 | Systematic Assessment |
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| Phlebectomy | Surgical and medical procedures | MedDRA 17.0 | Systematic Assessment |
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| Spinal laminectomy | Surgical and medical procedures | MedDRA 17.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
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| Thrombophlebitis superficial | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
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Not provided
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Information | AbbVie | 800-633-9110 |
| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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