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The purpose of this study was to evaluate physical activity and its changes in participants with rheumatoid arthritis (RA) who were treated with adalimumab therapy in clinical practice.
This post-marketing observational study was conducted in a multi-country, multi-center and single-arm format. Data were collected prospectively. Adult participants with diagnosis of RA who were assigned for treatment with adalimumab (Humira®) were eligible for participation. During this period four follow-up visits were planned for observation of the participant and documentation of data. Ideally, these visits should have been performed approximately 3 (V1), 6 (V2), 9 (V3) and 12 (V4) months after the baseline visit (V0).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Rheumatoid Arthritis | Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice. |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Total Physical Activity Short Questionnaire to Assess Health-enhancing Physical Activity (SQUASH) Score | The quantitative SQUASH score (scores range from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), scores range from 0 to 4082.400, leisure time activities (SQUASH-B), scores range from 0 to 6123.600, household activities (SQUASH-C), scores range from 0 to 3402.000, and activity at work and school (SQUASH-D), scores range from 0 to 3402.000. The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level. | Month 0 (baseline) and Month 12 (Last Observation Carried Forward (LOCF)) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Total Physical Activity SQUASH Score | The quantitative SQUASH score (scores range from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), scores range from 0 to 4082.400, leisure time activities (SQUASH-B), scores range from 0 to 6123.600, household activities (SQUASH-C), scores range from 0 to 3402.000, and activity at work and school (SQUASH-D), scores range from 0 to 3402.000. The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level. |
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Inclusion Criteria:
Exclusion Criteria:
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Study population consisted of participants with rheumatoid arthritis (RA) who were treated with adalimumab as per locally approved label and prescription guidelines. The decision to be treated with adalimumab had to be independent from study inclusion.
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| Name | Affiliation | Role |
|---|---|---|
| Elena Smirnova, MD | AbbVie | Study Director |
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 462 participants were enrolled: 460 were in the main analysis set (MAS) population; 2 were excluded from MAS, as adalimumab treatment was not documented within this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With Rheumatoid Arthritis | Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Baseline analyses accounts for main analysis set (MAS) population (all participants who received at least 1 dose of study drug).
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants With Rheumatoid Arthritis | Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice. |
| 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 | Mean Change From Baseline in Total Physical Activity Short Questionnaire to Assess Health-enhancing Physical Activity (SQUASH) Score | The quantitative SQUASH score (scores range from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), scores range from 0 to 4082.400, leisure time activities (SQUASH-B), scores range from 0 to 6123.600, household activities (SQUASH-C), scores range from 0 to 3402.000, and activity at work and school (SQUASH-D), scores range from 0 to 3402.000. The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level. | Analysis included all participants who received at least one dose of adalimumab with evaluable data. | Posted | Mean | Standard Deviation | units on a scale | Month 0 (baseline) and Month 12 (Last Observation Carried Forward (LOCF)) |
|
Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months.
Non serious adverse events were not collected for this study.
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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 | Participants With Rheumatoid Arthritis | Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Information | AbbVie | 800-633-9110 |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Month 3, Month 6 and Month 9 |
| Mean Change From Baseline in SQUASH-A Scores | SQUASH subscores capture physical activity. SQUASH-A subscore captures commuting activities, with scores ranging from 0 to 4082.400. The SQUASH subscores have non-negative values. Higher values indicate a higher individual activity level. | Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF |
| Mean Change From Baseline in SQUASH-B Scores | SQUASH subscores capture physical activity. SQUASH-B subscore captures leisure time activities, with scores ranging from 0 to 6123.600. The SQUASH subscores have non-negative values. Higher values indicate a higher individual activity level. | Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF |
| Mean Change From Baseline in SQUASH-C Scores | SQUASH subscores capture physical activity. SQUASH-C subscore captures house-hold activities, with scores ranging from 0 to 3402.000. The SQUASH subscores have non-negative values. Higher values indicate a higher individual activity level. | Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF |
| Mean Change From Baseline in SQUASH-D Scores | SQUASH subscores capture physical activity. SQUASH-D subscore captures activity at work and school, with scores ranging from 0 to 3402.000. The SQUASH subscores have non-negative values. Higher values indicate a higher individual activity level. | Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF |
| Mean Change From Baseline in Disease Activity Index - 28 Joints (DAS28) Score | The DAS28 is a validated index of rheumatoid arthritis disease activity. Tender joint counts and swollen joint counts across 28 joints, C-reactive protein, and general health assessed via the visual analog scale (VAS) 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. | Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF |
| Percentage of Participants in Clinical Disease Remission (DAS28<2.6) | Remission is defined as DAS28 of less than 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Tender joint counts and swollen joint counts across 28 joints, C-reactive protein (CRP), and general health assessed via the visual analog scale (VAS) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity. | Month 0, Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF |
| Percentage of Participants With Low Disease Activity State (LDAS, DAS28<3.2) | LDAS is defined as DAS28 of less than 3.2. The DAS28 is a validated index of rheumatoid arthritis disease activity. Tender joint counts and swollen joint counts across 28 joints, C-reactive protein (CRP), and general health assessed via the visual analog scale (VAS) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity. | Month 0, Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF |
| Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants in Remission or LDAS | This outcome analyses the quantitative SQUASH score and individual SQUASH scores by DAS28 categories. The quantitative SQUASH score (ranging from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), leisure time activities (SQUASH-B), household activities (SQUASH-C) and activity at work and school (SQUASH-D). The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level. DAS28 categories being assessed are remission (defined as DAS28 of less than 2.6) and LDAS (defined as DAS28 of less than 3.2).The DAS28 is a validated index of rheumatoid arthritis disease activity. Tender joint counts and swollen joint counts across 28 joints, C-reactive protein (CRP), and general health assessed via the visual analog scale (VAS) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity. | Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF |
| Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants Those Who Did Not Attain Remission or LDAS | This outcome analyses the quantitative SQUASH score and individual SQUASH scores by DAS28 categories. The quantitative SQUASH score (ranging from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), leisure time activities (SQUASH-B), household activities (SQUASH-C) and activity at work and school (SQUASH-D). The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level. DAS28 categories being assessed are remission (defined as DAS28 of less than 2.6) and LDAS (defined as DAS28 of less than 3.2).The DAS28 is a validated index of rheumatoid arthritis disease activity. Tender joint counts and swollen joint counts across 28 joints, C-reactive protein (CRP), and general health assessed via the visual analog scale (VAS) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity. | Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF |
| Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score | The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight 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 response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores range from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from baseline in the overall score indicates improvement. | Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF |
| Correlation Between Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) and DAS28 Scores | The SQUASH and its subscores are instruments to measure the physical activity level, whereas the DAS28 measures disease activity. In order to evaluate the relationship between physical function and disease activity (as measured by the two scales), Pearson correlation coefficients were calculated for the SQUASH scores and the DAS28. A decrease in physical functioning is likely to be connected to stronger disease activity. | Month 0 and Month 12 LOCF |
| Correlation Between Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) and HAQ-DI Scores | The SQUASH and its subscores are instruments to measure the physical activity level, whereas the HAQ-DI measures physical functioning. In order to evaluate the relationship between physical function and physical activity (as measured by the both scales), Pearson correlation coefficients were calculated for the SQUASH scores and the HAQ-DI. A decrease in physical functioning is likely to prohibit physical activity. | Month 0 and Month 12 LOCF |
| Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Age Categories | The quantitative SQUASH score (scores range from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), scores range from 0 to 4082.400, leisure time activities (SQUASH-B), scores range from 0 to 6123.600, household activities (SQUASH-C), scores range from 0 to 3402.000, and activity at work and school (SQUASH-D), scores range from 0 to 3402.000. The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level. | Month 0 and Month 12 LOCF |
| Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Gender | The quantitative SQUASH score (scores range from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), scores range from 0 to 4082.400, leisure time activities (SQUASH-B), scores range from 0 to 6123.600, household activities (SQUASH-C), scores range from 0 to 3402.000, and activity at work and school (SQUASH-D), scores range from 0 to 3402.000. The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level. | Month 0 and Month 12 LOCF |
| Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Education | The quantitative SQUASH score (scores range from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), scores range from 0 to 4082.400, leisure time activities (SQUASH-B), scores range from 0 to 6123.600, household activities (SQUASH-C), scores range from 0 to 3402.000, and activity at work and school (SQUASH-D), scores range from 0 to 3402.000. The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level. | Month 0 and Month 12 LOCF |
| Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Occupation | The quantitative SQUASH score (scores range from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), scores range from 0 to 4082.400, leisure time activities (SQUASH-B), scores range from 0 to 6123.600, household activities (SQUASH-C), scores range from 0 to 3402.000, and activity at work and school (SQUASH-D), scores range from 0 to 3402.000. The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level. | Month 0 and Month 12 LOCF |
| years |
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| Gender | Count of Participants | Participants |
|
Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice. |
|
|
| Secondary | Mean Change From Baseline in Total Physical Activity SQUASH Score | The quantitative SQUASH score (scores range from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), scores range from 0 to 4082.400, leisure time activities (SQUASH-B), scores range from 0 to 6123.600, household activities (SQUASH-C), scores range from 0 to 3402.000, and activity at work and school (SQUASH-D), scores range from 0 to 3402.000. The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level. | Analysis included all participants who received at least one dose of adalimumab with evaluable data. | Posted | Mean | Standard Deviation | units on a scale | Month 3, Month 6 and Month 9 |
|
|
|
| Secondary | Mean Change From Baseline in SQUASH-A Scores | SQUASH subscores capture physical activity. SQUASH-A subscore captures commuting activities, with scores ranging from 0 to 4082.400. The SQUASH subscores have non-negative values. Higher values indicate a higher individual activity level. | Analysis included all participants who received at least one dose of adalimumab with evaluable data. | Posted | Mean | Standard Deviation | units on a scale | Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF |
|
|
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| Secondary | Mean Change From Baseline in SQUASH-B Scores | SQUASH subscores capture physical activity. SQUASH-B subscore captures leisure time activities, with scores ranging from 0 to 6123.600. The SQUASH subscores have non-negative values. Higher values indicate a higher individual activity level. | Analysis included all participants who received at least one dose of adalimumab with evaluable data. | Posted | Mean | Standard Deviation | units on a scale | Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF |
|
|
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| Secondary | Mean Change From Baseline in SQUASH-C Scores | SQUASH subscores capture physical activity. SQUASH-C subscore captures house-hold activities, with scores ranging from 0 to 3402.000. The SQUASH subscores have non-negative values. Higher values indicate a higher individual activity level. | Analysis included all participants who received at least one dose of adalimumab with evaluable data. | Posted | Mean | Standard Deviation | units on a scale | Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF |
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| Secondary | Mean Change From Baseline in SQUASH-D Scores | SQUASH subscores capture physical activity. SQUASH-D subscore captures activity at work and school, with scores ranging from 0 to 3402.000. The SQUASH subscores have non-negative values. Higher values indicate a higher individual activity level. | Analysis included all participants who received at least one dose of adalimumab with evaluable data. | Posted | Mean | Standard Deviation | units on a scale | Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF |
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| Secondary | Mean Change From Baseline in Disease Activity Index - 28 Joints (DAS28) Score | The DAS28 is a validated index of rheumatoid arthritis disease activity. Tender joint counts and swollen joint counts across 28 joints, C-reactive protein, and general health assessed via the visual analog scale (VAS) 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. | Analysis included all participants who received at least one dose of adalimumab with evaluable data. | Posted | Mean | Standard Deviation | units on a scale | Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF |
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| Secondary | Percentage of Participants in Clinical Disease Remission (DAS28<2.6) | Remission is defined as DAS28 of less than 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Tender joint counts and swollen joint counts across 28 joints, C-reactive protein (CRP), and general health assessed via the visual analog scale (VAS) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity. | Analysis included all participants who received at least one dose of adalimumab with evaluable data. | Posted | Number | percentage of participants | Month 0, Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF |
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| Secondary | Percentage of Participants With Low Disease Activity State (LDAS, DAS28<3.2) | LDAS is defined as DAS28 of less than 3.2. The DAS28 is a validated index of rheumatoid arthritis disease activity. Tender joint counts and swollen joint counts across 28 joints, C-reactive protein (CRP), and general health assessed via the visual analog scale (VAS) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity. | Analysis included all participants who received at least one dose of adalimumab with evaluable data. | Posted | Number | percentage of participants | Month 0, Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF |
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| Secondary | Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants in Remission or LDAS | This outcome analyses the quantitative SQUASH score and individual SQUASH scores by DAS28 categories. The quantitative SQUASH score (ranging from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), leisure time activities (SQUASH-B), household activities (SQUASH-C) and activity at work and school (SQUASH-D). The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level. DAS28 categories being assessed are remission (defined as DAS28 of less than 2.6) and LDAS (defined as DAS28 of less than 3.2).The DAS28 is a validated index of rheumatoid arthritis disease activity. Tender joint counts and swollen joint counts across 28 joints, C-reactive protein (CRP), and general health assessed via the visual analog scale (VAS) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity. | Analysis included all participants who received at least one dose of adalimumab with evaluable data. | Posted | Mean | Standard Deviation | units on a scale | Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF |
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| Secondary | Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants Those Who Did Not Attain Remission or LDAS | This outcome analyses the quantitative SQUASH score and individual SQUASH scores by DAS28 categories. The quantitative SQUASH score (ranging from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), leisure time activities (SQUASH-B), household activities (SQUASH-C) and activity at work and school (SQUASH-D). The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level. DAS28 categories being assessed are remission (defined as DAS28 of less than 2.6) and LDAS (defined as DAS28 of less than 3.2).The DAS28 is a validated index of rheumatoid arthritis disease activity. Tender joint counts and swollen joint counts across 28 joints, C-reactive protein (CRP), and general health assessed via the visual analog scale (VAS) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity. | Analysis included all participants who received at least one dose of adalimumab with evaluable data. | Posted | Mean | Standard Deviation | units on a scale | Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF |
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| Secondary | Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score | The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight 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 response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores range from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from baseline in the overall score indicates improvement. | Analysis included all participants who received at least one dose of adalimumab with evaluable data. | Posted | Mean | Standard Deviation | units on a scale | Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF |
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| Secondary | Correlation Between Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) and DAS28 Scores | The SQUASH and its subscores are instruments to measure the physical activity level, whereas the DAS28 measures disease activity. In order to evaluate the relationship between physical function and disease activity (as measured by the two scales), Pearson correlation coefficients were calculated for the SQUASH scores and the DAS28. A decrease in physical functioning is likely to be connected to stronger disease activity. | Analysis included all participants who received at least one dose of adalimumab with evaluable data. | Posted | Number | Correlation coeficient | Month 0 and Month 12 LOCF |
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| Secondary | Correlation Between Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) and HAQ-DI Scores | The SQUASH and its subscores are instruments to measure the physical activity level, whereas the HAQ-DI measures physical functioning. In order to evaluate the relationship between physical function and physical activity (as measured by the both scales), Pearson correlation coefficients were calculated for the SQUASH scores and the HAQ-DI. A decrease in physical functioning is likely to prohibit physical activity. | Analysis included all participants who received at least one dose of adalimumab with evaluable data. | Posted | Number | Correlation coeficient | Month 0 and Month 12 LOCF |
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| Secondary | Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Age Categories | The quantitative SQUASH score (scores range from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), scores range from 0 to 4082.400, leisure time activities (SQUASH-B), scores range from 0 to 6123.600, household activities (SQUASH-C), scores range from 0 to 3402.000, and activity at work and school (SQUASH-D), scores range from 0 to 3402.000. The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level. | Analysis included all participants who received at least one dose of adalimumab with evaluable data. | Posted | Mean | Standard Deviation | units on a scale | Month 0 and Month 12 LOCF |
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| Secondary | Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Gender | The quantitative SQUASH score (scores range from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), scores range from 0 to 4082.400, leisure time activities (SQUASH-B), scores range from 0 to 6123.600, household activities (SQUASH-C), scores range from 0 to 3402.000, and activity at work and school (SQUASH-D), scores range from 0 to 3402.000. The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level. | Analysis included all participants who received at least one dose of adalimumab with evaluable data. | Posted | Mean | Standard Deviation | units on a scale | Month 0 and Month 12 LOCF |
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| Secondary | Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Education | The quantitative SQUASH score (scores range from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), scores range from 0 to 4082.400, leisure time activities (SQUASH-B), scores range from 0 to 6123.600, household activities (SQUASH-C), scores range from 0 to 3402.000, and activity at work and school (SQUASH-D), scores range from 0 to 3402.000. The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level. | Analysis included all participants who received at least one dose of adalimumab with evaluable data. | Posted | Mean | Standard Deviation | units on a scale | Month 0 and Month 12 LOCF |
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| Secondary | Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Occupation | The quantitative SQUASH score (scores range from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), scores range from 0 to 4082.400, leisure time activities (SQUASH-B), scores range from 0 to 6123.600, household activities (SQUASH-C), scores range from 0 to 3402.000, and activity at work and school (SQUASH-D), scores range from 0 to 3402.000. The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level. | Analysis included all participants who received at least one dose of adalimumab with evaluable data. | Posted | Mean | Standard Deviation | units on a scale | Month 0 and Month 12 LOCF |
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|
| 32 |
| 460 |
| 0 |
| 0 |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| CARDIAC FAILURE | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
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| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
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| CHEST PAIN | General disorders | MedDRA 18.1 | Non-systematic Assessment |
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| NO THERAPEUTIC RESPONSE | General disorders | MedDRA 18.1 | Non-systematic Assessment |
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| OEDEMA PERIPHERAL | General disorders | MedDRA 18.1 | Non-systematic Assessment |
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| CHOLECYSTITIS ACUTE | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
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| DRUG HYPERSENSITIVITY | Immune system disorders | MedDRA 18.1 | Non-systematic Assessment |
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| HYPERSENSITIVITY | Immune system disorders | MedDRA 18.1 | Non-systematic Assessment |
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| BRONCHITIS | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
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| CYTOMEGALOVIRUS HEPATITIS | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| HERPES OPHTHALMIC | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| LOCALISED INFECTION | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| PULMONARY TUBERCULOSIS | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| TONSILLITIS | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| VAGINAL INFECTION | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 18.1 | Non-systematic Assessment |
|
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 18.1 | Non-systematic Assessment |
|
| LUPUS-LIKE SYNDROME | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| LUNG ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| PANCREATIC CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| INTERCOSTAL NEURALGIA | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| ISCHAEMIC STROKE | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| LOSS OF CONSCIOUSNESS | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| RENAL FAILURE | Renal and urinary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| PLEURISY | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| ECZEMA | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| PHOTODERMATOSIS | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| SKIN DISORDER | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
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.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001519 | Behavior |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Month 12 (N=265) |
|
| Month 12 LOCF (N=382) |
|
| Title | Measurements |
|---|---|
|
| Month 12 (N=257) |
|
| Month 12 LOCF (N=375) |
|
| Title | Measurements |
|---|---|
|
| Month 12 (N=261) |
|
| Month 12 LOCF (N=379) |
|
| Title | Measurements |
|---|---|
|
| Month 12 (N=266) |
|
| Month 12 LOCF (N=382) |
|
| Title | Measurements |
|---|---|
|
| Month 12 (N=334) |
|
| Month 12 LOCF (N=433) |
|
| Title | Measurements |
|---|---|
|
| Month 9 (N=362) |
|
| Month 12 (N=334) |
|
| Month 12 LOCF (N=434) |
|
| Title | Measurements |
|---|---|
|
| Month 9 (N=362) |
|
| Month 12 (N=334) |
|
| Month 12 LOCF (N=434) |
|
| Title | Measurements |
|---|---|
|
| SQUASH-C (Month 3, N=200) |
|
| SQUASH-D (Month 3, N=205) |
|
| SQUASH (Month 6, N=181) |
|
| SQUASH-A (Month 6, N=187) |
|
| SQUASH-B (Month 6, N=183) |
|
| SQUASH-C (Month 6, N=186) |
|
| SQUASH-D (Month 6, N=189) |
|
| SQUASH (Month 9, N=162) |
|
| SQUASH-A (Month 9, N=165) |
|
| SQUASH-B (Month 9, N=164) |
|
| SQUASH-C (Month 9, N=165) |
|
| SQUASH-D (Month 9, N=167) |
|
| SQUASH (Month 12, N=167) |
|
| SQUASH-A (Month 12, N=171) |
|
| SQUASH-B (Month 12, N=167) |
|
| SQUASH-C (Month 12, N=169) |
|
| SQUASH-D (Month 12, N=171) |
|
| SQUASH (Month 12 LOCF, N=211) |
|
| SQUASH-A (Month 12 LOCF, N=214) |
|
| SQUASH-B (Month 12 LOCF, N=211) |
|
| SQUASH-C (Month 12 LOCF, N=212) |
|
| SQUASH-D (Month 12 LOCF, N=214) |
|
| Title | Measurements |
|---|---|
|
| SQUASH-C (Month 3, N=163) |
|
| SQUASH-D (Month 3, N=164) |
|
| SQUASH (Month 6, N=135) |
|
| SQUASH-A (Month 6, N=140) |
|
| SQUASH-B (Month 6, N=136) |
|
| SQUASH-C (Month 6, N=139) |
|
| SQUASH-D (Month 6, N=141) |
|
| SQUASH (Month 9, N=111) |
|
| SQUASH-A (Month 9, N=116) |
|
| SQUASH-B (Month 9, N=113) |
|
| SQUASH-C (Month 9, N=116) |
|
| SQUASH-D (Month 9, N=117) |
|
| SQUASH (Month 12, N=88) |
|
| SQUASH-A (Month 12, N=94) |
|
| SQUASH-B (Month 12, N=90) |
|
| SQUASH-C (Month 12, N=92) |
|
| SQUASH-D (Month 12, N=95) |
|
| SQUASH (Month 12 LOCF, N=162) |
|
| SQUASH-A (Month 12 LOCF, N=167) |
|
| SQUASH-B (Month 12 LOCF, N=163) |
|
| SQUASH-C (Month 12 LOCF, N=166) |
|
| SQUASH-D (Month 12 LOCF, N=167) |
|
| Title | Measurements |
|---|---|
|
| Month 12 (N=284) |
|
| Month 12 LOCF (N=396) |
|
| Title | Measurements |
|---|---|
|
| SQUASH-A and DAS28 (Month 12 LOCF, N=386) |
|
| SQUASH-B and DAS28 (Month 0, N=424) |
|
| SQUASH-B and DAS28 (Month 12 LOCF, N=386) |
|
| SQUASH-C and DAS28 (Month 0, N=429) |
|
| SQUASH-C and DAS28 (Month 12 LOCF, N=386) |
|
| SQUASH-D and DAS28 (Month 0, N=432) |
|
| SQUASH-D and DAS28 (Month 12 LOCF, N=386) |
|
| Title | Measurements |
|---|---|
|
| SQUASH-A (Month 12 LOCF, N=385) |
|
| SQUASH-B (Month 0, N=422) |
|
| SQUASH-B (Month 12 LOCF, N=385) |
|
| SQUASH-C (Month 0, N=427) |
|
| SQUASH-C (Month 12 LOCF, N=385) |
|
| SQUASH-D (Month 0, N=430) |
|
| SQUASH-D (Month 12 LOCF, N=385) |
|
| Title | Measurements |
|---|---|
|
| SQUASH A (>=65 years, N=80) |
|
| SQUASH B (<65 years, N=298) |
|
| SQUASH B (>=65 years, N=77) |
|
| SQUASH C (<65 years, N=300) |
|
| SQUASH C (>=65 years, N=79) |
|
| SQUASH D (<65 years, N=302) |
|
| SQUASH D (>=65 years, N=80) |
|
| Title | Measurements |
|---|---|
|
| SQUASH-A (Female, N=312) |
|
| SQUASH-B (Male, N=70) |
|
| SQUASH-B (Female, N=305) |
|
| SQUASH-C (Male, N=70) |
|
| SQUASH-C (Female, N=309) |
|
| SQUASH-D (Male, N=70) |
|
| SQUASH-D (Female, N=312) |
|
|
| SQUASH-A (Lower than High School, N=184) |
|
| SQUASH-B (High School, N=195) |
|
| SQUASH-B (Lower than High School, N=180) |
|
| SQUASH-C (High School, N=198) |
|
| SQUASH-C (Lower than High School, N=181) |
|
| SQUASH-D (High School, N=198) |
|
| SQUASH-D (Lower than High School, N=184) |
|
|
| SQUASH-A (Non-manual job, N=193) |
|
| SQUASH-B (Manual job, N=185) |
|
| SQUASH-B (Non-manual job, N=189) |
|
| SQUASH-C (Manual job, N=186) |
|
| SQUASH-C (Non-manual job, N=192) |
|
| SQUASH-D (Manual job, N=188) |
|
| SQUASH-D (Non-manual job, N=193) |
|